Payment of benefits
Amounts
Except as provided in section 1395mm of this title, and subject to the succeeding provisions of this section, there shall be paid from the Federal Supplementary Medical Insurance Trust Fund, in the case of each individual who is covered under the insurance program established by this part and incurs expenses for services with respect to which benefits are payable under this part, amounts equal to—
in the case of services described in section 1395k(a)(1) of this title—80 percent of the reasonable charges for the services; except that (A) an organization which provides medical and other health services (or arranges for their availability) on a prepayment basis (and either is sponsored by a union or employer, or does not provide, or arrange for the provision of, any inpatient hospital services) may elect to be paid 80 percent of the reasonable cost of services for which payment may be made under this part on behalf of individuals enrolled in such organization in lieu of 80 percent of the reasonable charges for such services if the organization undertakes to charge such individuals no more than 20 percent of such reasonable cost plus any amounts payable by them as a result of subsection (b), (B) with respect to items and services described in section 1395x(s)(10)(A) of this title, the amounts paid shall be 100 percent of the reasonable charges for such items and services, (C) with respect to expenses incurred for those physicians’ services for which payment may be made under this part that are described in section 1395y(a)(4) of this title, the amounts paid shall be subject to such limitations as may be prescribed by regulations, (D) with respect to clinical diagnostic laboratory tests for which payment is made under this part (i)(I) on the basis of a fee schedule under subsection (h)(1) (for tests furnished before
in the case of services described in section 1395k(a)(2) of this title (except those services described in subparagraphs (C), (D), (E), (F), (G), (H), and (I) of such section and unless otherwise specified in section 1395rr of this title)—
with respect to home health services (other than a covered osteoporosis drug) (as defined in section 1395x(kk) of this title), the amount determined under the prospective payment system under section 1395fff of this title;
with respect to other items and services (except those described in subparagraph (C), (D), or (E) of this paragraph and except as may be provided in section 1395ww of this title or section 1395yy(e)(9) of this title)—
furnished before
the reasonable cost of such services, as determined under section 1395x(v) of this title, or
the customary charges with respect to such services,
less the amount a provider may charge as described in clause (ii) of section 1395cc(a)(2)(A) of this title, but in no case may the payment for such other services exceed 80 percent of such reasonable cost, or
if such services are furnished before
if such services are furnished on or after
if (and for so long as) the conditions described in section 1395f(b)(3) of this title are met, the amounts determined under the reimbursement system described in such section;
with respect to services described in the second sentence of section 1395x(p) of this title, 80 percent of the reasonable charges for such services;
with respect to clinical diagnostic laboratory tests for which payment is made under this part (i)(I) on the basis of a fee schedule determined under subsection (h)(1) (for tests furnished before
with respect to—
outpatient hospital radiology services (including diagnostic and therapeutic radiology, nuclear medicine and CAT scan procedures, magnetic resonance imaging, and ultrasound and other imaging services, but excluding screening mammography and, for services furnished on or after
effective for procedures performed on or after
the amount determined under subsection (n) or, for services or procedures performed on or after
with respect to a covered osteoporosis drug (as defined in section 1395x(kk) of this title) furnished by a home health agency, 80 percent of the reasonable cost of such service, as determined under section 1395x(v) of this title;
with respect to items and services described in section 1395x(s)(10)(A) of this title, the lesser of—
the reasonable cost of such services, as determined under section 1395x(v) of this title, or
the customary charges with respect to such services; and
with respect to personalized prevention plan services (as defined in section 1395x(hhh)(1) of this title) furnished by an outpatient department of a hospital, the amount determined under paragraph (1)(X),
in the case of services described in section 1395k(a)(2)(D) of this title—
except as provided in subparagraph (B), the costs which are reasonable and related to the cost of furnishing such services or which are based on such other tests of reasonableness as the Secretary may prescribe in regulations, including those authorized under section 1395x(v)(1)(A) of this title, less the amount a provider may charge as described in clause (ii) of section 1395cc(a)(2)(A) of this title, but in no case may the payment for such services (other than for items and services described in section 1395x(s)(10)(A) of this title) exceed 80 percent of such costs; or
with respect to the services described in clause (ii) of section 1395k(a)(2)(D) of this title that are furnished to an individual enrolled with a MA plan under part C pursuant to a written agreement described in section 1395w–23(a)(4) of this title, the amount (if any) by which—
the amount of payment that would have otherwise been provided (I) under subparagraph (A) (calculated as if “100 percent” were substituted for “80 percent” in such subparagraph) for such services if the individual had not been so enrolled, or (II) in the case of such services furnished on or after the implementation date of the prospective payment system under section 1395m(o) of this title, under such section (calculated as if “100 percent” were substituted for “80 percent” in such section) for such services if the individual had not been so enrolled; exceeds
the amount of the payments received under such written agreement for such services (not including any financial incentives provided for in such agreement such as risk pool payments, bonuses, or withholds),
less the amount the federally qualified health center may charge as described in section 1395w–27(e)(3)(B) of this title;
in the case of facility services described in section 1395k(a)(2)(F) of this title, and outpatient hospital facility services furnished in connection with surgical procedures specified by the Secretary pursuant to subsection (i)(1)(A), the applicable amount as determined under paragraph (2) or (3) of subsection (i) or subsection (t);
in the case of covered items (described in section 1395m(a)(13) of this title) the amounts described in section 1395m(a)(1) of this title;
in the case of outpatient critical access hospital services, the amounts described in section 1395m(g) of this title;
in the case of prosthetic devices and orthotics and prosthetics (as described in section 1395m(h)(4) of this title), the amounts described in section 1395m(h) of this title;
in the case of—
outpatient physical therapy services, outpatient speech-language pathology services, and outpatient occupational therapy services furnished—
by a rehabilitation agency, public health agency, clinic, comprehensive outpatient rehabilitation facility, or skilled nursing facility,
by a home health agency to an individual who is not homebound, or
by another entity under an arrangement with an entity described in clause (i) or (ii); and
outpatient physical therapy services, outpatient speech-language pathology services, and outpatient occupational therapy services furnished—
by a hospital to an outpatient or to a hospital inpatient who is entitled to benefits under part A but has exhausted benefits for inpatient hospital services during a spell of illness or is not so entitled to benefits under part A, or
by another entity under an arrangement with a hospital described in clause (i),
the amounts described in section 1395m(k) of this title;
in the case of services described in section 1395k(a)(2)(E) of this title that are not described in paragraph (8), the amounts described in section 1395m(k) of this title; and
with respect to rural emergency hospital services furnished on or after
Paragraph (3)(A) shall not apply to Federally qualified health center services furnished on or after the implementation date of the prospective payment system under section 1395m(o) of this title. For services furnished on or after
Deductible provision
Mental disorders
Notwithstanding any other provision of this part, with respect to expenses incurred in a calendar year in connection with the treatment of mental, psychoneurotic, and personality disorders of an individual who is not an inpatient of a hospital at the time such expenses are incurred, there shall be considered as incurred expenses for purposes of subsections (a) and (b)—
for expenses incurred in years prior to 2010, only 62½ percent of such expenses;
for expenses incurred in 2010 or 2011, only 68¾ percent of such expenses;
for expenses incurred in 2012, only 75 percent of such expenses;
for expenses incurred in 2013, only 81¼ percent of such expenses; and
for expenses incurred in 2014 or any subsequent calendar year, 100 percent of such expenses.
For purposes of subparagraphs (A) through (D) of paragraph (1), the term “treatment” does not include brief office visits (as defined by the Secretary) for the sole purpose of monitoring or changing drug prescriptions used in the treatment of such disorders or partial hospitalization services or intensive outpatient services that are not directly provided by a physician.
Nonduplication of payments
Information for determination of amounts due
Maximum rate of payment per visit for independent rural health clinics
In establishing limits under subsection (a) on payment for rural health clinic services provided by rural health clinics (other than such clinics in hospitals with less than 50 beds), the Secretary shall establish such limit, for services provided prior to
in 1988, after March 31, at $46 per visit, and
in a subsequent year (before
In establishing limits under subsection (a) on payment for rural health clinic services furnished on or after
in 2021, after March 31, at $100 per visit;
in 2022, at $113 per visit;
in 2023, at $126 per visit;
in 2024, at $139 per visit;
in 2025, at $152 per visit;
in 2026, at $165 per visit;
in 2027, at $178 per visit;
in 2028, at $190 per visit; and
in a subsequent year, at the limit established under this paragraph for the previous year increased by the percentage increase in the MEI applicable to primary care services furnished as of the first day of such subsequent year.
In establishing limits under subsection (a) on payment for rural health clinic services furnished on or after
in 2021, after March 31, at an amount equal to the greater of—
with respect to a rural health clinic that had a per visit payment amount established for services furnished in 2020—
the per visit payment amount applicable to such rural health clinic for rural health clinic services furnished in 2020, increased by the percentage increase in the MEI applicable to primary care services furnished as of the first day of 2021; or
the limit described in paragraph (2)(A); and
with respect to a rural health clinic that did not have a per visit payment amount established for services furnished in 2020—
the per visit payment amount applicable to such rural health clinic for rural health clinic services furnished in 2021; or
the limit described in paragraph (2)(A); and
in a subsequent year, at an amount equal to the greater of—
the amount established under subclause (I) or (II) of clause (i), as applicable, or this subclause for the previous year with respect to such rural health clinic, increased by the percentage increase in the MEI applicable to primary care services furnished as of the first day of such subsequent year; or
the limit established under paragraph (2) for such subsequent year.
A rural health clinic described in this subparagraph is a rural health clinic that—
as of
as of
submitted an application for enrollment under section 1395cc(j) of this title (or a request for such a temporary enrollment for such emergency period) that was received not later than
Physical therapy services
Subject to paragraphs (4) and (5), in the case of physical therapy services of the type described in section 1395x(p) of this title and speech-language pathology services of the type described in such section through the application of section 1395x(ll)(2) of this title, but (except as provided in paragraph (6)) not described in subsection (a)(8)(B), and physical therapy services and speech-language pathology services of such type which are furnished by a physician or as incident to physicians’ services, with respect to expenses incurred in any calendar year, no more than the amount specified in paragraph (2) for the year shall be considered as incurred expenses for purposes of subsections (a) and (b). The preceding sentence shall not apply to expenses incurred with respect to services furnished after
With respect to services furnished during 2018 or a subsequent year, in the case of physical therapy services of the type described in section 1395x(p) of this title, speech-language pathology services of the type described in such section through the application of section 1395x(ll)(2) of this title, and physical therapy services and speech-language pathology services of such type which are furnished by a physician or as incident to physicians’ services, with respect to expenses incurred in any calendar year, any amount that is more than the amount specified in paragraph (2) for the year shall not be considered as incurred expenses for purposes of subsections (a) and (b) unless the applicable requirements of paragraph (7) are met.
The amount specified in this paragraph—
for 1999, 2000, and 2001, is $1,500, and
for a subsequent year is the amount specified in this paragraph for the preceding year increased by the percentage increase in the MEI (as defined in section 1395u(i)(3) of this title) for such subsequent year;
except that if an increase under subparagraph (B) for a year is not a multiple of $10, it shall be rounded to the nearest multiple of $10.
Subject to paragraphs (4) and (5), in the case of occupational therapy services (of the type that are described in section 1395x(p) of this title (but (except as provided in paragraph (6)) not described in subsection (a)(8)(B)) through the operation of section 1395x(g) of this title and of such type which are furnished by a physician or as incident to physicians’ services), with respect to expenses incurred in any calendar year, no more than the amount specified in paragraph (2) for the year shall be considered as incurred expenses for purposes of subsections (a) and (b). The preceding sentence shall not apply to expenses incurred with respect to services furnished after
With respect to services furnished during 2018 or a subsequent year, in the case of occupational therapy services (of the type that are described in section 1395x(p) of this title through the operation of section 1395x(g) of this title and of such type which are furnished by a physician or as incident to physicians’ services), with respect to expenses incurred in any calendar year, any amount that is more than the amount specified in paragraph (2) for the year shall not be considered as incurred expenses for purposes of subsections (a) and (b) unless the applicable requirements of paragraph (7) are met.
This subsection shall not apply to expenses incurred with respect to services furnished during 2000, 2001, 2002, 2004, and 2005.
With respect to expenses incurred during the period beginning on
In the case of outpatient therapy services for which an exception is requested under the first sentence of subparagraph (A), the claim for such services shall contain an appropriate modifier (such as the KX modifier used as of
In applying this paragraph with respect to a request for an exception with respect to expenses that would be incurred for outpatient therapy services (including services described in subsection (a)(8)(B)) that would exceed the threshold described in clause (ii) for a year, the request for such an exception, for services furnished on or after
The threshold under this clause for a year is $3,700. Such threshold shall be applied separately—
for physical therapy services and speech-language pathology services; and
for occupational therapy services.
6
Such factors may include the following:
The therapy provider has had a high claims denial percentage for therapy services under this part or is less compliant with applicable requirements under this subchapter.
The therapy provider has a pattern of billing for therapy services under this part that is aberrant compared to peers or otherwise has questionable billing practices for such services, such as billing medically unlikely units of services in a day.
The therapy provider is newly enrolled under this subchapter or has not previously furnished therapy services under this part.
The services are furnished to treat a type of medical condition.
The therapy provider is part of group 7
For purposes of carrying out this subparagraph, the Secretary shall provide for the transfer, from the Federal Supplementary Medical Insurance Trust Fund under section 1395t of this title, of $5,000,000 to the Centers for Medicare & Medicaid Services Program Management Account for fiscal years 2015 and 2016, to remain available until expended. Such funds may not be used by a contractor under section 1395ddd(h) of this title for medical reviews under this subparagraph.
The targeted review process under this subparagraph shall not apply to services for which expenses are incurred beyond the period for which the exceptions process under subparagraph (A) is implemented, except as such process is applied under paragraph (7)(B).
In applying paragraphs (1) and (3) to services furnished during the period beginning not later than
With respect to outpatient therapy services furnished beginning on or after
Nothing in clause (i) shall be construed as changing the method of payment for outpatient therapy services under section 1395m(g) of this title.
For purposes of paragraphs (1)(B) and (3)(B), with respect to services described in such paragraphs, the requirements described in this paragraph are as follows:
Inclusion of appropriate modifier
Targeted medical review for certain services above threshold
In general
Threshold
The threshold under this clause for—
a year before 2028, is $3,000;
2028, is the amount specified in subclause (I) increased by the percentage increase in the MEI (as defined in section 1395u(i)(3) of this title) for 2028; and
a subsequent year, is the amount specified in this clause for the preceding year increased by the percentage increase in the MEI (as defined in section 1395u(i)(3) of this title) for such subsequent year;
except that if an increase under subclause (II) or (III) for a year is not a multiple of $10, it shall be rounded to the nearest multiple of $10.
Application
The threshold under clause (ii) shall be applied separately—
for physical therapy services and speech-language pathology services; and
for occupational therapy services.
Funding
With respect to services furnished on or after
Fee schedules for clinical diagnostic laboratory tests; percentage of prevailing charge level; nominal fee for samples; adjustments; recipients of payments; negotiated payment rate
Subject to subsections (d)(1) and (aa) of section 1395m of this title, the Secretary shall establish fee schedules for clinical diagnostic laboratory tests (including prostate cancer screening tests under section 1395x(oo) of this title consisting of prostate-specific antigen blood tests) for which payment is made under this part, other than such tests performed by a provider of services for an inpatient of such provider.
In the case of clinical diagnostic laboratory tests performed by a physician or by a laboratory (other than tests performed by a qualified hospital laboratory (as defined in subparagraph (D)) for outpatients of such hospital), the fee schedules established under subparagraph (A) shall be established on a regional, statewide, or carrier service area basis (as the Secretary may determine to be appropriate) for tests furnished on or after
In the case of clinical diagnostic laboratory tests performed by a qualified hospital laboratory (as defined in subparagraph (D)) for outpatients of such hospital, the fee schedules established under subparagraph (A) shall be established on a regional, statewide, or carrier service area basis (as the Secretary may determine to be appropriate) for tests furnished on or after
In this subsection, the term “qualified hospital laboratory” means a hospital laboratory, in a sole community hospital (as defined in section 1395ww(d)(5)(D)(iii) of this title), which provides some clinical diagnostic laboratory tests 24 hours a day in order to serve a hospital emergency room which is available to provide services 24 hours a day and 7 days a week.
Except as provided in clause (v), subparagraph (B), and paragraph (4), the Secretary shall set the fee schedules at 60 percent (or, in the case of a test performed by a qualified hospital laboratory (as defined in paragraph (1)(D)) for outpatients of such hospital, 62 percent) of the prevailing charge level determined pursuant to the third and fourth sentences of section 1395u(b)(3) of this title for similar clinical diagnostic laboratory tests for the applicable region, State, or area for the 12-month period beginning
Notwithstanding clause (i)—
any change in the fee schedules which would have become effective under this subsection for tests furnished on or after
the Secretary shall not adjust the fee schedules under clause (i) to take into account any increase in the consumer price index for 1988,
the annual adjustment in the fee schedules determined under clause (i) for each of the years 1991, 1992, and 1993 shall be 2 percent, and
the annual adjustment in the fee schedules determined under clause (i) for each of the years 1994 and 1995, 1998 through 2002, and 2004 through 2008 shall be 0 percent.
In establishing fee schedules under clause (i) with respect to automated tests and tests (other than cytopathology tests) which before
After determining the adjustment to the fee schedules under clause (i), the Secretary shall reduce such adjustment—
for 2011 and each subsequent year, by the productivity adjustment described in section 1395ww(b)(3)(B)(xi)(II) of this title; and
for each of 2011 through 2015, by 1.75 percentage points.
Subclause (I) shall not apply in a year where the adjustment to the fee schedules determined under clause (i) is 0.0 or a percentage decrease for a year. The application of the productivity adjustment under subclause (I) shall not result in an adjustment to the fee schedules under clause (i) being less than 0.0 for a year. The application of subclause (II) may result in an adjustment to the fee schedules under clause (i) being less than 0.0 for a year, and may result in payment rates for a year being less than such payment rates for the preceding year.
The Secretary shall reduce by 2 percent the fee schedules otherwise determined under clause (i) for 2013, and such reduced fee schedules shall serve as the base for 2014 and subsequent years.
The Secretary may make further adjustments or exceptions to the fee schedules to assure adequate reimbursement of (i) emergency laboratory tests needed for the provision of bona fide emergency services, and (ii) certain low volume high-cost tests where highly sophisticated equipment or extremely skilled personnel are necessary to assure quality.
In addition to the amounts provided under the fee schedules (for tests furnished before
In establishing any fee schedule under this subsection, the Secretary may provide for an adjustment to take into account, with respect to the portion of the expenses of clinical diagnostic laboratory tests attributable to wages, the relative difference between a region’s or local area’s wage rates and the wage rate presumed in the data on which the schedule is based.
For purposes of subsections (a)(1)(D)(i) and (a)(2)(D)(i), the limitation amount for a clinical diagnostic laboratory test performed—
on or after
after
after
after
after
after
after
after
In the case of a bill or request for payment for a clinical diagnostic laboratory test for which payment may otherwise be made under this part on an assignment-related basis or under a provider agreement under section 1395cc of this title, payment may be made only to the person or entity which performed or supervised the performance of such test; except that—
if a physician performed or supervised the performance of such test, payment may be made to another physician with whom he shares his practice,
in the case of a test performed at the request of a laboratory by another laboratory, payment may be made to the referring laboratory but only if—
the referring laboratory is located in, or is part of, a rural hospital,
the referring laboratory is wholly owned by the entity performing such test, the referring laboratory wholly owns the entity performing such test, or both the referring laboratory and the entity performing such test are wholly-owned by a third entity, or
not more than 30 percent of the clinical diagnostic laboratory tests for which such referring laboratory (but not including a laboratory described in subclause (II)),8
in the case of a clinical diagnostic laboratory test provided under an arrangement (as defined in section 1395x(w)(1) of this title) made by a hospital, critical access hospital, or skilled nursing facility, payment shall be made to the hospital or skilled nursing facility.
In the case of such a bill or request for payment for a clinical diagnostic laboratory test for which payment may otherwise be made under this part, and which is not described in subparagraph (A), payment may be made to the beneficiary only on the basis of the itemized bill of the person or entity which performed or supervised the performance of the test.
Payment for a clinical diagnostic laboratory test, including a test performed in a physician’s office but excluding a test performed by a rural health clinic may only be made on an assignment-related basis or to a provider of services with an agreement in effect under section 1395cc of this title.
A person may not bill for a clinical diagnostic laboratory test, including a test performed in a physician’s office but excluding a test performed by a rural health clinic, other than on an assignment-related basis. If a person knowingly and willfully and on a repeated basis bills for a clinical diagnostic laboratory test in violation of the previous sentence, the Secretary may apply sanctions against the person in the same manner as the Secretary may apply sanctions against a physician in accordance with paragraph (2) of section 1395u(j) of this title in the same manner such paragraphs apply 9
For tests furnished before
Notwithstanding paragraphs (1) and (4) and section 1395m–1 of this title, the Secretary shall establish a national minimum payment amount under this part for a diagnostic or screening pap smear laboratory test (including all cervical cancer screening technologies that have been approved by the Food and Drug Administration as a primary screening method for detection of cervical cancer) equal to $14.60 for tests furnished in 2000. For such tests furnished in subsequent years, such national minimum payment amount shall be adjusted annually as provided in paragraph (2).
The Secretary shall establish by regulation procedures for determining the basis for, and amount of, payment under this subsection for any clinical diagnostic laboratory test with respect to which a new or substantially revised HCPCS code is assigned on or after
Determinations under subparagraph (A) shall be made only after the Secretary—
makes available to the public (through an Internet website and other appropriate mechanisms) a list that includes any such test for which establishment of a payment amount under this subsection is being considered for a year;
on the same day such list is made available, causes to have published in the Federal Register notice of a meeting to receive comments and recommendations (and data on which recommendations are based) from the public on the appropriate basis under this subsection for establishing payment amounts for the tests on such list;
not less than 30 days after publication of such notice convenes a meeting, that includes representatives of officials of the Centers for Medicare & Medicaid Services involved in determining payment amounts, to receive such comments and recommendations (and data on which the recommendations are based);
taking into account the comments and recommendations (and accompanying data) received at such meeting, develops and makes available to the public (through an Internet website and other appropriate mechanisms) a list of proposed determinations with respect to the appropriate basis for establishing a payment amount under this subsection for each such code, together with an explanation of the reasons for each such determination, the data on which the determinations are based, and a request for public written comments on the proposed determination; and
taking into account the comments received during the public comment period, develops and makes available to the public (through an Internet website and other appropriate mechanisms) a list of final determinations of the payment amounts for such tests under this subsection, together with the rationale for each such determination, the data on which the determinations are based, and responses to comments and suggestions received from the public.
Under the procedures established pursuant to subparagraph (A), the Secretary shall—
set forth the criteria for making determinations under subparagraph (A); and
make available to the public the data (other than proprietary data) considered in making such determinations.
The Secretary may convene such further public meetings to receive public comments on payment amounts for new tests under this subsection as the Secretary deems appropriate.
For purposes of this paragraph:
The term “HCPCS” refers to the Health Care Procedure Coding System.
A code shall be considered to be “substantially revised” if there is a substantive change to the definition of the test or procedure to which the code applies (such as a new analyte or a new methodology for measuring an existing analyte-specific test).
Notwithstanding any other provision in this part, in the case of any diagnostic laboratory test for HbA1c that is labeled by the Food and Drug Administration for home use and is furnished on or after
Outpatient surgery
The Secretary shall, in consultation with appropriate medical organizations—
specify those surgical procedures which are appropriately (when considered in terms of the proper utilization of hospital inpatient facilities) performed on an inpatient basis in a hospital but which also can be performed safely on an ambulatory basis in an ambulatory surgical center (meeting the standards specified under section 1395k(a)(2)(F)(i) of this title), critical access hospital, or hospital outpatient department, and
specify those surgical procedures which are appropriately (when considered in terms of the proper utilization of hospital inpatient facilities) performed on an inpatient basis in a hospital but which also can be performed safely on an ambulatory basis in a physician’s office.
The lists of procedures established under subparagraphs (A) and (B) shall be reviewed and updated not less often than every 2 years, in consultation with appropriate trade and professional organizations.
For services furnished prior to the implementation of the system described in subparagraph (D), subject to subparagraph (E), the amount of payment to be made for facility services furnished in connection with a surgical procedure specified pursuant to paragraph (1)(A) and furnished to an individual in an ambulatory surgical center described in such paragraph shall be equal to 80 percent of a standard overhead amount established by the Secretary (with respect to each such procedure) on the basis of the Secretary’s estimate of a fair fee which—
takes into account the costs incurred by such centers, or classes of centers, generally in providing services furnished in connection with the performance of such procedure, as determined in accordance with a survey (based upon a representative sample of procedures and facilities) of the actual audited costs incurred by such centers in providing such services,
takes such costs into account in such a manner as will assure that the performance of the procedure in such a center will result in substantially less amounts paid under this subchapter than would have been paid if the procedure had been performed on an inpatient basis in a hospital, and
in the case of insertion of an intraocular lens during or subsequent to cataract surgery includes payment which is reasonable and related to the cost of acquiring the class of lens involved.
Each amount so established shall be reviewed and updated not later than
The amount of payment to be made under this part for facility services furnished, in connection with a surgical procedure specified pursuant to paragraph (1)(B), in a physician’s office shall be equal to 80 percent of a standard overhead amount established by the Secretary (with respect to each such procedure) on the basis of the Secretary’s estimate of a fair fee which—
takes into account additional costs, not usually included in the professional fee, incurred by physicians in securing, maintaining, and staffing the facilities and ancillary services appropriate for the performance of such procedure in the physician’s office, and
takes such items into account in such a manner which will assure that the performance of such procedure in the physician’s office will result in substantially less amounts paid under this subchapter than would have been paid if the services had been furnished on an inpatient basis in a hospital.
Each amount so established shall be reviewed and updated not later than
Notwithstanding the second sentence of each of subparagraphs (A) and (B), except as otherwise specified in clauses (ii), (iii), and (iv), if the Secretary has not updated amounts established under such subparagraphs or under subparagraph (D), with respect to facility services furnished during a fiscal year (beginning with fiscal year 1986 or a calendar year (beginning with 2006)), such amounts shall be increased by the percentage increase in the Consumer Price Index for all urban consumers (U.S. city average) as estimated by the Secretary for the 12-month period ending with the midpoint of the year involved.
In each of the fiscal years 1998 through 2002, the increase under this subparagraph shall be reduced (but not below zero) by 2.0 percentage points.
In fiscal year 2004, beginning with
In fiscal year 2005, the last quarter of calendar year 2005, and each of calendar years 2006 through 2009, the increase under this subparagraph shall be 0 percent.
Taking into account the recommendations in the report under section 626(d) of Medicare Prescription Drug, Improvement, and Modernization Act of 2003, the Secretary shall implement a revised payment system for payment of surgical services furnished in ambulatory surgical centers.
In the year the system described in clause (i) is implemented, such system shall be designed to result in the same aggregate amount of expenditures for such services as would be made if this subparagraph did not apply, as estimated by the Secretary and taking into account reduced expenditures that would apply if subparagraph (E) were to continue to apply, as estimated by the Secretary.
The Secretary shall implement the system described in clause (i) for periods in a manner so that it is first effective beginning on or after
The Secretary may implement such system in a manner so as to provide for a reduction in any annual update for failure to report on quality measures in accordance with paragraph (7).
In implementing the system described in clause (i) for 2011 and each subsequent year, any annual update under such system for the year, after application of clause (iv), shall be reduced by the productivity adjustment described in section 1395ww(b)(3)(B)(xi)(II) of this title. The application of the preceding sentence may result in such update being less than 0.0 for a year, and may result in payment rates under the system described in clause (i) for a year being less than such payment rates for the preceding year.
There shall be no administrative or judicial review under section 1395ff, 1395oo of this title, or otherwise, of the classification system, the relative weights, payment amounts, and the geographic adjustment factor, if any, under this subparagraph.
With respect to surgical procedures furnished on or after
the standard overhead amount under subparagraph (A) for a facility service for such procedure, without the application of any geographic adjustment, exceeds
the Medicare OPD fee schedule amount established under the prospective payment system for hospital outpatient department services under paragraph (3)(D) of subsection (t) for such service for such year, determined without regard to geographic adjustment under paragraph (2)(D) of such subsection,
the Secretary shall substitute under subparagraph (A) the amount described in clause (ii) for the standard overhead amount for such service referred to in clause (i).
The aggregate amount of the payments to be made under this part for outpatient hospital facility services or critical access hospital services furnished before
the amount determined with respect to such services under subsection (a)(2)(B); or
the blend amount (described in subparagraph (B)).
The blend amount for a cost reporting period is the sum of—
the cost proportion (as defined in clause (ii)(I)) of the amount described in subparagraph (A)(i), and
the ASC proportion (as defined in clause (ii)(II)) of the standard overhead amount payable with respect to the same surgical procedure as if it were provided in an ambulatory surgical center in the same area, as determined under paragraph (2)(A), less the amount a provider may charge as described in clause (ii) of section 1395cc(a)(2)(A) of this title.
Subject to paragraph (4), in this paragraph:
The term “cost proportion” means 75 percent for cost reporting periods beginning in fiscal year 1988, 50 percent for portions of cost reporting periods beginning on or after
The term “ASC proportion” means 25 percent for cost reporting periods beginning in fiscal year 1988, 50 percent for portions of cost reporting periods beginning on or after
In the case of a hospital that—
makes application to the Secretary and demonstrates that it specializes in eye services or eye and ear services (as determined by the Secretary),
receives more than 30 percent of its total revenues from outpatient services, and
on
was an eye specialty hospital or an eye and ear specialty hospital, or
was operated as an eye or eye and ear unit (as defined in subparagraph (B)) of a general acute care hospital which, on the date of the application described in clause (i), operates less than 20 percent of the beds that the hospital operated on
the cost proportion and ASC proportion in effect under subclauses (I) and (II) of paragraph (3)(B)(ii) for cost reporting periods beginning in fiscal year 1988 shall remain in effect for cost reporting periods beginning on or after
For purposes of this 10
The Secretary is authorized to provide by regulations that in the case of a surgical procedure, specified by the Secretary pursuant to paragraph (1)(A), performed in an ambulatory surgical center described in such paragraph, there shall be paid (in lieu of any amounts otherwise payable under this part) with respect to the facility services furnished by such center and with respect to all related services (including physicians’ services, laboratory, X-ray, and diagnostic services) a single all-inclusive fee established pursuant to subparagraph (B), if all parties furnishing all such services agree to accept such fee (to be divided among the parties involved in such manner as they shall have previously agreed upon) as full payment for the services furnished.
In implementing this paragraph, the Secretary shall establish with respect to each surgical procedure specified pursuant to paragraph (1)(A) the amount of the all-inclusive fee for such procedure, taking into account such factors as may be appropriate. The amount so established with respect to any surgical procedure shall be reviewed periodically and may be adjusted by the Secretary, when appropriate, to take account of varying conditions in different areas.
Any person, including a facility having an agreement under section 1395k(a)(2)(F)(i) of this title, who knowingly and willfully presents, or causes to be presented, a bill or request for payment, for an intraocular lens inserted during or subsequent to cataract surgery for which payment may be made under paragraph (2)(A)(iii), is subject to a civil money penalty of not to exceed $2,000. The provisions of section 1320a–7a of this title (other than subsections (a) and (b)) shall apply to a civil money penalty under the previous sentence in the same manner as such provisions apply to a penalty or proceeding under section 1320a–7a(a) of this title.
For purposes of paragraph (2)(D)(iv), the Secretary may provide, in the case of an ambulatory surgical center that does not submit, to the Secretary in accordance with this paragraph, data required to be submitted on measures selected under this paragraph with respect to a year, any annual increase provided under the system established under paragraph (2)(D) for such year shall be reduced by 2.0 percentage points. A reduction under this subparagraph shall apply only with respect to the year involved and the Secretary shall not take into account such reduction in computing any annual increase factor for a subsequent year.
Except as the Secretary may otherwise provide, the provisions of subparagraphs (B), (C), (D), and (E) of paragraph (17) of subsection (t) shall apply with respect to services of ambulatory surgical centers under this paragraph in a similar manner to the manner in which they apply under such paragraph and, for purposes of this subparagraph, any reference to a hospital, outpatient setting, or outpatient hospital services is deemed a reference to an ambulatory surgical center, the setting of such a center, or services of such a center, respectively.
The Secretary shall conduct a similar type of review as required under paragraph (22) of section 1395l(t) of this title),11
In the case of a part B rebatable drug (as defined in paragraph (2) of section 1395w–3a(i) of this title) for which payment under this subsection is not packaged into a payment for a service furnished on or after
Temporary additional payments for non-opioid treatments for pain relief.—
In general.—
In the case of surgical services furnished on or after
Transition.—
A drug or biological that meets the requirements of section 416.174 of title 42, Code of Federal Regulations (or any successor regulation) and is a non-opioid treatment for pain relief (as defined in clause (iv) of subsection (t)(16)(G)) shall receive additional payment in the amount specified in clause (ii) of such subsection, subject to the limitation under clause (iii) of such subsection.
Accrual of interest on balance of excess or deficit not paid
Hepatitis B vaccine
Fee schedule for services of certified registered nurse anesthetists
The Secretary shall establish a fee schedule for services of certified registered nurse anesthetists under section 1395x(s)(11) of this title.
In establishing the fee schedule under this paragraph the Secretary may utilize a system of time units, a system of base and time units, or any appropriate methodology.
The provisions of this subsection shall not apply to certain services furnished in certain hospitals in rural areas under the provisions of section 9320(k) of the Omnibus Budget Reconciliation Act of 1986, as amended by section 6132 of the Omnibus Budget Reconciliation Act of 1989.
Except as provided in paragraph (3), the fee schedule established under paragraph (1) shall be initially based on audited data from cost reporting periods ending in fiscal year 1985 and such other data as the Secretary determines necessary.
In establishing the initial fee schedule for those services, the Secretary shall adjust the fee schedule to the extent necessary to ensure that the estimated total amount which will be paid under this subchapter for those services plus applicable coinsurance in 1989 will equal the estimated total amount which would be paid under this subchapter for those services in 1989 if the services were included as inpatient hospital services and payment for such services was made under part A in the same manner as payment was made in fiscal year 1987, adjusted to take into account changes in prices and technology relating to the administration of anesthesia.
The Secretary shall also reduce the prevailing charge of physicians for medical direction of a certified registered nurse anesthetist, or the fee schedule for services of certified registered nurse anesthetists, or both, to the extent necessary to ensure that the estimated total amount which will be paid under this subchapter plus applicable coinsurance for such medical direction and such services in 1989 and 1990 will not exceed the estimated total amount which would have been paid plus applicable coinsurance but for the enactment of the amendments made by section 9320 of the Omnibus Budget Reconciliation Act of 1986. A reduced prevailing charge under this subparagraph shall become the prevailing charge but for subsequent years for purposes of applying the economic index under the fourth sentence of section 1395u(b)(3) of this title.
Except as provided in subparagraphs (C) and (D), in determining the amount paid under the fee schedule under this subsection for services furnished on or after
the conversion factor shall be—
for services furnished in 1991, $15.50,
for services furnished in 1992, $15.75,
for services furnished in 1993, $16.00,
for services furnished in 1994, $16.25,
for services furnished in 1995, $16.50,
for services furnished in 1996, $16.75, and
for services furnished in calendar years after 1996, the previous year’s conversion factor increased by the update determined under section 1395w–4(d) of this title for physician anesthesia services for that year;
the payment areas to be used shall be the fee schedule areas used under section 1395w–4 of this title (or, in the case of services furnished during 1991, the localities used under section 1395u(b) of this title) for purposes of computing payments for physicians’ services that are anesthesia services;
the geographic adjustment factors to be applied to the conversion factor under clause (i) for services in a fee schedule area or locality is— 12
in the case of services furnished in 1991, the geographic work index value and the geographic practice cost index value specified in section 1395u(q)(1)(B) of this title for physicians’ services that are anesthesia services furnished in the area or locality, and
in the case of services furnished after 1991, the geographic work index value, the geographic practice cost index value, and the geographic malpractice index value used for determining payments for physicians’ services that are anesthesia services under section 1395w–4 of this title,
with 70 percent of the conversion factor treated as attributable to work and 30 percent as attributable to overhead for services furnished in 1991 (and the portions attributable to work, practice expenses, and malpractice expenses in 1992 and thereafter being the same as is applied under section 1395w–4 of this title).
Except as provided in clause (ii) and subparagraph (D), in determining the amount paid under the fee schedule under this subsection for services furnished on or after
The conversion factor used under clause (i) shall be—
for services furnished in 1991, $10.50,
for services furnished in 1992, $10.75, and
for services furnished in 1993, $11.00.
In the case of services of a certified registered nurse anesthetist who is medically directed or medically supervised by a physician which are furnished on or after
Notwithstanding subclauses (I) through (V) of subparagraph (A)(i)—
in the case of a 1990 conversion factor that is greater than $16.50, the conversion factor for a calendar year after 1990 and before 1996 shall be the 1990 conversion factor reduced by the product of the last digit of the calendar year and one-fifth of the amount by which the 1990 conversion factor exceeds $16.50; and
in the case of a 1990 conversion factor that is greater than $15.49 but less than $16.51, the conversion factor for a calendar year after 1990 and before 1996 shall be the greater of—
the 1990 conversion factor, or
the conversion factor specified in subparagraph (A)(i) for the year involved.
Notwithstanding subparagraph (C), in no case may the conversion factor used to determine payment for services in a fee schedule area or locality under this subsection, as adjusted by the adjustment factors specified in subparagraphs 13
Payment for the services of a certified registered nurse anesthetist (for which payment may otherwise be made under this part) may be made on the basis of a claim or request for payment presented by the certified registered nurse anesthetist furnishing such services, or by a hospital, critical access hospital, physician, group practice, or ambulatory surgical center with which the certified registered nurse anesthetist furnishing such services has an employment or contractual relationship that provides for payment to be made under this part for such services to such hospital, critical access hospital, physician, group practice, or ambulatory surgical center.
No hospital or critical access hospital that presents a claim or request for payment for services of a certified nurse anesthetist under this part may treat any uncollected coinsurance amount imposed under this part with respect to such services as a bad debt of such hospital or critical access hospital for purposes of this subchapter.
If an adjustment under paragraph (3)(B) results in a reduction in the reasonable charge for a physicians’ service and a nonparticipating physician furnishes the service to an individual entitled to benefits under this part after the effective date of the reduction, the physician’s actual charge is subject to a limit under section 1395u(j)(1)(D) of this title.
Incentive payments for physicians’ services furnished in underserved areas
In the case of physicians’ services furnished in a year to an individual, who is covered under the insurance program established by this part and who incurs expenses for such services, in an area that is designated (under section 254e(a)(1)(A) of this title) as a health professional shortage area as identified by the Secretary prior to the beginning of such year, in addition to the amount otherwise paid under this part, there also shall be paid to the physician (or to an employer or facility in the cases described in clause (A) of section 1395u(b)(6) of this title) (on a monthly or quarterly basis) from the Federal Supplementary Medical Insurance Trust Fund an amount equal to 10 percent of the payment amount for the service under this part.
For each health professional shortage area identified in paragraph (1) that consists of an entire county, the Secretary shall provide for the additional payment under paragraph (1) without any requirement on the physician to identify the health professional shortage area involved. The Secretary may implement the previous sentence using the method specified in subsection (u)(4)(C).
The Secretary shall post on the Internet website of the Centers for Medicare & Medicaid Services a list of the health professional shortage areas identified in paragraph (1) that consist of a partial county to facilitate the additional payment under paragraph (1) in such areas.
There shall be no administrative or judicial review under section 1395ff of this title, section 1395oo of this title, or otherwise, respecting—
the identification of a county or area;
the assignment of a specialty of any physician under this paragraph;
the assignment of a physician to a county under this subsection; or
the assignment of a postal ZIP Code to a county or other area under this subsection.
Payments to hospital outpatient departments for radiology; amount; definitions
14
the amount determined with respect to such services under subsection (a)(2)(B), or
the blend amount for radiology services and diagnostic procedures determined in accordance with subparagraph (B).
The blend amount for radiology services and diagnostic procedures for a cost reporting period is the sum of—
the cost proportion (as defined in clause (ii)) of the amount described in subparagraph (A)(i); and
the charge proportion (as defined in clause (ii)(II)) of 62 percent (for services described in subsection (a)(2)(E)(i)), or (for procedures described in subsection (a)(2)(E)(ii)), 42 percent or such other percent established by the Secretary (or carriers acting pursuant to guidelines issued by the Secretary) based on prevailing charges established with actual charge data, of the prevailing charge or (for services described in subsection (a)(2)(E)(i) furnished on or after
In this subparagraph:
The term “cost proportion” means 50 percent, except that such term means 65 percent in the case of outpatient radiology services for portions of cost reporting periods which occur in fiscal year 1989 and in the case of diagnostic procedures described in subsection (a)(2)(E)(ii) for portions of cost reporting periods which occur in fiscal year 1990, and such term means 42 percent in the case of outpatient radiology services for portions of cost reporting periods beginning on or after
The term “charge proportion” means 100 percent minus the cost proportion.
Limitation on benefit for payment for therapeutic shoes for individuals with severe diabetic foot disease
In the case of shoes described in section 1395x(s)(12) of this title—
no payment may be made under this part, with respect to any individual for any year, for the furnishing of—
more than one pair of custom molded shoes (including inserts provided with such shoes) and 2 additional pairs of inserts for such shoes, or
more than one pair of extra-depth shoes (not including inserts provided with such shoes) and 3 pairs of inserts for such shoes, and
with respect to expenses incurred in any calendar year, no more than the amount of payment applicable under paragraph (2) shall be considered as incurred expenses for purposes of subsections (a) and (b).
Payment for shoes (or inserts) under this part shall be considered to include payment for any expenses for the fitting of such shoes (or inserts).
Except as provided by the Secretary under subparagraphs (B) and (C), the amount of payment under this paragraph for custom molded shoes, extra-depth shoes, and inserts shall be the amount determined for such items by the Secretary under section 1395m(h) of this title.
The Secretary may establish payment amounts for shoes and inserts that are lower than the amount established under section 1395m(h) of this title if the Secretary finds that shoes and inserts of an appropriate quality are readily available at or below the amount established under such section.
In accordance with procedures established by the Secretary, an individual entitled to benefits with respect to shoes described in section 1395x(s)(12) of this title may substitute modification of such shoes instead of obtaining one (or more, as specified by the Secretary) pair of inserts (other than the original pair of inserts with respect to such shoes). In such case, the Secretary shall substitute, for the payment amount established under section 1395m(h) of this title, a payment amount that the Secretary estimates will assure that there is no net increase in expenditures under this subsection as a result of this subparagraph.
In this subchapter, the term “shoes” includes, except for purposes of subparagraphs (A)(ii) and (B) of paragraph (2), inserts for extra-depth shoes.
Repealed. Pub. L. 103–432, title I, § 123(b)(2)(A)(ii), Oct. 31, 1994, 108 Stat. 4411
Requests for payment to include information on referring physician
Each request for payment, or bill submitted, for an item or service furnished by an entity for which payment may be made under this part and for which the entity knows or has reason to believe there has been a referral by a referring physician (within the meaning of section 1395nn of this title) shall include the name and unique physician identification number for the referring physician.
In the case of a request for payment for an item or service furnished by an entity under this part on an assignment-related basis and for which information is required to be provided under paragraph (1) but not included, payment may be denied under this part.
In the case of a request for payment for an item or service furnished by an entity under this part not submitted on an assignment-related basis and for which information is required to be provided under paragraph (1) but not included—
if the entity knowingly and willfully fails to provide such information promptly upon request of the Secretary or a carrier, the entity may be subject to a civil money penalty in an amount not to exceed $2,000, and
if the entity knowingly, willfully, and in repeated cases fails, after being notified by the Secretary of the obligations and requirements of this subsection to provide the information required under paragraph (1), the entity may be subject to exclusion from participation in the programs under this chapter for a period not to exceed 5 years, in accordance with the procedures of subsections (c), (f), and (g) of section 1320a–7 of this title.
The provisions of section 1320a–7a of this title (other than subsections (a) and (b)) shall apply to civil money penalties under clause (i) in the same manner as they apply to a penalty or proceeding under section 1320a–7a(a) of this title.
Cap on prevailing charge; billing on assignment-related basis
With respect to services described in section 1395x(s)(2)(K)(ii) of this title (relating to nurse practitioner or clinical nurse specialist services), payment may be made on the basis of a claim or request for payment presented by the nurse practitioner or clinical nurse specialist furnishing such services, or by a hospital, critical access hospital, skilled nursing facility or nursing facility (as defined in section 1396r(a) of this title), physician, group practice, or ambulatory surgical center with which the nurse practitioner or clinical nurse specialist has an employment or contractual relationship that provides for payment to be made under this part for such services to such hospital, physician, group practice, or ambulatory surgical center.
No hospital or critical access hospital that presents a claim or request for payment under this part for services described in section 1395x(s)(2)(K)(ii) of this title may treat any uncollected coinsurance amount imposed under this part with respect to such services as a bad debt of such hospital for purposes of this subchapter.
Other prepaid organizations
Prospective payment system for hospital outpatient department services
Amount of payment
In general
Definition of covered OPD services
For purposes of this subsection, the term “covered OPD services”—
means hospital outpatient services designated by the Secretary;
subject to clause (iv), includes inpatient hospital services designated by the Secretary that are covered under this part and furnished to a hospital inpatient who (I) is entitled to benefits under part A but has exhausted benefits for inpatient hospital services during a spell of illness, or (II) is not so entitled;
includes implantable items described in paragraph (3), (6), or (8) of section 1395x(s) of this title;
does not include any therapy services described in subsection (a)(8) or ambulance services, for which payment is made under a fee schedule described in section 1395m(k) of this title or section 1395m(l) of this title and does not include screening mammography (as defined in section 1395x(jj) of this title), diagnostic mammography, or personalized prevention plan services (as defined in section 1395x(hhh)(1) of this title); and
does not include applicable items and services (as defined in subparagraph (A) of paragraph (21)) that are furnished on or after
System requirements
Under the payment system—
the Secretary shall develop a classification system for covered OPD services;
the Secretary may establish groups of covered OPD services, within the classification system described in subparagraph (A), so that services classified within each group are comparable clinically and with respect to the use of resources and so that an implantable item is classified to the group that includes the service to which the item relates;
the Secretary shall, using data on claims from 1996 and using data from the most recent available cost reports, establish relative payment weights for covered OPD services (and any groups of such services described in subparagraph (B)) based on median (or, at the election of the Secretary, mean) hospital costs and shall determine projections of the frequency of utilization of each such service (or group of services) in 1999;
subject to paragraph (19), the Secretary shall determine a wage adjustment factor to adjust the portion of payment and coinsurance attributable to labor-related costs for relative differences in labor and labor-related costs across geographic regions in a budget neutral manner;
the Secretary shall establish, in a budget neutral manner, outlier adjustments under paragraph (5) and transitional pass-through payments under paragraph (6) and temporary additional payments for non-opioid treatments for pain relief under paragraph (16)(G), and other adjustments as determined to be necessary to ensure equitable payments, such as adjustments for certain classes of hospitals;
the Secretary shall develop a method for controlling unnecessary increases in the volume of covered OPD services;
the Secretary shall create additional groups of covered OPD services that classify separately those procedures that utilize contrast agents from those that do not; and
with respect to devices of brachytherapy consisting of a seed or seeds (or radioactive source), the Secretary shall create additional groups of covered OPD services that classify such devices separately from the other services (or group of services) paid for under this subsection in a manner reflecting the number, isotope, and radioactive intensity of such devices furnished, including separate groups for palladium-103 and iodine-125 devices and for stranded and non-stranded devices furnished on or after
For purposes of subparagraph (B), items and services within a group shall not be treated as “comparable with respect to the use of resources” if the highest median cost (or mean cost, if elected by the Secretary under subparagraph (C)) for an item or service within the group is more than 2 times greater than the lowest median cost (or mean cost, if so elected) for an item or service within the group; except that the Secretary may make exceptions in unusual cases, such as low volume items and services, but may not make such an exception in the case of a drug or biological that has been designated as an orphan drug under section 360bb of title 21.
Calculation of base amounts
Aggregate amounts that would be payable if deductibles were disregarded
The Secretary shall estimate the sum of—
the total amounts that would be payable from the Trust Fund under this part for covered OPD services in 1999, determined without regard to this subsection, as though the deductible under subsection (b) did not apply, and
the total amounts of copayments estimated to be paid under this subsection by beneficiaries to hospitals for covered OPD services in 1999, as though the deductible under subsection (b) did not apply.
Unadjusted copayment amount
In general
Adjusted to be 20 percent when fully phased in
Rules for new services
Calculation of conversion factors
For 1999
In general
Product described
Subsequent years
Adjustment for service mix changes
OPD fee schedule increase factor
Calculation of medicare OPD fee schedule amounts
The Secretary shall compute a medicare OPD fee schedule amount for each covered OPD service (or group of such services) furnished in a year, in an amount equal to the product of—
the conversion factor computed under subparagraph (C) for the year, and
the relative payment weight (determined under paragraph (2)(C)) for the service or group.
Pre-deductible payment percentage
The pre-deductible payment percentage for a covered OPD service (or group of such services) furnished in a year is equal to the ratio of—
the medicare OPD fee schedule amount established under subparagraph (D) for the year, minus the unadjusted copayment amount determined under subparagraph (B) for the service or group, to
the medicare OPD fee schedule amount determined under subparagraph (D) for the year for such service or group.
Productivity and other adjustment
After determining the OPD fee schedule increase factor under subparagraph (C)(iv), the Secretary shall reduce such increase factor—
for 2012 and subsequent years, by the productivity adjustment described in section 1395ww(b)(3)(B)(xi)(II) of this title; and
for each of 2010 through 2019, by the adjustment described in subparagraph (G).
The application of this subparagraph may result in the increase factor under subparagraph (C)(iv) being less than 0.0 for a year, and may result in payment rates under the payment system under this subsection for a year being less than such payment rates for the preceding year.
Other adjustment
For purposes of subparagraph (F)(ii), the adjustment described in this subparagraph is—
for each of 2010 and 2011, 0.25 percentage point;
for each of 2012 and 2013, 0.1 percentage point;
for 2014, 0.3 percentage point;
for each of 2015 and 2016, 0.2 percentage point; and
for each of 2017, 2018, and 2019, 0.75 percentage point.
Medicare payment amount
The amount of payment made from the Trust Fund under this part for a covered OPD service (and such services classified within a group) furnished in a year is determined, subject to paragraph (7), as follows:
Fee schedule adjustments
Subtract applicable deductible
Apply payment proportion to remainder
Outlier adjustment
In general
Subject to subparagraph (D), the Secretary shall provide for an additional payment for each covered OPD service (or group of services) for which a hospital’s charges, adjusted to cost, exceed—
a fixed multiple of the sum of—
the applicable medicare OPD fee schedule amount determined under paragraph (3)(D), as adjusted under paragraph (4)(A) (other than for adjustments under this paragraph or paragraph (6)); and
any transitional pass-through payment under paragraph (6); and
at the option of the Secretary, such fixed dollar amount as the Secretary may establish.
Amount of adjustment
Limit on aggregate outlier adjustments
In general
Applicable percentage
For purposes of clause (i), the term “applicable percentage” means a percentage specified by the Secretary up to (but not to exceed)—
for a year (or portion of a year) before 2004, 2.5 percent; and
for 2004 and thereafter, 3.0 percent.
Transitional authority
In applying subparagraph (A) for covered OPD services furnished before
apply such subparagraph to a bill for such services related to an outpatient encounter (rather than for a specific service or group of services) using OPD fee schedule amounts and transitional pass-through payments covered under the bill; and
use an appropriate cost-to-charge ratio for the hospital involved (as determined by the Secretary), rather than for specific departments within the hospital.
Exclusion of separate drug and biological APCS from outlier payments
Transitional pass-through for additional costs of innovative medical devices, drugs, and biologicals
In general
The Secretary shall provide for an additional payment under this paragraph for any of the following that are provided as part of a covered OPD service (or group of services):
Current orphan drugs
Current cancer therapy drugs and biologicals and brachytherapy
Current radiopharmaceutical drugs and biological products
New medical devices, drugs, and biologicals
A medical device, drug, or biological not described in clause (i), (ii), or (iii) if—
payment for the device, drug, or biological as an outpatient hospital service under this part was not being made as of
the cost of the drug or biological or the average cost of the category of devices is not insignificant in relation to the OPD fee schedule amount (as calculated under paragraph (3)(D)) payable for the service (or group of services) involved.
Use of categories in determining eligibility of a device for pass-through payments
The following provisions apply for purposes of determining whether a medical device qualifies for additional payments under clause (ii) or (iv) of subparagraph (A):
Establishment of initial categories
In general
Authorization of implementation other than through regulations
Establishing criteria for additional categories
In general
Standard
Deadline
Adding categories
Period for which category is in effect
Subject to subparagraph (K), a category of medical devices established under clause (i) or (ii) shall be in effect for a period of at least 2 years, but not more than 3 years, that begins—
in the case of a category established under clause (i), on the first date on which payment was made under this paragraph for any device described by such category (including payments made during the period before
in the case of any other category, on the first date on which payment is made under this paragraph for any medical device that is described by such category.
Requirements treated as met
A medical device shall be treated as meeting the requirements of subparagraph (A)(iv), regardless of whether the device meets the requirement of subclause (I) of such subparagraph, if—
the device is described by a category established and in effect under clause (i); or
the device is described by a category established and in effect under clause (ii) and an application under section 360e of title 21 has been approved with respect to the device, or the device has been cleared for market under section 360(k) of title 21, or the device is exempt from the requirements of section 360(k) of title 21 pursuant to subsection (l) or (m) of section 360 of title 21 or section 360j(g) of title 21.
Nothing in this clause shall be construed as requiring an application or prior approval (other than that described in subclause (II)) in order for a covered device described by a category to qualify for payment under this paragraph.
Limited period of payment
Drugs and biologicals
Subject to subparagraph (G), the payment under this paragraph with respect to a drug or biological shall only apply during a period of at least 2 years, but not more than 3 years, that begins—
on the first date this subsection is implemented in the case of a drug or biological described in clause (i), (ii), or (iii) of subparagraph (A) and in the case of a drug or biological described in subparagraph (A)(iv) and for which payment under this part is made as an outpatient hospital service before such first date; or
in the case of a drug or biological described in subparagraph (A)(iv) not described in subclause (I), on the first date on which payment is made under this part for the drug or biological as an outpatient hospital service.
Medical devices
Payment shall be made under this paragraph with respect to a medical device only if such device—
is described by a category of medical devices established and in effect under subparagraph (B); and
is provided as part of a service (or group of services) paid for under this subsection and provided during the period for which such category is in effect under such subparagraph.
Amount of additional payment
Subject to subparagraph (E)(iii), the amount of the payment under this paragraph with respect to a device, drug, or biological provided as part of a covered OPD service is—
subject to subparagraph (H), in the case of a drug or biological, the amount by which the amount determined under section 1395u(o) of this title (or if the drug or biological is covered under a competitive acquisition contract under section 1395w–3b of this title, an amount determined by the Secretary equal to the average price for the drug or biological for all competitive acquisition areas and year established under such section as calculated and adjusted by the Secretary for purposes of this paragraph) for the drug or biological exceeds the portion of the otherwise applicable medicare OPD fee schedule that the Secretary determines is associated with the drug or biological; or
in the case of a medical device, the amount by which the hospital’s charges for the device, adjusted to cost, exceeds the portion of the otherwise applicable medicare OPD fee schedule that the Secretary determines is associated with the device.
Limit on aggregate annual adjustment
In general
Applicable percentage
For purposes of clause (i), the term “applicable percentage” means—
for a year (or portion of a year) before 2004, 2.5 percent; and
for 2004 and thereafter, a percentage specified by the Secretary up to (but not to exceed) 2.0 percent.
Uniform prospective reduction if aggregate limit projected to be exceeded
Limitation of application of functional equivalence standard
In general
Application
Clause (i) shall apply to the application of a functional equivalence standard to a drug or biological on or after
such application was being made to such drug or biological prior to
the Secretary applies such standard to such drug or biological only for the purpose of determining eligibility of such drug or biological for additional payments under this paragraph and not for the purpose of any other payments under this subchapter.
Rule of construction
Pass-through extension for certain drugs and biologicals
Temporary payment rule for certain drugs and biologicals
In the case of a drug or biological whose period of pass-through status under this paragraph ended on
the payment amount that would otherwise apply under subparagraph (D)(i) for such drug or biological during such period; or
the payment amount that applied under such subparagraph (D)(i) for such drug or biological on
Special payment adjustment rules for last quarter of 2018
In the case of a drug or biological whose period of pass-through status under this paragraph ended on
The Secretary shall remove the packaged costs of such drug or biological (as determined by the Secretary) from the payment amount under this subsection for the covered OPD service (or group of services) with which it is packaged.
The Secretary shall not make any adjustments to payment amounts under this subsection for a covered OPD service (or group of services) for which no costs were removed under clause (i).
Additional pass-through extension and special payment adjustment rule for certain diagnostic radiopharmaceuticals
In the case of a drug or biological furnished in the context of a clinical study on diagnostic imaging tests approved under a coverage with evidence development determination whose period of pass-through status under this paragraph concluded on
extend such pass-through status for such drug or biological for the 9-month period beginning on
remove, during such period, the packaged costs of such drug or biological (as determined by the Secretary) from the payment amount under this subsection for the covered OPD service (or group of services) with which it is packaged; and
not make any adjustments to payment amounts under this subsection for a covered OPD service (or group of services) for which no costs were removed under clause (ii).
Pass-through extension for certain devices
In general
No adjustment for packaged costs
No application of aggregate limit or budget neutrality
Notwithstanding any other provision of this subsection, this subparagraph shall not be taken into account—
in applying the limit on annual aggregate adjustments under subparagraph (E) for 2023; or
in making any budget neutrality adjustments under this subsection for 2023.
Transitional adjustment to limit decline in payment
Before 2002
Subject to subparagraph (D), for covered OPD services furnished before
at least 90 percent, but less than 100 percent, of the pre-BBA amount (as defined in subparagraph (F)), the amount of payment under this subsection shall be increased by 80 percent of the amount of such difference;
at least 80 percent, but less than 90 percent, of the pre-BBA amount, the amount of payment under this subsection shall be increased by the amount by which (I) the product of 0.71 and the pre-BBA amount, exceeds (II) the product of 0.70 and the PPS amount;
at least 70 percent, but less than 80 percent, of the pre-BBA amount, the amount of payment under this subsection shall be increased by the amount by which (I) the product of 0.63 and the pre-BBA amount, exceeds (II) the product of 0.60 and the PPS amount; or
less than 70 percent of the pre-BBA amount, the amount of payment under this subsection shall be increased by 21 percent of the pre-BBA amount.
2002
Subject to subparagraph (D), for covered OPD services furnished during 2002, for which the PPS amount is—
at least 90 percent, but less than 100 percent, of the pre-BBA amount, the amount of payment under this subsection shall be increased by 70 percent of the amount of such difference;
at least 80 percent, but less than 90 percent, of the pre-BBA amount, the amount of payment under this subsection shall be increased by the amount by which (I) the product of 0.61 and the pre-BBA amount, exceeds (II) the product of 0.60 and the PPS amount; or
less than 80 percent of the pre-BBA amount, the amount of payment under this subsection shall be increased by 13 percent of the pre-BBA amount.
2003
Subject to subparagraph (D), for covered OPD services furnished during 2003, for which the PPS amount is—
at least 90 percent, but less than 100 percent, of the pre-BBA amount, the amount of payment under this subsection shall be increased by 60 percent of the amount of such difference; or
less than 90 percent of the pre-BBA amount, the amount of payment under this subsection shall be increased by 6 percent of the pre-BBA amount.
Hold harmless provisions
Temporary treatment for certain rural hospitals
In the case of a hospital located in a rural area and that has not more than 100 beds or a sole community hospital (as defined in section 1395ww(d)(5)(D)(iii) of this title) located in a rural area, for covered OPD services furnished before
In the case of a hospital located in a rural area and that has not more than 100 beds and that is not a sole community hospital (as defined in section 1395ww(d)(5)(D)(iii) of this title), for covered OPD services furnished on or after
In the case of a sole community hospital (as defined in section 1395ww(d)(5)(D)(iii) of this title) that has not more than 100 beds, for covered OPD services furnished on or after
Permanent treatment for cancer hospitals and children’s hospitals
PPS amount defined
Pre-BBA amount defined
In general
Base payment-to-cost ratio defined
For purposes of this subparagraph, the “base payment-to-cost ratio” for a hospital means the ratio of—
the hospital’s reimbursement under this part for covered OPD services furnished during the cost reporting period ending in 1996 (or in the case of a hospital that did not submit a cost report for such period, during the first subsequent cost reporting period ending before 2001 for which the hospital submitted a cost report), including any reimbursement for such services through cost-sharing described in subparagraph (E), to
the reasonable cost of such services for such period.
The Secretary shall determine such ratios as if the amendments made by section 4521 of the Balanced Budget Act of 1997 were in effect in 1996.
Interim payments
No effect on copayments
Application without regard to budget neutrality
The additional payments made under this paragraph—
shall not be considered an adjustment under paragraph (2)(E); and
shall not be implemented in a budget neutral manner.
Copayment amount
In general
Election to offer reduced copayment amount
Limitation on copayment amount
To inpatient hospital deductible amount
To specified percentage
The Secretary shall reduce the national unadjusted copayment amount for a covered OPD service (or group of such services) furnished in a year in a manner so that the effective copayment rate (determined on a national unadjusted basis) for that service in the year does not exceed the following percentage:
For procedures performed in 2001, on or after
For procedures performed in 2002 or 2003, 55 percent.
For procedures performed in 2004, 50 percent.
For procedures performed in 2005, 45 percent.
For procedures performed in 2006 and thereafter, 40 percent.
No impact on deductibles
Computation ignoring outlier and pass-through adjustments
Part B rebatable drugs
Periodic review and adjustments components of prospective payment system
Periodic review
Budget neutrality adjustment
Update factor
Special rule for ambulance services
Special rules for certain hospitals
In the case of hospitals described in clause (iii) or (v) of section 1395ww(d)(1)(B) of this title—
the system under this subsection shall not apply to covered OPD services furnished before
the Secretary may establish a separate conversion factor for such services in a manner that specifically takes into account the unique costs incurred by such hospitals by virtue of their patient population and service intensity.
Limitation on review
There shall be no administrative or judicial review under section 1395ff of this title, 1395oo of this title, or otherwise of—
the development of the classification system under paragraph (2), including the establishment of groups and relative payment weights for covered OPD services, of wage adjustment factors, other adjustments, and methods described in paragraph (2)(F);
the calculation of base amounts under paragraph (3);
periodic adjustments made under paragraph (6);
the establishment of a separate conversion factor under paragraph (8)(B); and
the determination of the fixed multiple, or a fixed dollar cutoff amount, the marginal cost of care, or applicable percentage under paragraph (5) or the determination of insignificance of cost, the duration of the additional payments, the determination and deletion of initial and new categories (consistent with subparagraphs (B) and (C) of paragraph (6)), the portion of the medicare OPD fee schedule amount associated with particular devices, drugs, or biologicals, and the application of any pro rata reduction under paragraph (6).
Authorization of adjustment for rural hospitals
Study
Authorization of adjustment
Drug APC payment rates
In general
The amount of payment under this subsection for a specified covered outpatient drug (defined in subparagraph (B)) that is furnished as part of a covered OPD service (or group of services)—
in 2004, in the case of—
a sole source drug shall in no case be less than 88 percent, or exceed 95 percent, of the reference average wholesale price for the drug;
an innovator multiple source drug shall in no case exceed 68 percent of the reference average wholesale price for the drug; or
a noninnovator multiple source drug shall in no case exceed 46 percent of the reference average wholesale price for the drug;
in 2005, in the case of—
a sole source drug shall in no case be less than 83 percent, or exceed 95 percent, of the reference average wholesale price for the drug;
an innovator multiple source drug shall in no case exceed 68 percent of the reference average wholesale price for the drug; or
a noninnovator multiple source drug shall in no case exceed 46 percent of the reference average wholesale price for the drug; or
in a subsequent year, shall be equal, subject to subparagraph (E)—
to the average acquisition cost for the drug for that year (which, at the option of the Secretary, may vary by hospital group (as defined by the Secretary based on volume of covered OPD services or other relevant characteristics)), as determined by the Secretary taking into account the hospital acquisition cost survey data under subparagraph (D); or
if hospital acquisition cost data are not available, the average price for the drug in the year established under section 1395u(o) of this title, section 1395w–3a of this title, or section 1395w–3b of this title, as the case may be, as calculated and adjusted by the Secretary as necessary for purposes of this paragraph.
Specified covered outpatient drug defined
In general
In this paragraph, the term “specified covered outpatient drug” means, subject to clause (ii), a covered outpatient drug (as defined in section 1396r–8(k)(2) of this title) for which a separate ambulatory payment classification group (APC) has been established and that is—
a radiopharmaceutical; or
a drug or biological for which payment was made under paragraph (6) (relating to pass-through payments) on or before
Exception
Such term does not include—
a drug or biological for which payment is first made on or after
a drug or biological for which a temporary HCPCS code has not been assigned; or
during 2004 and 2005, an orphan drug (as designated by the Secretary).
Payment for designated orphan drugs during 2004 and 2005
Acquisition cost survey for hospital outpatient drugs
Annual GAO surveys in 2004 and 2005
In general
Recommendations
Subsequent secretarial surveys
Survey requirements
Differentiation in cost
Comment on proposed rates
Adjustment in payment rates for overhead costs
MedPAC report on drug APC design
The Medicare Payment Advisory Commission shall submit to the Secretary, not later than
a description and analysis of the data available with regard to such expenses;
a recommendation as to whether such a payment adjustment should be made; and
if such adjustment should be made, a recommendation regarding the methodology for making such an adjustment.
Adjustment authorized
Classes of drugs
For purposes of this paragraph:
Sole source drugs
The term “sole source drug” means—
a biological product (as defined under section 1395x(t)(1) of this title); or
a single source drug (as defined in section 1396r–8(k)(7)(A)(iv) of this title).
Innovator multiple source drugs
Noninnovator multiple source drugs
Reference average wholesale price
Inapplicability of expenditures in determining conversion, weighting, and other adjustment factors
Payment for new drugs and biologicals until HCPCS code assigned
Miscellaneous provisions
Application of reclassification of certain hospitals
Threshold for establishment of separate APCS for drugs
Payment for devices of brachytherapy and therapeutic radiopharmaceuticals at charges adjusted to cost
Special payment rule
In general
In the case of covered OPD services furnished on or after
the payment rate that would otherwise apply under this subsection for stereotactic radiosurgery, complete course of treatment of cranial lesion(s) consisting of 1 session that is multi-source Cobalt 60 based (identified as of
the payment rate that would otherwise apply under this subsection for linear accelerator based stereotactic radiosurgery, complete course of therapy in one session (identified as of
the payment rate for the service described in subclause (I) shall be reduced to an amount equal to the payment rate for the service described in subclause (II).
Hospital described
A hospital described in this clause is a hospital that is not—
located in a rural area (as defined in section 1395ww(d)(2)(D) of this title);
classified as a rural referral center under section 1395ww(d)(5)(C) of this title; or
a sole community hospital (as defined in section 1395ww(d)(5)(D)(iii) of this title).
Not budget neutral
Application of appropriate use criteria for certain imaging services
Payment incentive for the transition from traditional X-ray imaging to digital radiography
Notwithstanding the previous provisions of this subsection:
Limitation on payment for film X-ray imaging services
Phased-in limitation on payment for computed radiography imaging services
In the case of an imaging service that is an X-ray taken using computed radiography technology (as defined in section 1395w–4(b)(9)(C) of this title)—
in the case of such a service furnished during 2018, 2019, 2020, 2021, or 2022, the payment amount for such service (including the X-ray component of a packaged service) that would otherwise be determined under this section (without application of this paragraph and before application of any other adjustment under this subsection) for such year shall be reduced by 7 percent; and
in the case of such a service furnished during 2023 or a subsequent year, the payment amount for such service (including the X-ray component of a packaged service) that would otherwise be determined under this section (without application of this paragraph and before application of any other adjustment under this subsection) for such year shall be reduced by 10 percent.
Application without regard to budget neutrality
The reductions made under this subparagraph—
shall not be considered an adjustment under paragraph (2)(E); and
shall not be implemented in a budget neutral manner.
Implementation
Temporary additional payments for non-opioid treatments for pain relief
In general
Amount of payment
Subject to the limitation under clause (iii), the amount of the payment specified in this clause is, with respect to a non-opioid treatment for pain relief that is—
a drug or biological product, the amount of payment for such drug or biological determined under section 1395w–3a of this title that exceeds the portion of the otherwise applicable Medicare OPD fee schedule that the Secretary determines is associated with the drug or biological; or
a medical device, the amount of the hospital’s charges for the device, adjusted to cost, that exceeds the portion of the otherwise applicable Medicare OPD fee schedule that the Secretary determines is associated with the device.
Limitation
Definition of non-opioid treatment for pain relief
In this subparagraph, the term “non-opioid treatment for pain relief” means a drug, biological product, or medical device that—
in the case of a drug or biological product, has a label indication approved by the Food and Drug Administration to reduce postoperative pain, or produce postsurgical or regional analgesia, without acting upon the body’s opioid receptors;
in case of a medical device, is used to deliver a therapy to reduce postoperative pain, or produce postsurgical or regional analgesia, and has—
an application under section 360e of title 21 that has been approved with respect to the device, been cleared for market under section 360(k) of such title, or is exempt from the requirements of section 360(k) of such title pursuant to subsection (l) or (m) or section 360 of such title or section 360j(g) of such title; and
demonstrated the ability to replace, reduce, or avoid intraoperative or postoperative opioid use or the quantity of opioids prescribed in a clinical trial or through data published in a peer-reviewed journal;
does not receive transitional pass-through payment under paragraph (6); and
has payment that is packaged into a payment for a covered OPD service (or group of services).
Quality reporting
Reduction in update for failure to report
In general
Non-cumulative application
Form and manner of submission
Development of outpatient measures
In general
Construction
Replacement of measures
Availability of data
Authorization of adjustment for cancer hospitals
Study
Authorization of adjustment
Target PCR adjustment
Floor on area wage adjustment factor for hospital outpatient department services in frontier States
In general
Limitation
Not budget neutral application of reduced expenditures resulting from quality incentives for computed tomography
Services furnished by an off-campus outpatient department of a provider
Applicable items and services
Off-campus outpatient department of a provider
In general
For purposes of paragraph (1)(B)(v) and this paragraph, subject to the subsequent provisions of this subparagraph, the term “off-campus outpatient department of a provider” means a department of a provider (as defined in section 413.65(a)(2) of title 42 of the Code of Federal Regulations, as in effect as of
on the campus (as defined in such section 413.65(a)(2)) of such provider; or
within the distance (described in such definition of campus) from a remote location of a hospital facility (as defined in such section 413.65(a)(2)).
Exception
Deemed treatment for 2017
Alternative exception beginning with 2018
For purposes of paragraph (1)(B)(v) and this paragraph with respect to applicable items and services furnished during 2018 or a subsequent year, the term “off-campus outpatient department of a provider” also shall not include a department of a provider (as so defined) that is not described in clause (ii) if—
the Secretary receives from the provider an attestation (pursuant to such section 413.65(b)(3)) not later than
the provider includes such department as part of the provider on its enrollment form in accordance with the enrollment process under section 1395cc(j) of this title; and
the department met the mid-build requirement of clause (v) and the Secretary receives, not later than 60 days after
Mid-build requirement described
Exclusion for certain cancer hospitals
For purposes of paragraph (1)(B)(v) and this paragraph with respect to applicable items and services furnished during 2017 or a subsequent year, the term “off-campus outpatient department of a provider” also shall not include a department of a provider (as so defined) that is not described in clause (ii) if the provider is a hospital described in section 1395ww(d)(1)(B)(v) of this title and—
in the case of a department that met the requirements of section 413.65 of title 42 of the Code of Federal Regulations after
in the case of a department that meets such requirements after such date, the Secretary receives from the provider an attestation that such department meets such requirements not later than 60 days after the date such requirements are first met with respect to such department.
Audit
Implementation
For purposes of implementing clauses (iii) through (vii):
Notwithstanding any other provision of law, the Secretary may implement such clauses by program instruction or otherwise.
Subchapter I of chapter 35 of title 44 shall not apply.
For purposes of carrying out this subparagraph with respect to clauses (iii) and (iv) (and clause (vii) insofar as it relates to clause (iv)), $10,000,000 shall be available from the Federal Supplementary Medical Insurance Trust Fund under section 1395t of this title, to remain available until
Availability of payment under other payment systems
Information needed for implementation
Limitations
There shall be no administrative or judicial review under section 1395ff of this title, section 1395oo of this title, or otherwise of the following:
The determination of the applicable items and services under subparagraph (A) and applicable payment systems under subparagraph (C).
The determination of whether a department of a provider meets the term described in subparagraph (B).
Any information that hospitals are required to report pursuant to subparagraph (D).
The determination of an audit under subparagraph (B)(vii).
Review and revisions of payments for non-opioid alternative treatments
In general
With respect to payments made under this subsection for covered OPD services (or groups of services), including covered OPD services assigned to a comprehensive ambulatory payment classification, the Secretary—
shall, as soon as practicable, conduct a review (part of which may include a request for information) of payments for opioids and evidence-based non-opioid alternatives for pain management (including drugs and devices, nerve blocks, surgical injections, and neuromodulation) with a goal of ensuring that there are not financial incentives to use opioids instead of non-opioid alternatives;
may, as the Secretary determines appropriate, conduct subsequent reviews of such payments; and
shall consider the extent to which revisions under this subsection to such payments (such as the creation of additional groups of covered OPD services to classify separately those procedures that utilize opioids and non-opioid alternatives for pain management) would reduce payment incentives to use opioids instead of non-opioid alternatives for pain management.
Priority
Revisions
Rules of construction
Nothing in this paragraph shall be construed to preclude the Secretary—
from conducting a demonstration before making the revisions described in subparagraph (C); or
prior to implementation of this paragraph, from changing payments under this subsection for covered OPD services (or groups of services) which include opioids or non-opioid alternatives for pain management.
Use of unique health identifiers; attestation
In general
No payment may be made under this subsection (or under an applicable payment system pursuant to paragraph (21)) for items and services furnished on or after
such department has obtained, and such items and services are billed under, a National Provider Identifier that is separate from such identifier for such provider;
such provider has submitted to the Secretary, during the 2-year period ending on the date such items and services are so furnished, an initial provider-based status attestation that such department is compliant with the requirements described in section 413.65 of title 42, Code of Federal Regulations (or a successor regulation), which, until the Secretary establishes the process described in subparagraph (B), may include an attestation submitted in accordance with paragraph (b)(3) of such section (as in effect on
after such provider has submitted an attestation under clause (ii), such provider has submitted a subsequent attestation within the timeframe specified by the Secretary.
Process for submission and review
In general
Funding
Off-campus outpatient department of a provider defined
For purposes of this paragraph, the term “off-campus outpatient department of a provider” means a department of a provider (as defined in section 413.65 of title 42, Code of Federal Regulations, or any successor regulation) that is not located—
on the campus (as defined in such section) of such provider; or
within the distance (described in such definition of campus) from a remote location of a hospital facility (as defined in such section).
Incentive payments for physician scarcity areas
In general
In the case of physicians’ services furnished on or after
by a primary care physician in a primary care scarcity county (identified under paragraph (4)); or
by a physician who is not a primary care physician in a specialist care scarcity county (as so identified),
in addition to the amount of payment that would otherwise be made for such services under this part, there also shall be paid an amount equal to 5 percent of the payment amount for the service under this part.
Determination of ratios of physicians to medicare beneficiaries in area
Based upon available data, the Secretary shall establish for each county or equivalent area in the United States, the following:
Number of physicians practicing in the area
The number of physicians who furnish physicians’ services in the active practice of medicine or osteopathy in that county or area, other than physicians whose practice is exclusively for the Federal Government, physicians who are retired, or physicians who only provide administrative services. Of such number, the number of such physicians who are—
primary care physicians; or
physicians who are not primary care physicians.
Number of medicare beneficiaries residing in the area
Determination of ratios
Primary care ratio
Specialist care ratio
Ranking of counties
Identification of counties
In general
The Secretary shall identify—
those counties and areas (in this paragraph referred to as “primary care scarcity counties”) with the lowest primary care ratios that represent, if each such county or area were weighted by the number of individuals determined under paragraph (2)(B), an aggregate total of 20 percent of the total of the individuals determined under such paragraph; and
those counties and areas (in this subsection referred to as “specialist care scarcity counties”) with the lowest specialist care ratios that represent, if each such county or area were weighted by the number of individuals determined under paragraph (2)(B), an aggregate total of 20 percent of the total of the individuals determined under such paragraph.
Periodic revisions
Identification of counties where service is furnished
Special rule
Judicial review
There shall be no administrative or judicial review under section 1395ff, 1395oo of this title, or otherwise, respecting—
the identification of a county or area;
the assignment of a specialty of any physician under this paragraph;
the assignment of a physician to a county under paragraph (2); or
the assignment of a postal ZIP Code to a county or other area under this subsection.
Rural census tracts
Physician defined
Publication of list of counties; posting on website
Increase of FQHC payment limits
In the case of services furnished by Federally qualified health centers (as defined in section 1395x(aa)(4) of this title), the Secretary shall establish payment limits with respect to such services under this part for services furnished—
in 2010, at the limits otherwise established under this part for such year increased by $5; and
in a subsequent year, at the limits established under this subsection for the previous year increased by the percentage increase in the MEI (as defined in section 1395u(i)(3) of this title) for such subsequent year.
Methods of payment
Incentive payments for primary care services
In general
Definitions
In this subsection:
Primary care practitioner
The term “primary care practitioner” means an individual—
who—
is a physician (as described in section 1395x(r)(1) of this title) who has a primary specialty designation of family medicine, internal medicine, geriatric medicine, or pediatric medicine; or
is a nurse practitioner, clinical nurse specialist, or physician assistant (as those terms are defined in section 1395x(aa)(5) of this title); and
for whom primary care services accounted for at least 60 percent of the allowed charges under this part for such physician or practitioner in a prior period as determined appropriate by the Secretary.
Primary care services
The term “primary care services” means services identified, as of
99201 through 99215.
99304 through 99340.
99341 through 99350.
Coordination with other payments
Limitation on review
Incentive payments for major surgical procedures furnished in health professional shortage areas
In general
Definitions
In this subsection:
General surgeon
Major surgical procedures
Coordination with other payments
Application
Incentive payments for participation in eligible alternative payment models
Payment incentive
In general
In the case of covered professional services furnished by an eligible professional during a year that is in the period beginning with 2019 and ending with 2026, and during 2028, and for which the professional is a qualifying APM participant with respect to such year, in addition to the amount of payment that would otherwise be made for such covered professional services under this part for such year, there also shall be paid to such professional an amount equal to 5 percent (or, with respect to 2025, 3.5 percent, or, with respect to 2026, 1.88 percent, or, with respect to 2028, 3.1 percent) of the estimated aggregate payment amounts for such covered professional services under this part for the preceding year. For purposes of the previous sentence, the payment amount for the preceding year may be an estimation for the full preceding year based on a period of such preceding year that is less than the full year. The Secretary shall establish policies to implement this subparagraph in cases in which payment for covered professional services furnished by a qualifying APM participant in an alternative payment model—
is made to an eligible alternative payment entity rather than directly to the qualifying APM participant; or
is made on a basis other than a fee-for-service basis (such as payment on a capitated basis).
Form of payment
Treatment of payment incentive
Coordination
Qualifying APM participant
For purposes of this subsection, the term “qualifying APM participant” means the following:
2019 and 2020
2021 through 2026 and 2028
With respect to each of 2021 through 2026 and 2028, an eligible professional described in either of the following clauses:
Medicare payment threshold option
Combination all-payer and medicare payment threshold option
An eligible professional—
for whom the Secretary determines, with respect to items and services furnished by such professional during the most recent period for which data are available (which may be less than a year), that at least 50 percent of the sum of—
payments described in clause (i); and
all other payments, regardless of payer (other than payments made by the Secretary of Defense or the Secretary of Veterans Affairs and other than payments made under subchapter XIX in a State in which no medical home or alternative payment model is available under the State program under that subchapter),
meet the requirement described in clause (iii)(I) with respect to payments described in item (aa) and meet the requirement described in clause (iii)(II) with respect to payments described in item (bb);
for whom the Secretary determines at least 25 percent of payments under this part for covered professional services furnished by such professional during the most recent period for which data are available (which may be less than a year) were attributable to such services furnished under this part through an eligible alternative payment entity; and
who provides to the Secretary such information as is necessary for the Secretary to make a determination under subclause (I), with respect to such professional.
Requirement
For purposes of clause (ii)(I)—
the requirement described in this subclause, with respect to payments described in item (aa) of such clause, is that such payments are made to an eligible alternative payment entity; and
the requirement described in this subclause, with respect to payments described in item (bb) of such clause, is that such payments are made under arrangements in which—
quality measures comparable to measures under the performance category described in section 1395w–4(q)(2)(B)(i) of this title apply;
certified EHR technology is used; and
the eligible professional participates in an entity that—
bears more than nominal financial risk if actual aggregate expenditures exceeds 18
with respect to beneficiaries under subchapter XIX, is a medical home that meets criteria comparable to medical homes expanded under section 1315a(c) of this title.
2027 and 2029 and subsequent years
With respect to 2027 and 2029 and each subsequent year, an eligible professional described in either of the following clauses:
Medicare payment threshold option
Combination all-payer and medicare payment threshold option
An eligible professional—
for whom the Secretary determines, with respect to items and services furnished by such professional during the most recent period for which data are available (which may be less than a year), that at least 75 percent of the sum of—
payments described in clause (i); and
all other payments, regardless of payer (other than payments made by the Secretary of Defense or the Secretary of Veterans Affairs and other than payments made under subchapter XIX in a State in which no medical home or alternative payment model is available under the State program under that subchapter),
meet the requirement described in clause (iii)(I) with respect to payments described in item (aa) and meet the requirement described in clause (iii)(II) with respect to payments described in item (bb);
for whom the Secretary determines at least 25 percent of payments under this part for covered professional services furnished by such professional during the most recent period for which data are available (which may be less than a year) were attributable to such services furnished under this part through an eligible alternative payment entity; and
who provides to the Secretary such information as is necessary for the Secretary to make a determination under subclause (I), with respect to such professional.
Requirement
For purposes of clause (ii)(I)—
the requirement described in this subclause, with respect to payments described in item (aa) of such clause, is that such payments are made to an eligible alternative payment entity; and
the requirement described in this subclause, with respect to payments described in item (bb) of such clause, is that such payments are made under arrangements in which—
quality measures comparable to measures under the performance category described in section 1395w–4(q)(2)(B)(i) of this title apply;
certified EHR technology is used; and
the eligible professional participates in an entity that—
bears more than nominal financial risk if actual aggregate expenditures exceeds 18 expected aggregate expenditures; or
with respect to beneficiaries under subchapter XIX, is a medical home that meets criteria comparable to medical homes expanded under section 1315a(c) of this title.
Use of patient approach
Additional definitions
In this subsection:
Covered professional services
Eligible professional
Alternative payment model (APM)
The term “alternative payment model” means, other than for purposes of subparagraphs (B)(ii)(I)(bb) and (C)(ii)(I)(bb) of paragraph (2), any of the following:
A model under section 1315a of this title (other than a health care innovation award).
The shared savings program under section 1395jjj of this title.
A demonstration under section 1395cc–3 of this title.
A demonstration required by Federal law.
Eligible alternative payment entity
The term “eligible alternative payment entity” means, with respect to a year, an entity that—
participates in an alternative payment model that—
requires participants in such model to use certified EHR technology (as defined in subsection (o)(4)); and
provides for payment for covered professional services based on quality measures comparable to measures under the performance category described in section 1395w–4(q)(2)(B)(i) of this title; and
bears financial risk for monetary losses under such alternative payment model that are in excess of a nominal amount; or
is a medical home expanded under section 1315a(c) of this title.
Limitation
There shall be no administrative or judicial review under section 1395ff of this title, 1395oo 19
The determination that an eligible professional is a qualifying APM participant under paragraph (2) and the determination that an entity is an eligible alternative payment entity under paragraph (3)(D).
The determination of the amount of the 5 percent (or, with respect to 2025, 3.5 percent, or, with respect to 2026, 1.88 percent, or, with respect to 2028, 3.1 percent) payment incentive under paragraph (1)(A), including any estimation as part of such determination.
Medical review of spinal subluxation services
In general
The Secretary shall implement a process for the medical review (as described in paragraph (2)) of treatment by a chiropractor described in section 1395x(r)(5) of this title by means of manual manipulation of the spine to correct a subluxation (as described in such section) of an individual who is enrolled under this part and apply such process to such services furnished on or after
services furnished by a such a 1 chiropractor whose pattern of billing is aberrant compared to peers; and
services furnished by such a chiropractor who, in a prior period, has a services denial percentage in the 85th percentile or greater, taking into consideration the extent that service denials are overturned on appeal.
Medical review
Prior authorization medical review
In general
Ending application of prior authorization medical review
Early request for prior authorization review permitted
Type of review
Relationship to law enforcement activities
No payment without prior authorization
With respect to a service described in paragraph (1) for which prior authorization medical review under this subsection applies, the following shall apply:
Prior authorization determination
Denial of payment
Submission of information
Timeliness
Application of limitation on beneficiary liability
Review by contractors
Multiple services
Construction
Implementation
Authority
Administration
Additional payments for certain rural health clinics with physicians or practitioners receiving data 2000 waivers
In general
Application
Requirements
For purposes of paragraph (1), the requirements described in this paragraph, with respect to a physician or practitioner, are the following:
The physician or practitioner is employed by or working under contract with a rural health clinic described in paragraph (1) that submits an application under paragraph (2).
The physician or practitioner first begins prescribing narcotic drugs in schedule III, IV, or V of section 812 of title 21 for the purpose of maintenance or detoxification treatment on or after
Funding
Specified COVID–19 testing-related services
For purposes of subsection (a)(1)(DD):
Description
In general
A specified COVID–19 testing-related service described in this paragraph is a medical visit that—
is in any of the categories of HCPCS evaluation and management service codes described in subparagraph (B);
is furnished during any portion of the emergency period (as defined in section 1320b–5(g)(1)(B) of this title) (beginning on or after
results in an order for or administration of a clinical diagnostic laboratory test described in section 1395w–22(a)(1)(B)(iv)(IV) of this title; and
relates to the furnishing or administration of such test or to the evaluation of such individual for purposes of determining the need of such individual for such test.
Categories of HCPCS codes
For purposes of subparagraph (A), the categories of HCPCS evaluation and management services codes are the following:
Office and other outpatient services.
Hospital observation services.
Emergency department services.
Nursing facility services.
Domiciliary, rest home, or custodial care services.
Home services.
Online digital evaluation and management services.
Specified outpatient payment provision
A specified outpatient payment provision described in this paragraph is any of the following:
The hospital outpatient prospective payment system under subsection (t).
The physician fee schedule under section 1395w–4 of this title.
The prospective payment system developed under section 1395m(o) of this title.
Section 1395m(g) of this title, with respect to an outpatient critical access hospital service.
The payment basis determined in regulations pursuant to subsection (a)(3) for rural health clinic services.
Special coinsurance rule for certain colorectal cancer screening tests
In general
Specified percent defined
For purposes of paragraph (1), the term “specified percent” means—
for 2022, 80 percent;
for 2023 through 2026, 85 percent; and
for 2027 through 2029, 90 percent.
Source
(Aug. 14, 1935, ch. 531, title XVIII, § 1833, as added Pub. L. 89–97, title I, § 102(a),Notes
Editorial Notes
References in Text
Codification
Amendments
Statutory Notes and Related Subsidiaries
Effective Date of 2025 Amendment
Effective Date of 2022 Amendment
Effective Date of 2021 Amendment
Effective Date of 2020 Amendment
Effective Date of 2016 Amendment
Effective Date of 2015 Amendment
Effective Date of 2012 Amendment
Effective Date of 2010 Amendment
Effective Date of 2008 Amendment
Effective Date of 2006 Amendment
Effective Date of 2003 Amendment
in the case of screening mammography, to services furnished on or after the date of the enactment of this Act [
in the case of diagnostic mammography, to services furnished on or after
Effective Date of 2000 Amendment
by subsection (a) [amending section 1395m of this title] shall apply to services furnished on or after the date of the enactment of BBRA [Pub. L. 106–113, § 1000(a)(6), approved
by subsection (b)(1) [amending this section] shall apply as if included in the enactment of section 403(e)(1) of BBRA (113 Stat. 1501A–371) [Pub. L. 106–113, § 1000(a)(6) [title IV, § 403(e)(1)]]; and
by subsection (b)(2) [amending provisions set out as a note under section 1395m of this title] shall apply as if included in the enactment of section 403(d)(2) of BBRA (113 Stat. 1501A–371) [Pub. L. 106–113, § 1000(a)(6) [title IV, § 403(d)(2)], set out as a note under section 1395m of this title].”
Effective Date of 1999 Amendment
Effective Date of 1997 Amendment
The amendments made by subsections (a)(1), (a)(2), and (b) [amending this section and sections 1395m and 1395y of this title] apply to services furnished on or after
The amendments made by subsections (a)(3) and (c) [amending this section and section 1395cc of this title] apply to services furnished on or after
The amendments made by subsection (d)(1) [amending this section] apply to expenses incurred on or after
Effective Date of 1994 Amendment
Enforcement; miscellaneous and technical amendments.—
The amendments made by subsections (a) and (e) [amending this section and section 1395w–4 of this title] shall apply to services furnished on or after the date of the enactment of this Act [
Practitioners.—
The amendments made by subsection (b) [amending this section and section 1395u of this title] shall apply to services furnished on or after
Effective Date of 1993 Amendment
Effective Date of 1990 Amendment
Effective Date of 1989 Amendment
The amendments made by this section [amending this section and section 1395x of this title] shall apply with respect to therapeutic shoes and inserts furnished on or after
In applying the amendments made by this section, the increase under subparagraph (C) of section 1833(o)(2) of the Social Security Act [42 U.S.C. 1395l(o)(2)(C)] shall apply to the dollar amounts specified under subparagraph (A) of such section (as amended by this section) in the same manner as the increase would have applied to the dollar amounts specified under subparagraph (A) of such section (as in effect before the date of the enactment of this Act [
Effective Date of 1988 Amendment
Effective Date of 1987 Amendment
Effective Date of 1986 Amendment
The amendments made by subsection (a)(1) [amending this section] shall apply to cost reporting periods beginning on or after
The amendments made by subsections (b)(1) and (c) [amending this section and sections 1395y and 1395cc of this title] shall apply to services furnished after
The Secretary of Health and Human Services shall first provide, under the amendment made by subsection (b)(2) [amending this section], for the review and update of procedure lists within 6 months after the date of the enactment of this Act [
The amendments made by subsection (d) [amending section 1320c–3 of this title] shall apply to contracts entered into or renewed after
The amendments made by paragraphs (1) and (2) [amending this section] shall apply to clinical diagnostic laboratory tests performed on or after
The amendment made by paragraph (3) [amending this section] shall apply to clinical diagnostic laboratory tests performed on or after
Effective Date of 1984 Amendment
Except as provided in paragraphs (2) and (3), the amendments made by this section [amending this section and sections 1395u, 1395cc, 1396a, and 1396b of this title and enacting provisions set out as notes under this section and section 1395u of this title] shall apply to clinical diagnostic laboratory tests furnished on or after
The amendments made by subsection (g)(2) [amending section 1396b of this title] shall apply to payments for calendar quarters beginning on or after
The amendments made by this section shall not apply to clinical diagnostic laboratory tests furnished to inpatients of a provider operating under a waiver granted pursuant to section 602(k) of the Social Security Amendments of 1983 [section 602(k) of Pub. L. 98–21, set out as a note under section 1395y of this title]. Payment for such services shall be made under part B of title XVIII of the Social Security Act [42 U.S.C. 1395j et seq.] at 80 percent (or 100 percent in the case of such tests for which payment is made on the basis of an assignment described in section 1842(b)(3)(B)(ii) of the Social Security Act [42 U.S.C. 1395u(b)(3)(B)(ii)] or under the procedure described in section 1870(f)(1) of such Act [42 U.S.C. 1395gg(f)(1)]) of the reasonable charge for such service. The deductible under section 1833(b) of such Act [42 U.S.C. 1395l(b)] shall not apply to such tests if payment is made on the basis of such an assignment or procedure.”
Effective Date of 1982 Amendment
Effective Date of 1981 Amendment
Effective Date of 1980 Amendment
Effective Date of 1978 Amendment
Effective Date of 1977 Amendment
Effective Date of 1972 Amendment
Effective Date of 1968 Amendment
Construction of 2008 Amendment
Construction Regarding Limiting Increases in Cost-Sharing
Medication-Induced Movement Disorder Outreach and Education
Implementation of 2022 Amendment
Provider Outreach and Reporting on Certain Behavioral Health Integration Services
Outreach.—
The Secretary of Health and Human Services (in this section referred to as the ‘Secretary’) shall conduct outreach to physicians and appropriate non-physician practitioners participating under the Medicare program under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) with respect to behavioral health integration services described by any of HCPCS codes 99492 through 99494 or 99484 (or any successor code). Such outreach shall include a comprehensive, one-time education initiative to inform such physicians and practitioners of the inclusion of such services as a covered benefit under the Medicare program, including describing the requirements to bill for such codes and the requirements for beneficiary eligibility for such services.
Reports to Congress.—
Provider outreach.—
Not later than 1 year after the date of the completion of the education initiative described in subsection (a), the Secretary shall submit to the Committee on Ways and Means and the Committee on Energy and Commerce of the House of Representatives and the Committee on Finance of the Senate a report on the outreach conducted under such subsection. Such report shall include a description of the methods used for such outreach.
Utilization rates.—
Not later than 18 months after the date of the completion of the education initiative described in subsection (a), and two years thereafter, the Secretary shall submit to the Committee on Ways and Means and the Committee on Energy and Commerce of the House of Representatives and the Committee on Finance of the Senate a report on the number of Medicare beneficiaries (including those beneficiaries accessing services in rural and underserved areas) who, during the preceding year, were furnished services described in subsection (a) for which payment was made under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.).”
Outreach and Reporting on Opioid Use Disorder Treatment Services Furnished by Opioid Treatment Programs
Outreach.—
Provider outreach.—
The Secretary of Health and Human Services (in this section referred to as the ‘Secretary’) shall conduct outreach to physicians and appropriate non-physician practitioners participating under the Medicare program under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) with respect to opioid use disorder treatment services furnished by an opioid treatment program (as defined in section 1861(jjj) of the Social Security Act (42 U.S.C. 1395x(jjj))). Such outreach shall include a comprehensive, one-time education initiative to inform such physicians and practitioners of the inclusion of such services as a covered benefit under the Medicare program, including describing the requirements for billing and the requirements for beneficiary eligibility for such services.
Beneficiary outreach.—
The Secretary shall conduct outreach to Medicare beneficiaries with respect to opioid use disorder treatment services furnished by an opioid treatment program (as defined in section 1861(jjj) of the Social Security Act (42 U.S.C. 1395x(jjj))), including a comprehensive, one-time education initiative informing such beneficiaries about the eligibility requirements to receive such services.
Reports to Congress.—
Outreach.—
Not later than 1 year after the date of the completion of the education initiatives described in subsection (a), the Secretary shall submit to the Committee on Ways and Means and the Committee on Energy and Commerce of the House of Representatives and the Committee on Finance of the Senate a report on the outreach conducted under such subsection. Such report shall include a description of the methods used for such outreach.
Utilization rates.—
Not later than 18 months after the date of the completion of the education initiatives described in subsection (a), and two years thereafter, the Secretary shall submit to the Committee on Ways and Means and the Committee on Energy and Commerce of the House of Representatives and the Committee on Finance of the Senate a report on the number of Medicare beneficiaries who, during the preceding year, were furnished opioid use disorder treatment services by an opioid treatment program (as defined in section 1861(jjj) of the Social Security Act (42 U.S.C. 1395x(jjj))) for which payment was made under title XVIII of such Act (42 U.S.C. 1395 et seq.).”
Centers for Medicare & Medicaid Services Provider Outreach and Reporting on Cognitive Assessment and Care Plan Services
Outreach.—
The Secretary of Health and Human Services (in this section referred to as the ‘Secretary’) shall conduct outreach to physicians and appropriate non-physician practitioners participating under the Medicare program under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) with respect to Medicare payment for cognitive assessment and care plan services furnished to individuals with cognitive impairment such as Alzheimer’s disease and related dementias, identified as of
Reports.—
HHS report on provider outreach.—
Not later than one year after the date of enactment of this Act [
GAO report on utilization rates.—
Not later than 3 years after such date of enactment, the Comptroller General of the United States shall submit to the Committee on Ways and Means and the Committee on Energy and Commerce of the House of Representatives and the Committee on Finance of the Senate a report on the number of Medicare beneficiaries who were furnished cognitive assessment and care plan services for which payment was made under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.). Such report shall include information on barriers Medicare beneficiaries face to access such services, and recommendations for such legislative and administrative action as the Comptroller General deems appropriate.”
Implementation of 2020 Amendment
Claims Modifier
Implementation of Provisions of Pub. L. 116–127
Implementation of 2019 Amendment
Implementation of 2018 Amendment
Improving Documentation of Services
In general.—
The Secretary of Health and Human Services shall, in consultation with stakeholders (including the American Chiropractic Association) and representatives of medicare administrative contractors (as defined in section 1874A(a)(3)(A) of the Social Security Act (42 U.S.C. 1395kk–1(a)(3)(A))), develop educational and training programs to improve the ability of chiropractors to provide documentation to the Secretary of services described in section 1861(r)(5) [42 U.S.C. 1395x(r)(5)] in a manner that demonstrates that such services are, in accordance with section 1862(a)(1) of such Act (42 U.S.C. 1395y(a)(1)), reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.
Timing.—
The Secretary shall make the educational and training programs described in paragraph (1) publicly available not later than
Funding.—
The Secretary shall use funds made available under paragraph (10) of section 1893(h) of the Social Security Act (42 U.S.C. 1395ddd(h)), as added by section 505, to carry out this subsection.”
Medicare Patient IVIG Access Demonstration Project
Establishment.—
The Secretary shall establish and implement a demonstration project under part B of title XVIII of the Social Security Act [42 U.S.C. 1395j et seq.] to evaluate the benefits of providing payment for items and services needed for the in-home administration of intravenous immune globin for the treatment of primary immune deficiency diseases.
Duration and Scope.—
Duration.—
Beginning not later than one year after the date of enactment of this Act [
if the date of enactment of the Disaster Tax Relief and Airport and Airway Extension Act of 2017 is on or before
if the date of enactment of such Act is after
Scope.—
The Secretary shall enroll for participation in the demonstration project for the period beginning on
Coverage.—
Except as otherwise provided in this section, items and services for which payment may be made under the demonstration program shall be treated and covered under part B of title XVIII of the Social Security Act in the same manner as similar items and services covered under such part.
Payment.—
The Secretary shall establish a per visit payment amount for items and services needed for the in-home administration of intravenous immune globin based on the national per visit low-utilization payment amount under the prospective payment system for home health services established under section 1895 of the Social Security Act (42 U.S.C. 1395fff).
Waiver Authority.—
The Secretary may waive such requirements of title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.] as may be necessary to carry out the demonstration project.
Study and Report to Congress.—
Interim evaluation and report.—
Not later than three years after the date of enactment of this Act, the Secretary shall submit to Congress a report that contains an interim evaluation of the impact of the demonstration project on access for Medicare beneficiaries to items and services needed for the in-home administration of intravenous immune globin.
Updated evaluation and report.—
Not later than 2 years after the date of the enactment of [the] Consolidated Appropriations Act, 2021 [
The total number of beneficiaries enrolled in the demonstration project during the updated report period.
The total number of claims submitted for services during the updated report period, disaggregated by month.
An analysis of the impact of the demonstration on beneficiary access to the in-home administration of intravenous immune globin, including the impact on beneficiary health.
An analysis of the impact of in-home administration of intravenous immune globin on overall costs to Medicare, including the cost differential between in-home administration of intravenous immune globin and administration of intravenous immune globin in a healthcare facility.
To the extent practicable, a survey of providers and enrolled beneficiaries that participated in the demonstration project that identifies barriers to accessing services, including reimbursement for items and services.
Recommendations to Congress on the appropriateness of establishing a permanent bundled services payment for the in-home administration of intravenous immune globin for Medicare beneficiaries.
Final evaluation and report.—
Not later than one year after the date of completion of the demonstration project, the Secretary shall submit to Congress a report that contains the following:
A final evaluation of the impact of the demonstration project on access for Medicare beneficiaries to items and services needed for the in-home administration of intravenous immune globin.
An analysis of the appropriateness of implementing a new methodology for payment for intravenous immune globulins in all care settings under part B of title XVIII of the Social Security Act (42 U.S.C. 1395k [1395j] et seq.).
An update to the report entitled ‘Analysis of Supply, Distribution, Demand, and Access Issues Associated with Immune Globulin Intravenous (IGIV)’, issued in February 2007 by the Office of the Assistant Secretary for Planning and Evaluation of the Department of Health and Human Services.
Funding.—
There shall be made available to the Secretary to carry out the demonstration project not more than $45,000,000 from the Federal Supplementary Medical Insurance Trust Fund under section 1841 of the Social Security Act (42 U.S.C. 1395t).
Definitions.—
In this section:
Demonstration project.—
The term ‘demonstration project’ means the demonstration project conducted under this section.
Medicare beneficiary.—
The term ‘Medicare beneficiary’ means an individual who is enrolled for benefits under part B of title XVIII of the Social Security Act.
Secretary.—
The term ‘Secretary’ means the Secretary of Health and Human Services.
Updated report period.—
The term ‘updated report period’ means the period beginning on
Implementation of 2013 Amendment
Implementation of 2012 Amendment
Collection of Additional Data
Strategy.—
The Secretary of Health and Human Services shall implement, beginning on
Consultation.—
In proposing and implementing such strategy, the Secretary shall consult with relevant stakeholders.”
Treatment of Certain Complex Diagnostic Laboratory Tests
Demonstration Project.—
In general.—
The Secretary of Health and Human Services (in this section referred to as the ‘Secretary’) shall conduct a demonstration project under part B [of] title XVIII of the Social Security Act [42 U.S.C. 1395j et seq.] under which separate payments are made under such part for complex diagnostic laboratory tests provided to individuals under such part. Under the demonstration project, the Secretary shall establish appropriate payment rates for such tests.
Covered complex diagnostic laboratory test defined.—
In this section, the term ‘complex diagnostic laboratory test’ means a diagnostic laboratory test—
that is an analysis of gene protein expression, topographic genotyping, or a cancer chemotherapy sensitivity assay;
that is determined by the Secretary to be a laboratory test for which there is not an alternative test having equivalent performance characteristics;
which is billed using a Health Care Procedure Coding System (HCPCS) code other than a not otherwise classified code under such Coding System;
which is approved or cleared by the Food and Drug Administration or is covered under title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.]; and
is described in section 1861(s)(3) of the Social Security Act (42 U.S.C. 1395x(s)(3)).
Separate payment defined.—
In this section, the term ‘separate payment’ means direct payment to a laboratory (including a hospital-based or independent laboratory) that performs a complex diagnostic laboratory test with respect to a specimen collected from an individual during a period in which the individual is a patient of a hospital if the test is performed after such period of hospitalization and if separate payment would not otherwise be made under title XVIII of the Social Security Act by reason of sections 1862(a)(14) and 1866(a)(1)(H)(i) of the such [sic] Act (42 U.S.C. 1395y(a)(14); 42 U.S.C. 1395cc(a)(1)(H)(i)).
Duration.—
Subject to subsection (c)(2), the Secretary shall conduct the demonstration project under this section for the 2-year period beginning on
Payments and Limitation.—
Payments under the demonstration project under this section shall—
be made from the Federal Supplemental [probably should be “Supplementary”] Medical Insurance Trust Fund under section 1841 of the Social Security Act (42 U.S.C. 1395t); and
may not exceed $100,000,000.
Report.—
Not later than 2 years after the completion of the demonstration project under this section, the Secretary shall submit to Congress a report on the project. Such report shall include—
an assessment of the impact of the demonstration project on access to care, quality of care, health outcomes, and expenditures under title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.] (including any savings under such title); and
such recommendations as the Secretary determines appropriate.
Implementation Funding.—
For purposes of administering this section (including preparing and submitting the report under subsection (d)), the Secretary shall provide for the transfer, from the Federal Supplemental [probably should be “Supplementary”] Medical Insurance Trust Fund under section 1841 of the Social Security Act (42 U.S.C. 1395t), to the Centers for Medicare & Medicaid Services Program Management Account, of $5,000,000. Amounts transferred under the preceding sentence shall remain available until expended.”
Treatment of Certified Registered Nurse Anesthetists
is consistent with the adjustments made by the special rule for teaching anesthesiologists under section 1848(a)(6) of the Social Security Act [42 U.S.C. 1395w–4(a)(6)], as added by subsection (a); and
maintains the existing payment differences between teaching anesthesiologists and teaching certified registered nurse anesthetists.”
Implementation of 2006 Amendment
Implementation of Clinically Appropriate Code Edits In Order To Identify and Eliminate Improper Payments for Therapy Services
Application of 2003 Amendment to Physician Specialties
GAO Study of Medicare Payment for Inhalation Therapy
Treatment of Certain Clinical Diagnostic Laboratory Tests Furnished to Hospital Outpatients in Certain Rural Areas
In General.—
Notwithstanding subsections (a), (b), and (h) of section 1833 of the Social Security Act (42 U.S.C. 1395l) and section 1834(d)(1) of such Act (42 U.S.C. 1395m(d)(1)), in the case of a clinical diagnostic laboratory test covered under part B of title XVIII of such Act [42 U.S.C. 1395j et seq.] that is furnished during a cost reporting period described in subsection (b) by a hospital with fewer than 50 beds that is located in a qualified rural area (identified under paragraph (12)(B)(iii) of section 1834(l) of the Social Security Act (42 U.S.C. 1395m(l)), as added by section 414(c)) as part of outpatient services of the hospital, the amount of payment for such test shall be 100 percent of the reasonable costs of the hospital in furnishing such test.
Application.—
A cost reporting period described in this subsection is a cost reporting period beginning during the period beginning on
Provision as Part of Outpatient Hospital Services.—
For purposes of subsection (a), in determining whether clinical diagnostic laboratory services are furnished as part of outpatient services of a hospital, the Secretary [of Health and Human Services] shall apply the same rules that are used to determine whether clinical diagnostic laboratory services are furnished as an outpatient critical access hospital service under section 1834(g)(4) of the Social Security Act (42 U.S.C. 1395m(g)(4)).”
GAO Report on Payments for Brachytherapy Devices
Moratorium on Physical Therapy Services Caps in 2003
Prompt Submission of Overdue Reports on Payment and Utilization of Outpatient Therapy Services
GAO Study of Ambulatory Surgical Center Payments
Study.—
In general.—
The Comptroller General of the United States shall conduct a study that compares the relative costs of procedures furnished in ambulatory surgical centers to the relative costs of procedures furnished in hospital outpatient departments under section 1833(t) of the Social Security Act (42 U.S.C. 1395l(t)). The study shall also examine how accurately ambulatory payment categories reflect procedures furnished in ambulatory surgical centers.
Consideration of asc data.—
In conducting the study under paragraph (1), the Comptroller General shall consider data submitted by ambulatory surgical centers regarding the matters described in clauses (i) through (iii) of paragraph (2)(B).
Report and recommendations.—
Report.—
Not later than
Recommendations.—
The report submitted under subparagraph (A) shall include recommendations on the following matters:
The appropriateness of using the groups of covered services and relative weights established under the outpatient prospective payment system as the basis of payment for ambulatory surgical centers.
If the relative weights under such hospital outpatient prospective payment system are appropriate for such purpose—
whether the payment rates for ambulatory surgical centers should be based on a uniform percentage of the payment rates or weights under such outpatient system; or
whether the payment rates for ambulatory surgical centers should vary, or the weights should be revised, based on specific procedures or types of services (such as ophthalmology and pain management services).
Whether a geographic adjustment should be used for payment of services furnished in ambulatory surgical centers, and if so, the labor and nonlabor shares of such payment.”
Demonstration Project for Coverage of Certain Prescription Drugs and Biologicals
Demonstration Project.—
The Secretary [of Health and Human Services] shall conduct a demonstration project under part B of title XVIII of the Social Security Act [42 U.S.C. 1395j et seq.] under which payment is made for drugs or biologicals that are prescribed as replacements for drugs and biologicals described in section 1861(s)(2)(A) or 1861(s)(2)(Q) of such Act (42 U.S.C. 1395x(s)(2)(A), 1395x(s)(2)(Q)), or both, for which payment is made under such part. Such project shall provide for cost-sharing applicable with respect to such drugs or biologicals in the same manner as cost-sharing applies with respect to part D [part D of this subchapter] drugs under standard prescription drug coverage (as defined in section 1860D–2(b) of the Social Security Act [42 U.S.C. 1395w–102(b)], as added by section 101(a)).
Demonstration Project Sites.—
The project established under this section shall be conducted in sites selected by the Secretary.
Duration.—
The Secretary shall conduct the demonstration project for the 2-year period beginning on the date that is 90 days after the date of the enactment of this Act [
Limitation.—
Under the demonstration project over the duration of the project, the Secretary may not provide—
coverage for more than 50,000 patients; and
more than $500,000,000 in funding.
Report.—
Not later than
Payment for Pancreatic Islet Cell Investigational Transplants for Medicare Beneficiaries in Clinical Trials
Clinical Trial.—
In general.—
The Secretary [of Health and Human Services], acting through the National Institute of Diabetes and Digestive and Kidney Disorders, shall conduct a clinical investigation of pancreatic islet cell transplantation which includes medicare beneficiaries.
Authorization of appropriations.—
There are authorized to be appropriated to the Secretary such sums as may be necessary to conduct the clinical investigation under paragraph (1).
Medicare Payment.—
Not earlier than
Scope of Payment.—
For purposes of subsection (b):
The term ‘routine costs’ means reasonable and necessary routine patient care costs (as defined in the Centers for Medicare & Medicaid Services Coverage Issues Manual, section 30–1), including immunosuppressive drugs and other followup care.
The term ‘transplantation and appropriate related items and services’ means items and services related to the acquisition and delivery of the pancreatic islet cell transplantation, notwithstanding any national noncoverage determination contained in the Centers for Medicare & Medicaid Services Coverage Issues Manual.
The term ‘medicare beneficiary’ means an individual who is entitled to benefits under part A of title XVIII of the Social Security Act [42 U.S.C. 1395c et seq.], or enrolled under part B of such title [42 U.S.C. 1395j et seq.], or both.
Construction.—
The provisions of this section shall not be construed—
to permit payment for partial pancreatic tissue or islet cell transplantation under title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.] other than payment as described in subsection (b); or
as authorizing or requiring coverage or payment conveying—
benefits under part A of such title [42 U.S.C. 1395c et seq.] to a beneficiary not entitled to such part A; or
benefits under part B of such title [42 U.S.C. 1395j et seq.] to a beneficiary not enrolled in such part B.”
GAO Study of Reduction in Medigap Premium Levels Resulting From Reductions in Coinsurance
MedPAC Study on Low-Volume, Isolated Rural Health Care Providers
Study.—
The Medicare Payment Advisory Commission shall conduct a study on the effect of low patient and procedure volume on the financial status of low-volume, isolated rural health care providers participating in the medicare program under title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.].
Report.—
Not later than 18 months after the date of the enactment of this Act [
whether low-volume, isolated rural health care providers are having, or may have, significantly decreased medicare margins or other financial difficulties resulting from any of the payment methodologies described in subsection (c);
whether the status as a low-volume, isolated rural health care provider should be designated under the medicare program and any criteria that should be used to qualify for such a status; and
any changes in the payment methodologies described in subsection (c) that are necessary to provide appropriate reimbursement under the medicare program to low-volume, isolated rural health care providers (as designated pursuant to paragraph (2)).
Payment Methodologies Described.—
The payment methodologies described in this subsection are the following:
The prospective payment system for hospital outpatient department services under section 1833(t) of the Social Security Act (42 U.S.C. 1395l(t)).
The fee schedule for ambulance services under section 1834(l) of such Act (42 U.S.C. 1395m(l)).
The prospective payment system for inpatient hospital services under section 1886 of such Act (42 U.S.C. 1395ww).
The prospective payment system for routine service costs of skilled nursing facilities under section 1888(e) of such Act (42 U.S.C. 1395yy(e)).
The prospective payment system for home health services under section 1895 of such Act (42 U.S.C. 1395fff).”
Special Rule for Payment for 2001
for services furnished on or after
for services furnished on or after
Transition Provisions Applicable to Subsection (t)(6)(B)
In general.—
In the case of a medical device provided as part of a service (or group of services) furnished during the period before initial categories are implemented under subparagraph (B)(i) of section 1833(t)(6) of the Social Security Act [42 U.S.C. 1395l(t)(6)(B)(i)] (as amended by subsection (a)), payment shall be made for such device under such section in accordance with the provisions in effect before the date of the enactment of this Act [
Application of current process.—
Notwithstanding any other provision of law, the Secretary shall continue to accept applications with respect to medical devices under the process established pursuant to paragraph (6) of section 1833(t) of the Social Security Act [42 U.S.C. 1395l(t)(6)] (as in effect on the day before the date of the enactment of this Act [
with respect to which an application was submitted (pursuant to such process) on or before such date; and
that meets the requirements of clause (ii) or (iv) of subparagraph (A) of such paragraph (as determined pursuant to such process),
shall be treated as a device with respect to which an initial category is required to be established under subparagraph (B)(i) of such paragraph (as amended by subsection (a)(2)).”
Study on Standards for Supervision of Physical Therapist Assistants
Delay in Implementation of Prospective Payment System for Ambulatory Surgical Centers
MedPAC Study and Report on Medicare Reimbursement for Services Provided by Certain Providers
Study.—
The Medicare Payment Advisory Commission shall conduct a study on the appropriateness of the current payment rates under the medicare program under title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.] for services provided by a—
certified nurse-midwife (as defined in subsection (gg)(2) of section 1861 of such Act (42 U.S.C. 1395x));
physician assistant (as defined in subsection (aa)(5)(A) of such section);
nurse practitioner (as defined in such subsection); and
clinical nurse specialist (as defined in subsection (aa)(5)(B) of such section).
The study shall separately examine the appropriateness of such payment rates for orthopedic physician assistants, taking into consideration the requirements for accreditation, training, and education.
Report.—
Not later than 18 months after the date of the enactment of this Act [
MedPAC Study on Access to Outpatient Pain Management Services
Study.—
The Medicare Payment Advisory Commission shall conduct a study on the barriers to coverage and payment for outpatient interventional pain medicine procedures under the medicare program under title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.]. Such study shall examine—
the specific barriers imposed under the medicare program on the provision of pain management procedures in hospital outpatient departments, ambulatory surgery centers, and physicians’ offices; and
the consistency of medicare payment policies for pain management procedures in those different settings.
Report.—
Not later than 1 year after the date of the enactment of this Act [
Establishment of Coding and Payment Procedures for New Clinical Diagnostic Laboratory Tests and Other Items on a Fee Schedule
Report on Procedures Used for Advanced, Improved Technologies
Congressional Intention Regarding Base Amounts in Applying HOPD PPS
Study and Report to Congress Regarding Special Treatment of Rural and Cancer Hospitals in Prospective Payment System for Hospital Outpatient Department Services
Study.—
In general.—
The Medicare Payment Advisory Commission (referred to in this section as ‘MedPAC’) shall conduct a study to determine the appropriateness (and the appropriate method) of providing payments to hospitals described in paragraph (2) for covered OPD services (as defined in paragraph (1)(B) of section 1833(t) of the Social Security Act (42 U.S.C. 1395l(t))) based on the prospective payment system established by the Secretary in accordance with such section.
Hospitals described.—
The hospitals described in this paragraph are the following:
A medicare-dependent, small rural hospital (as defined in section 1886(d)(5)(G)(iv) of the Social Security Act (42 U.S.C. 1395ww(d)(5)(G)(iv))).
A sole community hospital (as defined in section 1886(d)(5)(D)(iii) of such Act (42 U.S.C. 1395ww(d)(5)(D)(iii))).
Rural health clinics (as defined in section 1861(aa)(2) of such Act (42 U.S.C. 1395x(aa)(2)).
Rural referral centers (as so classified under section 1886(d)(5)(C) of such Act (42 U.S.C. 1395ww(d)(5)(C)).
Any other rural hospital with not more than 100 beds.
Any other rural hospital that the Secretary determines appropriate.
A hospital described in section 1886(d)(1)(B)(v) of such Act (42 U.S.C. 1395ww(d)(1)(B)(v)).
Report.—
Not later than 2 years after the date of the enactment of this Act [
Comments.—
Not later than 60 days after the date on which MedPAC submits the report under subsection (b) to the Secretary of Health and Human Services, the Secretary shall submit comments on such report to Congress.”
GAO Study on Resources Required To Provide Safe and Effective Outpatient Cancer Therapy
Study.—
The Comptroller General of the United States shall conduct a nationwide study to determine the physician and non-physician clinical resources necessary to provide safe outpatient cancer therapy services and the appropriate payment rates for such services under the medicare program. In making such determination, the Comptroller General shall—
determine the adequacy of practice expense relative value units associated with the utilization of those clinical resources;
determine the adequacy of work units in the practice expense formula; and
assess various standards to assure the provision of safe outpatient cancer therapy services.
Report to Congress.—
The Comptroller General shall submit to Congress a report on the study conducted under subsection (a). The report shall include recommendations regarding practice expense adjustments to the payment methodology under part B of title XVIII of the Social Security Act [42 U.S.C. 1395j et seq.], including the development and inclusion of adequate work units to assure the adequacy of payment amounts for safe outpatient cancer therapy services. The study shall also include an estimate of the cost of implementing such recommendations.”
Focused Medical Reviews of Claims During Moratorium Period
Study and Report on Utilization
Study.—
In general.—
The Secretary of Health and Human Services shall conduct a study which compares—
utilization patterns (including nationwide patterns, and patterns by region, types of settings, and diagnosis or condition) of outpatient physical therapy services, outpatient occupational therapy services, and speech-language pathology services that are covered under the medicare program under title XVIII of the Social Security Act (42 U.S.C. 1395) [42 U.S.C. 1395 et seq.] and provided on or after
such patterns for such services that were provided in 1998 and 1999.
Review of claims.—
In conducting the study under this subsection the Secretary of Health and Human Services shall review a statistically significant number of claims for reimbursement for the services described in subparagraph (A).
Report.—
Not later than
Phase-in of PPS for Ambulatory Surgical Centers
“If the Secretary of Health and Human Services implements a revised prospective payment system for services of ambulatory surgical facilities under section 1833(i) of the Social Security Act (42 U.S.C. 1395l(i)), prior to incorporating data from the 1999 Medicare cost survey or a subsequent cost survey, such system shall be implemented in a manner so that—
in the first year of its implementation, only a proportion (specified by the Secretary and not to exceed one-fourth) of the payment for such services shall be made in accordance with such system and the remainder shall be made in accordance with current regulations; and
in each of the following 2 years a proportion (specified by the Secretary and not to exceed one-half and three-fourths, respectively) of the payment for such services shall be made under such system and the remainder shall be made in accordance with current regulations.
By not later than
MedPAC Study on Postsurgical Recovery Care Center Services
In general.—
The Medicare Payment Advisory Commission shall conduct a study on the cost-effectiveness and efficacy of covering under the medicare program under title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.] services of a post-surgical recovery care center (that provides an intermediate level of recovery care following surgery). In conducting such study, the Commission shall consider data on these centers gathered in demonstration projects.
Report.—
Not later than 1 year after the date of the enactment of this Act [Nov. 29,1999], the Commission shall submit to Congress a report on such study and shall include in the report recommendations on the feasibility, costs, and savings of covering such services under the medicare program.”
Medicare Reimbursement for Telehealth Services
In General.—
For services furnished on and after
Methodology for Determining Amount of Payments.—
Taking into account the findings of the report required under section 192 of the Health Insurance Portability and Accountability Act of 1996 (Public Law 104–191; 110 Stat. 1988), the findings of the report required under paragraph (c), and any other findings related to the clinical efficacy and cost-effectiveness of telehealth applications, the Secretary shall establish a methodology for determining the amount of payments made under subsection (a) within the following parameters:
The payment shall [be] shared between the referring physician or practitioner and the consulting physician or practitioner. The amount of such payment shall not be greater than the current fee schedule of the consulting physician or practitioner for the health care services provided.
The payment shall not include any reimbursement for any telephone line charges or any facility fees, and a beneficiary may not be billed for any such charges or fees.
The payment shall be made subject to the coinsurance and deductible requirements under subsections (a)(1) and (b) of section 1833 of the Social Security Act (42 U.S.C. 1395l).
The payment differential of section 1848(a)(3) of such Act (42 U.S.C. 1395w–4(a)(3)) shall apply to services furnished by non-participating physicians. The provisions of section 1848(g) of such Act (42 U.S.C. 1395w–4(g)) and section 1842(b)(18) of such Act (42 U.S.C. 1395u(b)(18)) shall apply. Payment for such service shall be increased annually by the update factor for physicians’ services determined under section 1848(d) of such Act (42 U.S.C. 1395w–4(d)).
Supplemental Report.—
Not later than
how telemedicine and telehealth systems are expanding access to health care services;
the clinical efficacy and cost-effectiveness of telemedicine and telehealth applications;
the quality of telemedicine and telehealth services delivered; and
the reasonable cost of telecommunications charges incurred in practicing telemedicine and telehealth in rural, frontier, and underserved areas.
Expansion of Telehealth Services for Certain Medicare Beneficiaries.—
In general.—
Not later than
Beneficiary described.—
A beneficiary described in this paragraph is a beneficiary under the medicare program under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) who does not reside in a rural area (as so defined) that is designated as a health professional shortage area under section 332(a)(1)(A) of the Public Health Service Act (42 U.S.C. 254e(a)(1)(A)), who is homebound or nursing homebound, and for whom being transferred for health care services imposes a serious hardship.
Report.—
The report described in paragraph (1) shall contain a detailed statement of the potential costs and savings to the medicare program of making the payments described in that paragraph using various reimbursement schemes.”
Report on Coverage of Outpatient Occupational Therapy Services
“Not later than
the establishment of a mechanism for assuring appropriate utilization of outpatient physical therapy services, outpatient occupational therapy services, and speech-language pathology services that are covered under the medicare program under title XVIII of the Social Security Act (42 U.S.C. 1395) [42 U.S.C. 1395 et seq.]; and
the establishment of an alternative payment policy for such services based on classification of individuals by diagnostic category, functional status, prior use of services (in both inpatient and outpatient settings), and such other criteria as the Secretary determines appropriate, in place of the uniform dollar limitations specified in section 1833(g) of such Act [42 U.S.C. 1395l(g)], as amended by paragraph (1).
The recommendations shall include how such a mechanism or policy might be implemented in a budget-neutral manner.”
Study and Report on Clinical Laboratory Tests
Adjustments to Payment Amounts for New Technology Intraocular Lenses
Establishment of process for review of amounts.—
Not later than 1 year after the date of the enactment of this Act [
Factors considered.—
In determining whether to provide an adjustment of payment with respect to a particular lens under paragraph (1), the Secretary shall take into account whether use of the lens is likely to result in reduced risk of intraoperative or postoperative complication or trauma, accelerated postoperative recovery, reduced induced astigmatism, improved postoperative visual acuity, more stable postoperative vision, or other comparable clinical advantages.
Notice and comment.—
The Secretary shall publish notice in the Federal Register from time to time (but no less often than once each year) of a list of the requests that the Secretary has received for review under this subsection, and shall provide for a 30-day comment period on the lenses that are the subjects of the requests contained in such notice. The Secretary shall publish a notice of the Secretary’s determinations with respect to intraocular lenses listed in the notice within 90 days after the close of the comment period.
Effective date of adjustment.—
Any adjustment of a payment amount (or payment limit) made under this subsection shall become effective not later than 30 days after the date on which the notice with respect to the adjustment is published under paragraph (3).”
Study of Medicare Coverage of Patient Care Costs Associated With Clinical Trials of New Cancer Therapies
Study of Annual Cap on Amount of Medicare Payment for Outpatient Physical Therapy and Occupational Therapy Services
Ambulatory Surgical Center Services; Inflation Update
Freeze in Allowance for Intraocular Lenses
Reduction in Payments Under Part B During Final Two Months of 1990
In General.—
Notwithstanding any other provision of law (including any other provision of this Act, other than subsection (b)(4)), payments under part B of title XVIII of the Social Security Act [42 U.S.C. 1395j et seq.] for items and services furnished during the period beginning on
Special Rules for Application of Reduction.—
Payment on the basis of cost reporting periods.—
In the case in which payment for services of a provider of services is made under part B of such title on a basis relating to the reasonable cost incurred for the services during a cost reporting period of the provider, the reduction made under subsection (a) shall be applied to payment for costs for such services incurred at any time during each cost reporting period of the provider any part of which occurs during the period described in such subsection, but only in the same proportion as the fraction of the cost reporting period that occurs during such period.
No increase in beneficiary charges in assignment-related cases.—
If a reduction in payment amounts is made under subsection (a) for items or services for which payment under part B of such title is made on an assignment-related basis (as defined in section 1842(i)(1) of the Social Security Act [42 U.S.C. 1395u(i)(1)]), the person furnishing the items or services shall be considered to have accepted payment of the reasonable charge for the items or services, less any reduction in payment amount made under subsection (a), as payment in full.
Treatment of payments to health maintenance organizations.—
Subsection (a) shall not apply to payments under risk-sharing contracts under section 1876 of the Social Security Act [42 U.S.C. 1395mm] or under similar contracts under section 402 of the Social Security Amendments of 1967 [Pub. L. 90–248, enacting section 1395b–1 of this title and amending section 1395ll of this title] or section 222 of the Social Security Amendments of 1972 [Pub. L. 92–603, amending sections 1395b–1 and 1395ll of this title and enacting provisions set out as a note under section 1395b–1 of this title].”
Effect on State Law
Development of Criteria Regarding Consultation With a Physician
Study of Reimbursement for Ambulance Services
PROPAC Study of Payments for Services in Hospital Outpatient Departments
Budget Neutrality
Adjustment of Contracts With Prepaid Health Plans
Study and Report to Congress Respecting Incentive Payments for Physicians’ Services Furnished in Underserved Areas
Fee Schedules for Physician Pathology Services
Applying Copayment and Deductible to Certain Outpatient Physicians’ Services
Other Physician Payment Studies
Study of Payment for Chemotherapy in Physicians’ Offices
Clinical Diagnostic Laboratory Tests; Limitation on Changes in Fee Schedules
GAO Study of Fee Schedules
Amounts Paid for Independent Rural Health Clinic Services
Report on Establishment of National Fee Schedules for Payment of Clinical Diagnostic Laboratory Tests
State Standards for Directors of Clinical Laboratories
In general.—
If a State (as defined for purposes of title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.]) provides for the licensing or other standards with respect to the operation of clinical laboratories (including such laboratories in hospitals) in the State under which such a laboratory may be directed by an individual with certain qualifications, nothing in such title shall be construed as authorizing the Secretary of Health and Human Services to require such a laboratory, as a condition of payment or participation under such title, to be directed by an individual with other qualifications.
Effective date.—
Paragraph (1) shall take effect on
Transitional Provisions for Payment of Fees for Clinical Diagnostic Laboratory Tests
shall take effect on
shall apply for the 12-month period beginning on that date, and
shall take into account the percentage increase or decrease in the Consumer Price Index for all urban consumers (United States city average) occurring over an 18-month period, rather than over a 12-month period.”
Extension of Medicare Physician Payment Provisions
Fee Schedules for Diagnostic Laboratory Tests and Feasibility of Direct Payments to Physicians; Report to Congress
The Comptroller General shall report to the Congress on—
the appropriateness of the fee schedules under section 1833(h) of the Social Security Act [42 U.S.C. 1395l(h)] and their impact on the volume and quality of clinical diagnostic laboratory tests;
the potential impact of the adoption of a national fee schedule; and
the potential impact of applying a national fee schedule to clinical diagnostic laboratory tests provided by hospitals to their outpatients.
The Secretary of Health and Human Services shall report to the Congress with respect to the advisability and feasibility of a system of direct payment to any physician for all clinical diagnostic laboratory tests ordered by such physician.
The reports required by paragraphs (1) and (2) shall be submitted not later than
Pacemaker Reimbursement Review and Reform
The Secretary of Health and Human Services shall issue revisions to the current guidelines for the payment under part B of title XVIII of the Social Security Act [42 U.S.C. 1395j et seq.] for the transtelephonic monitoring of cardiac pacemakers. Such revised guidelines shall include provisions regarding the specifications for and frequency of transtelephonic monitoring procedures which will be found to be reasonable and necessary.
Except as provided in subparagraph (B), if the guidelines required by paragraph (1) have not been issued and put into effect by
weekly during the first month after implantation,
once every two months during the period representing 80 percent of the estimated life of the implanted device, and
monthly thereafter.
Subparagraph (A) shall not apply in cases where the Secretary determines that special medical factors (including possible evidence of pacemaker or lead malfunction) justify more frequent transtelephonic monitoring procedures.”