Washington Healthcare Update – July 2020 #1 | McGuireWoods Consulting

This week in Washington: The House and Senate are out for a two-week working period until July 17th.

Upcoming Hearings/Markups

Congress

Hearings/Markups

  • Senate Committee on Health, Education, Labor and Pensions (HELP): “COVID-19: Update on Progress Toward Safely Getting Back to Work and Back to School”
  • House Committee on Energy and Commerce: High Anxiety and Stress: Legislation to Improve Mental Health During Crisis
  • Senate Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies: Review of Operation Warp Speed – Researching, Manufacturing, & Distributing a Safe & Effective Coronavirus Vaccine
  • House Committee on Oversight and Reform, Select Subcommittee on the Coronavirus Crisis: The Administration’s Efforts to Procure, Stockpile, And Distribute Critical Supplies

House

  • House Passes ACA Enhancement, Drug Pricing Bill
  • Pallone Requests HHS Release State COVID-19 Testing Strategies
  • House Energy and Commerce Chair, Others Request HHS to Explain Canceled Coronavirus Research Grant

Senate

  • Senate Democrats Introduce Resolution, Demand Trump Administration Defend ACA
  • Grassley, Walden Request Investigation into COVID-19 Nursing Home Deaths

Administration

  • HHS Expects 10 Million Point-Of-Care Tests Will Be Available this Month

Proposed Regulations/Guidance

  • FDA Announces Public Meeting for Stakeholder Input on GDUFA Reauthorization
  • CMS: Calendar Year 2021 Payment and Policy Changes for Home Health Agencies and Calendar Year 2021 Home Infusion Therapy Benefit

Final Regulations/Guidance

  • FDA: COVID-19 Vaccine Should Show 50% Efficacy, Trials Should Include Minorities

Reports

  • GAO: Science and Tech Spotlight — E-Cigarettes

Upcoming Hearings/Markups

Wednesday, July 8, 2020

House Committee on Energy and Commerce: “Addressing the Urgent Needs of our Tribal Communities”

The House Committee on Energy and Commerce will hold a hearing on how best to help tribal communities hit hardest by the COVID-19 pandemic.

Find more details on the hearing here.

Hearings/Markups

Senate Committee on Health, Education, Labor and Pensions (HELP): “COVID-19: Update on Progress Toward Safely Getting Back to Work and Back to School”

Tuesday, June 30, 2020: The Senate HELP committee held hearing in its continuing series on Americans returning to work and school during the COVID-19 pandemic. Find more details on the hearing here.

Why this is important: Senate HELP Committee Chair Lamar Alexander (R-TN) suggested during the hearing that either states or Congress pay for COVID-19 tests to encourage people to return to work and cover the testing cost for students returning to school. In addition, National Institute of Allergy and Infectious Diseases (NIAID) Director Anthony Fauci added that surveillance testing is going to be very important to not only understand the current occurrence of the virus and society, but where it is going.

House Committee on Energy and Commerce: High Anxiety and Stress: Legislation to Improve Mental Health During Crisis

Tuesday, June 30, 2020:The Subcommittee on Health of the Committee on Energy and Commerce held a hearing to discuss 22 pieces of legislation, a response to mental health concerns during the COVID-19 pandemic. Find more details on the hearing here.

Why this is important: Mental health experts testifying before the committee said the social isolation, job loss and even the coronavirus’ attacks on the human brain has led to a surge of suicides, depression, anxiety and other mental health ills.

Senate Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies: Review of Operation Warp Speed – Researching, Manufacturing, & Distributing a Safe & Effective Coronavirus Vaccine

Thursday, July 2, 2020: The Subcommittee on Labor, Health and Human Services, Education, and Related Agencies of the Senate Committee on Appropriations held a hearing to discuss the progress of Operation Warp Speed, continuing efforts to provide a COVID-19 vaccine. Find more details on the hearing here.

Why this is important: As of the morning of this hearing, 128,000 Americans have died and nearly 2.7 million have tested positive for COVID-19. The hearing addressed where the vaccine development process stands, with estimates at the end of this year, or start of 2021.

House Committee on Oversight and Reform, Select Subcommittee on the Coronavirus Crisis: The Administration’s Efforts to Procure, Stockpile, And Distribute Critical Supplies

Thursday, July 2, 2020: The Select Subcommittee on the Coronavirus Crisis of the House Committee on Oversight and Reform held a hearing to examine the Trump Administration’s efforts to procure needed personal protective equipment, testing media, and other medical supplies in response to the coronavirus pandemic. The hearing also covered the federal government’s plans to coordinate the distribution of supplies to states and local communities and to replenish the Strategic National Stockpile to meet current and future demand. Find more details on the hearing here.

Why this is important: Major suppliers, manufacturers and distributors to hospitals, medical offices and nursing homes expressed concern to the subcommittee that obtaining personal protective equipment for U.S. medical personnel and patients under current conditions is “not sustainable.” The companies shared requests to the White House Supply Chain Task Force for a coordinated federal response, saying they lack the data to obtain the best prices and prioritize supplies.

House

House Passes ACA Enhancement, Drug Pricing Bill

On June 29, the House passed the Patient Protection and Affordable Care Enhancement Act, 234-179. The bill by House Democrats is meant to enhance the Affordable Care Act (ACA) by boosting the law’s tax credits, reversing the Trump administration rules seen as undermining the law and encourage states to take up Medicaid expansion. The bill also includes drug-pricing provisions as an offset. According to the Congressional Budget Office (CBO) score for the legislation, if the 14 states that have yet to take up the Medicaid expansion would do so, another 4 million people could gain coverage.

Find the legislation here.

Pallone Requests HHS Release State COVID-19 Testing Strategies

On June 26, House Energy & Commerce Committee Chairman Frank Pallone (D-NJ) sent a letter to the Department of Health and Human Services (HHS), requesting it send all state and local COVID-19 testing plans to Congress by July 6. In a letter, Rep. Pallone outlined how each state, locality, territory and tribe receiving Paycheck Protection Program funding is required to send HHS their plans for COVID-19 testing and goals for the rest of the year. He said since the Trump Administration is delegating the testing strategy to states and localities, those plans should become public.

Find the full letter here.

House Energy and Commerce Chair, Others Request HHS to Explain Canceled Coronavirus Research Grant

On June 26, Chairs of the House Energy and Commerce Committee Chair and others, the House Science Committee and their investigations subcommittees asked the Department of Health and Human Services (HHS) Secretary Alex Azar for a briefing on the April decision to cancel the grant to the nonprofit EcoHealth Alliance. The group was studying how coronaviruses spread from bats to people. The National Institutes of Health (NIH) ended its grant after reports linked the work to a Wuhan, China lab at the center of conspiracy theories about the origin of the COVID-19 pandemic.

Reps. Frank Pallone (D-NJ), Diana DeGette (D-CO), Eddie Bernice Johnson (D-TX) and Bill Foster (D-IL) sent a letter requesting details about White House and other federal agencies’ involvement in the decision, whether other grants have been canceled and any analysis indicating that funds from the EcoHealth grant improperly went to the Wuhan lab.

Find the letter here.

Senate

Senate Democrats Introduce Resolution, Demand Trump Administration Defend ACA

On June 30, Sens. Chris Van Hollen (D-MD), Ben Cardin (D-MD) and Jon Tester (D-MT) introduced a resolution requesting the Trump Administration halt efforts to undermine the Affordable Care Act (ACA), and instead defend the law against the constitutional challenge as they say the Department of Justice is required. The resolution points out that if the Supreme Court case that could invalidate the ACA were successful, millions of people would lose access to Medicaid coverage, subsidies to purchase individual market plans, the exchanges and consumer protections. Consumer would face coverage denials and discrimination based on health status as well.

Find the resolution here.

Grassley, Walden Request Investigation into COVID-19 Nursing Home Deaths

On June 29, Senate Finance Committee Chairman Chuck Grassley (R-IA) and House Energy and Commerce Committee Ranking Member Greg Walden (R-OR) sent a letter to the Office of the Inspector General (OIG) at the Department of Health and Human Services (HHS) requesting the OIG initiate an investigation into whether or not five states – California, Michigan, New Jersey, New York and Pennsylvania – violated federal guidance in pressuring nursing home facilities to accept patients who tested positive for COVID-19. The letter cites guidance issued by the Centers for Disease Control and Prevention (CDC) as well as the Centers for Medicare and Medicaid Services (CMS), suggesting state officials that pressured COVID-positive patients back into nursing homes may have risked their health and safety.

Find the letter here.

Administration

HHS Expects 10 Million Point-Of-Care Tests Will Be Available this Month

On July 1, the Department of Health and Human Services (HHS) announced that it expects an additional 5 million COVID-19 point-of-care tests will come onto the market this month, which should bring the total number of available point-of-care tests to 10 million. Assistant Secretary for Health Brett Giroir estimates that there could be as many as 20 million available by September of this year.

Proposed Regulations/Guidance

FDA Announces Public Meeting for Stakeholder Input on GDUFA Reauthorization

The Food and Drug Administration (FDA) will hold a virtual public meeting to request public input on the reauthorization of the Generic Drug User Fee Amendments of 2012 for fiscal years 2023 through 2027 (GDUFA III). FDA’s current GDUFA authorization (GDUFA II) expires at the end of fiscal year 2022 (in September 2022).

The virtual meeting will take place July 21, 2020.

Deadline for registration is July 7, 2020, at this link here.

CMS: Calendar Year 2021 Payment and Policy Changes for Home Health Agencies and Calendar Year 2021 Home Infusion Therapy Benefit

On June 25, the Centers for Medicare and Medicaid Services (CMS) proposed to permanently expand home health telehealth options, initially approved for use during the COVID-19 pandemic, as part of its proposed 2021 home health pay rule. The rule would also implement new wage index calculations while capping cuts that could be tied to those calculations. According to CMS, home health agencies would see a 2.6 percent Medicare pay bump under the rule. The proposal also updates the home health wage index, but also includes a 5 percent cap on decreases in a geographic area’s wage index value for 2021.

Find the proposed rule here. Public comments are due by August 31, 2020.

IRS: Payments to Health Sharing Ministries, Direct Primary Care Deductible

On June 8, the Internal Revenue Service (IRS) proposed that premiums and fees paid for direct primary care or health care sharing ministries be eligible for reimbursement by employers under health reimbursement arrangements (HRAs) and for deduction as a medical expense. The draft IRS rule stems from a June 24, 2019, executive order that required the IRS to issue regulations within six months to allow certain arrangements, including direct primary care and HCSMs, as eligible medical expenses under section (213)d of the IRS code.

Find the draft rule here.

Final Regulations/Guidance

FDA: COVID-19 Vaccine Should Show 50% Efficacy, Trials Should Include Minorities

On June 30, the Food and Drug Administration (FDA) released guidance stating a coronavirus vaccine should demonstrate at least 50% efficacy in placebo-controlled trials, meaning it will prevent disease or decrease severity in at least half of the people vaccinated. The guidance came out just days after National Institute of Allergy and Infectious Diseases (NIAID) Director Anthony Fauci said he would “settle” for a 75% effective vaccine. The guidance also urged vaccine sponsors to include diverse populations in all stages of COVID-19 vaccine clinical trials. FDA is especially focused on ensuring trials include racial and ethnic minorities, elderly individuals, people with comorbidities and pregnant women.

Find the guidance here.

Courts

Find a comprehensive look at “Courts and Healthcare Policy in 2020” here.

Reports

GAO: Science and Tech Spotlight — E-Cigarettes

On June 30, the Government Accountability Office (GAO) released a report highlighting E-cigarettes, battery-powered devices that generate an inhalable aerosol that usually contains nicotine. They are used as alternatives to regular cigarettes. According to the report millions of teens and young adults reported that now use e-cigarettes. In 2019, nearly 28% of high-school students and 11% of middle-school students reported using e-cigarettes. About 8% of adults ages 18 to 24 reported using them in 2018.

The GAO reports that E-cigarettes are relatively new, and their long-term effects are not yet known. Although they may potentially be less harmful substitutes for traditional cigarettes, risks of addiction, injury, and death from e-cigarettes are becoming more apparent.

Find the full report here.