Washington Healthcare Update

July 27, 2020

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This week in Washington: House passes first set of Appropriations bills; President Trump signs Executive Orders on Prescription Drugs after COVID-19 bill stalled.

Upcoming Hearings/Markups

Congress

Hearings/Markups

House

Senate

Administration

Proposed Regulations/Guidance

Final Regulations/Guidance

Courts

Reports

Upcoming Hearings/Markups

Tuesday, July 28, 2020

Senate Committee on Finance: Part 1: Protecting the Reliability of the U.S. Medical Supply Chain During the COVID-19 Pandemic

The Senate Committee on Finance will hold a hearing on the COVID-19 pandemic’s effects on the U.S. medical supply chain in a two-part series.

Find more details on the hearing here.

Wednesday, July 29, 2020

House Committee on Energy and Commerce: Improving Access to Care: Legislation to Reauthorize Key Public Health Programs

The Subcommittee of Health on the Committee on Energy and Commerce will hold a hearing to discuss the following legislation:

  • H.R. 2075, the “School-Based Health Centers Reauthorization Act of 2019”
  • H.R. 4078, the “EARLY Act Reauthorization of 2019”
  • H.R. 4439, the “Creating Hope Reauthorization Act”
  • H.R. 4764, the “Timely Reauthorization of Necessary Stem-cell Programs Lends Access to Needed Therapies Act of 2019” or the “TRANSPLANT Act of 2019”
  • H.R. 5373, the “United States Anti-Doping Agency Reauthorization Act of 2019”

Find more details on the hearing here.

Thursday, July 30, 2020

Senate Committee on Finance: Part 2: Protecting the Reliability of the U.S. Medical Supply Chain During the COVID-19 Pandemic

The Senate Committee on Finance will hold a second hearing on the COVID-19 pandemic’s effects on the U.S. medical supply chain, in a two-part series.

Find more details on the hearing here.

Hearings/Markups

Senate Committee on Aging: The COVID-19 Pandemic and Seniors: A Look at Racial Health Disparities

Tuesday, July 21, 2020: The Senate Committee on Aging held a hearing on how the COVID-19 pandemic and racial health disparities are affecting the country’s seniors.

Find more details on the hearing here.

Why this is important: Ranking Member Sen. Bob Casey (D-PA) highlighted how challenges to the Affordable Care Act (ACA) have erected barriers between communities of color and accessible health care, and how this has exacerbated the deadly impact of the virus for older Americans of color.

House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations: Pathway to a Vaccine: Efforts to Develop a Safe, Effective and Accessible COVID-19 Vaccine

The Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce held a hearing to cover ongoing efforts to develop a COVID-19 vaccine. Operation Warp Speed finalists testified on whether the rapid pace of vaccine development could lead to approvals of vaccines that are not up to the Food and Drug Administration’s (FDA) historical standards. AstraZeneca, Johnson & Johnson, Merck, Moderna and Pfizer testified at the hearing.

Find more details on the hearing here.

Why this is important: Leaders of the companies working on COVID-19 vaccines predict they should have shots available by early 2021, but said they will rely on the federal government to determine how to distribute them.

House

House Passes First Set of Appropriations Bills

On July 24, the House approved a $259.5 billion spending package in a 224-189 vote. The four-bill minibus adds to the budgets at the departments of State, Interior, Agriculture, Veterans Affairs and other agencies. The package is the first of two fiscal 2021 funding bundles that House Democrats plan to pass by the end of the month. The House will take up a seven-bill, $1.4 trillion package this week that would fund the Pentagon and the Departments of Labor, Health and Human Services, Education, Homeland Security, Justice, Transportation, Energy and more.

Appropriations Committee Urges Domestic Production of Drugs, Domestic Production of Influenza Vaccine

On July 23, the House Appropriations Committee urged the Department of Health and Human Services (HHS) to boost domestic production of drugs and drug ingredients and to make more influenza vaccine than usual to gear up for a second wave of coronavirus infections colliding with flu season. The committee added that Medicare can hopefully improve vaccination rates among seniors by figuring out how to make vaccines free in Part D, similar to coverage in Part B. The proposals were included in the HHS spending bill passed by the House Appropriations Committee last week, with a 30-22 vote.

Senate

Senate GOP to Unveil COVID-19 Aid Bill, After Delay

On July 23, Senate Majority Leader Mitch McConnell (R-KY) announced a delay in the Senate Republicans’ counteroffer to the Democratic $3.4 trillion coronavirus bill. The bill is expected to be released today. The delay put in jeopardy a bipartisan goal of getting a bill done by July 31 in jeopardy. The Republican $1 trillion bill will include $105 billion in support for school reopening, a liability shield for businesses that reopen, a reduced boost in federal unemployment insurance down to 70 percent of pre-pandemic pay and a possible second round of Paycheck Protection Program loans for businesses. A side-package will propose more direct payments to individuals, according to Treasury Secretary Steve Mnuchin.

Republican Senators Call for Grassley Drug Pricing Bill to be put in COVID-19 Relief Plan

On July 22, Sens. Mike Braun (R-IN), Bill Cassidy (R-LA), Susan Collins (R-ME), Cindy Hyde-Smith (R-MS) and Martha McSally (R-AZ) gave floor speeches in support of the Prescription Drug Pricing Reduction Act of 2019 (S. 2543), Senate Finance Chair Chuck Grassley’s (R-IA) drug pricing bill. Sen. Grassley wrote a bipartisan bill with Ranking Member Ron Wyden (D-OR), which was reported out of the Senate Finance Committee. Sen. Grassley, in seeking support for the bill, made changes to the bipartisan bill with no Democrats supporting.

Find the bill here.

Senate Refuses to Vote on Bill That Would Require Trump to Invoke DPA

On July 22, the Senate rejected Sens. Chris Murphy (D-CT) and Tammy Baldwin’s (D-WI) request to pass by unanimous consent a bill that would require President Trump to invoke the Defense Production Act (DPA) to provide states with medical equipment, such as tests, respirators, gowns and gloves. During a Senate floor debate, Sen. Ron Johnson (R-WI) objected to Murphy and Baldwin’s bill, the Medical Supply Transparency and Delivery Act (S. 3627), arguing that the two senators were trying to bypass the committee of jurisdiction. The House included its version of the Medical Supply Transparency and Delivery Act as part of its COVID-19 relief package, the Health and Economic Recovery Omnibus Emergency Solutions Act, which passed the House on May 15.

Administration

President Trump Signs Four Executive Orders Related to Prescription Drug Prices

On July 24, President Trump announced four executive orders that, with one exception, attempt to reboot prescription drug pricing proposals. One order directs the federal government to require federally funded health clinics to give patients any discount the clinic receives for insulin and EpiPens, although the clinic may charge a small administration fee. A second executive order calls on the Department of Health and Human Services (HHS) to write new rules allowing importation of lower-cost drugs from Canada and other countries. The Trump Administration announced this proposal nearly a year ago, but has not finalized it. 

The third order revives another long-standing administration proposal that was never implemented to limit rebates secured by pharmacy benefit managers (PBMs) who negotiate prices with drug manufacturers on behalf of health insurers. The final order, which was originally proposed two years ago by the Trump Administration, but never implemented, would direct Medicare to develop a program to secure some drugs at the same prices that other nations are able to negotiate.

Find more information here.

HHS Secretary Azar Renews COVID-19 Public Health Emergency

On July 23, the Department of Health and Human Services (HHS) Secretary Alex Azar signed a continuation of the COVID-19 public health emergency shortly before it was set to expire July 25, extending temporary payment and enforcement flexibility affecting a wide range of stakeholders. The emergency declaration gave the Trump administration broad authority to loosen telehealth restrictions, waive Medicare regulations and ease Health Insurance Portability and Accountability Act (HIPAA) rules.

HHS to Send $5B to Nursing Homes, Mandates Staff Testing in Hotspots

On July 22, the Department of Health and Human Services (HHS) announced it would distribute an additional $5 billion to nursing homes nationwide from the provider relief fund, contingent upon nursing homes’ completing infection control best practices training. HHS also will require nursing home staff be tested for COVID-19 in states experiencing outbreaks. The funding can be used for hiring additional staff, implementing infection control programs, increasing testing and providing technology to facilitate virtual family visits.

OMB Starts Review of Final Stark, Anti-Kickback Rules

On July 21, the White House Office of Management and Budget (OMB) began reviewing final physician self-referral and anti-kickback statute regulatory reforms. The Department of Health and Human Services (HHS) last year released the proposals to change the physician self-referral and anti-kickback statute regulations in a bid to ease providers’ participation in value-based pay models. The proposed changes from the Centers for Medicare and Medicaid Services (CMS) include new, permanent exceptions to the Stark Law for value-based pay arrangements within and outside of Medicare. The HHS Office of Inspector General’s proposed rule includes a new safe harbor under the anti-kickback statute for certain incentives beneficiaries can access through CMS demonstrations.

FDA: Opioid, OUD Drug Labels Must Include Naloxone Co-Prescribing Info

On July 23, the Food and Drug Administration (FDA) announced that drug manufacturers to are required include naloxone co-prescribing information in labeling for all opioids and opioid use disorder (OUD) medications, including buprenorphine, methadone and naltrexone. The information, which will be included in the label’s prescribing information section, should recommend that health care professionals consider prescribing naloxone alongside any prescription for an OUD treatment medication or opioid.

FDA Issues EUA for Pooled COVID-19 Test

On July 20, the Food and Drug Administration (FDA) granted the first emergency use authorization (EUA) for a COVID-19 pooling test to Quest Diagnostics. The EUA, reissued for Quest’s SARS-CoV-2 real-time reverse transcription polymerase chain reaction diagnostic test, allows the device to test up to four different specimens at one time.

Find the EUA here.

Proposed Regulations/Guidance

FDA Seeks Input on Proposed “Right To Try” Reporting Requirements

On July 23, the Food and Drug Administration (FDA) proposed annual reporting requirements for drug manufacturers who provide investigational drugs to patients under the Right to Try pathway. The FDA proposes the reports be submitted separately from investigational new drug application reports, and it asks stakeholders for input on which entities should be responsible for submitting the annual Right to Try summary reports. The proposed rule is required under the Right to Try Act, which mandates companies that make their investigational drugs available through that pathway submit annual summaries to FDA. FDA then will make a consolidated version of those reports publicly available.

Find the proposed rule here. Public comments are due by Sept. 22, 2020.

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 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 Aug. 31, 2020.

Final Regulations/Guidance

FDA Guidance: Relaxed Requirements for COVID-19 Specimen Transport

On July 20, the Food and Drug Administration (FDA) will temporarily allow commercial manufacturers and labs to distribute and use devices and liquids that are intended to stabilize and transport clinical specimens collected as part of COVID-19 testing, even if they do not adhere to premarket notification or unique device identification requirements. Manufacturers must still comply with applicable registration and listing requirements. The policy will be in effect only for the duration of the COVID-19 public health emergency. It applies to viral transport media, sterile phosphate buffered saline (PBS) and sterile normal saline that are used to stabilize and transport clinical specimens, usually obtained on swabs.

Find the guidance here.

Courts

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

Most Insurers in Risk Corridor Class Actions Settle with DOJ for About $3.7B

On July 22, most insurers participating in two class action suits against the government over the Affordable Care Act’s (ACA) temporary risk corridors problem have settled with the Department of Justice (DOJ) and the classes are slated to get more than $3.7 billion in payments owed for the 2014, 2015 and 2016 benefit years. The case continues, however, as both have split into subsets that include insurers disputing the Department of Health and Human Services’ (HHS) attempt to deduct payments that plans owe for other reasons.

Reports

GAO: VA Health Care – Actions Needed to Improve Oversight of Graduate Medical Education Reimbursement

On July 17, the Government Accountability Office (GAO) released a report on the Department of Veterans Affairs’ (VA) Graduate Medical Education program that trains more than 45,000 medical and dental residents annually. It reimbursed affiliated medical schools and teaching hospitals about $765 million in 2019, covering residents’ salaries for their work at VA facilities. After detecting payment errors at one facility, VA added a new oversight process meant to complement an existing requirement that facilities audit reimbursements. According to the GAO report, overlap between the two processes, and insufficient tools, guidance and training for both may prevent VA from detecting payment errors.

Find GAO’s recommendations here, and the full report here.

If you have any questions, contact the following individuals atMcGuireWoods Consulting:

Stephanie Kennan, Senior Vice President
Mariam Eatedali, Research Associate

Founded in 1998,McGuireWoods Consulting LLC(MWC) is a full-service public affairs firm offering infrastructure andeconomic development, strategic communications & grassroots, and governmentrelations services. McGuireWoods Consulting is a subsidiary of theMcGuireWoods LLPlaw firm and has been named in The National Law Journal’s special annualreport, “The Influence 50,” for the past several years. In the most recentreport, McGuireWoods Consulting was ranked 15th of the 1,900 governmentrelations firms in Washington, D.C.

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