The following LPG Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from March 29 - April 4. 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 March 29, Reps. Raja Krishnamoorthi (D-IL) and Anna Eshoo (D-CA) introduced a resolution through the Congressional Review Act to overturn the Trump Administration’s Department of Health & Human Services’ (HHS) Sunset Rule that requires agencies to review all regulations or have them expire. On March 19, the Biden Administration delayed the rule’s March 21, 2021, effective date until March 22, 2022.
The House is in recess until April 12.
Senate
The Senate is in recess until April 12.
The Finance Committee is expected to consider the nomination of Chiquita Brooks-LaSure for Administrator of the Centers for Medicare & Medicaid Services (CMS) the week of April 12.
NON-CORONAVIRUS REGULATORY UPDATE
On March 29, the White House Office of Management & Budget (OMB) received an interim final rule from CMS entitled COVID-19 Vaccine Immunization Requirements for Long Term Care Residents and Staff (CMS-3414).
On March 30, CMS delayed the Community Health Access and Rural Transformation Model Accountable Care Organizations Transformation Track Request for Applications release date from spring 2021 to spring 2022. The model aims to address disparities by allowing rural communities to leverage innovative financial arrangements, and operational and regulatory flexibilities.
On March 30, HHS issued the Semiannual Regulatory Agenda, listing expected forthcoming regulatory actions under development throughout HHS.
On March 30, the Center for Medicare & Medicaid Innovation released a new Frequently Asked Questions document for the Value-Based Insurance Design Model’s Hospice Benefit Component.
On March 31, HHS announced that it is increasing its outreach budget for the Affordable Care Act (ACA) Special Enrollment Period from $50 million to $100 million, to publicize the expanded premium subsidies through the American Rescue Plan.
The Food & Drug Administration (FDA) will host meetings entitled Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards on April 7.
NON-CORONAVIRUS WHITE HOUSE UPDATE
On March 31, President Biden introduced a $2.5 trillion infrastructure package entitled the American Jobs Plan, which includes $400 billion to expand home and community-based care through Medicaid; and other infrastructure improvements.
On April 1, the White House Office of National Drug Control Policy released a list of priorities for the Administration’s first year, including:
Expanding access to evidence-based treatment;
Advancing racial equity issues in our approach to drug policy;
Enhancing evidence-based harm reduction efforts;
Supporting evidence-based prevention efforts to reduce youth substance use;
Reducing the supply of illicit substances;
Advancing recovery-ready workplaces and expanding the addiction workforce; and
Expanding access to recovery support services.
CORONAVIRUS UPDATE
House
On March 31, Democrats on the Select Subcommittee on the Coronavirus Crisis released documents obtained in the investigation of the Trump Administration’s efforts to procure and distribute personal protective equipment and other critical supplies during COVID-19. The investigation found that former President Trump failed to heed an urgent private warning regarding COVID-19 in early 2020; White House officials pursued an ineffective, ad hoc approach to supply contracts; and the Trump Administration relied on outside advisors rather than career professionals to arrange contracts.
Senate
None of note.
Regulatory
On March 29, the Centers for Disease Control and Prevention (CDC) released a report that the Pfizer and Moderna COVID-19 vaccines reduced the risk of COVID-19 infection by about 80% after the first dose and 90% after the second shot using data from those who received the vaccine.
On March 29, HHS, CDC, and the Administration for Community Living awarded $100 million to help increase vaccinations among older adults and people with disabilities to advance the key goals of protecting vulnerable communities and advancing equity.
On April 1, HHS and the CDC launched the We Can Do This campaign and the COVID-19 Community Corps, a network of community organizations, local leaders, and others to increase vaccine confidence and uptake.
On April 1, the HHS Office of the Assistant Secretary for Planning and Evaluation released an issue brief detailing the expansions of health care coverage from the American Rescue Plan, including enhancing and expanding eligibility for advance payments of premium tax credits, and changing the availability of health plans with zero- and low-premiums.
On March 31, the CDC and National Institutes of Health launched the Say Yes! COVID Test pilot to provide a month of free, rapid COVID-19 antigen tests to people in Pitt County, NC, and Chattanooga, TN., to determine if frequent self-administered COVID-19 testing helps residents reduce community transmission of COVID-19 and study if frequent testing has an impact on their thoughts about COVID-19 vaccination.
On March 31, the FDA authorized several tests for over-the-counter (OTC) use without a prescription when used for serial screening, as well as a serial screening test for use in a point-of-care (POC) setting without a prescription, and an additional screening test for POC use with a prescription. The authorized tests are Quidel QuickVue At-Home OTC COVID-19 test, three Abbott BinaxNOW home and POC tests, and BD Veritor System for Rapid Detection POC test.
On April 1, the FDA authorized Moderna to put additional doses in each COVID-19 vaccine vial, up to 15 doses in multi-dose vials that previously held 10 doses. The FDA also authorized vaccinators to extract additional doses.
White House
On March 29, President Biden increased the number of pharmacies in the federal pharmacy vaccination program from 17,000 to nearly 40,000 and increased the number of mass vaccination sites by 12. President Biden also announced funding for community organizations to provide transportation and assistance for at-risk seniors and people with disabilities to access vaccines. With these changes, Biden touted that 90% of adults would be eligible for vaccination by April 19 and 90% will have a vaccination site within five miles of their residence. A fact sheet on the plans is available here.
On March 29, President Biden advocated for states to pause reopening efforts and reinstate mask mandates, as COVID-19 cases are beginning to rise.
On March 29, the White House Office of Science and Technology Policy asked 27 agencies, including HHS, to nominate experts for the Task Force on Scientific Integrity to review the effectiveness of scientific integrity policies across the Federal Government and investigate political interference in scientific research.
On March 29, White House Press Secretary Jen Psaki reiterated the White House’s stance that the private sector should take the lead on vaccine passports to certify COVID-19 vaccinations but the Administration may make privacy and security recommendations. On April 2, Florida Governor Ron DeSantis (R) issued an executive order preventing the governmental entities in the state from issuing "vaccine passports" and prohibiting businesses from requiring customers to show proof of COVID vaccination.
Other
On March 29, Humanigen announced positive Phase III clinical trial results of lenzilumab for the treatment of hospitalized COVID-19 patients.
On March 29, Lilly, Vir Biotechnology, and GlaxoSmithKline (GSK) announced positive Phase II clinical trial results of a monoclonal antibody drug cocktail of bamlanivimab and VIR-7831 for the treatment of mild to moderate COVID-19 symptoms.
On March 29, GlaxoSmithKline reached an agreement with Novavax and the UK Government Vaccines Taskforce to manufacture up to 60 million doses of Novavax’ COVID-19 vaccine for the UK.
On March 29, Moderna shipped the 100-millionth dose of its COVID-19 vaccine to the U.S. According to the CDC, more than 67 million doses of the Moderna COVID-19 vaccine have been administered in the U.S.
On March 29, the Kaiser Family Foundation published a report that found wide variation in reported vaccination rates by county across the US and there are mixed findings on how county vaccination rates align with national prioritization recommendations and state prioritization decisions.
On March 30, the World Health Organization (WHO) investigation of the origins of COVID-19 found that the transmission of COVID-19 from bats to humans through another animal is the most likely source of the virus. The report concluded that a leak from a laboratory setting was extremely unlikely. The WHO announced it would continue to investigate the origins of COVID-19.
On March 30, Pfizer predicted its COVID-19 vaccine manufacturing capacity will reach 2.5 billion doses by the end of 2021 due to the optimization of production processes, increased production facilities, regulatory approval for six dose vials, and the expansion of our manufacturing and supplier networks.
On March 30, 27 world leaders called for greater international cooperation to combat COVID-19, advocating in favor of working together towards a new international treaty for pandemic preparedness and response and equal access to tests, treatments and vaccines and support health systems.
On March 30, the Department of Defense awarded a $22.1 million contract to String King Lacrosse to produce 8.9 million cloth masks to be distributed to disadvantaged communities.
On March 31, Pfizer released results from a Phase III COVID-19 vaccine trial in those 12 to 15 years old demonstrating 100% efficacy and robust antibody responses.
On March 31, World Trade Organization (WTO) chief Ngozi Okonjo-Iweala announced the organization will hold a meeting with COVID-19 vaccine manufacturers and WTO member countries to negotiate fairer manufacturing and distribution terms for developing countries in two weeks.
On March 31, Emergent BioSolutions’ manufacturing plant contaminated up to 15 million doses of Johnson & Johnson’s (J&J) vaccine, forcing regulators to delay authorization of the plant’s production lines.
On April 1, Pfizer released results from a Phase III COVID-19 vaccine trial demonstrating 91.3% efficacy and no safety concerns six months after the second dose. The vaccine was also 100% effective in preventing COVID-19 cases in South Africa, where the B.1.351 lineage is prevalent.
All 50 states have announced plans to expand eligibility for COVID-19 vaccinations to all people by May 1.
As of April 4, more than 104 million people have received the first dose of COVID-19 vaccines (nearly 60 million have received both doses) and nearly 208 million doses have been distributed, according to the CDC COVID Data Tracker.
As of April 4, the U.S. had 30,681,592 confirmed COVID-19 cases resulting in 554,813 deaths, according to the Johns Hopkins University & Medicine Coronavirus Resource Center.
RULES AT THE WHITE HOUSE OMB
HHS-CMS
FY 2022 Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals, and the Long-Term Care Hospital Prospective Payment System (CMS-1752); Proposed Rule; Received 2/16/21
FY 2022 Skilled Nursing Facility (SNFs) Prospective Payment System Rate Update and Quality Reporting Requirements (CMS-1746); Proposed Rule; Received 2/25/21
FY 2022 Inpatient Psychiatric Facilities Prospective Payment System Rate and Quality Reporting Updates (CMS-1750); Proposed Rule; Received 2/25/21
FY 2022 Inpatient Rehabilitation Facility (IRF) Prospective Payment System Rate Update and Quality Reporting Requirements (CMS-1748); Proposed Rule; Received 2/25/21
Modification of Limitations on Redesignation by the Medicare Geographic Classification Review Board (CMS-1762); Interim Final Rule; Received 2/26/21
FY 2022 Hospice Wage Index, Payment Rate Update, and Quality Reporting Requirements (CMS-1754); Proposed Rule; Received 2/26/21
Comprehensive Care for Joint Replacement Model Three-Year Extension and Modifications to Episode Definition and Pricing (CMS-5529); Final Rule; Received 3/19/21
HHS Notice of Benefit and Payment Parameters for 2022 (CMS-9914); Final Rule, Received 3/24/21
COVID-19 Vaccine Immunization Requirements for LTC Residents and Staff (CMS-3414); Interim Final Rule; 3/29/21
REPORTS
HHS Office of Inspector General (OIG)
On March 29, OIG released a report entitled Illinois Medicaid Fraud Control Unit: 2019 Onsite Review. The report found that the Illinois Medicaid Fraud Control Unit (MFCU) generally operated in accordance with applicable laws, regulations, and policy transmittals. OIG recommended that the Illinois MFCU develop and implement a plan to address the challenges presented by the Unit's organizational structure, establish minimum criteria for referrals of patient abuse and neglect to be sent to the MFCU, establish a process to coordinate on cases and improve collaboration with Federal partners, take steps to ensure that MFCU staff report all convictions and adverse actions to Federal partners within the appropriate timeframes, take steps to ensure that newly hired investigators complete new employee trainings, and take steps to ensure that supervisory reviews of case files are conducted and documented in accordance with Unit policy. MFCU agreed with the recommendations. A summary of the report is available here.
On March 31, OIG released a report entitled An Ophthalmology Clinic in California: Audit of Medicare Payments for Eye Injections of Eylea and Lucentis. The report found that an ophthalmology clinic in California generally complied with Medicare requirements when billing for intravitreal injections of Eylea and Lucentis but did not always comply with Medicare requirements when billing for other services provided on the same day as the intravitreal injections, and other services and drugs that were not separately payable or not reasonable and necessary. OIG recommended that the clinic refund estimated overpayments for intravitreal injections of Eylea and for other services provided on the same day as intravitreal injections of Eylea and Lucentis and two procedural recommendations on implementing policies and procedures to ensure that the clinic complies with Medicare requirements. A summary of a report is available here.
On March 31, OIG released a report entitled Data on Medicaid Managed Care Payments to Providers Are Incomplete and Inaccurate. The report found that most States did not provide complete or accurate payment data in the Transformed Medicaid Statistical Information System (T-MSIS) on managed care payments to providers, and two States failed to provide any data for January 2020. About half of States did not provide complete or accurate information about the amounts that managed care plans pay to providers for services-the amount paid. OIG recommended that CMS review States' managed care payment data in T-MSIS and ensure that States have corrective action plans to improve data completeness and quality; should make public its reviews of States' managed care data; and should clarify and expand its initiative on payment data. A summary of the report is available here.
Government Accountability Office (GAO)
On March 31, GAO released the 6th report on the federal response to COVID-19 entitled COVID-19: Sustained Federal Action Is Crucial as Pandemic Enters Its Second Year. GAO identified multiple ways agencies can improve response efforts including implementing 38 previous recommendations and 28 new recommendations including:
Centralizing HHS publicly available COVID-19 information, including nursing home data;
Finalizing and implementing a post-payment review process to validate COVID-19 Uninsured Program claims and to help ensure timely identification of improper payments;
Requiring nursing homes to offer COVID-19 vaccinations to residents and staff and design and implement associated quality measures;
Developing metrics to assess the number of vaccines administered by the Veterans Affairs (VA) vaccine rollout;
Developing preliminary vaccination targets for the VA for when it will move from one vaccination phase to another;
Developing a process for sharing information to facilitate decision-making and guidance consistency related to devices with Emergency Use Authorization; and
Other recommendations to promote transparency and data centralization.
A summary of the report is available here.
On March 31, GAO released a report entitled Biomedical Research: Information on Federal Contributions to Remdesivir. GAO reviewed federal contributions to development of remdesivir and related agency patent rights and found that federal contributions did not result in government patent rights because federally-supported research did not generate new inventions. A summary of the report is available here.
On March 31, GAO released a report entitled Patient-Centered Outcomes Research Institute (PCORI): Review of the Audit of the Financial Statements for FY 2020. GAO did not identify any significant issues related to PCORI’s fiscal year 2020 financial statements. A summary of the report is available here.
Congressional Research Service (CRS)
On March 29, CRS released a report entitled Domestic Funding for COVID-19 Vaccines: An Overview. The report presented an overview of appropriations for selected domestic COVID-19 vaccine related activities, including research and development, regulation, manufacture, and purchase; and domestic vaccination programs.
On March 31, CRS released a report entitled Drug Pricing and Intellectual Property: The Legislative Landscape for the 117th Congress. The report outlined the variety of drug pricing and intellectual property related bills Congress will likely tackle this year including: pharmaceutical patent reforms, regulatory exclusivity reforms, government-directed price regulation, COVID-19 specific legislation, and omnibus drug pricing bills with pharmaceutical intellectual property provisions.
HEARINGS
House
Energy & Commerce Health Committee
Opioid-related hearing
April 14, Details TBD
Senate
Finance Committee
Nomination Hearing of Brooks-LaSure for CMS Administration
Likely the week of April 12
OTHER HEALTH POLICY NEWS
On March 29, a study published in JAMA Network found that half of out-of-pocket offsets, such as drug coupons or vouchers, arose from pharmacies or pharmacy benefit managers, and half from pharmaceutical manufacturers. The study suggests that offsets were associated with a significant reduction in out-of-pocket costs but were concentrated among a small set of drugs and not targeted to areas with relatively more vulnerable residents.
On March 29, the American Medical Association released an analysis of medical liability insurance premiums. The report found more than 30% of premiums increased from 2019 to 2020, the highest jump since 2005.
On March 30, the Federal Communications Commission unanimously approved a process for distributing nearly $250 million to help pay health care providers’ telehealth costs during COVID-19.
On March 31, the American Hospital Association (AHA) requested that HHS Secretary Xavier Becerra award a waiver of certain 340B program eligibility criteria for 340B hospitals enrolled during the PHE that may have experienced a temporary change in payer mix due to COVID-19 and urge HHS to use the 1135 waiver authority to temporarily waive the 340B Medicare Disproportionate Share Hospital disproportionate patient percentage eligibility criteria and allow currently participating 340B hospitals continued access to the program.
On March 31, the AHA and the American Society of Health-System Pharmacists sent a joint letter to the FDA urging the agency to review insurer "white bagging" policies, policies to dispense drugs to hospitals, requiring these medications come from select network specialty pharmacies.
On March 31, Community Catalyst released a report entitled Making “Convenient Care” the Right Care for All: Improving State Oversight of Urgent Care Centers and Retail Health Clinics. The report found that urgent care centers and retail health clinics are under regulated and that these settings do not promote people who live in low-income and medically underserved communities getting access to needed care.
On March 31, CVS won renewal of its contract for the Government-wide Service Benefit Plan that will into effect January 1, 2022 and now includes specialty pharmacy in addition to existing retail, mail and clinical pharmacy services.
On April 1-2, MedPAC held its April public meeting. The Commission discussed the following topics:
Mandated report: Medicare’s skilled nursing facility value-based purchasing program and proposed replacement;
Streamlining CMS’s portfolio of alternative payment models;
Rebalancing Medicare Advantage benchmark policy;
Revising Medicare’s indirect medical education payments to better reflect teaching hospitals’ costs;
Medicare’s vaccine coverage and payment;
Improving Medicare’s policies for separately payable drugs in the hospital outpatient prospective payment system;
Congressional request: Private equity and Medicare; and
Mandated report: Assessing the impact of recent changes to Medicare’s clinical laboratory fee schedule payment rates.