The following LPG Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from September 7 – September 13. 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
On September 9, the House Energy & Commerce Committee marked up 38 bills, including a number of bills to address the opioid epidemic. More information can be found here.
On September 10, Democrats on the House Energy & Commerce; House Oversight & Reform; Senate Finance; and Senate Health, Education, Labor, and Pensions (HELP) Committees released a report on their investigation of Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma. The report argues that CMS Administrator Verma abused the federal contracting process and wasted more than $3.5 million on communications consultants. On September 10, leadership of these committees called for the Government Accountability Office (GAO) to review CMS payments to private consultants for potential violation of federal law prohibiting the use of taxpayer funds for publicity or propaganda purposes.
The House will return for votes on September 14.
Treasury Secretary Steven Mnuchin and House Speaker Nancy Pelosi (D-CA) agreed to avert a government shutdown with a short-term spending deal and keep a continuing resolution (CR) separate from COVID-19 relief spending. A draft of funding exceptions by the Trump administration for the CR is available here. Current government funding expires on Sept. 30. Senate Appropriations Chair Richard Shelby (R-AL) voiced support for short-term spending extended through December. House Budget Chair John Yarmuth (D-KY) predicted that Congress would likely pass additional short-term funding to extend government funding into early 2021 if the CR extends funding to December. Chair Yarmuth also predicted that action on annual spending bills will not happen until after the September 30 deadline.
NON-CORONAVIRUS REGULATORY UPDATE
On September 8, CMS published the Skilled-Nursing Facility, Long Term Care Hospital, Inpatient Rehabilitation Facility, Home Health, and Hospice Quality Reporting Program COVID-19 public reporting tip sheets. These documents explain CMS’s strategies to account for CMS quality data, which were exempted from public reporting due to COVID-19.
On September 8, Office of Management and Budget (OMB) concluded its review of the Food & Drug Administration (FDA) proposed rule entitled Amendments to "Intended Use" Regulations.
On September 9, the Centers for Disease Control and Prevention (CDC) published a report entitled the Health Insurance Coverage: Early Release of Estimates From the National Health Interview Survey, 2019. This report details health insurance coverage statistics in 2019, broken down by age, gender, poverty status, race and ethnicity, state Medicaid expansion status, and type of insurance. Notably, 35.7 million people were uninsured in the second half of 2019, compared to 30.7 million in the first half of the year.
On September 9, CMS sent OMB a proposed rule entitled Revisions to Medicare Part A Enrollments (CMS-4194) for review.
On September 10, the FDA released a report entitled Assessment of Combination Product Review Practices in PDUFA VI. This report assesses Prescription Drug User Fee Act product review practices.
On September 10 and 11, the FDA’s Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee held a meeting to review Purdue Pharma’s OxyContin abuse deterrent reformulation. This meeting discussed the impact of the reformulated drug to determine if there was a decline in the risk of overdose and consider relabeling changes.
On September 10, the FDA sent OMB a final rule entitled Importation of Prescription Drugs for review. The FDA also sent OMB a notice entitled Importation of Certain Food and Drug Administration-Approved Human Prescription Drugs, Including Biological Products, and Combination Products; Final Guidance (OC, 2020-449) for review.
CORONAVIRUS UPDATE
Legislative
On September 7, President Trump said he would not meet with Congressional leadership to negotiate a COVID-19 relief package. On September 8, Senate GOP introduced a $500 billion relief package entitled Delivering Immediate Relief to America’s Families, Schools and Small Businesses Act (S. 178). The package includes funding for the post office; the Paycheck Protection Program; unemployment; $105 billion for schools; $16 billion for testing, contact tracing, and surveillance; $31 billion in funding related to vaccine, therapeutic and diagnostic development; and liability protections measures. A summary of the package is available here. On September 10, the Senate failed to advance the package in a 53-47 vote. Senate Minority Leader Chuck Schumer (D-NY) and Speaker Pelosi immediately reacted, promising it “is headed nowhere” and called the package a political move.
On September 8, Oversight Chair Carolyn Maloney (D-NY), Coronavirus Select Subcommittee Chair Jim Clyburn (D-SC), Oversight Economic and Consumer Policy Subcommittee Chair Raja Krishnamoorthi (D-IL), Oversight Ranking Member James Comer (R-KY), and Oversight Economic and Consumer Policy Subcommittee Ranking Member Michael Cloud (R-TX) askedthe U.S. Department of Health & Human Services (HHS) how they plan on determining prioritization and deployment strategies of a COVID-19 vaccine. The letter urged HHS to prioritize fairness and equity and emphasizes the need for a safe and effective vaccine.
On September 9, the Senate HELP Committee held a hearing entitled Vaccines: Saving Lives, Ensuring Confidence, and Protecting Public Health. Surgeon General Jerome Adams assured the committee that a COVID-19 vaccine will be scientifically proven to be safe and effective before it is approved. National Institutes of Health (NIH) Director Francis Collins said he has “cautious optimism” about a vaccine being approved by the end of 2020. Witnesses included: Francis Collins, MD, Director, NIH, and Jerome Adams, MD, Surgeon General, HHS.
On September 9, Sens. Robert Casey (D-PA) and Elizabeth Warren (D-MA) released a report entitled Rapidly Increasing Postal Service Delivery Delays for Mail-Order Prescription Drugs Pose Health Risks for Millions of Americans. The report identified that mail-order prescription drug deliveries have encountered an average of 3 to 4 days in delays, an increase from 2 to 3 days, based on reports from pharmacies and pharmacy benefit managers. The Senators followed this report with a letter to the U.S. Postal Service Board of Governors voicing their concern that delays are putting patients at risk and called to reverse actions taken by Postmaster General Louis DeJoy that may have contributed to delays.
On September 10, 14 House lawmakers from both parties urged FDA Commissioner Stephen Hahn to consider an expedited authorization and lower sensitivity standards for low-cost, rapid, in-home coronavirus tests.
Regulatory
On September 8, FDA Commissioner Hahn committed to ensuring the safety and effectiveness of a COVID-19 vaccine before approval. Commissioner Hahn sent an email to the 17,000-person FDA staff, promising that the agency would adhere to science in a review of a potential COVID-19 vaccine.
On September 8, HHS announced the agency has shipped 13,477 testing devices and more than 4.7 million tests to 13,343 nursing homes that participate in the Medicare and Medicaid program. The agency plans to ship 192,000 tests to another 507 facilities this week and distribute 750,000 rapid, Abbott BinaxNOW COVID-19 tests next week.
On September 9, HHS submitted a request for information on Testing for Coronavirus Disease 2019 (COVID-19) - Surge Capacity. The request asks COVID-19 testing labs if they would be able to boost testing capacity if provided supplementary testing instruments and reagents from Thermo Fisher Scientific. The request asks labs to propose requests for machines and timelines on how quickly they could increase testing capacities with additional instruments. Comments will be accepted until September 20.
On September 9, FDA chief medical device regulator Jeff Shuren and diagnostics director Tim Stenzel published an op-ed in the New England Journal of Medicine, arguing that low quality COVID-19 tests produce false positive results, adding an additional burden to public health officials, and having fewer, high quality tests is more efficient.
On September 9, HHS Assistant Secretary for Health Brett Giroir released guidance entitled Licensed Pharmacists and Pharmacy Interns Regarding COVID-19 Vaccines and Immunity under the Public Readiness and Emergency Preparedness Act. This guidance allows for State-licensed pharmacists and pharmacy interns to administer FDA authorized or licensed COVID-19 vaccinations.
On September 10, eight Senior FDA career executives wrote an op-ed committing to making decisions surrounding COVID-19 vaccines based on science and not political influence.
On September 10, FDA Commissioner Hahn and Deputy Commissioner Anand Shah wrote an op-ed advocating for returning drug manufacturing to the U.S. The leaders recommend studying contracting practices which may contribute to drug shortages, incentivizing manufacturers to produce domestically, and further investment in medical manufacturing.
On September 10, the FDA Center for Biologics Evaluation and Research and FDA Commissioner Hahn announced the agency plans to update guidance on Emergency Use Authorization (EUA) requirements for companies seeking authorization for COVID-19 vaccines. This new guidance, referenced as “EUA-plus,” would increase data and information requirements, similar to the normal FDA drug approval process.
On September 10, the NIH launched two Phase III clinical trials for the use of blood thinners to prevent or reduce the formation of blood clots for those with COVID-19. Researchers have previously found that patients who died from COVID-19 formed life-threatening blood clots.
On September 10, the FDA released guidance entitled Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency (PHE). This guidance recommends for drug manufacturers to address deviations from current good manufacturing practice, develop comprehensive resumption plans, and prioritize drugs that are in shortage or at risk of shortage.
On September 10, the CDC published a report entitled Delay or Avoidance of Medical Care Because of COVID-19–Related Concerns — United States, June 2020. The report found that over 40% people delayed or avoided medical treatment during the COVID-19 PHE.
The FDA will hold its first coronavirus vaccine advisory meeting on October 22.
Other
On September 8, CEOs of Pfizer, Merck, AstraZeneca, Sanofi, GlaxoSmithKline, BioNTech, Johnson & Johnson, Moderna, and Novavax signed a pledge expressing their commitment to safety and efficacy by completing Phase III COVID-19 vaccine clinical trials before seeking approval or EUA, among concerns of community trust in a potential vaccine.
On September 7, Sinovac Biotech Ltd. announced that in Phase I/II clinical trial the company’s COVID-19 vaccine, CoronaVac, appeared to be safe for older people, causing a slightly lower immune response compared to younger adults. Official data from the clinical trial has not been released.
On September 9, AstraZeneca and the University of Oxford paused its Phase III COVID-19 vaccine clinical trial due to a participant experiencing neurological symptoms consistent with transverse myelitis, a rare spinal inflammatory disorder. On September 12, the trial was restarted in the United Kingdom after the Medicines and Health Regulatory Authority said it was safe to resume. The trial is still paused in the U.S. The companies still predict the vaccine could still be ready by the end of the year or early 2021, even with the delay.
On September 9, Duke University’s Margolis Center for Health Policy and The Rockefeller Foundation released a report entitled A National Decision Point: Effective Testing and Screening for Covid-19. The report predicts that the U.S. will need 200 million COVID-19 tests every month in order to contain outbreaks and return to normal activity. The report also outlines how schools, nursing homes, and businesses can develop testing plans.
On September 10, the Kaiser Family Foundation (KFF) estimated that most adults do not think a COVID-19 vaccine will be widely available before the presidential election. KFF also found that many people are worried that political pressures will lead the FDA to rush to approve a vaccine, without ensuring safety and effectiveness.
On September 10, the World Health Organization announced it would need $35 billion for the Access to COVID-19 Tools Accelerator to reach the organization’s goal of producing 2 billion vaccine doses for the global coalition.
On September 10, Maryland Governor Larry Hogan announced the acquisition of 250,000 rapid point-of-care antigen tests for nursing homes, assisted-living facilities, and correctional and juvenile detention centers. Maryland is the first state to acquire antigen tests, as part of the bipartisan interstate testing compact to deploy five million tests.
Democrat Presidential Nominee Joe Biden encouraged “full transparency" regarding a potential COVID-19 vaccine and posed three questions to the Trump administration: what criteria will be used to ensure safety and efficacy, who will validate that those standards were met, and what is the vaccine distribution plan.
As of September 13, the U.S. had 6,492,744 confirmed COVID-19 cases resulting in 193,734 deaths, according to the Johns Hopkins University & Medicine Coronavirus Resource Center.
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
Medicaid & CHIP Managed Care (CMS-2408-F); Final Rule; Received 9/26/2019
Strengthening Oversight of Accrediting Organizations (AO) and Preventing AO Conflict of Interest, and Related Provisions (CMS-3367); Proposed Rule; Received 2/18/20
Specialty Care Models to Improve Quality of Care and Reduce Expenditures (CMS-5527); Proposed Rule; Received 3/10/20
Payment Policies for Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) (CMS-1738); Proposed Rule; Received 4/28/20
Modernizing and Clarifying the Physician Self-Referral Regulations (CMS-1720); Final Rule; Received 7/21/20
Revisions to Medicare Part A Enrollments (CMS-4194)l Proposed Rule; Received 9/9/20
HHS-FDA
Annual Summary Reporting Requirements Under the Right to Try Act; Proposed Rule; Received 3/31/20
Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment; Guidance for Industry; Notice; Received 5/28/2020
Importation of Prescription Drugs; Final Rule; Received 9/10/20
Importation of Certain Food and Drug Administration-Approved Human Prescription Drugs, Including Biological Products, and Combination Products; Final Guidance (OC, 2020-449); Notice; 9/10/2020
HHS-HRSA
Implementation of Executive Order 13937, "Executive Order on Access to Affordable Life-saving Medications"; Interim Final Rule; Received 9/1/20
HHS-OCR
HIPAA Privacy: Changes To Support, and Remove Barriers to, Coordinated Care and Individual Engagement; Proposed Rule; Received 7/31/20
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 September 9, OIG released a report entitled Audit of Medicare Part D Pharmacy Fees: Horizon Blue Cross Blue Shield, Inc. The report found that in Calendar Year 2013-2016, Horizon Blue Cross Blue Shield complied with Federal requirements for reporting pharmacy fees in its direct and indirect remuneration reports and appropriately reported pharmacy fees that its pharmacy benefit managers charged to pharmacies. OIG found that reported pharmacy fees appropriately so OIG did not pose recommendations. A summary of this report is available here.
On September 9, OIG released updates to the Civil Monetary Penalties and Affirmative Exclusions.
On September 10, OIG released a report entitled Billions in Estimated Medicare Advantage (MA) Payments From Diagnoses Reported Only on Health Risk Assessments (HRAs) Raise Concerns. The report finds that CMS provided $2.6 billion in risk-adjusted payments to MA plans in 2017, based on patient diagnoses unrelated to any other clinical services. OIG determined that 80% of estimated payments were generated by in-home HRAs. OIG identified three concerns: data integrity issues due to MA organizations (MAOs) not submitting all service records as required; care coordination issues from beneficiaries not receiving follow-up care to address diagnoses identified during HRAs; and a payment integrity concerns because if diagnoses are inaccurate or unsupported, the associated risk-adjusted payments would be inappropriate. OIG recommends that CMS require MAOs to implement best practices to ensure care coordination for HRAs and provide additional oversight of MAOs that drove most of the risk-adjusted payments. OIG also recommends that CMS reassess the risks and benefits of allowing in-home HRAs to be used as sources of diagnoses for risk adjustment and require MAOs to flag any MAO-initiated HRAs in their MA encounter data. CMS argued the fraud risks raised by OIG are premature. A summary of the report is available here.
On September 11, OIG released a report entitled Baylor Scott & White—College Station: Audit of Outpatient Outlier Payments. The report found that College Station did not properly bill outlier payments claims, resulting in improper outlier payments due to inadequate controls to prevent errors related to overcharged observation time, charge errors, and coding errors. OIG recommends College Station refund overpayments and improve procedures, provide education and implement changes to their billing system to ensure accurate Medicare billing. A summary of the report is available here.
Government Accountability Office (GAO)
On September 9, GAO released a report entitled Medicaid Information Technology: Effective CMS Oversight and States' Sharing of Claims Processing and Information Retrieval Systems Can Reduce Costs. The report finds that CMS reimbursed billions of dollars to states for the development, operation, and maintenance of claims processing and information retrieval systems, including the Medicaid Management Information Systems (MMIS) and Eligibility and Enrollment (E&E) systems. GAO estimates that states spent a total of $44.1 billion on MMIS and E&E systems and CMS reimbursed the states $34.3 billion. GAO recommended that CMS should develop formal procedures for the Advance Planning Document review process and other improvements. A summary of this report is available here.
Congressional Budget Office (CBO)
On September 8, CBO released a report entitled Monthly Budget Review for August 2020.CBO estimates that the federal budget deficit in August 2020 was $198 billion, $3 billion less than August 2019. The report estimated that the cumulative federal budget deficit for the first 11 months of FY 2020 was $3.0 trillion, $1.9 trillion more than the deficit recorded for the same period of FY 2019.
UPCOMING HEARINGS
Senate
Health, Education, Labor and Pension Committee
September 23, 10:00 a.m., G50 Dirksen Senate Office Building
COVID-19: An Update on the Federal Response
Witnesses include: Anthony Fauci, MD, Director, National Institute of Allergy and Infectious Diseases, NIH; Robert Redfield, MD, Director, CDC; Brett Giroir, MD, Assistant Secretary for Health, HHS; and Stephen Hahn, MD, FDA Commissioner, FDA.
House
None of note.
OTHER HEALTH POLICY NEWS
On September 8, the Better Medicare Alliance released a report entitled Social Risk Factors Are High Among Low-Income Medicare Beneficiaries Enrolled in MA. This report found that MA serves a beneficiary population facing higher rates of social risk factors, including lower-income, lower levels of education, and being non-English speaking, than traditional Medicare.
On September 8, researchers at Harvard published a study in Health Affairs finding that Arkansas’s Medicaid work requirements did not increase employment and those who lost Medicaid experienced adverse consequences, including problems paying off medical debt and delayed care because of cost.
On September 9, the United States of Care released a report entitled A System Under Stress, Exacerbated: The Employer-Sponsored Health Insurance (ESI) System at a Crossroads. The report calls for improvements in the ESI market, including cost growth targets, greater transparency, and increasing competition through drug price negotiations.
On September 10, more than 1,100 hospitals urged HHS to stop drug manufacturers from restricting 340B discounts on drugs purchased through contract pharmacies. This letter comes as some manufacturers threaten to cut off these discounts.