The following LPG Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from May 10 – May 16. 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 May 11, Energy & Commerce Chairman Frank Pallone (D-NJ), Health Subcommittee Chair Anna Eshoo (D-CA), and Oversight & Investigations Subcommittee Chair Diana DeGette (D-CO) urgedHealth & Human Services (HHS) Secretary Xavier Becerra to restore the Food & Drug Administration’s (FDA) premarket review authority and reinstate the requirement for premarket review of COVID-19 laboratory developed tests.
On May 11, 70 Representatives urged HHS Secretary Becerra to support and strengthen the Medicare Advantage (MA) program. The letter highlighted the diversity of the MA population and the effectiveness of the program.
On May 12, the Energy & Commerce Committee held a hearing entitled The FY2022 HHS Budget.Chairman Pallone highlighted the increase in funds for HHS and its adjoining agencies, a 23.5% increase from the 2021 enacted level, including investments in public health preparedness, combating health inequities, expanding cross-agency research capabilities, and investments in improving mental health and combating the opioid epidemic. HHS Secretary Becerra was the sole witness. The committee memo can be found here.
On May 11, the House passed the following health-related bills:
H.R. 433 – Family Support Services for Addiction Act of 2021;
H.R. 1475 – Pursuing Equity in Mental Health Act;
H.R. 586 – STANDUP Act of 2021;
H.R. 721 – Mental Health Services for Students Act of 2021, as amended;
H.R. 2877 – Behavioral Intervention Guidelines Act of 2021;
H.R. 1260 – Bipartisan Solution to Cyclical Violence Act of 2021;
H.R. 1205 – Improving Mental Health Access from the Emergency Department Act of 2021;
H.R. 1324 – Effective Suicide Screening and Assessment in the Emergency Department Act of 2021;
H.R. 1480 – HERO Act;
H.R. 2862 – Campaign to Prevent Suicide Act;
H.R. 2981 – Suicide Prevention Lifeline Improvement Act of 2020; and
H.R. 2955 – Suicide Prevention Act.
On May 11, the House failed to suspend the rules and pass H.R. 1629, Fairness in Orphan Drug Exclusivity Act in a 250 - 168 vote, where a two-thirds majority is required for passage. The House will now consider this legislation on May 19.
On May 13, House Republicans voted to remove Rep. Liz Cheney (R-WY) from her leadership role as GOP Conference Chair and voted 134-46 in a secret ballot to appoint Rep. Elise Stefanik (R-NY) to that position.
On May 13, Reps. Suzan DelBene (D-WA), Mike Kelly (R-PA), Ami Bera (D-CA), and Larry Bucshon (R-IN) introduced the Improving Seniors’ Timely Access to Care Act, which would streamline and standardize the way MA plans use prior authorization, and increase oversight and transparency around prior authorization.
Senate
On May 11, Finance Chairman Ron Wyden (D-OR) announced the following staff changes to the Democrat health team:
Anna Kaltenboeck as Senior Health Advisor, focusing on drug pricing and outpatient prescription drug coverage under Medicare Part D;
Eva DuGoff as Senior Health Advisor, focusing on health insurance coverage under the marketplaces established by the Affordable Care Act and MA; and
Liz Dervan as Health Counsel on Medicaid and the Children’s Health Insurance Program (CHIP).
On May 11, the Health, Education, Labor & Pensions (HELP) Committee held a hearing entitled An Update from Federal Officials on Efforts to Combat COVID-19. HELP Chair Patty Murray (D-WA) emphasized the need for action to increase vaccine access for countries that need them and supported offering aid to global communities to the COVID crisis. HHS Chief Science Officer David Kessler predicted that COVID-19 vaccine booster shots will be free. Witnesses included: Anthony Fauci, MD, Director, National Institute of Allergy and Infectious Diseases, National Institutes of Health; David Kessler, MD, Chief Science Officer, COVID Response, HHS; Peter Marks, MD, Director, Center for Biologics Evaluation and Research, FDA; and Rochelle Walensky, MD, Director, Centers for Disease Control and Prevention (CDC).
On May 11, the Senate confirmed Andrea Palm for HHS Deputy Secretary in a 61-37 vote.
On May 12, the Senate advanced Chiquita Brooks-LaSure’s nomination for Centers for Medicare & Medicaid Services (CMS) Administrator in a procedural vote of 51-48 to bring the nomination to the floor. Sens. Susan Collins (R-ME) and Jerry Moran (R-KS) joined the Democrats to advance her nomination.
On May 12, the Finance Committee held a hearing entitled The COVID-19 Pandemic and Beyond: Improving Mental Health and Addiction Services in Our Communities. Chair Debbie Stabenow (D-MI) advocated for legislation to reimburse behavioral health care clinics the same way as Federally Qualified Health Centers. Witnesses included: Victor Armstrong, Director, North Carolina Division of Mental Health, Developmental Disabilities And Substance Abuse Services, North Carolina HHS; Stephanie Woodard, Senior Advisor On Behavioral Health, Nevada HHS; Lenette Kosovich, CEO, Rimrock Foundation; and Malkia Newman, Team Supervisor, CNS Healthcare Anti-Stigma Program.
NON-CORONAVIRUS REGULATORY UPDATE
On May 10, the HHS Office for Civil Rights updated its interpretation of prohibitions on discrimination based on sex to include sexual orientation and gender identity. The agency updated its interpretation, in light of the Supreme Court’s decision in Bostock v. Clayton County and subsequent court decisions.
On May 11, HHS Secretary Becerra announced that more than one million Americans have signed up for coverage on HealthCare.gov during the Special Enrollment Period for COVID-19. Secretary Becerra supported the passage of the American Families Plan.
On May 11, the White House Office of Management & Budget (OMB) received a proposed rule from Health Resources & Services Administration (HRSA) entitled Rescission of the Final Rule “Implementation of Executive Order on Access to Affordable Life-Saving Medications.”
On May 11, OMB received a notice from the FDA entitled Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification; Guidance for Industry; Availability
On May 11, OMB received a proposed rule from CMS entitled CY 2022 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1753).
On May 11, FDA issued a notice entitled COVID-19: Developing Drugs and Biological Products for Treatment or Prevention.
On May 12, OMB received a proposed rule from CMS entitled Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value Based Payments (VBP) for Drugs Covered in Medicaid (CMS-2482).
On May 12, OMB received a final rule from CMS entitled Basic Health Program; Federal Funding Methodology for Program Year 2022 (CMS-2438).
On May 12, CMS and Abt Associates announced they are recruiting Medicare-certified hospice providers to participate in a beta test of the draft hospice patient assessment instrument called Hospice Outcomes & Patient Evaluation. Recruitment ends June 14, 2021. Data collection is anticipated to begin in fall 2021.
On May 13, CMS published a blog post highlighting lessons learned from the CMS Artificial Intelligence Health Outcomes Challenge. The blog highlighted the competition’s strong, diverse participant interest; the impressive participant submissions; and the benefit of public-private partnerships.
On May 13, HHS Secretary Becerra urged the Supreme Court to uphold the Trump Administration’s site-neutral policy and cuts to Medicare Part B reimbursement for hospitals in the 340B drug program.
On May 13, CMS issued a delay for the final rule entitled Medicare Coverage of Innovative Technology (MCIT) and Definition of "Reasonable and Necessary" (CMS-3372). The rule is delayed until December 15, 2021.
On May 13, CMS issued guidance to states on the implementation of the temporary 10% increase to the federal medical assistance percentage (FMAP) for certain Medicaid expenditures for home and community-based services (HCBS). The letter also describes opportunities for states to strengthen the HCBS system in response to COVID-19, increase access to HCBS for Medicaid beneficiaries, adequately protect the HCBS workforce, safeguard financial stability for HCBS providers, and accelerate long-term services and supports. A summary of the guidance is available here.
On May 14, CMS released data highlighting the impact of COVID-19 on Medicaid and CHIP beneficiaries and utilization of health services. The data indicate that beneficiaries have foregone millions of primary, preventive, and mental health care visits due to the COVID-19.
The National Clinical Care Commission will hold a meeting May 19 and June 1, 2021, to evaluate and make recommendations regarding improvements to the coordination and leveraging of federal programs related to diabetes and its complications.
NON-CORONAVIRUS WHITE HOUSE UPDATE
President Biden is expected to unveil his full budget request on May 27. This submission will likely include proposed changes to Medicare, Medicaid, and drug pricing.
CORONAVIRUS UPDATE
House
On May 10, the moderate Democrats’ Blue Dog Coalition announced that Andy LaVigne will be its Executive Director.
Senate
None of note.
Regulatory
On May 10, FDA expanded the emergency use authorization (EUA) for Pfizer's COVID-19 vaccines for kids age 12 to 15. On May 11, the CDC Advisory Committee on Immunization Practices recommended the vaccine for kids age 12 to 15 in a 14-0 vote. The Pfizer vaccine is the first shot available for those under 16.
On May 10, the Treasury Department launched the Coronavirus State and Local Fiscal Recovery Funds to provide $350 billion in emergency funding for eligible state, local, territorial, and Tribal governments, to respond to acute pandemic response needs, fill revenue shortfalls among these governments, and support the communities and populations hardest-hit by the COVID-19 crisis.
On May 11, HRSA awarded $40 million in emergency home visiting funds to states, territories, and DC to support children and families affected by the COVID-19 pandemic, through the Maternal, Infant, and Early Childhood Home Visiting Program.
On May 11, CDC released findings that monitoring demographic and social factors affecting COVID-19 vaccine access for older adults and prioritizing efforts to ensure equitable access to COVID-19 vaccine are needed to ensure high vaccination rates.
On May 13, CMS issued an interim final rule entitled COVID-19 Vaccine Requirements for Long-Term Care (LTC) Facilities and Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs-IID) Residents, Clients, and Staff. This rule would require long-term care facilities to offer COVID-19 vaccines to residents and staff and require staff to provide weekly reporting of vaccination rates.
On May 13, CDC updated guidance for fully vaccinated individuals, allowing fully vaccinated people to resume activities, indoor and outdoor, without wearing a mask or physically distancing, except where required by federal, state, local, tribal, or territorial laws, rules, and regulations, including local business and workplace guidance.
On May 14, CDC released the largest CDC COVID-19 vaccine effectiveness study that found that the Pfizer and Moderna COVID-19 vaccines reduced the risk of getting sick with COVID-19 by 94% among fully-vaccinated health care personnel from a geographically diverse population.
FDA Vaccines and Related Biological Products Advisory Committee will hold a virtual meeting June 10 to discuss the approach to issuing EUAs for children to receive COVID-19 vaccines.
White House
On May 11, the White House announced that Uber and Lyft will offer free rides to COVID-19 vaccination sites through July 4.
On May 11, the White House told governors that the Johnson & Johnson (J&J) COVID-19 vaccine was not immediately available for states to order and states will not receive any doses of the J&J vaccine next week.
On May 13, the Biden Administration announced that it will invest $7.4 billion to expand the public health workforce, and strengthen and modernize public health infrastructure to prepare for future health emergencies. The funding will also go towards supporting vaccinations, testing, contact tracing, and community outreach.
Other
On May 10, World Trade Organization (WTO) Director-General Ngozi Okonjo-Iweala predicted that the organization will reach a decision regarding waiving COVID-19 vaccine patents and intellectual property rules by December.
On May 10, a study published in The Lancet found that the risk of severe long-term COVID-19 complications for those who were not hospitalized is low.
On May 10, Novavax predicted that its COVID-19 vaccine would not be authorized in the U.S. until at least July and noted that production is lagging.
On May 14, the World Health Organization labeled the COVID-19 strain from India as a “variant of concern.”
As of May 16, over 156 million people have received the first dose of COVID-19 vaccines (nearly 122 million have received both doses) and more than 344 million doses have been distributed, according to the CDC COVID Data Tracker.
As of May 14, the U.S. had 32,924,567 confirmed COVID-19 cases resulting in 585,709 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
HHS-HRSA
Rescission of the Final Rule “Implementation of Executive Order on Access to Affordable Life-Saving Medications”; Proposed Rule; 5/10/21
REPORTS
HHS Office of Inspector General (OIG)
On May 10, OIG released a report entitled Medicare Hospice Provider Compliance Audit: Suncoast Hospice. The report found that Suncoast did not always comply with Medicare requirements, claiming Medicare reimbursement for hospice services for which the clinical record did not support the beneficiary's terminal prognosis or the level of care claimed and for services that were not provided. This resulted in an estimated $47.4 million in Medicare reimbursement for hospice services that did not comply with Medicare requirements. OIG recommended that Suncoast refund the Medicare overpayments and strengthen its policies and procedures to ensure that hospice services comply with Medicare requirements. Suncoast disagreed with the recommendations and findings. A summary of the report is available here.
On May 11, OIG released a report entitled Risk Assessment of the Food and Drug Administration's Travel Card Program. The report found that the FDA generally designed and implemented controls and strategies to mitigate the potential risks of illegal, improper, or erroneous purchases in its travel card program. OIG assessed the FDA travel card program as low risk. A summary of the report is available here.
On May 12, OIG released a report entitled Medicare Could Have Saved up to $20 Million Over 5 Years if CMS Oversight Had Been Adequate To Prevent Payments for Medically Unnecessary Cholesterol Blood Tests. The report found that Medicare paid providers that had billed for medically unnecessary cholesterol laboratory tests, resulting in an estimated $20.4 million of Medicare payments made to at-risk providers for direct LDL tests. OIG recommended that CMS direct Medicare contractors to develop oversight mechanisms to identify at-risk providers and prevent improper payments and educate providers on the billing of direct LDL tests in addition to lipid panels. CMS did not agree with the first recommendation and already addressed the second recommendation. A summary of the report is available here.
On May 13, OIG released a report entitled New York Made Unallowable Payments Totaling More Than $9 Million to the Same Managed Care Organization (MCO) for Beneficiaries Assigned More Than One Medicaid Identification Number. The report found that New York improperly claimed Federal Medicaid reimbursement for Medicaid beneficiaries who were assigned more than one Medicaid ID number, resulting in an estimated $10.6 million in overpayment. OIG recommended that New York refund and recover improper managed care payments made to the same MCO on behalf of beneficiaries with more than one Medicaid ID number prior to and after our audit period. New York did not agree or disagree with the recommendations but described steps that it has taken or plans to take to address them. A summary of the report is available here.
On May 14, OIG released a report entitled Minnesota Made Capitation Payments to Managed Care Organizations for Medicaid Beneficiaries With Concurrent Eligibility in Another State. The report found that Minnesota made some capitation payments on behalf of beneficiaries who should not have been eligible for Medicaid benefits in Minnesota because they were concurrently eligible and residing in another State, resulting in $1.1 million in overpayment. OIG recommended that Minnesota develop new procedures or enhance current ones to identify beneficiaries with concurrent eligibility in another State and ensure that county caseworkers follow procedures to timely review and terminate eligibility for beneficiaries who were identified as concurrently eligible in another State. Minnesota accepted the recommendations and described actions it has taken or plans to take to address them. A summary of the report is available here.
Government Accountability Office (GAO)
On May 10, GAO released a report entitled Maternal Mortality and Morbidity: Additional Efforts Needed to Assess Program Data for Rural and Underserved Areas. The report found that the CDC Pregnancy Mortality Surveillance System indicated that deaths during pregnancy or up to 1 year postpartum due to pregnancy-related causes were higher in rural areas compared to metropolitan areas from 2011-2016. GAO noted that CDC and HRSA collect data that is not systematically disaggregated and analyzed by rural and underserved areas. GAO recommended that CDC and HRSA disaggregate and analyze program data by rural and underserved areas, and that HHS's workgroups establish a formal coordinated approach for monitoring maternal health efforts. HHS concurred with the recommendations. A summary of the report is available here.
On May 12, GAO released its 11th annual report highlighting opportunities to reduce fragmentation, overlap, and duplication in the federal government. The report contains 112 new actions that Congress and the Administration could take to save money and improve efficiency across a wide range of government programs and activities. A summary of the report is available here.
HEARINGS
House
Financial Services and General Government Subcommittees
The Need for Universal Broadband: Lessons from the COVID-19 Pandemic
May 18, 10:30 a.m.
Witnesses included: Joi Chaney, National Urban League; Matt Dunne, Center on Rural Innovation; and Max Stier, Partnership for Public Service.
Oversight & Reform Committee
May 18, 10:00 a.m.
Witness: Richard Gonzales, CEO, AbbVie.
Senate
Finance Committee
COVID-19 Health Care Flexibilities: Perspectives, Experiences, and Lessons Learned
May 19, 10:00 a.m.
Witnesses include: Jessica Farb, Director, Health Care GAO; Kisha Davis, M.D., Member, Commission On Federal And State Policy American Academy of Family Physicians; Linda DeCherrie, M.D., Clinical Director, Mount Sinai At Home And Professor, Geriatrics And Palliative Medicine, Icahn School Of Medicine At Mount Sinai, Mount Sinai Health System; Narayana Murali, M.D., Executive Director, Board Member, America’s Physician Groups Marshfield Clinic; and Robert Berenson, M.D., Institute Fellow Urban Institute
Judiciary Subcommittee on Competition Policy, Antitrust, and Consumer Rights
Antitrust Applied: Hospital Consolidation Concerns and Solutions
May 19, 2:30 p.m.
HELP Primary Health and Retirement Security Subcommittee
A Dire Shortage and Getting Worse: Solving the Crisis in the Health Care Workforce
May 20, 10:00 a.m.
OTHER HEALTH POLICY NEWS
On May 13, Missouri Gov. Mike Parson (R) formally withdrew the state’s Medicaid expansion application to the federal government, following state lawmakers' refusal to fund the program. In 2020, Missouri voters approved a constitutional amendment supporting expansion.
On May 13, the Robert Wood Johnson Foundation and Harvard School of Public Health released a report that the public broadly believes the activities of public health agencies are important to the health of the U.S. and supports substantial increases in spending on public health programs. The public lacks the high level of trust in key public health institutions necessary to address today’s and future challenges, and voiced concerns about how the system functions now.
On May 14, a study published in JAMA Network Open found that most U.S. hospitals are not in compliance with the 2019 price transparency rules, which require hospitals to post their prices online in an accessible format.