The following LPG Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from November 9 - November 14. 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.

BIDEN TRANSITION

  • On November 9, the Biden transition team created a Coronavirus Task Force, a 12-person team dedicated to coordinating a COVID-19 response for the President-elect. The team is co-chaired by former Surgeon General Vivek Murthy, former FDA Commissioner David Kessler, and Marcella Nunez-Smith and also includes former Biomedical Advanced Research & Development Authority Chief Rick Bright, Atul Gawande, former FDA Chief Scientist Luciana Borio, infectious disease specialist Michael Osterholm, Eric Goosby, Robert Rodriguez, Loyce Pace, Celine Gounder, Zeke Emanuel, and Julie Morita.

  • On November 10, President-elect Biden formed a 52-person transition team for all federal agencies, bringing back many officials from the Obama administration. Names of members of the transition team can be found here.

  • On November 11, President-elect Biden named Ron Klain as White House Chief of Staff. Klain previously served as the Vice President’s Chief of Staff during the Obama administration, in former President Bill Clinton’s second term administration, and served as White House Ebola Response Coordinator in 2014.

  • As of November 14, the General Services Administration has yet to recognize Biden as the next president and has not signed a letter of ascertainment to give the Biden team $6.3 million in transition funding and access to agency officials and information.

NON-CORONAVIRUS LEGISLATIVE UPDATE

  • On November 10, 46 Congress members expressed concern to the U.S. Department of Justice (DOJ) over the $8.3 billion Purdue Pharma settlement, specifically opposing converting the company into a public benefit company and instead favoring selling Purdue Pharma to a new private owner.

  • On November 12, Democratic Congressional health leaders voiced concern with the Centers for Medicare & Medicaid Services’ (CMS) recent approval of two Georgia waivers that the lawmakers allege are “illegal, reckless and outrageous.” CMS recently approved Georgia’s Medicaid 1115 waiver to expand Medicaid to cover people up to 100% of poverty and add work requirements and premiums. CMS also granted permission under a 1332 waiver for the state to exit healthcare.gov and instead rely on agents and brokers to enroll residents starting in 2023. Senate Finance Committee Ranking Member Ron Wyden (D-OR), Health, Education, Labor, & Pensions Committee Ranking Member Patty Murray (D-WA), House Ways & Means Committee Chairman Richard Neal (D-MA), Energy & Commerce Committee Chairman Frank Pallone (D-NJ), and Education & Labor Committee Chairman Bobby Scott (D-VA) argued that the work requirements and the elimination of HealthCare.gov undermines access to health care in the state.

 House     

  • The House is scheduled to return on November 16 and the Democrats and Republicans are scheduled to hold their leadership elections that week.

  • The House is expected to vote on a series of health care bills, including:

    • H.R. 4499, the NIMHD Research Endowment Revitalization Act of 2020, that would allow the Director of the National Institute on Minority Health and Health Disparities to facilitate minority health disparities research;

    • H.R. 5668, the MODERN Labeling Act of 2020, that would modernize the labeling of certain generic drugs;

    • H.R. 4712, the Fairness in Orphan Drug Exclusivity Act, that would reduce limitations on exclusive approval or licensure of orphan drugs;

    • H.R. 2466, the State Opioid Response Grant Authorization Act of 2020, that would extend the State Opioid Response Grants program through Fiscal Year (FY) 2026 at a rate of $1.5 billion per year; and

    • H.R. 2281, the Easy MAT for Opioid Addiction Act, that would allow practitioners to prescribe up to a three-day supply (instead of one day) of buprenorphine to a patient suffering from substance abuse disorder before the patient enrolls in treatment.

Senate

  • On November 10, Senators Mitch McConnell (R-KY) and Chuck Schumer (D-NY) were reelected as leaders of the Republican and Democratic Senate caucuses by acclamation.

  • On November 10, the Senate Appropriations Committee released all FY21 funding measures and the FY21 subcommittee allocations, totaling $1.39 trillion. The committee proposed $96.3 billion in base discretionary funding for Health & Human Services (HHS), an increase of $1.9 billion from FY 2020. House and Senate appropriators are expected to begin negotiations over the appropriations soon. Highlights of Labor, HHS, Education, and Related Agencies is available here. An explanatory statement for the funding is available here. The subcommittee allocations can be found here.

 NON-CORONAVIRUS REGULATORY UPDATE

  • On November 9, CMS published a final rule entitled Medicaid & Children’s Health Insurance Program (CHIP) Managed Care (CMS-2408-F). The final rule rolls back regulations on Medicaid and Children’s Health Insurance Plans issued by the Obama administration by easing network adequacy requirements, which according to CMS, will reduce administrative burden. A summary of the rule is available here. A fact sheet is available here.

  • On November 9, CMS released data entitled the Medical Loss Ratio Refunds by State and Market for 2019. The report estimates that insurers will have to pay $2.5 billion in medical loss ratio rebates nationwide to 11.2 million eligible enrollees.

  • On November 12, CMS announced that 818,365 enrolled in Affordable Care Act plans using healthcare.gov, 20% of whom were new enrollees, during the first week of open enrollment. State-run marketplaces have not yet released their enrollment numbers. 

  • On November 12, DOJ announced that Indivior Solutions will pay $600 million in criminal and civil liability related to the marketing of the opioid-addiction-treatment drug Suboxone.

  • On November 12, the White House Office of Management and Budget (OMB) concludedreview of an FDA Draft Guidance entitled Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act; Draft Guidance for Industry; Availability (2019-522).

  • The FDA will host a meeting on the Reauthorization of the Biosimilar User Fee Act for fiscal years 2023 through 2027 on November 19.

  • 2021 Medicare Open Enrollment is open and will run through December 7, 2020.

NON-CORONAVIRUS WHITE HOUSE UPDATE

  • None of note.

CORONAVIRUS UPDATE  

Legislative

  • On November 10, Majority Leader McConnell called for a highly targeted $500 billion relief package and voiced his unwillingness to pursue a multitrillion dollar package. House Speaker Nancy Pelosi (D-CA) and Senate Minority Leader Schumer indicated their interest in passing a $2 trillion relief measure and not conceding to a smaller deal.

Regulatory 

  • On November 9, the Food & Drug Administration (FDA) granted an Emergency Use Authorization (EUA) to Lilly’s investigational monoclonal antibody therapeutic, bamlanivimab, to treat non-hospitalized patients with mild or moderate COVID-19. Lilly estimated that it will have 1 million doses of the antibody by the end of the year. As a stipulation to receiving the EUA, the FDA required Lilly to hire an independent third party to test batches and vet quality-testing data of bamlanivimab, due to quality control issues the company previously had.

○        On November 10, HHS announced plans to allocate initial doses of bamlanivimab to state health departments, based on a states' number of hospitalized COVID-19 patients and the number of overall cases. HHS is predicted to ship more than 79,000 doses this week. Operation Warp Speed (OWS) previously purchased 300,000 doses of the therapy, with the option to purchase an additional 650,000 doses. 

○        On November 10, CMS announced that Medicare beneficiaries can receive bamlanivimab (and other authorized or approved monoclonal antibodies) to treat COVID-19 with no cost-sharing during the public health emergency (PHE). CMS indicated it will release related Medicare billing and coding instructions soon. Additional reimbursement related information is available here.

  • On November 9, HHS Assistant Secretary for Health Admiral Brett Giroir announced that the agency paused further shipments of rapid COVID-19 tests to some states until they distribute tests they already received. Starting at the end of September, HHS shippedAbbott BinaxNOW Ag Card rapid test to states to assist efforts to reopen states. Hawaii, Massachusetts, Nevada, New Mexico, North Dakota, Vermont, Virginia, and West Virginia have yet to use their rapid tests from HHS.

  • On November 10, HHS Secretary Alex Azar announced that, assuming EUA authorization, Pfizer could begin delivering the company’s COVID-19 vaccine at the end of November, with goals of delivering 20 million doses each month. Secretary Azar also predicted that a COVID-19 vaccine could be widely available to the general public by the spring of 2021. 

  • On November 10, the FDA released guidance entitled Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017 Guidance for Industry. This guidance provides stakeholders information regarding FDA’s implementation of the Prescription Drug User Fee Amendments of 2017 and explains the new fee structure and the types of fees.

  • On November 10, the Centers for Disease Control and Prevention posted a scientific brief detailing the benefit of masks for personal protection and others. This is the first time the agency officially recognized the personal benefit of masks.

  • On November 12, HHS announced partnerships with 19 large chain pharmacies and pharmacy networks, including CVS, Rite Aid, Walgreens, Publix, Costco, Kroger, and Walmart, to distribute COVID-19 vaccines. This program covers approximately 60% of pharmacies nationwide.

  • COVID-19 information released by CMS is posted here; specific waivers are available here.

White House

  • A series of White House Advisors tested positive for COVID-19: White House political director Brian Jack, White House chief of staff Mark Meadows, HUD Secretary Ben Carson, senior adviser President Trump's re-election campaign Corey Lewandowski, RNC chief of staff Richard Walters, and Advisor to the President David Bossie are among the most recent positive COVID-19 cases.

Other

  • On November 9, Pfizer announced the company’s COVID-19 mRNA-based vaccine candidate, BNT162b2, was over 90% effective in preventing COVID-19, based on interim efficacy analysis. This is the first vaccine candidate to show Phase III efficacy.

  • On November 9, the Vaccine Working Group on Ethics and Policy released an op-ed in STATNews entitled Make pre-approval Covid-19 vaccines available through expanded access, not an EUA. This op-ed warns the FDA against authorizing COVID-19 vaccine candidates through EUA, due to the potential for this authorization process to exempt companies from reporting of adverse events, thereby undermining COVID-19 vaccine trials that continue to determine safety and efficacy. 

  • On November 9, the Urban Institute released a report entitled Affordable Care Act (ACA) Offers Protection as the COVID-19 Pandemic Erodes Employer Health Insurance Coverage.The report found that 3.1 million adults lost employer-sponsored health insurance between March and September 2020 but there was not a drastic increase in the number of uninsured. The report found that ACA health insurance coverage options are blunting some of insurance losses during the COVID-19 pandemic. 

  • On November 10, Novavax released its $1.6 billion OWS contract to support development, manufacturing and the purchase of 100 million doses of the company’s COVID-19 vaccine candidate if approved, through the company’s third quarter financial filings. OWS has yet to officially release the contract.

  • On November 10, the American Medical Association published new vaccine-specific CPT codes to report immunizations for COVID-19.

  • Some governors and public health officials are warning the public of new restrictions, as a new wave of COVID-19 cases and deaths sweep the nation going into the holiday season, while others are wary of reinstating restrictions that would negatively affect business. On November 10, Wisconsin Governor Tony Evers (D) signed an executive order asking residents to stay at home, while Maryland Governor Larry Hogan (R) and New York Governor Andrew Cuomo (D) reinstated indoor capacity limits and other restrictions to limit the spread of COVID-19.

  • On November 11, the Russian Direct Investment Fund announced that the Sputnik V COVID-19 vaccine candidate is 92% effective at protecting against COVID-19, according to interim results. Study data and trial protocols have not been published. Researchers estimate that 40,000 to 45,000 Russians have already been vaccinated and project that 1.5 million people will receive the shot by the end of the year. 

  • On November 11, Moderna announced it has collected enough Phase III trial data for an interim analysis of the company’s COVID-19 vaccine candidate, mRNA-1273, and expects to release the data soon. Moderna has not yet released any conclusions from the data.

  • On November 12, AstraZeneca announced that the company’s blood-cancer medicine, Calquence, failed to decrease deaths or respiratory failures for hospitalized COVID-19 patients with respiratory symptoms. 

  • On November 12, Medicines Patent Pool announced the non-profit is working with 18 generic pharmaceutical manufacturers to accelerate access to COVID-19 treatments for low- and middle-income countries.

  • On November 12, a study published in the Lancet Respiratory Medicine found that inhaled nebulized interferon beta-1a, SNG001, improved recovery time from COVID-19 in a small U.K. trial. Researchers support further study of SNG001 as a potential COVID-19 treatment.

  • On November 12, a study published in the JAMA Network found that fluvoxamine prevented the worsening of symptoms of nonhospitalized COVID-19 patients in a small clinical trial. Researchers support further study of fluvoxamine as a potential COVID-19 treatment.

  • On November 12, the Biotechnology Industry Organization (BIO) expressed concern to the National Governors Association regarding state-level vaccine safety and efficacy reviews that could delay access to FDA-approved COVID-19 vaccines.

  • On November 13, the U.S. set a new single-day record for coronavirus infections (170,333) and hospitalizations (68,516).

  • As of November 14, the U.S. had 10,877,379 confirmed COVID-19 cases resulting in 245,519 deaths, according to the Johns Hopkins University & Medicine Coronavirus Resource Center. COVID-19 is now the third leading cause of death in the U.S., according to Scientific American.

RULES AT THE WHITE HOUSE OMB

Pending Review

HHS-CMS

  • Conditions for Coverage for End-Stage Renal Disease Facilities-Third Party Payments (CMS-3337-P); Received 6/6/19

  • International Pricing Index Model for Medicare Part B Drugs (CMS-5528-P); Proposed Rule; Received 6/20/19

  • Strengthening Oversight of Accrediting Organizations (AO) and Preventing AO Conflict of Interest, and Related Provisions (CMS-3367); Proposed Rule; Received 2/18/20

  • Modernizing and Clarifying the Physician Self-Referral Regulations (CMS-1720); Final Rule; Received 7/21/20

  • Revisions to Medicare Part A Enrollments (CMS-4194) Proposed Rule; Received 9/9/20

  • Contract Year 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program, Medicare Cost Plan Program, and PACE (CMS-4190); Final Rule; Received 9/28/20

  • HHS Notice of Benefit and Payment Parameters for 2022 (CMS-9914); Proposed Rule; Received 11/3/20

  • CY 2021 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1736); Final Rule; Received 11/5/20

  • CY 2021 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1734); Final Rule; Received 11/6/20

HHS-OIG

  • Revisions to the Safe Harbors Under the Anti-Kickback Statute and Beneficiary Inducements Civil Monetary Penalties Rules Regarding Beneficiary Inducement; Final Rule; Received 7/21/20

REPORTS     

HHS Office of Inspector General (OIG)

  • On November 9, OIG released a report entitled Office of Refugee Resettlement Ensured That Selected Care Providers Were Prepared To Respond to the COVID-19 Pandemic. The report found that Office of Refugee Resettlement facilities were generally prepared to respond to an emergency event, such as the COVID-19 pandemic, in accordance with Federal guidelines. OIG also found that the facilities had policies and procedures, the capability to quarantine COVID-19 cases in their facilities, and adequate personal protective equipment. A summary of the report is available here.

  • On November 9, OIG released a report entitled Ohio Did Not Correctly Determine Medicaid Eligibility for Some Newly Enrolled Beneficiaries. The report found that Ohio did not always accurately determine eligibility for beneficiaries and did not always provide supporting documentation to verify that ineligible beneficiaries were newly eligible. OIG also found that Ohio's eligibility determination system lacked the necessary system functionality, eligibility caseworkers made errors, and Ohio did not always maintain documentation to support eligibility determinations. OIG recommended that redetermine current Medicaid eligibility, ensure that its eligibility determination system has the functionality to verify eligibility requirements and perform eligibility determinations in accordance with Federal and State requirements, educate eligibility caseworkers about relevant Federal and State eligibility requirements, and ensure that documentation supporting eligibility determinations is maintained in beneficiaries' records. A summary of the report is available here.

Congressional Research Service (CRS)

  • On November 10, the Congressional Research Service (CRS) released a report entitled Medicaid Financing and Expenditures. This report found that Medicaid expenditures totaled $627 billion, with the federal government paying $405 billion and states paying the remaining $222 billion of Medicaid expenditures. CRS warned that the recession that began in February 2020 may reverse the recent trend of slowing Medicaid growth, given that Medicaid enrollment has increased during the first few months of the recession, further putting pressure on state budgets.

 Government Accountability Office (GAO)

  • On November 13, GAO released a report entitled Medicaid Program Integrity: Action Needed to Ensure CMS Completes Financial Management Reviews in a Timely Manner.The report found that two-thirds of financial management reviews (FMR) initiated in FY 2016 to FY 2019 were still under review in June 2020, which can delay state actions to address program vulnerabilities. GAO recommended that CMS should develop and implement time frames to ensure the timely completion of FMRs. A summary of the report is available here.

  • On November 13, GAO released a report entitled Private Health Insurance: Markets Remained Concentrated through 2018, with Increases in the Individual and Small Group Markets. The report found that in FY 2017 and FY 2018 enrollment in private health insurance plans in the individual, small group, and large group markets have become more concentrated among a small number of issuers. The report also found that at least 43 states were highly concentrated for each market in FY 2018. A summary of the report is available here.

Congressional Budget Office (CBO)

  • On November 9, the CBO released a report entitled Monthly Budget Review: Summary for FY 2020. The report found that the federal budget deficit totaled $3.1 trillion in FY 2020, partially attributed to the COVID-19 PHE. A summary of the report is available here.

UPCOMING HEARINGS

Senate

  • None of note.

House

  • None of note.

OTHER HEALTH POLICY NEWS  

  • On November 10, the U.S. Supreme Court began arguments for California v. Texas, the lawsuit challenging the ACA minimum-coverage provision and the constitutionality of the entire ACA. In oral arguments, Justice Brett Kavanaugh and Chief Justice John Roberts indicated that they would be in favor of severing the minimum-coverage provision from the rest of the law. The court also discussed whether the states and individuals who filed lawsuits had the right to file the lawsuits. A decision will be announced sometime between March and July.

  • On November 10, the U.S. Court of Appeals for the Federal Circuit denied a petition for the court to revisit the August 14 decision for the insurers to not receive the unpaid Cost-Sharing Reduction (CSR) payments subsidies. The original panel ruled that the federal government owes the insurers damages from the elimination of CSR payments in ACA exchanges in 2017, however the insurers would not receive the unpaid CSR payments subsidies because they already recovered the costs by raising premiums to attain bigger tax credits – a practice known as “silver loading.”

  • On November 11, 27 health care associations called for congressional leaders to delay the implementation of Medicare sequestration cuts currently scheduled for January 1, 2021, until the end of the COVID-19 PHE.