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Title VI — Health Budget; Payments; Cost Containment Measures

H.R. 3421 · 118th Congress · May 17, 2023 · Lineage

VI Health Budget; Payments; Cost Containment Measures

A Budgeting

Sec. 601 National health budget

(a)
National health budget—
(1)
In general— By not later than September 1 of each year, beginning with the year prior to the date on which benefits first become available as described in section 106(a), the Secretary shall establish a national health budget, which specifies a budget for the total expenditures to be made for covered health care items and services under this Act.
(2)
Division of budget into components— The national health budget shall consist of the following components:
(A)
An operating budget.
(B)
A capital expenditures budget.
(C)
A special projects budget.
(D)
Quality assessment activities under title V.
(E)
Health professional education expenditures.
(F)
Administrative costs, including costs related to the operation of regional offices.
(G)
A reserve fund.
(H)
Prevention and public health activities.
(3)
Allocation among components— The Secretary shall allocate the funds received for purposes of carrying out this Act among the components described in paragraph (2) in a manner that ensures—
(A)
that the operating budget allows for every participating provider in the Medicare for All Program to meet the needs of their respective patient populations;
(B)
that the special projects budget is sufficient to meet the health care needs within areas described in paragraph (2)(C) through the construction, renovation, and staffing of health care facilities in a reasonable timeframe;
(C)
a fair allocation for quality assessment activities; and
(D)
that the health professional education expenditure component is sufficient to provide for the amount of health professional education expenditures sufficient to meet the need for covered health care services.
(4)
Regional allocation— The Secretary shall annually provide each regional office with an allotment the Secretary determines appropriate for purposes of carrying out this Act in such region, including payments to providers in such region, capital expenditures in such region, special projects in such region, health professional education in such region, administrative expenses in such region, and prevention and public health activities in such region.
(5)
Operating budget— The operating budget described in paragraph (2)(A) shall be used for—
(A)
payments to institutional providers pursuant to section 611; and
(B)
payments to individual providers pursuant to section 612.
(6)
Capital expenditures budget— The capital expenditures budget described in paragraph (2)(B) shall be used for—
(A)
the construction or renovation of health care facilities, excluding congregate or segregated facilities for individuals with disabilities who receive long-term care services and support; and
(B)
major equipment purchases.
(7)
Special projects budget— The special projects budget described in paragraph (2)(C) shall be used for the purposes of allocating funds for the construction of new facilities, major equipment purchases, and staffing in rural or medically underserved areas (as defined in section 330(b)(3) of the Public Health Service Act (42 U.S.C. 254b(b)(3))), including areas designated as health professional shortage areas (as defined in section 332(a) of the Public Health Service Act (42 U.S.C. 254e(a))), and to address health disparities, including racial, ethnic, national origin, primary language use, age, disability, sex (including gender identity and sexual orientation), geography, or socioeconomic health disparities.
(8)
Temporary worker assistance—
(A)
In general— For up to 5 years following the date on which benefits first become available as described in section 106(a), at least 1 percent of the budget shall be allocated to programs providing assistance to workers who perform functions in the administration of the health insurance system, or related functions within health care institutions or organizations who may be affected by the implementation of this Act and who may experience economic dislocation as a result of the implementation of this Act.
(B)
Clarification— Assistance described in subparagraph (A) shall include wage replacement, retirement benefits, job training and placement, preferential hiring, and education benefits.
(9)
Reserve fund— The reserve fund described in paragraph (2)(G) shall be used to respond to the costs of an epidemic, pandemic, natural disaster, or other such health emergency, or market-shift adjustments related to patient volume.
(10)
Supplemental Indian Health Service allocation— The Secretary shall annually determine the need to provide an allotment of supplemental funds to Indian Health Services, including payments to providers, capital expenditures, special projects, health professional education, administrative expenses, and prevention and public health activities.
(b)
Definitions— In this section:
(1)
Capital expenditures— The term capital expenditures means expenses for the purchase, lease, construction, or renovation of capital facilities and for major equipment.
(2)
Health professional education expenditures— The term health professional education expenditures means expenditures in hospitals and other health care facilities to cover costs associated with teaching and related research activities, including the impact of workforce diversity on patient outcomes.

B Payments to Providers

Sec. 611 Payments to institutional providers based on global budgets

(a)
In general— Not later than the beginning of each fiscal quarter during which an institutional provider of care (including hospitals, skilled nursing facilities, Federally qualified health centers, and independent dialysis facilities) is to furnish items and services under this Act, the Secretary shall pay to such institutional provider a lump sum in accordance with the succeeding provisions of this subsection and consistent with the following:
(1)
Payment in Full— Such payment shall be considered as payment in full for all operating expenses for items and services furnished under this Act, whether inpatient or outpatient, by such provider for such quarter, including outpatient or any other care provided by the institutional provider or provided by any health care provider who provided items and services pursuant to an agreement paid through the global budget as described in paragraph (3).
(2)
Quarterly Review— The regional director, on a quarterly basis, shall review whether requirements of the institutional provider’s participation agreement and negotiated global budget have been performed and shall determine whether adjustments to such institutional provider’s payment are warranted. This review shall include consideration for additional funding necessary for unanticipated items and services for individuals with complex medical needs or market-shift adjustments related to patient volume. The review shall also include an assessment of any adjustments made to ensure that accuracy and need for adjustment was appropriate.
(3)
Agreements for Salaried Payments for Certain Providers— Certain group practices and other health care providers, as determined by the Secretary, with agreements to provide items and services at a specified institutional provider paid a global budget under this subsection may elect to be paid through such institutional provider’s global budget in lieu of payment under section 612 of this title. Any—
(A)
individual health care professional of such group practice or other provider receiving payment through an institutional provider’s global budget shall be paid on a salaried basis that is equivalent to salaries or other compensation rates negotiated for individual health care professionals of such institutional provider; and
(B)
any group practice or other health care provider that receives payment through an institutional provider global budget under this paragraph shall be subject to the same reporting and disclosure requirements of the institutional provider.
(4)
Interim adjustments— The regional director shall consider a petition for adjustment of any payment under this section filed by an institutional provider at any time based on the following:
(A)
Factors that led to increased costs for the institutional provider that can reasonably be considered to be unanticipated and out of the control of the institutional provider, such as—
(i)
natural disasters;
(ii)
outbreaks of epidemics or infectious diseases;
(iii)
unexpected facility or equipment repairs or purchases;
(iv)
significant and unexpected increases in pharmaceutical or medical device prices; and
(v)
unanticipated increases in complex or high-cost patients or care needs.
(B)
Changes in Federal or State law that result in a change in costs.
(C)
Reasonable increases in labor costs, including salaries and benefits, and changes in collective bargaining agreements, prevailing wage, or local law.
(b)
Payment amount—
(1)
In general— The amount of each payment to a provider described in subsection (a) shall be determined before the start of each fiscal year through negotiations between the provider and the regional director with jurisdiction over such provider. Such amount shall be based on factors specified in paragraph (2).
(2)
Payment factors— Payments negotiated pursuant to paragraph (1) shall take into account, with respect to a provider—
(A)
the historical volume of services provided for each item and services in the previous 3-year period;
(B)
the actual expenditures of such provider in such provider’s most recent cost report under title XVIII of the Social Security Act for each item and service compared to—
(i)
such expenditures for other institutional providers in the director’s jurisdiction; and
(ii)
normative payment rates established under comparative payment rate systems, including any adjustments, for such items and services;
(C)
projected changes in the volume and type of items and services to be furnished;
(D)
wages for employees, including any necessary increases for mandatory minimum safe registered nurse-to-patient ratios and optimal staffing levels for physicians and other health care workers;
(E)
the provider’s maximum capacity to provide items and services;
(F)
education and prevention programs;
(G)
permissible adjustment to the provider’s operating budget due to factors such as—
(i)
an increase in primary or specialty care access;
(ii)
efforts to decrease health care disparities in rural or medically underserved areas;
(iii)
a response to emergent epidemic conditions;
(iv)
an increase in complex or high-cost patients or care needs; or
(v)
proposed new and innovative patient care programs at the institutional level;
(H)
whether the provider is located in a high social vulnerability index community, ZIP Code, or census track, or is a minority-serving provider; and
(I)
any other factor determined appropriate by the Secretary.
(3)
Limitation— Payment amounts negotiated pursuant to paragraph (1) may not—
(A)
take into account capital expenditures of the provider or any other expenditure not directly associated with the provision of items and services by the provider to an individual;
(B)
be used by a provider for capital expenditures or such other expenditures;
(C)
exceed the provider’s capacity to provide care under this Act; or
(D)
be used to pay or otherwise compensate any board member, executive, or administrator of the institutional provider who has any interest or relationship prohibited under section 301(b)(2) of this Act or disclosed under section 301 of this Act.
(4)
Limitation on Compensation— Compensation costs for any employee or any contractor or any subcontractor employee of an institutional provider receiving global budgets under this section shall meet the compensation cap established in section 702 of the Bipartisan Budget Act of 2013 (41 U.S.C. 4304(a)(16)) and implementing regulations.
(5)
Regional negotiations permitted— Subject to section 614, a regional director may negotiate changes to an institutional provider’s global budget, including any adjustments to address unforeseen market-shifts related to patient volume.
(c)
Baseline rates and adjustments—
(1)
In general— The Secretary shall use existing prospective payment systems under title XVIII of the Social Security Act to serve as the comparative payment rate system in global budget negotiations described in subsection (b). The Secretary shall update such comparative payment rate systems annually.
(2)
Specifications— In developing the comparative payment rate system, the Secretary shall use only the operating base payment rates under each such prospective payment systems with applicable adjustments.
(3)
Limitation— The comparative rate system established under this subsection shall not include the value-based payment adjustments and the capital expenses base payment rates that may be included in such a prospective payment system.
(4)
Initial year— In the first year that global budget payments under this Act are available to institutional providers and for purposes of selecting a comparative payment rate system used during initial global budget negotiations for each institutional provider, the Secretary shall take into account the appropriate prospective payment system from the most recent year under title XVIII of the Social Security Act to determine what operating base payment the institutional provider would have been paid for covered items and services furnished the preceding year with applicable adjustments, excluding value-based payment adjustments, based on such prospective payment system.
(d)
Operating expenses— For purposes of this title, “operating expenses” of a provider include the following:
(1)
The cost of all items and services associated with the provision of inpatient care and outpatient care, including the following:
(A)
Wages and salary costs for physicians, nurses, and other health care practitioners employed by an institutional provider, including mandatory minimum safe registered nurse-to-patient staffing ratios and optimal staffing levels for physicians and other healthcare workers.
(B)
Wages and salary costs for all ancillary staff and services.
(C)
Costs of all pharmaceutical products administered by health care clinicians at the institutional provider’s facilities or through services provided in accordance with State licensing laws or regulations under which the institutional provider operates.
(D)
Costs for infectious disease response preparedness, including maintenance of a 1-year or 365-day stockpile of personal protective equipment, occupational testing and surveillance, medical services for occupational infectious disease exposure, and contact tracing.
(E)
Purchasing and maintenance of medical devices, supplies, and other health care technologies, including diagnostic testing equipment.
(F)
Costs of all incidental services necessary for safe patient care and handling.
(G)
Costs of patient care, education, and prevention programs, including occupational health and safety programs, public health programs, and necessary staff to implement such programs, for the continued education and health and safety of clinicians and other individuals employed by the institutional provider.
(2)
Administrative costs for the institutional provider.

Sec. 612 Payment to individual providers through fee-for-service

(a)
In general— In the case of a provider not described in section 611(a) (including those in group practices who are not receiving payment on a salaried basis described in section 611(a)(3) and providers of home and community-based services), payment for items and services furnished under this Act for which payment is not otherwise made under section 611 shall be made by the Secretary in amounts determined under the fee schedule established pursuant to subsection (b). Such payment shall be considered to be payment in full for such items and services, and a provider receiving such payment may not charge the individual receiving such item or service in any amount.
(b)
Fee schedule—
(1)
Establishment— Not later than 1 year after the date of the enactment of this Act, and in consultation with providers and regional office directors, the Secretary shall establish a national fee schedule for items and services payable under this Act. The Secretary shall evaluate the effectiveness of the fee-for-service structure and update such fee schedule annually.
(2)
Amounts— In establishing payment amounts for items and services under the fee schedule established under paragraph (1), the Secretary shall take into account—
(A)
the amounts payable for such items and services under title XVIII of the Social Security Act; and
(B)
the expertise of providers and value of items and services furnished by such providers.
(c)
Electronic billing— The Secretary shall establish a uniform national system for electronic billing for purposes of making payments under this subsection.
(d)
Physician practice review board— Each director of a regional office, in consultation with representatives of physicians practicing in that region, shall establish and appoint a physician practice review board to assure quality, cost effectiveness, and fair reimbursements for physician-delivered items and services. The use of mechanisms that discriminate against people with disabilities is prohibited for use in any value or cost-effectiveness assessments.

Sec. 613 Ensuring accurate valuation of services under the Medicare physician fee schedule

(a)
Standardized and documented review process— Section 1848(c)(2) of the Social Security Act (42 U.S.C. 1395w–4(c)(2)) is amended by adding at the end the following new subparagraph:

“(P) Standardized and documented review process

“(i) In general—Not later than one year after the date of enactment of this subparagraph, the Secretary shall establish, document, and make publicly available, in consultation with the Office of Primary Health Care, a standardized process for reviewing the relative values of physicians' services under this paragraph.

“(ii) Minimum requirements—The standardized process shall include, at a minimum, methods and criteria for identifying services for review, prioritizing the review of services, reviewing stakeholder recommendations, and identifying additional resources to be considered during the review process.”

(b)
Planned and documented use of funds— Section 1848(c)(2)(M) of the Social Security Act (42 U.S.C. 1395w–4(c)(2)(M)) is amended by adding at the end the following new clause:

“(x) Planned and documented use of funds—For each fiscal year (beginning with the first fiscal year beginning on or after the date of enactment of this clause), the Secretary shall provide to Congress a written plan for using the funds provided under clause (ix) to collect and use information on physicians’ services in the determination of relative values under this subparagraph.”

(c)
Internal tracking of reviews—
(1)
In general— Not later than 1 year after the date of enactment of this Act, the Secretary shall submit to Congress a proposed plan for systematically and internally tracking the Secretary’s review of the relative values of physicians' services, such as by establishing an internal database, under section 1848(c)(2) of the Social Security Act (42 U.S.C. 1395w–4(c)(2)), as amended by this section.
(2)
Minimum requirements— The proposal shall include, at a minimum, plans and a timeline for achieving the ability to systematically and internally track the following:
(A)
When, how, and by whom services are identified for review.
(B)
When services are reviewed or reviewed or when new services are added.
(C)
The resources, evidence, data, and recommendations used in reviews.
(D)
When relative values are adjusted.
(E)
The rationale for final relative value decisions.
(d)
Frequency of review— Section 1848(c)(2) of the Social Security Act (42 U.S.C. 1395w–4(c)(2)) is amended—
(1)
in subparagraph (B)(i), by striking “5” and inserting “4”; and
(2)
in subparagraph (K)(i)(I), by striking “periodically” and inserting “annually”.
(e)
Consultation with Medicare Payment Advisory Commission—
(1)
In general— Section 1848(c)(2) of the Social Security Act (42 U.S.C. 1395w–4(c)(2)) is amended—
(A)
in subparagraph (B)(i), by inserting “in consultation with the Medicare Payment Advisory Commission,” after “The Secretary,”; and
(B)
in subparagraph (K)(i)(I), as amended by subsection (d)(2), by inserting “, in coordination with the Medicare Payment Advisory Commission,” after “annually”.
(2)
Conforming amendments— Section 1805 of the Social Security Act (42 U.S.C. 1395b–6) is amended—
(A)
in subsection (b)(1)(A), by inserting the following before the semicolon at the end: “and including coordinating with the Secretary in accordance with section 1848(c)(2) to systematically review the relative values established for physicians' services, identify potentially misvalued services, and propose adjustments to the relative values for physicians' services”; and
(B)
in subsection (e)(1), in the second sentence, by inserting “or the Ranking Minority Member” after “the Chairman”.
(f)
Periodic audit by the Comptroller General— Section 1848(c)(2) of the Social Security Act (42 U.S.C. 1395w–4(c)(2)), as amended by subsection (a), is amended by adding at the end the following new subparagraph:

“(Q) Periodic audit by the Comptroller General

“(i) In general—The Comptroller General of the United States (in this subsection referred to as the “Comptroller General”) shall periodically audit the review by the Secretary of relative values established under this paragraph for physicians' services.

“(ii) Access to information—The Comptroller General shall have unrestricted access to all deliberations, records, and data related to the activities carried out under this paragraph, in a timely manner, upon request.”

Sec. 614 Payment prohibitions; capital expenditures; special projects

(a)
Sense of Congress— It is the sense of Congress that tens of millions of people in the United States do not receive healthcare services while billions of dollars that could be spent on providing health care are diverted to profit. There is a moral imperative to correct the massive deficiencies in our current health system and to eliminate profit from the provision of health care.
(b)
Prohibitions— Payments to providers under this Act may not take into account, include any process for the provision of funding for, or be used by a provider for—
(1)
marketing of the provider;
(2)
the profit or net revenue of the provider, or increasing the profit or net revenue of the provider;
(3)
incentive payments, bonuses, or other compensation based on patient utilization of items and services or any financial measure applied with respect to the provider (or any group practice, integrated health care delivery system, or other provider with which the provider contracts or has a pecuniary interest), including any value-based payment or employment-based compensation;
(4)
any agreement or arrangement described in section 203(a)(4) of the Labor-Management Reporting and Disclosure Act of 1959 (29 U.S.C. 433(a)(4)); or
(5)
political or contributions prohibited under section 317 of the Federal Elections Campaign Act of 1971 (52 U.S.C. 30119(a)(1)).
(c)
Payments for capital expenditures—
(1)
In general— The Secretary shall pay, from amounts made available for capital expenditures pursuant to section 601(a)(2)(B), such sums determined appropriate by the Secretary to providers who have submitted an application to the regional director of the region or regions in which the provider operates or seeks to operate in a time and manner specified by the Secretary for purposes of funding capital expenditures of such providers.
(2)
Priority— The Secretary shall prioritize allocation of funding under paragraph (1) to projects that propose to use such funds to improve service in a medically underserved area (as defined in section 330(b)(3) of the Public Health Service Act (42 U.S.C. 254b(b)(3))) or to address health disparities, including racial, ethnic, national origin, primary language use, age, disability, sex (including gender identity and sexual orientation), geography, or socioeconomic health disparities.
(3)
Limitation— The Secretary shall not grant funding for capital expenditures under this subsection for capital projects that are financed directly or indirectly through the diversion of private or other non-Medicare for All Program funding that results in reductions in care to patients, including reductions in registered nursing staffing patterns and changes in emergency room or primary care services or availability.
(4)
Capital assets not funded by the Medicare for All program— Operating expenses and funds shall not be used by an institutional provider receiving payment for capital expenditures under this subsection for a capital asset that was not funded by the Medicare for All program without the approval of the regional director or directors of the region or regions where the capital asset is located.
(d)
Prohibition against co-Mingling operating and capital funds— Providers that receive payment under this title shall be prohibited from using, with respect to funds made available under this Act—
(1)
funds designated for operating expenditures for capital expenditures or for profit; or
(2)
funds designated for capital expenditures for operating expenditures.
(e)
Payments for special projects—
(1)
In general— The Secretary shall allocate to each regional director, from amounts made available for special projects pursuant to section 601(a)(2)(C), such sums determined appropriate by the Secretary for purposes of funding projects described in such section, including the construction, renovation, or staffing of health care facilities, in rural, underserved, or health professional or medical shortage areas within such region and to address health disparities, including racial, ethnic, national origin, primary language use, age, disability, sex, including gender identity and sexual orientation, geography, or socioeconomic health disparities. Each regional director shall, prior to distributing such funds in accordance with paragraph (2), present a budget describing how such funds will be distributed to the Secretary.
(2)
Distribution— A regional director shall distribute funds to providers operating in the region of such director’s jurisdiction in a manner determined appropriate by the director.
(f)
Prohibition on financial incentive metrics in payment determinations— The Secretary may not utilize any quality metrics or standards for the purposes of establishing provider payment methodologies, programs, modifiers, or adjustments for provider payments under this title.

Sec. 615 Office of Health Equity

Title XVII of the Public Health Service Act (42 U.S.C. 300u et seq.) is amended by adding at the end the following:

“1712. Office of Health Equity

“(a) In general—There is established, in the Office of the Secretary of Health and Human Services, an Office of Health Equity, to be headed by a Director, to ensure coordination and collaboration across the programs and activities of the Department of Health and Human Services with respect to ensuring health equity.

“(b) Monitoring, tracking, and availability of data

“(1) In general—In carrying out subsection (a), the Director of the Office of Health Equity shall monitor, track, and make publicly available data on—

“(A) the disproportionate burden of disease and death among people of color, disaggregated by race, major ethnic group, Tribal affiliation, national origin, primary language use, English proficiency status, immigration status, length of stay in the United States age, disability, sex (including gender identity and sexual orientation), incarceration, homelessness, geography, and socioeconomic status;

“(B) barriers to health, including such barriers relating to income, education, housing, food insecurity (including availability, access, utilization, and stability), employment status, working conditions, and conditions related to the physical environment (including pollutants and population density);

“(C) barriers to health care access, including—

“(i) lack of trust and awareness;

“(ii) lack of transportation;

“(iii) geography;

“(iv) hospital and service closures;

“(v) lack of health care infrastructure and facilities; and

“(vi) lack of health care professional staffing and recruitment;

“(D) disparities in quality of care received, including discrimination in health care settings and the use of racially-biased practice guidelines and algorithms; and

“(E) disparities in utilization of care.

“(2) Analysis of cross-sectional information—The Director of the Office of Health Equity shall ensure that the data collection and reporting process under paragraph (1) allows for the analysis of cross-sectional information on people’s identities.

“(c) Policies—In carrying out subsection (a), the Director of the Office of Health Equity shall develop, coordinate, and promote policies that enhance health equity, including by—

“(1) providing recommendations on—

“(A) cultural competence, implicit bias, and ethics training with respect to health care workers;

“(B) increasing diversity in the health care workforce; and

“(C) ensuring sufficient health care professionals and facilities; and

“(2) ensuring adequate public health funding at the local and State levels to address health disparities.

“(d) Consultation—In carrying out subsection (a), the Director of the Office of Health Equity, in coordination with the Director of the Indian Health Service, shall consult with Indian Tribes and with Urban Indian organizations on data collection, reporting, and implementation of policies.

“(e) Annual report—In carrying out subsection (a), the Director of the Office of Health Equity shall develop and publish an annual report on—

“(1) statistics collected by the Office;

“(2) proposed evidence-based solutions to mitigate health inequities; and

“(3) health care professional staffing levels and access to facilities.

“(f) Centralized electronic repository—In carrying out subsection (a), the Director of the Office of Health Equity shall—

“(1) establish and maintain a centralized electronic repository to incorporate data collected across Federal departments and agencies on race, ethnicity, Tribal affiliation, national origin, primary language use, English proficiency status, immigration status, length of stay in the United States age, disability, sex (including gender identity and sexual orientation), incarceration, homelessness, geography, and socioeconomic status; and

“(2) make such data available for public use and analysis.

“(g) Privacy—Notwithstanding any other Federal or State law, no Federal or State official or employee or other entity shall disclose, or use, for any law enforcement or immigration purpose, any personally identifiable information (including with respect to an individual’s religious beliefs, practices, or affiliation, national origin, ethnicity, or immigration status) that is collected or maintained pursuant to this section.”

Sec. 616 Office of Primary Care

Title XVII of the Public Health Service Act (42 U.S.C. 300u et seq.) is amended by adding at the end the following:

“1713. Office of Primary Care

“(a) In general—There is established, in the Office of Health Equity established under section 1712, an Office of Primary Health Care, to be headed by a Director, to ensure coordination and collaboration across the programs and activities of the Department of Health and Human Services with respect to increasing access to high-quality primary health care, particularly in underserved areas and for underserved populations.

“(b) National Goals—Not later than 1 year after the date of enactment of this section, the Director of the Office of Primary Health Care shall publish national goals—

“(1) to increase access to high-quality primary health care, particularly in underserved areas and for underserved populations; and

“(2) to address health disparities, including with respect to race, ethnicity, national origin (disaggregated by major ethnic group and Tribal affiliation), primary language use, English proficiency status, immigration status, length of stay in the United States, age, disability, sex (including gender identity and sexual orientation), incarceration, homelessness, geography, and socioeconomic status.

“(c) Other responsibilities—In carrying out subsections (a) and (b), the Director of the Office of Primary Health Care shall—

“(1) coordinate, in consultation with the Secretary, health professional education policies and goals to achieve the national goals published pursuant to subsection (b);

“(2) develop and maintain a system to monitor the number and specialties of individuals pursuing careers in, or practicing, primary health care through their health professional education, any postgraduate training, and professional practice;

“(3) develop, coordinate, and promote policies that expand the number of primary health care practitioners, registered nurses, advance practice clinicians, and dentists;

“(4) recommend appropriate training, technical assistance, and patient protection enhancements for primary care health professionals, including registered nurses, to achieve uniform high quality and patient safety;

“(5) provide recommendations on targeted programs and resources for Federally qualified health centers, rural health centers, community health centers, and other community-based organizations;

“(6) provide recommendations for broader patient referral to additional resources, not limited to health care, and collaboration with other organizations and sectors that influence health outcomes; and

“(7) consult with the Secretary on the allocation of the special projects budget under section 601(a)(2)(C) of the Medicare for All Act.

“(d) Rule of construction—Nothing in this section shall be construed—

“(1) to preempt any provision of State law establishing practice standards or guidelines for health care professionals, including professional licensing or practice laws or regulations; or

“(2) to require that any State impose additional educational standards or guidelines for health care professionals.”

Sec. 617 Payments for prescription drugs and approved devices and equipment

The prices to be paid for covered pharmaceuticals, medical supplies, medical technologies, and medically necessary equipment covered under this Act shall be negotiated annually by the Secretary.
(1)
In general— Notwithstanding any other provision of law, the Secretary shall, for fiscal years beginning on or after the date of the enactment of this subsection, negotiate with pharmaceutical manufacturers the prices (including discounts, rebates, and other price concessions) that may be charged to the Medicare for All Program during a negotiated price period (as specified by the Secretary) for covered drugs for eligible individuals under the Medicare for All Program. In negotiating such prices under this section, the Secretary shall take into account the following factors:
(A)
The comparative clinical effectiveness and cost effectiveness, when available from an impartial source, of such drug.
(B)
The budgetary impact of providing coverage of such drug.
(C)
The number of similarly effective drugs or alternative treatment regimens for each approved use of such drug.
(D)
The total revenues from global sales obtained by the manufacturer for such drug and the associated investment in research and development of such drug by the manufacturer.
(2)
Finalization of negotiated price— The negotiated price of each covered drug for a negotiated price period shall be finalized not later than 30 days before the first fiscal year in such negotiated price period.
(3)
Competitive licensing authority—
(A)
In general— Notwithstanding any exclusivity under clause (iii) or (iv) of section 505(j)(5)(F) of the Federal Food, Drug, and Cosmetic Act, clause (iii) or (iv) of section 505(c)(3)(E) of such Act, section 351(k)(7)(A) of the Public Health Service Act, or section 527(a) of the Federal Food, Drug, and Cosmetic Act, or by an extension of such exclusivity under section 505A of such Act or section 505E of such Act, and any other provision of law that provides for market exclusivity (or extension of market exclusivity) with respect to a drug, in the case that the Secretary is unable to success fully negotiate an appropriate price for a covered drug for a negotiated price period, the Secretary shall authorize the use of any patent, clinical trial data, or other exclusivity granted by the Federal Government with respect to such drug as the Secretary determines appropriate for purposes of manufacturing such drug for sale under Medicare for All Program. Any entity making use of a competitive license to use patent, clinical trial data, or other exclusivity under this section shall provide to the manufacturer holding such exclusivity reasonable compensation, as determined by the Secretary based on the following factors:
(i)
The risk-adjusted value of any Federal Government subsidies and investments in research and development used to support the development of such drug.
(ii)
The risk-adjusted value of any investment made by such manufacturer in the research and development of such drug.
(iii)
The impact of the price, including license compensation payments, on meeting the medical need of all patients at a reasonable cost.
(iv)
The relationship between the price of such drug, including compensation payments, and the health benefits of such drug.
(v)
Other relevant factors determined appropriate by the Secretary to provide reasonable compensation.
(B)
Reasonable compensation— The manufacturer described in subparagraph (A) may seek recovery against the United States in the United States Court of Federal Claims.
(C)
Interim period— Until 1 year after a drug described in subparagraph (A) is approved under section 505(j) of the Federal Food, Drug, and Cosmetic Act or section 351(k) of the Public Health Service Act and is provided under license issued by the Secretary under such subparagraph, the Medicare for All Program shall not pay more for such drug than the average of the prices available, during the most recent 12-month period for which data is available prior to the beginning of such negotiated price period, from the manufacturer to any wholesaler, retailer, provider, health maintenance organization, nonprofit entity, or governmental entity in the ten OECD (Organization for Economic Cooperation and Development) countries that have the largest gross domestic product with a per capita income that is not less than half the per capita income of the United States.
(D)
Authorization for Secretary to procure drugs directly— The Secretary may procure a drug manufactured pursuant to a competitive license under subparagraph (A) for purposes of this Act.
(4)
FDA review of licensed drug applications— The Secretary shall prioritize review of applications under section 505(j) of the Federal Food, Drug, and Cosmetic Act for drugs licensed under paragraph (3)(A).
(5)
Prohibition of anticompetitive behavior— No drug manufacturer may engage in anticompetitive behavior with another manufacturer that may interfere with the issuance and implementation of a competitive license or run contrary to public policy.
(6)
Required reporting— The Secretary may require pharmaceutical manufacturers to disclose to the Secretary such information that the Secretary determines necessary for purposes of carrying out this subsection.