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This week in Washington: House hearing on the response to COVID-19 by the Department of Veterans Affairs; Senate hearing on caring for seniors amid the COVID-19 crisis.
Congress
Hearings/Markups
- Senate Committee on Health, Education, Labor and Pensions (HELP): “COVID-19: Safely Getting Back to Work and Back to School”
- House Committee on Energy and Commerce: “Protecting Scientific Integrity in the COVID-19 Response”
House
Senate
Administration
- Trump Administration Launches Serology Test Pilot Program
- HHS: State Health Departments Will Distribute Remdesivir to Hospitals
Proposed Regulations/Guidance
- DEA: Controls to Enhance the Cultivation of Marijuana for Research in the U.S.
- FDA: Change in Safety Requirements for Diabetic Drugs
- CMS: Coordinating Care from Out-of-State Providers for Medicaid-Eligible Children with Medically Complex Conditions – Reopened Comment Period
- CMS Proposes 2.9 Percent Pay Increase for Inpatient Rehab Facilities
Final Regulations/Guidance
- FDA: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products
- FDA: COVID-19 – Developing Drugs and Biological Products for Treatment or Prevention
- FDA Commissioner Hahn Discusses FDA Return to On-site Inspections
Courts
Reports
Upcoming Hearings/Markups
Tuesday, May 19, 2020
House Committee on Appropriations: “Department of Veterans Affairs – Response to COVID-19”
The House Committee on Appropriations, subcommittee on Military Construction, Veterans Affairs, and Related Agencies will hold a hearing on the response to COVID-19 by the Department of Veterans Affairs, with a witness panel of officials from the VA.
Find more details on the hearing as they become available here.
Thursday, May 21, 2020
Senate Committee on Aging: “Caring for Seniors Amid the COVID-19 Crisis”
The Senate Committee on Aging will hold a hearing on caring for senior citizens during the ongoing COVID-19 pandemic.
Find more details on the hearing as they become available here.
Hearings/Markups
Senate Committee on Health, Education, Labor and Pensions (HELP): “COVID-19: Safely Getting Back to Work and Back to School”
Thursday, May 12: The Senate HELP committee held a full committee hearing on the country’s transition back to leaving homes for work and school, with a panel that includes Dr. Anthony Fauci from the National Institutes of Health (NIH), Dr. Robert Redfield from the CDC, Dr. Brett Giroir from HHS and Dr. Stephen Hahn from FDA.
Find more details on the hearing here.
Why this is important: The subject of the hearing was reopening the economy, but some members of the committee asked about Remdesivir, a drug by Gilead that has shown some promise in treating COVID-19 patients. Democratic members expressed concern on the affordability of the drug, despite the CARES Act’s requiring public and private insurers to cover at no cost vaccines recommended by the Advisory Committee on Immunization Practices at the Centers for Disease Control and Prevention (CDC). The members fear higher premiums for Americans.
House Committee on Energy and Commerce: “Protecting Scientific Integrity in the COVID-19 Response”
Thursday, May 14: The Subcommittee on Health of the Committee on Energy and Commerce held a hearing on protecting scientific transparency and support during the ongoing coronavirus pandemic.
Find more details on the hearing here.
Why this is important: Dr. Rick Bright, an immunologist for the Department of Health and Human Services (HHS), issued a warning in testimony before the committee, and alleged in a whistleblower complaint that he was removed from his position for prioritizing science in the government’s coronavirus response, with increased concern for the spread of the virus this coming fall.
House
On May 15, the House passed the Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES Act), 208-199. The passed legislation omits the Paycheck Guarantee Act, which would have guaranteed 100 percent coverage of workers’ wages up to $90,000 a year, as well omitting $2,000 recurring stimulus checks. The $3 trillion bill includes assistance to state and local governments, hazard pay for frontline health care workers, forgiveness of student debt and bolstering Medicaid and Medicare. The bill would also assist farmers, protect renters and homeowners from evictions and foreclosures, and extend family and medical leave provisions previously approved by Congress. The legislation would also provide relief for essential workers, such as aviation, rail and Amtrak workers, as well as extend work visas for immigrants. It is not expected to pass in the Senate, and the Trump administration has announced that the bill will be vetoed by President Trump if it were to reach his desk.
Ways & Means Chair Asks CMS to Slow Down Allowing Elective Care
On May 8, House Ways & Means Committee Chair Richard Neal (D-MA) sent a letter to the Centers for Medicare and Medicaid Services (CMS) asking to slow down allowing hospitals and health systems to reopen for nonemergency services until facilities meet certain requirements. Neal’s letter is a response to CMS-issued recommendations to facilities on reopening for elective surgeries and non-COVID-19 care in mid-April.
Senate
Senate Republicans Release COVID-19 Data Privacy Bill
On May 14, Senate Commerce Committee Chairman Roger Wicker (R-MS) released legislation that will give consumers control over how their personal health, device, geolocation and proximity data can be collected. The COVID-19 Consumer Data Protection Act sets up regulation, under the Federal Trade Commission (FTC), specifying that companies will need to get “affirmative express consent” from individuals in order to collect their data for tracking the spread of COVID-19. The bill is cosponsored by Sens. John Thune (R-SD), Deb Fischer (R-NE), Jerry Moran (R-KS) and Marsha Blackburn (R-TN).
Find the bill here.
Administration
Trump Administration Launches Serology Test Pilot Program
Last week, the Trump administration launched serology test pilot programs in New York City and Detroit to understand how health care workers and first responders have experienced COVID-19 infections. Under the pilot program, New York City will conduct more than 120,000 serology tests on hospital workers and first responders.
HHS: State Health Departments Will Distribute Remdesivir to Hospitals
On May 9, the Department of Health and Human Services (HHS) announced that state health departments will have authority to decide which hospitals receive doses of the investigational COVID-19 drug Remdesivir. The announcement does not address reallocation plans or provide additional guidance on what state health departments should consider when deciding where to distribute the drugs.
Proposed Regulations/Guidance
DEA: Controls to Enhance the Cultivation of Marijuana for Research in the U.S.
On March 20, the Drug Enforcement Agency (DEA) released a proposed rule for adding additional research marijuana growing licenses. The only research-grade medical marijuana currently grown in the U.S. is at the University of Mississippi, while 37 prospective producers have applied for and are awaiting decisions on their applications to grow research marijuana.
Find the proposed rule here. Public comments are due by May 22, 2020.
FDA: Change in Safety Requirements for Diabetic Drugs
On March 9, the Food and Drug Administration (FDA) released a draft guidance to no longer require drug manufacturers to conduct large cardiovascular safety studies for all new type 2 diabetes therapies. The FDA is recommending new safety requirements that will focus on evaluations that are broader than heart disease. Companies will need to include at least 4,000 patients exposed to the drug in phase III clinical trials, with at least 1,500 patients exposed to the drug for at least one year and 500 patients exposed to the drug for at least two years.
Find the draft guidance here. Public comments are due by June 8, 2020.
CMS: Coordinating Care from Out-of-State Providers for Medicaid-Eligible Children with Medically Complex Conditions – Reopened Comment Period
As of today, May 4, the Centers for Medicare and Medicaid Services (CMS) reopened the comment period for the request for information (RFI), Coordinating Care from Out-of-State Providers for Medicaid-Eligible Children with Medically Complex Conditions, by 30 additional days. The RFI is to address access to care across state lines in Medicaid for children with medical complexity.
Find the proposed rule here. The new comment period deadline is June 3, 2020.
CMS Proposes 2.9 Percent Pay Increase for Inpatient Rehab Facilities
On April 16, the Centers for Medicare and Medicaid Services (CMS) released a proposal to increase pay for inpatient rehabilitation facilities in fiscal 2021, lift the requirements for postadmission evaluations and allow nonphysician practitioners to provide more services. CMS proposes to increase the inpatient rehabilitation facility payment by 2.9 percent, and proposes to maintain outlier payments at 3 percent of total payments. CMS says this would be an overall $270 million increase in fiscal 2021 relative to fiscal 2020. The proposal includes adoption of the Office of Management and Budget’s (OMB) statistical area delineations and would apply a 5 percent cap on wage index decreases from fiscal 2020 to fiscal 2021.
Find the proposed rule here. Public comments are due by June 15, 2020.
Final Regulations/Guidance
FDA: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products
On May 12, the Food and Drug Administration (FDA) released an industry guidance that drug sponsors should initiate COVID-19 drug development discussions using a pre-investigational new drug meeting request instead of a pre-Emergency Use Authorization request. The FDA has established a multispecialty, multidisciplinary team to review the drug development proposals.
Find the guidance here.
FDA: COVID-19 – Developing Drugs and Biological Products for Treatment or Prevention
On May 12, the Food and Drug Administration (FDA) released a clinical trial guidance urging drug and biologic sponsors to study potential COVID-19 drugs in randomized, placebo-controlled trials that include high-risk individuals and patients with renal impairment. The FDA also wants sponsors to ensure racial and ethnic minorities and elderly people, as well as those with high-risk conditions, are represented in clinical trials.
Find the guidance here.
FDA Commissioner Hahn Discusses FDA Return to On-site Inspections
On May 11, Food and Drug Administration (FDA) Commissioner Stephen Hahn sent out a memo laying out a process to return to in-person surveillance inspections that have been delayed by the COVID-19 pandemic. The FDA is working with the Centers for Disease Control and Prevention (CDC) to create a process for deciding when and how to return to on-site facility inspections.
Find the memo here.
Courts
Find a comprehensive look at “Courts and Healthcare Policy in 2020” here.
DOJ Seeks More Time to Resolve Risk Corridor Cases
On May 12, the Department of Justice (DOJ) requested that the Federal Court of Claims give more time to consider its next steps in the cases over the Affordable Care Act’s (ACA) risk corridor program after the Supreme Court ruled 8-1 in Maine Community Health Options v. USA. The ruling determines that the government is obligated to pay the $12 billion or so owed to insurers in that case. DOJ tells the court it wants to figure out how to consistently resolve existing and potential new cases, but the Department of Health and Human Services (HHS) must first determine the precise amounts owed to insurers, including any debts the plaintiffs may owe the department. DOJ also wants a chance to consider other legal arguments.
Reports
GAO: Biomedical Research – HHS Has Not Yet Used New Authorities to Improve Recruitment and Retention of Scientists
On May 8, the Government Accountability Office (GAO) released a report on how the Department of Health and Human Services (HHS) has had trouble recruiting and retaining medical, engineering and other science and technology professionals to support activities like biomedical and clinical research. This research can include studies of HIV, flu and COVID-19. The 21st Century Cures Act provides additional hiring and retention authority, allowing HHS to hire up to 2,000 scientists with certain specialized graduate degrees, and increasing top pay to hire and retain an expert staff. HHS is preparing guidance based on discussion with its agencies to implement the act’s recruitment and retention flexibilities.
Find the full report here.
If you have any questions, contact the following individuals atMcGuireWoods Consulting:
Stephanie Kennan, Senior Vice President
Mariam Eatedali, Research Associate
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