Health Care Watch: June 28, 2021
The following Health Care Watch provides a summary of legislative and regulatory health care activities from June 21 - 27. Where available, hyperlinks are included to the relevant documents. Please let us know if you have any questions or would like additional information on the items below.
NON-CORONAVIRUS LEGISLATIVE UPDATE
House
On June 22, Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) released a bill entitled Cures 2.0, building on the 21st Century Cures Act that would:
Create a national testing and response strategy for future pandemics;
Support the development of antimicrobial innovations;
Increase health literacy and education for patients and caregivers;
Fund grants for innovative drug development and cell and gene therapy;
Improve Food & Drug Administration (FDA)-Centers for Medicare & Medicaid Services (CMS) communication regarding transformative new therapies;
Increase access to telehealth under Medicaid and CHIP, and extend Medicare telehealth flexibilities;
Cover breakthrough devices through Medicare; and
Support the Advanced Research Projects Agency for Health.
A summary of the bill is available here.
On June 22, Reps. Liz Cheney (R-WY) and Debbie Dingell (D-MI) introduced H.R.4040 to extend telehealth flexibilities under the Medicare program.
On June 23, a bipartisan collection of representatives introduced H.R. 4043, which would grant four years of Medicare coverage to breakthrough devices and require CMS to make a permanent coverage determination.
On June 24, the Energy & Commerce Health Subcommittee held a hearing entitled Empowered by Data: Legislation to Advance Equity and Public Health. The Subcommittee discussed and considered the following legislation:
H.R. 379, the "Improving Social Determinants of Health Act of 2021";
H.R. 666, the "Anti-Racism in Public Health Act of 2021";
H.R. 778, the "Secure Data and Privacy for Contact Tracing Act of 2021";
H.R. 791, the "Tracking COVID–19 Variants Act";
H.R. 831, the "Health Standards To Advance Transparency, Integrity, Science, Technology Infrastructure, and Confidential Statistics Act of 2021" or the "Health STATISTICS Act of 2021";
H.R. 925, the "Data to Save Moms Act";
H.R. 943, the "Social Determinants for Moms Act";
H.R. 976, the "Ensuring Transparent Honest Information on COVID–19 Act" or the "ETHIC Act";
H.R. 2125, the "Quit Because of COVID–19 Act";
H.R. 2503, the "Social Determinants Accelerator Act of 2021";
H.R. 3894, the "Collecting and Analyzing Resources Integral and Necessary for Guidance for Social Determinants of Health Act of 2021" or the "CARING for Social Determinants of Health Act of 2021";
H.R. 3969, to amend title XXVII of the Public Health Service Act to include activities to address social determinants of health in the calculation of medical loss ratios; and
H.R. ____, to require the Comptroller General of the United States to submit to Congress a report on actions taken by the Secretary of Health and Human Services to address social determinants of health.
Subcommittee Chair Anna Eshoo (D-CA) highlighted the lack of robust public health systems across the U.S. that slowed down the nation’s response to COVID-19. Subcommittee Ranking Member Brett Guthrie (R-KY) noted that MA plans offer benefits that address social determinants of health (SDOH) and advocated for continued support of MA. Members and witnesses discussed the following topics: how Medicare Advantage (MA) plans address SDOH, how private insurance can address SDOH, improving data coordination, addressing the needs of specific vulnerable populations, and other topics. Witnesses included: Romilla Batra, M.D., Chief Medical Officer, SCAN Health Plan; Beth Blauer, Executive Director, Johns Hopkins University Centers for Civic Impact; Karen DeSalvo, M.D., Chief Health Officer, Google Health; Faisel Syed, M.D. National Director of Primary Care ChenMed; and Kara Odom Walker, M.D., Executive Vice President, Chief Population Health Officer, Nemours Children's Health System.
On June 24, Democrats unveiled draft budget legislation allocating $3.47 billion to the FDA in FY2022, an increase of $257 million from FY2021 levels. On June 25, the Agriculture-FDA Appropriations Subcommittee approved this legislation. A summary of the funding bill is available here.
On June 24, Energy & Commerce Chairman Frank Pallone (D-NJ) and Oversight & Reform Chairwoman Carolyn Maloney (D-NY) announced that their Committees will investigate the approval and pricing of Biogen Inc.’s Alzheimer’s drug, Aduhelm. On June 23, Biogen released a statement that the company would not increase the price of Aduhelm following health care advocates voicing their concerns regarding the drug’s $56,000 per year list price.
Senate
On June 20, Majority Leader Chuck Schumer (D-NY) and Sen. Bernie Sanders (I-VT) announced a partnership to add dental, vision, and hearing coverage to Medicare in the American Jobs and Families Plans.
On June 22, the Judiciary Intellectual Property Subcommittee held a hearing entitled Protecting Real Innovations by Improving Patent Quality. Judiciary Intellectual Property Subcommittee Chairman Patrick Leahy (D-VT) highlighted fraudulent patent issues around COVID-19 diagnostics and emphasized the need to improve patent quality. Witnesses included: Bridget Asay, Partner, Stris & Maher LLP; Julio Garceran, Chief Intellectual Property Counsel, Cree, Inc.; Troy R. Lester Vice President Patents Acushnet Company Fairhaven, MA Mr. Jorge L. Contreras Presidential Scholar And Professor Of Law S.J. Quinney College of Law, University of Utah
On June 22, Finance Committee Ranking Member Mike Crapo (R-ID) and Health, Education, Labor & Pensions (HELP) Ranking Member Richard Burr (R-NC) reintroduced the Lower Costs, More Cures Act to lower prescription drug prices, promote transparency, and encourage American innovation of new treatments and cures. The legislation includes: incentivizing lower-cost alternatives and biosimilars, establishing an annual out-of-pocket cap of $3,100 for Medicare Part D enrollees and allow certain patients to pay in monthly installments; decreasing beneficiary cost sharing from 25% to 15% of costs before the out-of-pocket cap is reached, promoting competition between Part D plans, making permanent the Center for Medicare and Medicaid Innovation model that enables Part D enrollees taking insulin to limit out-of-pocket costs to $35, requiring drug manufacturers to provide pricing information on direct-to-consumer advertising, and other measures. A section summary is available here.
On June 23, Finance Chair Ron Wyden (D-OR) released principles for prescription drug pricing reform, including:
Allowing Medicare to negotiate drug prices;
Restructuring the Part D benefit in order to reduce high patient out-of-pocket spending to affordable monthly limits;
Discontinuing certain rebate practices that limit competition and patient access to affordable drugs, and seek greater transparency in the supply chain;
Requiring rebates on drugs that increase in price above inflation;
Extending these reforms beyond the Medicare and Medicaid populations; and
Developing policies that reward scientific innovation, not gaming of the patent system.
On June 24, the Finance Committee held a hearing entitled Hearing to Consider the Pending Nominations of Sarah Bianchi, of Virginia, to be Deputy U.S. Trade Representative (Asia, Africa, Investment, Services, Textiles, and Industrial Competitiveness), with the rank of Ambassador, Jayme Ray White, of Washington, to be a Deputy U.S. Trade Representative (Western Hemisphere, Europe, the Middle East, Labor, and Environment), with the rank of Ambassador, and Melanie Anne Egorin, of the District of Columbia, to be an Assistant Secretary of Health & Human Services (HHS). Wyden highlighted that, once confirmed, Egorin will have to address rising mental health issues and drug pricing.
On June 24, Sen. Bob Casey (D-PA) and Rep. Dingell introduced bills in their respective chambers to expand access to home and community-based services under Medicaid for seniors and people with disabilities.
On June 24, Sens. Chuck Grassley (R-IA), Dick Durbin (D-IL), and Angus King (I-ME) reintroduced the Drug-price Transparency for Competition Act that would require direct-to-consumer advertisements for prescription drugs and biologics to contain a disclosure of their list price. A summary of the legislation is available here.
On June 24, the Senate confirmed Dawn O'Connell to be Assistant Secretary for Preparedness and Response and Miriam Delphin-Rittmon to be Assistant Secretary for Mental Health and Substance Use and lead the Substance Abuse and Mental Health Services Administration (SAMHSA).
NON-CORONAVIRUS REGULATORY UPDATE
On June 21, HHS, the Department of Treasury, and the Department of Labor issued a joint Request for Information for the proposed rule entitled Reporting on Pharmacy Benefits and Prescription Drug Costs. These reporting requirements are applicable to commercial health insurance plans as a result of section 204 of Title II of Division BB of the Consolidated Appropriations Act of 2021. Responses are due in 30 days.
On June 21, CMS released the Medicaid and CHIP Enrollment December 2020 and January 2021 Enrollment Trend Snapshot. The snapshot found an increase in Medicaid and Children's Health Insurance Program (CHIP) enrollment during COVID-19, resulting in one-in-four Americans (80.5 million) currently being covered by Medicaid and CHIP. Nearly 10 million individuals enrolled in coverage during COVID-19. A summary of this snapshot is available here.
On June 21, CMS announced $20 million to support State-based Marketplaces in modernizing and updating Marketplaces systems, programs, or technology to comply with federal Marketplace requirements. This funding comes from the American Rescue Plan.
On June 22, FDA issued a notice entitled Authorization and Revocation of Emergency Use of Drugs during the COVID-19 Pandemic, Availability.
On June 23, CMS issued guidance entitled Remanufacturing of Medical Devices.
On June 24, FDA issued an emergency use authorization (EUA) for Actemra for the treatment of hospitalized COVID-19 patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation.
On June 24, FDA granted Breakthrough Therapy designation to Eli Lilly’s investigational antibody therapy donanemab for Alzheimer's disease.
On June 24, CMS Administrator Chiquita Brooks-LaSure sent letters to Indiana and Arizona formally revoking their Medicaid work requirements.
On June 24, CMS issued a notice entitled the Prescription Drug Marketing; Administrative Procedures, Policies, and Requirements
On June 24, the White House Office of Management & Budget (OMB) concluded the proposed rule from CMS entitled CY 2022 Home Health Prospective Payment System Rate Update, Home Infusion Therapy Services, and Quality Reporting Requirements (CMS-1747).
On June 25, HHS Secretary Xavier Becerra signed a memorandum appointing members to the 340B Administrative Dispute Resolution Board but did not release the names of the appointed members.
On June 25, FDA issued guidance entitled Sponsor Responsibilities -- Safety Reporting Requirements and Safety Assessment for Investigational New Drug Application and Bioavailability/Bioequivalence Studies; Draft Guidance.
NON-CORONAVIRUS WHITE HOUSE UPDATE
None of note.
CORONAVIRUS UPDATE
House
On June 23, Rep. Maloney and Select Subcommittee on the Coronavirus Crisis Chairman James Clyburn (D-SC) sent letters to AstraZeneca and Johnson & Johnson requesting information on the issues and corrective measures regarding the manufacturing issues at the Emergent BioSolutions facility, as part of the Committees’ investigation of manufacturing problems and deficient controls that resulted in the contamination of millions of COVID-19 vaccines.
Senate
On June 22, the HELP Committee held a hearing entitled Vaccines: America's Shot at Ending the COVID-19 Pandemic. HELP Chair Patty Murray (D-WA) highlighted that many states are falling behind on COVID-19 vaccinations and noted the inequities in vaccination rates in Black and Latino communities, rural communities, Evangelical communities, and among Republicans. Witnesses included: Susan Bailey, M.D., Immediate Past President, American Medical Association; Jeanette Betancourt, Senior Vice President, U.S. Social Impact Sesame Workshop; Curtis Chang, Consulting Professor, Duke Divinity School; and Michelle Nichols, M.D., Associate Dean of Clinical Affairs, Morehouse School of Medicine.
Regulatory
On June 21, the Occupational Safety and Health Administration issued an interim final rule entitled Occupational Exposure to COVID–19; Emergency Temporary Standard. Employers must comply with the provisions listed in the rule by July 6.
On June 23, the National Institutes of Health launched a study looking at COVID-19 vaccination during pregnancy and postpartum to evaluate the antibody responses in these specific groups.
On June 25, the HHS COVID-19 Health Equity Task Force held a meeting discussing interim recommendations addressing the inequities, the impact of long-COVID, and access to personal protection equipment, testing, and therapeutics.
White House
On June 23, President Biden and the bipartisan group of senators, coined the ‘G20,’ including Sens. Rob Portman (R-OH), Mitt Romney (R-UT), Joe Manchin (D-WV), Bill Cassidy (R-LA), and Kyrsten Sinema (D-AZ), came to an agreement on the framework of a $1.2 trillion infrastructure package, with $579 billion in new spending. President Biden appears to back this agreement but did note that he would like to see an additional “human infrastructure” portion in addition to this package
On June 21, White House announced the distribution list for 55 million COVID-19 vaccine doses that the U.S. has pledged to allocate by the end of this month. This will not include AstraZeneca vaccines due to manufacturing delays. About 41 million of the 55 million doses will be shared through COVAX, including:
14 million for Latin America and the Caribbean;
16 million for Asia; and
10 million for Africa.
On June 23, the White House acknowledged that the U.S. will not reach its goal of having 70% of all American adults at least partly vaccinated by July 4, resetting the goal to vaccinate 70% of adults 27 and older by July 4.
Other
On June 21, Cuba announced that their homegrown three-shot Abdala COVID-19 vaccine reached 92.28% efficacy.
As of June 25, over 179 million people in the U.S. have received the first dose of COVID-19 vaccines (more than 153 million have received both doses) and more than 381 million doses have been distributed, according to the CDCCOVID Data Tracker.
As of June 25, the U.S. had more than 33.6 million confirmed COVID-19 cases resulting in 603,966 deaths, according to the Johns Hopkins University & Medicine Coronavirus Resource Center.
RULES AT THE WHITE HOUSE OMB
HHS-CMS
Modification of Limitations on Redesignation by the Medicare Geographic Classification Review Board (CMS-1762); Interim Final Rule; Received 2/26/21
CY 2022 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1751); Proposed Rule; Received 3/30/21
CY 2022 Home Health Prospective Payment System Rate Update, Home Infusion Therapy Services, and Quality Reporting Requirements (CMS-1747); Proposed Rule; Received 4/30/21
CY 2022 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System and Quality Incentive Program (CMS-1749); Proposed Rule; 5/3/21
CY 2022 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1753); Proposed Rule; 5/11/21
Basic Health Program; Federal Funding Methodology for Program Year 2022 (CMS-2438); Final Rule; 5/12/21
HHS-FDA
Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification; Guidance for Industry; Availability; Notice; 5/11/21
Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act; Draft Guidance for Industry; Availability; Notice; 5/11/21
Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers; Guidance for Industry; Availability; Notice; 5/11/21
Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act; Draft Guidance for Industry; Availability; Notice; 5/11/21
Remanufacturing of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Prerule; 5/26/21
REPORTS
Health & Human Services (HHS) Office of Inspector General (OIG)
On June 22, OIG released a report entitled COVID-19 Had a Devastating Impact on Medicare Beneficiaries in Nursing Homes During 2020. The report found that 20% of Medicare beneficiaries in nursing homes were diagnosed with either COVID-19 or likely COVID-19 in 2020. Almost 1,000 more beneficiaries died per day in April 2020 than in April 2019 and overall mortality in nursing homes increased to 22% in 2020, an increase from 17% in 2019. OIG committed to understanding and helping to protect nursing home residents from the impacts of COVID-19. OIG noted that additional data analysis may help CMS in its efforts to understand the effects of the pandemic and health disparities within the nursing home population and prepare for and deal with future crises. A summary of this report is available here.
On June 23, OIG released a report entitled Medicare Lacks Consistent Oversight of Cybersecurity for Networked Medical Devices in Hospitals. The report found that CMS' survey protocol does not include requirements for networked device cybersecurity, and Medicare accreditation organizations (AOs) do not use their discretion to require hospitals to have such cybersecurity plans but AOs sometimes review limited aspects of device cybersecurity. OIG recommended that CMS and HHS identify and implement an appropriate way to address cybersecurity of networked medical devices in its quality oversight of hospitals. CMS agreed with the importance of cybersecurity of networked medical devices for providers. A summary of the report is available here.
On June 25, OIG released a report entitled Medicare Hospice Provider Compliance Audit: Northwest Hospice, LLC.The report found that NW Hospice received some Medicare reimbursement for hospice services that did not comply with Medicare requirements, resulting in at least $3.9 million in unallowable Medicare reimbursements. OIG recommended that NW Hospice refund Medicare overpayments and strengthen its policies and procedures to ensure that hospice services comply with Medicare requirements. NW Hospice agreed to take appropriate action to refund payments for services determined not to have complied with Medicare requirements. A summary of the report is available here.
On June 25, OIG released a report entitled Kentucky Claimed Millions in Unallowable School-Based Medicaid Administrative Costs. The report found that Kentucky did not claim school-based Medicaid administrative costs in accordance with Federal requirements and used an invalid RMS to allocate costs to Medicaid and it included unallowable costs in its cost pools, resulting in $58.9 million in unallowable payments. OIG recommended that Kentucky refund Medicaid unallowable payments, amend its cost allocation plan (CAP), enhance random moment sampling procedures and ensure that its Medicaid administrative cost claim complies with Federal requirements for allocable costs, enhance policies and procedures to ensure that changes to its RMTS methodology are incorporated into a CAP amendment and promptly submitted to the Division of Cost Allocation for review, and review school-based Medicaid administrative costs claimed after the audit period and refund any unallowable amounts. Kentucky generally disagreed with the findings and did not address the recommendations. A summary of the report is available here.
Government Accountability Office (GAO)
On June 21, GAO released a report entitled Physician Workforce: Caps on Medicare-Funded Graduate Medical Education (GME) at Teaching Hospitals. The report found that 70% of hospitals trained more residents than what Medicare funded through physician GME payments, indicating they can train more physicians now than when these caps were set. From talking to stakeholders, GAO found that giving hospitals additional time to establish and grow their GME programs before their caps are hospitals' resident caps. GAO also suggested that targeting the extension to under-resourced hospitals would help alleviate stress for these hospitals. Stakeholders also noted that extending the cap-establishment window would not address all challenges that under-resourced hospitals face when starting new GME programs. A summary of the report is available here.
HEARINGS
House
Appropriations Labor, Health & Human Services, Education, and Related Agencies Subcommittee
Fiscal Year (FY) Appropriations 2022 Markup: Labor, Health & Human Services, Education, and Related Agencies
July 12, TBD
Appropriations Committee
FY Appropriations 2022 Markup
July 16-17, TBD
Appropriations Committee
June 30, 12:00 a.m.
Senate
None of note.
OTHER HEALTH POLICY NEWS
On June 21, the Kaiser Family Foundation (KFF) released a report on MA Enrollment in 2021 that found enrollment in MA has more than doubled over the past decade. In 2021, 42% of beneficiaries are enrolled in an MA play, with two-thirds of MA enrollees in individual plans and one-in-five MA enrollees in group plans offered to retirees by employers and unions. UnitedHealthcare and Humana account for 45% of all MA enrollees nationwide in 2021 and they have consistently accounted for a large share of MA enrollment.
On June 21, the Supreme Court denied insurers’ request to take up an appeals court decision finding the government can mitigate its obligation to reimburse plans for Affordable Care Act cost-sharing reduction (CSRs). Maine Community Health Options and Community Health Choice petitioned the Supreme Court over a lower court decision holding that plans that engaged in “silver loading” are not eligible to be repaid for lost CSR payments.
On June 22, KFF highlighted existing policy proposals to address the cost of prescription drugs to both consumers and payers, including eliminating the Medicaid drug rebate cap; limiting or prohibiting “spread pricing” in Medicaid by pharmacy benefit managers (PBMs) by requiring “pass through” pricing that limits PBM fees; modify rules on Medicaid “best price,” as part of other changes to the rebate formula or to facilitate value-based payment arrangements; increasing the minimum Medicaid rebate amount based on launch price or other factors that define a high-cost drug; and allowing buyers to import drugs from foreign markets to access lower prices generally available in other countries.
On June 23, the Partnership for America’s Health Care Future released a report on the fiscal costs of lowering the Medicare eligibility age to 60. The report predicted that lowering the eligibility age would result in approximately 14 million 60- to 64-year-olds enrolling in Medicare Part A, about 8 million enrolling in Part B, and 6.5 million enrolling in Part D. Gross Medicare expenditures would increase by $82.9 billion in 2022 and the Hospital Insurance Trust Fund would be depleted in 2024, two years sooner than currently projected.
On June 23, a Missouri County judge deemed a citizen-led effort to expand Medicaid illegal due to the lack of a funding source for the program.
On June 24, Georgia announced it is delaying the July 1 partial Medicaid expansion program until at least August 1, 2021.
On June 24, the U.N. Office on Drugs and Crime released the World Drug Report that found that around 275 million people used drugs globally in 2020 and over 36 million people suffered from drug use disorders.
On June 24, KFF released a report that found that about half of emergency ambulance rides among privately insured people pose a risk of a surprise bill and for many of the largest states, at least two-thirds of ground ambulance rides pose a risk of surprise bills.
On June 25, KFF released a report that found that one in six Medicare beneficiaries reported a cost-related problem in 2018, but these problems are slightly less common among beneficiaries in Traditional Medicare than in MA due to supplemental coverage.