Washington Healthcare Update - June 2020 #1

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This week in Washington: House to hold hearing on how governor's are battling the COVID-19 pandemic, Senate planning two hearings on preparing Americans to go back to college safely.

Upcoming Hearings/Markups

Congress

Hearings/Markups

  • House Ways and Means Committee: “The Disproportionate Impact of COVID-19 on Communities of Color”

House

  • House Energy and Commerce: Letter to Trump Administration on COVID-19 Vaccine Plan

Senate

  • Senate Democrats Urge HHS to Protect ACA’s Antidiscrimination Provisions in Midst of COVID-19 Pandemic

Administration

  • CMS: Part D Senior Savings Model to Lower Insulin Prices
  • HHS Announces National Strategic COVID-19 Testing Plan
  • HHS Gives $4.9B to Nursing Homes during COVID-19 Pandemic
  • Trump Administration Announces Operation Warp Speed, AstraZeneca COVID-19 Vaccine to be Available Beginning in October

Proposed Regulations/Guidance

  • 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: Pushes Back Cigarette Warning Compliance Date, Per Court Order
  • FDA: Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications – Questions and Answers

Courts

  • Appeals Court Upholds CMS’s Fix for Improper Cuts to Inpatient Rates

Reports

  • GAO: Science and Tech Spotlight – COVID-19 Vaccine Development

Upcoming Hearings/Markups

Tuesday, June 2, 2020

House Committee on Energy and Commerce: “How Governors are Battling the COVID-19 Pandemic”

The Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce will hold a remote hearing to cover how state governors are addressing the current coronavirus pandemic. The panel of witnesses includes the governors from Colorado, Michigan and Arkansas. Find more details on the hearing here.

Senate Finance Committee: “COVID-19 and Beyond: Oversight of the FDA’s Foreign Drug Manufacturing Inspection Process”

The Senate Finance full committee will hold a hearing on how the coronavirus pandemic is affecting the FDA’s foreign drug manufacturing inspection process. Find more details on the hearing here.

Thursday, June 4, 2020

Senate Health, Education, Labor and Pensions Committee (HELP): “COVID-19: Going Back to College Safely”

The Senate HELP committee will hold a hearing on preparing Americans to go back to college during the COVID-19 pandemic. Find more details on the hearing here.

Wednesday, June 10, 2020

Senate Health, Education, Labor and Pensions Committee (HELP): “COVID-19: Going Back to College Safely”

The Senate HELP committee will hold a second hearing on preparing Americans to go back to college during the COVID-19 pandemic. Find more details on the hearing here.

Hearings/Markups

House Ways and Means Committee: “The Disproportionate Impact of COVID-19 on Communities of Color”

Wednesday, May 27, 2020: The House Ways and Means Committee held a hearing on how the COVID-19 pandemic is affecting American communities of color. Find more details on the hearing here.

Why this is important: Specific data on coronavirus infection rates remains incomplete, yet data from the Centers for Disease Control and Prevention (CDC) last month showed that African Americans make up approximately 30 percent of cases, despite representing 13 percent of the U.S. population.

House

House Energy and Commerce: Letter to Trump Administration on COVID-19 Vaccine Plan

On May 21, the House Energy and Commerce Committee Chair Frank Pallone (D-NJ) and ranking member Greg Walden (R-OR), and oversight subcommittee Chair Diana DeGette (D-CO) and ranking member Brett Guthrie (R-KY) sent a letter to the Trump administration regarding a need for a national COVID-19 vaccine plan. The plan should lay out how the federal government will scale manufacturing of potential vaccines, prioritize and allocate vaccines to at-risk populations, ensure all Americans can afford a vaccine regardless of insurance coverage and conduct public education and outreach. The letter was addressed to the White House Coronavirus Task Force Coordinator Deborah Birx and requested a briefing on the White House’s Operation Warp Speed, which aims to speed vaccine clinical trials.

Find the letter here.

Senate

Senate Democrats Urge HHS to Protect ACA’s Anti-Discrimination Provisions in Midst of COVID-19 Pandemic

On May 22, thirty-one Senate Democrats led by Sens. Bob Menendez (D-NJ) and Patty Murray (D-WA) sent a letter to the Department of Health and Human Services (HHS) asking for the withdrawal of a proposal to roll back the Affordable Care Act’s (ACA) nondiscrimination provisions. The senators argue that the consumer protections are particularly critical to vulnerable communities during the COVID-19 pandemic.

The Office of Management and Budget (OMB) has been reviewing the final version of the rule since April 23 and it could be released shortly, although HHS has at least 10 meetings scheduled with stakeholders on the rule through June 9, according to OMB.

Follow the rule at OMB here.

Find the letter here.

Administration

CMS: Part D Senior Savings Model to Lower Insulin Prices

On May 26, the Centers for Medicare and Medicaid Services (CMS) announced that more than 1,750 standalone Medicare Part D prescription drug plans and Medicare Advantage plans with prescription drug coverage have applied to offer lower insulin costs through the Part D Senior Savings Model for the 2021 plan year. Participating Part D prescription drug plans will provide Medicare beneficiaries access to a set of insulin at a maximum $35 copay for a month’s supply, from the beginning of the year through the Part D coverage gap. The model follows on the Trump administration’s previously announced 13.5 percent decline in the average monthly basic Part D premium since 2017 to the lowest level in seven years.

Find more information here.

HHS Announces National Strategic COVID-19 Testing Plan

On May 24, the Department of Health and Human Services (HHS) revealed a national strategic COVID-19 testing plan, a report required by Congress, which would include information for states as well on estimates of testing production. The 81-page plan puts much of the testing responsibility on individual states, territories and tribes, and provides guidance and information on testing technologies, platforms and inventories. States are required to submit a testing plan for May and June to HHS by May 30 and a plan for the remainder of 2020 on June 15. The report says the amount of testing necessary depends on various factors in each state, including the number of contacts per case, community transmissions and hospitalizations. It includes a target goal for testing in each state.

Find the full report here.

HHS Gives $4.9B to Nursing Homes during COVID-19 Pandemic

On May 22, the Department of Health and Human Services (HHS) announced it is distributing $4.9 billion from the provider relief fund to skilled nursing facilities as nursing homes continue to call for more funding to test residents. Each nursing home will receive $50,000, plus a distribution of $2,500 per bed. Certified nursing homes with six or more certified beds are eligible. However, nursing homes must agree to the terms and conditions HHS set forth in its original distribution of the provider fund.

Find more information here.

Trump Administration Announces Operation Warp Speed, AstraZeneca COVID-19 Vaccine to be Available Beginning in October

On May 21, the Trump administration announced that the Department of Health and Human Services (HHS) will pay AstraZeneca $1.2 billion to research and make at least 300 million COVID-19 investigational vaccine doses, but the federal procurement database lists a contract for $413 million. That discrepancy is due at least in part to the actual sale of those 300 million doses. The agreement with AstraZeneca covers 40 percent of the project now, and HHS will pay the remaining 60 percent if the vaccine is proven safe, effective and granted emergency use authorization or licensure by the FDA. The Trump administration’s press release claims that first doses of the vaccine could be delivered as early as Oct. 22 of this year.

Find more information here.

Proposed Regulations/Guidance

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: Pushes Back Cigarette Warning Compliance Date, Per Court Order

On May 28, the Food and Drug Administration (FDA) followed a court order to push back the date by which all cigarette packages and advertisements must bear new textual warning label statements and color graphics that depict the negative health consequences of smoking. The change is made with a guidance in the Federal Register, Submission of Plans for Cigarette Packages and Cigarette Advertisements. The new date is Oct. 16, 2021. The FDA has also revised its final rule that requires new health warnings on cigarette packages and in cigarette advertisements. The revised rule, Tobacco Products; Required Warnings for Cigarette Packages and Advertisements, identified 11 new cigarette health warnings and gave cigarette makers until June 18, 2021, to add warnings to each product package and advertisement.

Find the revised rule here.

Find the submission guidance here.

FDA: Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications – Questions and Answers

On May 27, the Food and Drug Administration (FDA) released guidance announcing it may not be able to continue meeting its prescription drug and biosimilars user fee goal dates, as many of its staff members are focusing on COVID-19 activities. In response to the pandemic, the agency intends to allocate resources to applications for investigational drug products, new drugs and biologics, and it will consider prioritizing generic drug application reviews if the products can help address the public health emergency.

Find the final guidance here.

Courts

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

Appeals Court Upholds CMS’s Fix for Improper Cuts to Inpatient Rates

On May 26, a federal appeals court ruled that hospitals that were underpaid by Medicare in fiscal 2014 through 2016 are not entitled to precise refunds. This is because the Centers for Medicare and Medicaid Services’s (CMS) alternative remedy, a one-time, across-the-board rate increase in 2017 that was meant to roughly offset the previous underpayments, was ruled as reasonable. The case is Shands Jacksonville Medical Center v. Azar.

Reports

GAO: Science and Tech Spotlight – COVID-19 Vaccine Development

On May 26, the Government Accountability Office (GAO) released a report on the development of a vaccine for the virus that causes COVID-19. Normally, the vaccine development process can take 10 to 15 years, but steps are being taken now to accelerate it. The Food and Drug Administration (FDA), for example, can expedite review and approval of new therapies for serious conditions. It can also issue emergency authorizations for vaccine candidates, if there is sufficient scientific evidence showing the product’s safety, effectiveness, risks and benefits.

There are more than 110 vaccines in development around the world as of May 15, 2020. At least three in the U.S. are receiving federal funding.

Find the full report here.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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