Directs the Secretary of Health and Human Services to: (1) revise the practice expense relative value units for drug administration services (including chemotherapy administration services) in accordance with this Act to determine the units to be used in determining the fee schedule amounts paid for drug administration services under the Medicare program; (2) recognize and make payments under Medicare for chemotherapy support services furnished incident to physicians' services; (3) recognize and establish a payment amount for the service of cancer therapy management to account for the greater pre-service and post-service work associated with visits and consultations conducted by physicians treating cancer patients compared to typical visits and consultations; and (4) develop a revised methodology for determining the payment amounts for services that are paid under the Medicare fee schedule and that do not have physician work relative value units, including radiation oncology services.
Amends SSA title XVIII to provide that if the Secretary requires direct supervision of a service by a physician, that supervision requirement may be fulfilled by one or more physicians other than the physician who ordered the service.
[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1622 Introduced in House (IH)]
108th CONGRESS
1st Session
H. R. 1622
To amend title XVIII of the Social Security Act and otherwise revise
the Medicare Program to reform the method of paying for covered drugs,
drug administration services, and chemotherapy support services.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
April 3, 2003
Mr. Norwood (for himself and Mrs. Capps) introduced the following bill;
which was referred to the Committee on Energy and Commerce, and in
addition to the Committee on Ways and Means, for a period to be
subsequently determined by the Speaker, in each case for consideration
of such provisions as fall within the jurisdiction of the committee
concerned
_______________________________________________________________________
A BILL
To amend title XVIII of the Social Security Act and otherwise revise
the Medicare Program to reform the method of paying for covered drugs,
drug administration services, and chemotherapy support services.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Quality Cancer Care Preservation
Act''.
SEC. 2. MEDICARE PAYMENT FOR DRUGS AND BIOLOGICALS.
(a) In General.--Section 1842(o)(1) of the Social Security Act (42
U.S.C. 1395u(o)(1)) is amended by striking ``95 percent of the average
wholesale price'' and inserting ``the payment amount specified in
section 1834(n)(2)''.
(b) Determination of Payment Amount.--Section 1834 of such Act (42
U.S.C. 1395m) is amended by adding at the end the following new
subsection:
``(n) Payment for Drugs and Biologicals.--
``(1) Reports by manufacturers.--
``(A) In general.--Every drug manufacturer shall
report to the Secretary, in the manner prescribed in
this paragraph, its average sales price (as defined in
subparagraph (B)) in the United States during each
calendar quarter for drugs and biologicals covered
under this part.
``(B) Definitions.--For purposes of this
subsection--
``(i) the term `manufacturer' means, with
respect to a drug or biological, the entity
identified by the Labeler Code portion of the
National Drug Code of such drug or biological;
and
``(ii) the term `average sales price' means
the weighted average of all final sales prices
to all purchasers, excluding sales specified in
subparagraph (C).
In determining such average sales prices, such prices
shall be net of volume discounts, chargebacks, short-
dated product discounts, free goods contingent on
purchases, rebates (other than those made or authorized
under section 1927), and all other price concessions
that result in a reduction of the ultimate cost to the
purchaser.
``(C) Consideration in calculation of average sales
prices.--The calculation of average sales price under
this subsection shall not include--
``(i) prices that are excluded from the
calculation of `best price' under section
1927(c)(1)(C);
``(ii) prices offered to entities that are
considered under subparagraph (B)(i) to be the
manufacturers of the drugs or biologicals
involved;
``(iii) prices offered by a manufacturer to
a hospital, nursing facility, hospice, or
health maintenance organization;
``(iv) prices to governmental entities; and
``(v) nominal prices offered to bona fide
charitable organizations.
``(D) Quarterly reports.--Each manufacturer shall
submit the report required by subparagraph (A) to the
Secretary by electronic means no later than 30 days
after the end of a calendar quarter with respect to
sales that occurred during such quarter. The Secretary
shall prescribe the format and other requirements for
the report.
``(E) Enforcement.--
``(i) Failure to timely report.--The
Secretary may impose a civil monetary penalty
in an amount not to exceed $100,000 on a
manufacturer that fails to provide the
information required under this paragraph on a
timely basis and in the manner required.
``(ii) False information.--For each item of
false information, the Secretary may impose a
civil money penalty in an amount not to exceed
$100,000 on a manufacturer that knowingly
provides false information under this
paragraph.
``(iii) Manner of imposition of civil
monetary penalties.--The provisions in section
1128A (other than subsections (a) and (b))
shall apply to a civil monetary penalty under
this subparagraph in the same manner as such
provisions apply to a penalty or proceeding
under section 1128A(a).
``(F) Confidentiality of information.--
Notwithstanding any other provision of law, information
disclosed by manufacturers under this paragraph is
confidential and shall not be disclosed by the
Secretary in any form other than as specifically
authorized by this subsection.
``(2) Calculation of payment amount.--
``(A) In general.--Except as otherwise provided in
this paragraph, the payment amount for a drug or
biological furnished during a calendar quarter shall be
120 percent of the average sales price of the drug or
biological for the second preceding calendar quarter as
determined under paragraph (1).
``(B) Methodology.--In determining payment amounts
under subparagraph (A), the Secretary may, in the
Secretary's discretion, use either the average sales
price for each drug or biological by specific drug or
biological, or a cumulative average sales price based
on sales data for all versions of a multiple-source
drug that the Secretary, acting through the Food and
Drug Administration, has determined are therapeutically
equivalent (as evidenced by `A' ratings in the
publication Approved Drug Products with Therapeutic
Equivalence Evaluations).
``(C) Increase to reflect additional costs
attributable to state and local taxes.--In the case of
a drug or biological that was subject to a State or
local sales tax or gross receipts tax when administered
or dispensed, the payment amount determined under
subparagraph (A) shall be increased by the amount of
such tax paid with respect to such drug or biological.
``(D) Substitution of higher payment amount.--If a
physician's, supplier's, or any other person's claim
for payment for services under this Act documents that
the price paid for a drug or biological was greater
than the payment amount determined under subparagraph
(A), the actual amount paid shall be substituted for
the payment amount determined under subparagraph (A),
unless the Secretary determines that the actual amount
paid was unreasonable under the circumstances.
``(E) Increase for bad debt and certain other
costs.--Upon the submission of supporting information,
the Secretary shall make an additional payment to a
physician or supplier to cover--
``(i) uncollectible deductibles and
coinsurance due from Medicare beneficiaries
with respect to drugs and biologicals furnished
to such beneficiaries; and
``(ii) costs incurred in procuring and
billing for drugs and biologicals furnished to
Medicare beneficiaries.''.
SEC. 3. MEDICARE PAYMENT FOR DRUG ADMINISTRATION SERVICES.
(a) General.--The Secretary of Health and Human Services (hereafter
in this Act referred to as ``the Secretary'') shall revise the practice
expense relative value units for drug administration services for years
beginning with the year 2005 in accordance with this section. For
purposes of this section, ``drug administration services'' includes
chemotherapy administration services, therapeutic and diagnostic
infusions and injections, and such other services as the Secretary
specifies.
(b) Direct Costs Equal to 100 Percent of CPEP Estimates.--Using the
information, including estimates of clinical staff time, developed in
the clinical practice expert panel process, including refinements by
American Medical Association committees, the Secretary shall estimate
the costs of the nursing and other clinical staff, supplies, and
procedure-specific equipment (exceeding a cost specified by the
Secretary) used in furnishing each type of drug administration service.
The Secretary shall utilize without revision the minutes of clinical
staff time determined in such process. The Secretary shall convert the
information from such process to estimated costs by applying the most
current available data on staff salary, supply, and equipment costs,
and such costs shall be updated to 2005 based on estimated changes in
prices since the date of such data.
(c) Total Practice Expenses.--The Secretary shall estimate the
total practice expenses of each drug administration service by assuming
that the direct costs for the service determined under subsection (b)
are 33.2 percent of such total practice expenses.
(d) Conversion to Relative Value Units.--The Secretary shall
convert the total practice expenses determined under subsection (c) to
practice expense relative value units for each drug administration
service by dividing such expenses by the conversion factor that will be
in effect for the physician fee schedule for 2005. The relative value
units as so determined shall be used in determining the fee schedule
amounts paid for drug administration services under section 1848 of the
Social Security Act (42 U.S.C. 1395w-4).
(e) Updates.--For years after 2005, the relative values determined
under subsection (d) shall continue in effect except that the Secretary
shall revise them as necessary to maintain their accuracy, provided
that such revisions are consistent with the methodology set forth in
this section.
(f) Multiple Pushes.--In establishing the payment amounts under
this section, the Secretary shall establish the payment amount for
intravenous chemotherapy administration by push technique based on the
administration of a single drug. The Secretary shall make the same
payment for each additional drug administered by push technique during
the same encounter, except to the extent that the Secretary finds that
the cost of administering additional drugs is less than the cost of
administering the first drug.
SEC. 4. PAYMENTS FOR CHEMOTHERAPY SUPPORT SERVICES.
(a) General.--Beginning in the year 2005, the Secretary shall
recognize and make payments under section 1848 of the Social Security
Act (42 U.S.C. 1395w-4) for chemotherapy support services furnished
incident to physicians' services. For the purposes of this section,
``chemotherapy support services'' are services furnished by the staff
of physicians to patients undergoing treatment for cancer that were not
included in the computation of clinical staff costs under section 3(b).
Such services include social worker services, nutrition counseling,
psychosocial services, and similar services.
(b) Direct Costs.--The Secretary shall estimate the cost of the
salary and benefits of staff furnishing chemotherapy support services
as they are provided in oncology practices that furnish these services
to cancer patients in a manner that is considered to be high quality
care. The estimate shall be based on the weekly cost of such services
per patient receiving chemotherapy.
(c) Total Costs.--The Secretary shall estimate the total practice
expenses of chemotherapy support services by assuming that the direct
costs for the service determined under subsection (b) are 33.2 percent
of such total practice expenses.
(d) Conversion to Relative Value Units.--The Secretary shall
convert the total practice expenses determined under subsection (c) to
practice expense relative value units for chemotherapy support services
by dividing such expenses by the conversion factor that will be in
effect for the physician fee schedule for 2005. The relative value
units as so determined shall be used in determining the fee schedule
amounts paid for chemotherapy support services under such section 1848.
(e) Updates.--For the years after 2005, the relative values
determined under subsection (d) shall continue in effect except that
the Secretary shall revise them as necessary to maintain their
accuracy, provided that such revisions are consistent with the
methodology set forth in this section.
SEC. 5. CANCER THERAPY MANAGEMENT SERVICES.
The Secretary shall recognize and establish a payment amount for
the service of cancer therapy management to account for the greater
pre-service and post-service work associated with visits and
consultations conducted by physicians treating cancer patients compared
to typical visits and consultations. The payment amount may vary by the
level and type of the related visit or consultation.
SEC. 6. OTHER SERVICES WITHOUT PHYSICIAN WORK RELATIVE VALUE UNITS.
The Secretary shall develop a revised methodology for determining
the payment amounts for services that are paid under the fee schedule
established by section 1848 of the Social Security Act (42 U.S.C.
1395w-4) and that do not have physician work relative value units,
including radiation oncology services. Such methodology shall result in
payment amounts that fully cover the costs of furnishing such services.
Until such time as the methodology for such services is revised and
implemented, all such services shall be protected from further payment
cuts due to factors such as shifts in utilization or removal of any one
specialty's services that are paid under the fee schedule established
by such section 1848 and that do not have physician work relative value
units.
SEC. 7. PHYSICIAN SUPERVISION OF SERVICES.
Section 1834 of the Social Security Act (42 U.S.C. 1395m), as
amended by section 2, is further amended by adding at the end the
following new subsection:
``(o) Supervision Requirements.--If the Secretary requires direct
supervision of a service by a physician, that supervision requirement
may be fulfilled by one or more physicians other than the physician who
ordered the service. If the supervising physician is different from the
ordering physician for a particular service, the ordering physician may
nevertheless bill for such service provided that the medical records
for the service involved identify the supervising physician or
physicians.''.
SEC. 8. REPORT TO CONGRESS.
No later than April 1, 2004, the Secretary shall submit to Congress
a report on the payment amounts that are projected to be adopted under
sections 2, 3, 4, and 5 of this Act.
SEC. 9. INSTITUTE OF MEDICINE STUDY.
(a) General.--The Secretary of Health and Human Services shall
request the Institute of Medicine to conduct the study described in
this section.
(b) Baseline Study.--The first phase of the study shall include the
following objectives:
(1) An assessment of the extent to which the current
Medicare payment system, prior to implementation of the
amendments made by this Act, facilitates appropriate access to
care by cancer patients in the various treatment settings.
(2) The identification of the comprehensive range of
services furnished to cancer patients in the outpatient
setting, including support services such as psychosocial
services and counseling, and recommendations regarding the
types of services that ought to be furnished to Medicare
patients with cancer.
(3) A discussion of the practice standards necessary to
assure the safe provision of services to cancer patients.
(4) An analysis of the extent to which the current Medicare
payment system supports the role of nurses in the provision of
oncology services and recommendations for any necessary
improvements in the payment system in that respect.
(5) The development of a framework for assessing how the
amendments made by this act affect the provision of care to
Medicare patients with cancer in the various treatment
settings.
(c) Second Phase of Study.--After the implementation of the
amendments made by this Act, the study shall determine whether and how
those amendments affected the provision of care to Medicare patients
with cancer.
(d) Consultation.--The Institute of Medicine shall consult with the
National Cancer Policy Board and organizations representing cancer
patients and survivors, oncologists, oncology nurses, social workers,
cancer centers, and other healthcare professionals who treat cancer
patients in planning and carrying out this study.
(e) Due Dates.--
(1) The study required by subsection (b) shall be submitted
to the Congress and the Secretary of Health and Human Services
no later than June 30, 2004.
(2) The study required by subsection (c) shall be submitted
to the Congress and the Secretary of Health and Human Services
no later than December 31, 2006.
SEC. 10. EFFECTIVE DATES.
(a) General.--Except as provided in this section, the provisions of
this Act shall apply to drugs, biologicals, and services furnished on
or after January 1, 2005.
(b) Reports From Manufacturers.--The first report by manufacturers
required by the provisions of section 2 shall be submitted no later
than October 30, 2004, with respect to sales that occurred in the
quarter ending September 30, 2004.
(c) Supervision of Services.--The amendment made by section 7 shall
be effective upon enactment.
(d) Services Other Than Drug Administration.--The Secretary shall
implement the requirements of section 6 no later than January 1, 2005.
<all>
Introduced in House
Introduced in House
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Subcommittee on Health.
Referred to the Subcommittee on Health.
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