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Title V — Miscellaneous

H.R. 19 · 116th Congress · Dec 9, 2019 · Lineage

V Miscellaneous

Sec. 501 Payment for biosimilar biological products during initial period

Section 1847A(c)(4) of the Social Security Act (42 U.S.C. 1395w–3a(c)(4)) is amended—
(1)
in each of subparagraphs (A) and (B), by redesignating clauses (i) and (ii) as subclauses (I) and (II), respectively, and moving such subclauses 2 ems to the right;
(2)
by redesignating subparagraphs (A) and (B) as clauses (i) and (ii) and moving such clauses 2 ems to the right;
(3)
by striking “unavailable.—In the case” and inserting “unavailable.—

“(A) In general—Subject to subparagraph (B), in the case”

(4)
by adding at the end the following new subparagraph:

“(B) Limitation on payment amount for biosimilar biological products during initial period—In the case of a biosimilar biological product furnished on or after July 1, 2020, in lieu of applying subparagraph (A) during the initial period described in such subparagraph with respect to the biosimilar biological product, the amount payable under this section for the biosimilar biological product is the lesser of the following:

“(i) The amount determined under clause (ii) of such subparagraph for the biosimilar biological product.

“(ii) The amount determined under subsection (b)(1)(B) for the reference biological product.”

Sec. 502 GAO study and report on average sales price

(a)
Study—
(1)
In general— The Comptroller General of the United States (in this section referred to as the “Comptroller General”) shall conduct a study on spending for applicable drugs under part B of title XVIII of the Social Security Act.
(2)
Applicable drugs defined— In this section, the term applicable drugs means drugs and biologicals—
(A)
for which reimbursement under such part B is based on the average sales price of the drug or biological; and
(B)
that account for the largest percentage of total spending on drugs and biologicals under such part B (as determined by the Comptroller General, but in no case less than 25 drugs or biologicals).
(3)
Requirements— The study under paragraph (1) shall include an analysis of the following:
(A)
The extent to which each applicable drug is paid for—
(i)
under such part B for Medicare beneficiaries; or
(ii)
by private payers in the commercial market.
(B)
Any change in Medicare spending or Medicare beneficiary cost-sharing that would occur if the average sales price of an applicable drug was based solely on payments by private payers in the commercial market.
(C)
The extent to which drug manufacturers provide rebates, discounts, or other price concessions to private payers in the commercial market for applicable drugs, which the manufacturer includes in its average sales price calculation, for—
(i)
formulary placement;
(ii)
utilization management considerations; or
(iii)
other purposes.
(D)
Barriers to drug manufacturers providing such price concessions for applicable drugs.
(E)
Other areas determined appropriate by the Comptroller General.
(b)
Report— Not later than 2 years after the date of the enactment of this Act, the Comptroller General shall submit to Congress a report on the study conducted under subsection (a), together with recommendations for such legislation and administrative action as the Secretary determines appropriate.

Sec. 503 Requiring prescription drug plans and MA–PD plans to report potential fraud, waste, and abuse to the Secretary of HHS

Section 1860D–4 of the Social Security Act (42 U.S.C. 1395w–104) is amended by adding at the end the following new subsection:

“(p) Reporting potential fraud, waste, and abuse—Beginning January 1, 2021, the PDP sponsor of a prescription drug plan shall report to the Secretary, as specified by the Secretary—

“(1) any substantiated or suspicious activities (as defined by the Secretary) with respect to the program under this part as it relates to fraud, waste, and abuse; and

“(2) any steps made by the PDP sponsor after identifying such activities to take corrective actions.”

Sec. 504 Establishment of pharmacy quality measures under Medicare part D

Section 1860D–4(c) of the Social Security Act (42 U.S.C. 1395w–104(c)) is amended by adding at the end the following new paragraph:

“(8) Application of pharmacy quality measures

“(A) In general—A PDP sponsor that implements incentive payments to a pharmacy or price concessions paid by a pharmacy based on quality measures shall use measures established or approved by the Secretary under subparagraph (B) with respect to payment for covered part D drugs dispensed by such pharmacy.

“(B) Standard pharmacy quality measures—The Secretary shall establish or approve standard quality measures from a consensus and evidence-based organization for payments described in subparagraph (A). Such measures shall focus on patient health outcomes and be based on proven criteria measuring pharmacy performance.

“(C) Effective date—The requirement under subparagraph (A) shall take effect for plan years beginning on or after January 1, 2023, or such earlier date specified by the Secretary if the Secretary determines there are sufficient measures established or approved under subparagraph (B) to meet the requirement under subparagraph (A).”

Sec. 505 Improving coordination between the Food and Drug Administration and the Centers for Medicare & Medicaid Services

(a)
In general—
(1)
Public meeting—
(A)
In general— Not later than 12 months after the date of the enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall convene a public meeting for the purposes of discussing and providing input on improvements to coordination between the Food and Drug Administration and the Centers for Medicare & Medicaid Services in preparing for the availability of novel medical products described in subsection (c) on the market in the United States.
(B)
Attendees— The public meeting shall include—
(i)
representatives of relevant Federal agencies, including representatives from each of the medical product centers within the Food and Drug Administration and representatives from the coding, coverage, and payment offices within the Centers for Medicare & Medicaid Services;
(ii)
stakeholders with expertise in the research and development of novel medical products, including manufacturers of such products;
(iii)
representatives of commercial health insurance payers;
(iv)
stakeholders with expertise in the administration and use of novel medical products, including physicians; and
(v)
stakeholders representing patients and with expertise in the utilization of patient experience data in medical product development.
(C)
Topics— The public meeting shall include a discussion of—
(i)
the status of the drug and medical device development pipeline related to the availability of novel medical products;
(ii)
the anticipated expertise necessary to review the safety and effectiveness of such products at the Food and Drug Administration and current gaps in such expertise, if any;
(iii)
the expertise necessary to make coding, coverage, and payment decisions with respect to such products within the Centers for Medicare & Medicaid Services, and current gaps in such expertise, if any;
(iv)
trends in the differences in the data necessary to determine the safety and effectiveness of a novel medical product and the data necessary to determine whether a novel medical product meets the reasonable and necessary requirements for coverage and payment under title XVIII of the Social Security Act pursuant to section 1862(a)(1)(A) of such Act (42 U.S.C. 1395y(a)(1)(A));
(v)
the availability of information for sponsors of such novel medical products to meet each of those requirements; and
(vi)
the coordination of information related to significant clinical improvement over existing therapies for patients between the Food and Drug Administration and the Centers for Medicare & Medicaid Services with respect to novel medical products.
(D)
Trade secrets and confidential information— No information discussed as a part of the public meeting under this paragraph shall be construed as authorizing the Secretary to disclose any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5, United States Code.
(2)
Improving transparency of criteria for Medicare coverage—
(A)
Draft guidance— Not later than 18 months after the public meeting under paragraph (1), the Secretary shall update the final guidance titled “National Coverage Determinations with Data Collection as a Condition of Coverage: Coverage with Evidence Development” to address any opportunities to improve the availability and coordination of information as described in clauses (iv) through (vi) of paragraph (1)(C).
(B)
Final guidance— Not later than 12 months after issuing draft guidance under subparagraph (A), the Secretary shall finalize the updated guidance to address any such opportunities.
(b)
Report on coding, coverage, and payment processes under medicare for novel medical products— Not later than 12 months after the date of the enactment of this Act, the Secretary shall publish a report on the Internet website of the Department of Health and Human Services regarding processes under the Medicare program under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) with respect to the coding, coverage, and payment of novel medical products described in subsection (c). Such report shall include the following:
(1)
A description of challenges in the coding, coverage, and payment processes under the Medicare program for novel medical products.
(2)
Recommendations to—
(A)
incorporate patient experience data (such as the impact of a disease or condition on the lives of patients and patient treatment preferences) into the coverage and payment processes within the Centers for Medicare & Medicaid Services;
(B)
decrease the length of time to make national and local coverage determinations under the Medicare program (as those terms are defined in subparagraph (A) and (B), respectively, of section 1862(l)(6) of the Social Security Act (42 U.S.C. 1395y(l)(6)));
(C)
streamline the coverage process under the Medicare program and incorporate input from relevant stakeholders into such coverage determinations; and
(D)
identify potential mechanisms to incorporate novel payment designs similar to those in development in commercial insurance plans and State plans under title XIX of such Act (42 U.S.C. 1396 et seq.) into the Medicare program.
(c)
Novel medical products described— For purposes of this section, a novel medical product described in this subsection is a medical product, including a drug, biological (including gene and cell therapy), or medical device, that has been designated as a breakthrough therapy under section 506(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(a)), a breakthrough device under section 515B of such Act (21 U.S.C. 360e–3), or a regenerative advanced therapy under section 506(g) of such Act (21 U.S.C. 356(g)).

Sec. 506 Patient consultation in Medicare national and local coverage determinations in order to mitigate barriers to inclusion of such perspectives

Section 1862(l) of the Social Security Act (42 U.S.C. 1395y(l)) is amended by adding at the end the following new paragraph:

“(7) Patient consultation in national and local coverage determinations—The Secretary may consult with patients and organizations representing patients in making national and local coverage determinations.”

Sec. 507 MedPAC report on shifting coverage of certain Medicare part B drugs to Medicare part D

(a)
Study— The Medicare Payment Advisory Commission (in this section referred to as the “Commission”) shall conduct a study on shifting coverage of certain drugs and biologicals for which payment is currently made under part B of title XVIII of the Social Security Act (42 U.S.C. 1395j et seq.) to part D of such title (42 U.S.C. 1395w–21 et seq.). Such study shall include an analysis of—
(1)
differences in program structures and payment methods for drugs and biologicals covered under such parts B and D, including effects of such a shift on program spending, beneficiary cost-sharing liability, and utilization management techniques for such drugs and biologicals; and
(2)
the feasibility and policy implications of shifting coverage of drugs and biologicals for which payment is currently made under such part B to such part D.
(b)
Report—
(1)
In general— Not later than June 30, 2021, the Commission shall submit to Congress a report containing the results of the study conducted under subsection (a).
(2)
Contents— The report under paragraph (1) shall include information, and recommendations as the Commission deems appropriate, regarding—
(A)
formulary design under such part D;
(B)
the ability of the benefit structure under such part D to control total spending on drugs and biologicals for which payment is currently made under such part B;
(C)
changes to the bid process under such part D, if any, that may be necessary to integrate coverage of such drugs and biologicals into such part D;
(D)
any other changes to the program that Congress should consider in determining whether to shift coverage of such drugs and biologicals from such part B to such part D; and
(E)
the feasibility and policy implications of creating a methodology to preserve the healthcare provider’s ability to take title of the drug, including a methodology under which—
(i)
prescription drug plans negotiate reimbursement rates and other arrangements with drug manufacturers on behalf of a wholesaler;
(ii)
wholesalers purchase the drugs from the manufacturers at the negotiated rate and ship them through distributors to physicians to administer to patients;
(iii)
physicians and hospitals purchase the drug from the wholesaler via the distributor;
(iv)
after administering the drug, the physician submits a claim to the MAC for their drug administration fee;
(v)
to be reimbursed for the purchase of the drug from the distributor, the physician furnishes the claim for the drug itself to the wholesaler and the wholesaler would refund the cost of the drug to the physician; and
(vi)
the wholesaler passes this claim to the PDP to receive reimbursement.

Sec. 508 Requirement that direct-to-consumer advertisements for prescription drugs and biological products include truthful and non-misleading pricing information

Part A of title XI of the Social Security Act is amended by adding at the end the following new section:

“1150C. Requirement that direct-to-consumer advertisements for prescription drugs and biological products include truthful and non-misleading pricing information

“(a) In general—The Secretary shall require that each direct-to-consumer advertisement for a prescription drug or biological product for which payment is available under title XVIII or XIX includes an appropriate disclosure of truthful and non-misleading pricing information with respect to the drug or product.

“(b) Determination by CMS—The Secretary, acting through the Administrator of the Centers for Medicare & Medicaid Services, shall determine the components of the requirement under subsection (a), such as the forms of advertising, the manner of disclosure, the price point listing, and the price information for disclosure.”

Sec. 509 Chief Pharmaceutical Negotiator at the Office of the United States Trade Representative

(a)
In general— Section 141 of the Trade Act of 1974 (19 U.S.C. 2171) is amended—
(1)
in subsection (b)(2)—
(A)
by striking “and one Chief Innovation and Intellectual Property Negotiator” and inserting “one Chief Innovation and Intellectual Property Negotiator, and one Chief Pharmaceutical Negotiator”;
(B)
by striking “or the Chief Innovation and Intellectual Property Negotiator” and inserting “the Chief Innovation and Intellectual Property Negotiator, or the Chief Pharmaceutical Negotiator”; and
(C)
by striking “and the Chief Innovation and Intellectual Property Negotiator” and inserting “the Chief Innovation and Intellectual Property Negotiator, and the Chief Pharmaceutical Negotiator”; and
(2)
in subsection (c), by adding at the end the following new paragraph:

“(7) The principal function of the Chief Pharmaceutical Negotiator shall be to conduct trade negotiations and to enforce trade agreements relating to United States pharmaceutical products and services. The Chief Pharmaceutical Negotiator shall be a vigorous advocate on behalf of United States pharmaceutical interests. The Chief Pharmaceutical Negotiator shall perform such other functions as the United States Trade Representative may direct.”

(b)
Compensation— Section 5314 of title 5, United States Code, is amended by striking “Chief Innovation and Intellectual Property Negotiator, Office of the United States Trade Representative.” and inserting the following:
(c)
Report required— Not later than the date that is one year after the appointment of the first Chief Pharmaceutical Negotiator pursuant to paragraph (2) of section 141(b) of the Trade Act of 1974, as amended by subsection (a), and annually thereafter, the United States Trade Representative shall submit to the Committee on Finance of the Senate and the Committee on Ways and Means of the House of Representatives a report describing in detail—
(1)
enforcement actions taken by the United States Trade Representative during the one-year period preceding the submission of the report to ensure the protection of United States pharmaceutical products and services; and
(2)
other actions taken by the United States Trade Representative to advance United States pharmaceutical products and services.

Sec. 510 Waiving Medicare coinsurance for colorectal cancer screening tests

Section 1833(a) of the Social Security Act (42 U.S.C. 1395l(a)) is amended—
(1)
by moving the flush text following paragraph (9) 2 ems to the left; and
(2)
by adding at the end of such flush text the following new sentence: “For items and services furnished on or after January 1, 2021, paragraph (1)(Y) shall apply with respect to a colorectal cancer screening test regardless of the code that is billed for the establishment of a diagnosis as a result of the test, or for the removal of tissue or other matter or other procedure that is furnished in connection with, as a result of, and in the same clinical encounter as the screening test.”.