The following LPG Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from October 12 - October 18. 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 October 13, House Energy & Commerce Committee Chairman Frank Pallone (D-NJ), House Ways & Means Committee Chairman Richard Neal (D-MA), and Senate Finance Committee Ranking Member Ron Wyden (D-OR) called for the Government Accountability Office (GAO) to review the Trump Administration’s plan to deliver $200 drug discount cards to 39 million Medicare beneficiaries. The congressmen also asked the Department of Health and Human Services (HHS) about the legality of the drug cards and how the Centers for Medicare & Medicaid Services (CMS) would administer the program. A draft of the CMS plan was leaked, citing the $7.9 billion price tag and other details of the plan. Eligible seniors are expected to be those who are enrolled in a Part D plan and not receiving the program’s low-income subsidies. The plan indicates that beneficiaries may begin receiving the cards later this month, although many beneficiaries are not expected to receive the cards until after the election. Notably, on October 16, reports indicated that HHS General Counsel Robert Charrow drafted an internal memo warning that the drug cards could violate election law and recommended that the White House seek approval from the Department of Justice before the plan is finalized and implemented – which will likely further stall the effort.
On October 14, Energy & Commerce Committee Ranking Member Greg Walden (R-OR), Brett Guthrie (R-KY), and Morgan Griffith (R-VA) asked the Food and Drug Administration (FDA) for information on the agency’s 2001 label change for Purdue Pharma’s OxyContin and how the changes affected the opioid crisis and opioid manufacturing. The Congressmen speculate that the label change may have helped promote higher-dose, longer-term opioid prescriptions, contributing to the opioid crisis.
Majority Leader Steny Hoyer (D-MD) informed members that the House may be called back to session during October to vote on a relief package.
The House Democratic Caucus plans to hold leadership elections on November 18 and 19.
Senate
On October 12 through 15, the Judiciary Committee held four days of hearings to consider the nomination of Amy Coney Barrett to be an Associate Justice of the Supreme Court. Barrett declined to answer many questions regarding the Affordable Care Act (ACA), but stated she was not "on a mission to destroy the ACA" and indicated that “the presumption is always in favor of severability” when the Court is reviewing the constitutionality of a statute. Over the course of the week, Barrett also said that her personal views on health care and abortion would not affect her court decisions. The Committee scheduled the vote to approve Barrett’s nomination for October 22. Senate Majority Mitch McConnell (R-KY) scheduled to bring the nomination to the Senate floor on October 23.
NON-CORONAVIRUS REGULATORY UPDATE
On October 13, CMS Administrator Seema Verma said in a speech to the Healthcare Payment Learning and Action Network that the Center for Medicare and Medicaid Innovation (CMMI) is in need of a “course correction in model design and portfolio selection if value-based care is to advance.” She indicated that only five of the 54 payment models developed by CMMI showed statistically significant savings and just three have been expanded nationally.
On October 15, the FDA released a notice of a new program entitled Quality Management Maturity for Active Pharmaceutical Ingredients Pilot Program for Foreign Facilities.
On October 15, the FDA released a notice of a new program entitled Quality Management Maturity for Finished Dosage Forms Pilot Program for Domestic Drug Product Manufacturers.
On October 15, the FDA Center for Devices and Radiological Health released video reports on implementing the Medical Device User Fee Amendments of 2017 commitments and the agency’s efforts so far. The FDA will hold a public meeting on October 27 to receive public feedback on the reauthorization of the medical device user fee amendment.
On October 15, CMS announced that the 2021 Medicare Open Enrollment is open and will run through December 7, 2020.
On October 15, CMS approved Georgia’s new Medicaid section 1115 demonstration entitled Pathways to Coverage. The waiver partially expands the state’s Medicaid program with work requirements and premium and income requirements. The waiver is predicted to expand Medicaid to 65,000 Georgians.
On October 15, the Health Resources and Services Administration announced $500 million in funding for the National Health Service Corps, Nurse Corps, and other workforce development loan repayment and scholarship programs to support, recruit, and retain qualified health professionals and students.
On October 15, the HHS Office of the Assistant Secretary for Health announced two challenges to improve maternal health. The Hypertension Innovator Award Competition: Innovative Methods of Blood Pressure Monitoring and Follow-up in Women during Pregnancy and/or Postpartum is a $3.3 million competition to identify pre-existing programs that care for women with hypertension who are pregnant and/or postpartum and provide effective monitoring and follow-up to improve rates of hypertension control. The Reducing Disparities in Breastfeeding Innovation Challenge is a $800,000 competition to identify effective, pre-existing programs that increase breastfeeding initiation and continuation rates, decrease disparities among breastfeeding mothers, and target gaps in breastfeeding education, instruction, and/or support for breastfeeding mothers.
On October 15, the HHS Office on Women's Health announced an $8 million contract with Premier, Inc. to improve maternal health data and create a network of at least 200 hospitals to deploy clinical, evidence-based best practices in maternity care.
On October 16, the FDA released the Generic Drugs Program Activities Report, detailing that the agency approved 667 generic drugs in the first 11 months of fiscal year (FY) 2020, a decrease from 935 approvals in FY 2019 and 781 in FY 2018.
On October 16, the FDA released a notice requesting nominations for the Medical Devices Advisory Committee for non-voting members. FDA also released a notice requesting nominations for Device Good Manufacturing Practice Advisory Committee and Medical Devices Advisory Committee voting members.
The Centers for Disease Control and Prevention (CDC) reported that drug overdose deaths increased by 10% between January and March of 2020 and the agency predicted that there will be over 75,500 drug-related deaths in 2020.
NON-CORONAVIRUS WHITE HOUSE UPDATE
None of note.
CORONAVIRUS UPDATE
Legislative
On October 12, Senate Majority Leader McConnell announced the Senate will vote on a $500 billion targeted relief package before the election, including funding for schools, hospitals, the Paycheck Protection Program (PPP), and protections from COVID-19-related lawsuits, refusing the $1.8 trillion deal offered by Treasury Secretary Steven Mnuchin. President Trump called for a large stimulus package, tweeting “STIMULUS! Go big or go home!!!” which is unlikely to happen.
On October 15, seven Senate Democrats urged the FDA to release the agency’s plan for ensuring a COVID-19 vaccine is safe and effective for older adults.
On October 17, Senate Majority Leader McConnell announced the chamber will vote on a revised relief package the week of October 19. The package is expected to include expanded unemployment benefits, new PPP money, more than $100 billion for schools, funding for testing and tracing, money for Operation Warp Speed to produce a vaccine and funding to distribute it.
Regulatory
On October 13, the National Institutes of Health (NIH) Data and Safety Monitoring Board paused Lilly’s Phase II clinical trial for the company’s monoclonal antibody treatment of COVID-19, LY-CoV555, due to a safety issue. Last week, Lilly submitted the antibody treatment for Emergency Use Authorization (EUA).
On October 13, the National Institute of Allergy and Infectious Diseases and the Accelerating COVID-19 Therapeutic Innovations and Vaccines program launched two studies for the treatment of COVID-19: (1) Boehringer Ingelheim and AbbVie’s monoclonal antibody risankizumab plus remdesivir and (2) Humanigen’s investigational monoclonal antibody lenzilumab plus remdesivir.
On October 13, Operation Warp Speed (OWS) announced a $31 million contract with Cytiva to expand the company’s manufacturing capacity for products that are essential in producing COVID-19 vaccines, including liquid and dry powder cell culture media, cell culture buffers, mixer bags, and XDR bioreactors.
On October 12, the FDA approved Pfizer to enroll children 12 to 16 in the company’s Phase III COVID-19 vaccine clinical trials. Pfizer is the first company to include children in COVID-19 vaccine clinical trials.
On October 12, the FDA granted EUA for Abbott Laboratories’ COVID-19 Immunoglobulin M lab-based serology test, AdviseDx.
On October 13, HHS and the Department of Defense (DOD) awarded Cue Health $481 million to expand the domestic production capacity of point-of-care COVID-19 tests, as part of an Other Transaction Agreement. The agreement will expand Cue’s domestic production to 100,000 COVID-19 test kits per day by March 2021, and deliver six million COVID-19 tests and 30,000 instruments to the federal government.
On October 13, the FDA issued and immediately implemented new guidance entitled Enforcement Policy for Modifications to FDA-Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 Public Health Emergency (PHE). The guidance expands access to certain FDA-cleared molecular tests intended for the detection and identification of flu viruses and respiratory syncytial viruses.
On October 13, the FDA granted EUA to Access Bio for the company’s 10 minute point-of-care COVID-19 antigen test. The test is projected to cost less than $20. Access Bio will manufacture 10 million units in November, with production increasing by early 2021.
On October 14, CMS expanded the list of covered telehealth services under Medicare fee-for-service during the COVID-19 PHE, with the program now paying for 144 services via telehealth. CMS is also providing additional support to state Medicaid and Children’s Health Insurance Program agencies to expand access to telehealth.
On October 14, OWS awarded AstraZeneca $486 million for the development and manufacturing of the company’s monoclonal antibody COVID-19 treatment, AZD7442. If the treatment is authorized by the FDA, the federal government will receive and distribute up to 100,000 doses at no cost.
On October 15, CMS revised the payment policy for COVID-19 labs: starting January 1, 2021, Medicare will pay $100 to labs that complete COVID-19 diagnostic tests within two calendar days and $75 for labs that take longer to complete.
On October 15, the World Health Organization (WHO) published data supporting that the COVID-19 treatment drugs remdesivir, interferon-beta, hydroxychloroquine, and ritonavir/lopinavir, do not lower the mortality of severe cases of COVID-19 or delay the need for ventilation.
On October 16, OWS announced an agreement with CVS and Walgreens to provide and administer COVID-19 vaccines with no out-of-pocket costs to residents of long-term care facilities (LTCFs), including skilled nursing facilities (SNFs), nursing homes, assisted living facilities, residential care homes, and adult family homes. LTCFs are able to opt in and indicate which pharmacy partner their facility prefers to have on-site, beginning October 19.
On October 16, CMS announced that the agency will allow Medicare-enrolled immunizers, including pharmacies, to bill directly and receive direct reimbursement from the Medicare program for vaccinating Medicare SNF residents during the PHE.
On October 13, it was reported that FDA Commissioner Stephen Hahn rejected efforts to change the FDA terminology for the COVID-19 vaccine authorization from EUA to “pre-licensure.” The Administration had been pushing FDA to make this change to ensure that Medicare would cover the costs of COVID-19 vaccines authorized under an EUA, given that Congress mandated earlier this year that Medicare cover the cost of administering a licensed vaccine (not vaccines authorized under EUAs). Commissioner Hahn voiced his concerns over appearing to politicize a COVID-19 vaccine and adding to confusion and distrust around a potential vaccine. An HHS spokesperson indicated that CMS is continuing to explore coverage options for vaccines authorized under EUA.
The FDA Vaccines and Related Biological Products Advisory Committee will hold the committee’s first COVID-19 meeting on October 22.
White House
None of note.
Other
On October 12, WHO Director-General Tedros Adhanom Ghebreyesus called the herd immunity strategy to combat COVID-19 “unethical,” instead favoring contact tracing efforts.
On October 12, IQVIA partnered with the FDA for the company’s CARE Project COVID-19 registry to share data and track how people are affected by exposure to COVID-19, including tracking the length and severity of symptoms and whether any medications or vitamin supplements they are taking affect the severity of their symptoms.
On October 12, Johnson & Johnson (J&J) temporarily paused the company’s Phase III COVID-19 vaccine clinical trials due to an unexplained illness in a study participant.
On October 12, Kaiser Family Foundation (KFF) released a report entitled Health Insurer Financial Performance Amid the Coronavirus Pandemic. The report found that insurer’s average margins increased and medical loss ratios dropped across the fully-insured group and Medicare Advantage (MA) markets, compared to 2019. KFF suggested that this resulted in higher profits for many insurers during COVID-19.
On October 12, a study published in JAMA Network entitled The COVID-19 Pandemic and the $16 Trillion Virus estimated that the cumulative financial costs of the COVID-19 pandemic is $16 trillion, including the loss of life, decreases in worker productivity, the lost income from the COVID-19–induced recession, and other indirect effects from COVID-19.
On October 13, Roche announced intentions to file for EUA for the company’s Elecsys COVID-19 antigen test, though the company did not release an official timeline.
On October 14, the Health Care Cost Institute released a report entitled The Impact of COVID-19 on Years of Life Lost. The report found that since April 2020, 1.9 million excess years of life have been lost due to COVID-19.
On October 14, Russia granted regulatory approval to a second COVID-19 vaccine, Vector Institute’s peptide-based, two-dose vaccine, EpiVacCorona. The vaccine has not gone through Phase III clinical trials and data from the previous clinical trials have not been released.
On October 15, 80 public health and infectious disease researchers published a letter in The Lancet warning against a herd immunity approach to COVID-19, calling the approach a “dangerous fallacy unsupported by scientific evidence.”
On October 15, the Commonwealth Fund released a report entitled The Impact of the COVID-19 Pandemic on Outpatient Care: Visits Return to Prepandemic Levels, but Not for All Providers and Patients.The report found that though visits have overall returned to levels prior to COVID-19, levels vary by different factors including age group and provider specialty.
On October 15, Pfizer Chief Executive Dr. Albert Bourla announced that the company will seek EUA for its COVID-19 vaccine after collecting safety and manufacturing data. Bourla predicted that the company will apply for authorization in the third week of November.
On October 15, the European Union released a report entitled Preparedness for COVID-19 vaccination strategies and vaccine deployment. The report details the country’s COVID-19 plans, including providing COVID-19 vaccines free of charge.
On October 15, the National Governor’s Association asked President Trump for additional guidance on states’ roles in the distribution and implementation of COVID-19 vaccines. The letter requested a plan of federal and state responsibilities; supply chain management; the vaccine allocation process; and funding to implement the responsibilities.
As of October 16, the U.S. had 8,027,412 confirmed COVID-19 cases resulting in 218,266 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
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
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) Proposed Rule; Received 9/9/20
Transparency in Coverage (CMS-9915); Final Rule; Received 9/11/20
Advance Notice of Methodological Changes for Calendar Year (CY) 2022 for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies – Part II; Notice; Received 9/21/20
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
Basic Health Program; Federal Funding Methodology for Program Year 2022 (CMS-2438); Proposed Rule; Received 9/29/20
CY 2021 Home Health Prospective Payment System Rate Update and Quality Reporting Requirements (CMS-1730); Final Rule; 10/5/20
CY 2021 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System and Quality Incentive Program (CMS-1732); Final Rule; 10/8/20
HHS-FDA
Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment; Guidance for Industry; Notice; Received 5/28/2020
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 October 13, OIG released a report entitled Medicare Improperly Paid Physicians for More Than Five Spinal Facet-Joint Injection Sessions During a Rolling 12-Month Period. The report found that Medicare did not pay physicians for selected facet-joint injection sessions in accordance with Federal requirements, resulting in $748,555 in improper payments. OIG found insufficient oversight to prevent or detect these improper payments, with the potential for Medicare to save $513,328. OIG recommends that CMS recover the improper payments, develop oversight mechanisms for the Medicare Administrative Contractors, and consider re-implementing the coverage limitation. A summary of the report is available here.
On October 16, OIG released a report entitled Cedars-Sinai Medical Center: Audit of Medicare Payments for Bariatric Surgeries. The report found that Cedars-Sinai did not fully comply with Medicare requirements and the Medicare contractor's local coverage determinations and local coverage article when billing for bariatric surgeries, resulting in $154,074 in overpayments. OIG recommends that Cedars-Sinai refund overpayments to Medicare, update its patient checklist to include all of Noridian's specifications for billing bariatric surgeries, and obtain supporting medical record documentation from other providers before performing future bariatric surgeries. A summary of the report is available here.
Congressional Budget Office (CBO)
On October 15, CBO released a presentation entitled CBO's Current Revenue Forecast. CBO predicts that federal revenues will decrease from 16.3% of Gross Domestic Product in 2019 to 15.5% in 2021, due to the economic disruption from COVID-19 and the federal government’s response. CBO predicted that revenues will rise after 2021, reaching almost 18% in 2030, due to temporary COVID-19 provisions expiring, scheduled increases in taxes, and other factors.
UPCOMING HEARINGS
Senate
None of note.
House
Ways & Means Oversight Subcommittee
October 20, 12:00pm
Maximizing Health Coverage Enrollment Amidst Administration Sabotage
Witnesses: Marlene Caride, Commissioner, New Jersey Department of Banking and Insurance; Kevin Patterson, Chief Executive Officer, Connect for Health Colorado; Andy Slavitt, Board Chair, United States of Care; abd Chris Pope, Senior Fellow, Manhattan Institute.
OTHER HEALTH POLICY NEWS
On October 12, the Commonwealth Fund released a report entitled the Medicare Data Hub. The report predicts that Medicare enrollment will increase 1.5 million beneficiaries per year from 2021 to 2029. The Commonwealth Fund also found that enrollment in private MA plans more than doubled between 2010 and 2020.
On October 12, Mallinckrodt Pharmaceuticals filed for bankruptcy protection to resolve opioid-related claims and reduce its debt from opioid- and Medicaid rebate-related settlements.
On October 13, J&J disclosed that the company will contribute up to an additional $1 billion to an all-in settlement amount that would resolve opioid lawsuits filed, increasing the company’s contribution to $5 billion. The terms of the settlement have not been finalized.
On October 13, a study published in JAMA Network entitled Family and Friend Perceptions of Quality of End-of-Life Care in MA vs Traditional Medicare found that family and friends of people who died while enrolled in MA reported lower quality of care in the last month of life, compared with family and friends of those who died while enrolled in traditional Medicare.
On October 14, KFF released a report finding that States predict that Medicaid enrollment and spending growth will increase in FY 2021, due to the Families First Coronavirus Response Act maintenance of eligibility requirements and the economic downturn from COVID-19.
On October 15, Sen. Kamala Harris (D-CA) paused campaign travel through October 18, after her communications director and a crewmember on a campaign flight tested positive for COVID-19.
On October 15, Democratic Presidential nominee Joe Biden and President Trump held separate town hall events, in lieu of a second presidential debate.
On October 15, the D.C. Circuit Court of Appeals indicated, in oral arguments, that the court would uphold price transparency requirements, requiring hospitals to disclose negotiated prices. The three-judge panel suggested that the requirements are not overly burdensome. The Court has not released when an official ruling will be decided. The requirements are scheduled to take effect January 1, 2021.
On October 16, Wakely released a report entitled Risk Corridors Recovery Payments Could Result in Approximately $300 Million in MLR Rebates. The report found that 2.4% of the $12 billion of ACA subsidies restored to health insurers this year will be rebated back to customers.