Washington Healthcare Update

April 27, 2020

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This week in Washington: Congress passes $484 billion COVID-19 package, with $321 billion for the Paycheck Protection Program; Supreme Court rules for commercial health insurers in $12 billion risk corridors case.

Congress

House

Senate

Administration

Proposed Regulations/Guidance

Final Regulations/Guidance

Courts

Reports

House

House, Senate Pass $484 Billion COVID-19 Package, President Trump Signs

Last week, the House passed a COVID-19 spending package, 388-5, which passed the Senate unanimously. On April 24, President Trump signed the spending package that will provide an immediate $321 billion infusion for the Paycheck Protection Program, the small business rescue fund that ran out of money last week. The package also provides another $60 billion in economic disaster loans for small businesses, $75 billion in emergency relief for hospitals and $25 billion for increased coronavirus testing, with $11 billion of that going to states. The spending package is the fourth in a series of coronavirus relief bills passed in Congress in less than two months, totaling $2.7 trillion in federal funds to fight the pandemic.

Senate

Whitehouse, Cassidy Ask CMS to Offer ACOs More Relief Amid Pandemic

On April 23, Sens. Sheldon Whitehouse (D-RI) and Bill Cassidy (R-LA) requested that the Centers for Medicare and Medicaid Services (CMS) extend relief for accountable care organizations (ACOs) due to the COVID-19 pandemic and waive the providers’ losses they might otherwise have to repay. Sen. Cassidy’s office said he is not considering legislation at this point. CMS responded that it is aware of the concerns and will keep looking closely to see where it can take more steps in the coming weeks.

Administration

Trump Administration Supports Continuing Public Charge Rule during COVID-19 Pandemic

On April 20, in a filed brief to the Supreme Court, the Trump administration announced that the public charge rule should remain in effect during the coronavirus pandemic. The filing was a response to three states’ requesting the Supreme Court halt the public charge rule during the pandemic, claiming it is keeping immigrants from being tested or treated for the virus. The Trump administration’s brief clarifies that the exemption for COVID-19-related services applies only if the recipient dis-enrolls from Medicaid after receiving the services.

Find the Trump administration’s response here.

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 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 Moving Forward on OTC Monograph Reform

As of April 23, the Food and Drug Administration (FDA) continues to move forward on the new over-the-counter (OTC) monograph regulatory and user fee framework, following the passage of the CARES Act. FDA plans to follow the performance goals and procedures that were detailed in the original 2017 OTC monograph user fee program plan. The FDA announced that it is currently engaged in significant and fast-moving COVID-19 response efforts but is allocating its remaining available resources among multiple competing priorities, including implementing OTC monograph reform.

Find the FDA’s goals here.

FDA Grants First EUA for an At-Home COVID-19 Test Kit

On April 21, the Food and Drug Administration (FDA) approved the first at-home diagnostic test for COVID-19 by reissuing emergency use authorization to Laboratory Corporation of America’s (LabCorp’s) reverse transcriptase polymerase chain reaction test. The FDA says the test should be available in most states in the coming weeks.

The authorization only applies to LabCorp’s COVID-19 test using the Pixel by LabCorp home collection kits. It is not a general authorization for at-home collection of patient samples using other collection swabs, media or tests or for tests fully conducted at home.

HHS: Toolkit to Help States Navigate COVID-19 Workforce Flexibility

On April 22, the Department of Health and Human Services (HHS) launched a toolkit to help state and local health care officials use workforce flexibilities offered by the Trump administration in response to the COVID-19 pandemic. The toolkit provides information on funding flexibility, liability protections and workforce training, allowing state and local regulators to see how workforce waivers have been applied around the country and to track whether they are working.

Find the toolkit here.

CMS, ONC Push Back Interoperability Policies

The Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator for Health IT (ONC) will delay enforcing certain aspects of the interoperability rules as of April 21. ONC emphasized that resources need to be focused on the COVID-19 pandemic. The rules were finalized in March. ONC will give stakeholders an additional three months, before enforcing certain provisions in the rules. This includes some Application Program Interface requirements and information blocking certification.

Find more information here.

CMS Will Give Providers MIPS Credit for Being Part of COVID-19 Trials

On April 20, the Centers for Medicare and Medicaid Services (CMS) announced it will give providers credit in the Merit-based Incentive Payment System (MIPS) for participating in clinical trials of drugs to treat COVID-19, and that credit will count heavily toward their MIPS score. To receive credit for participating in a COVID-19 clinical trial, providers will need to prove that they participated in a trial using a drug or biologic to treat patients with COVID-19 infections and report findings through a clinical data repository or clinical data registry for an entire study. The trial could be a traditional double-blind placebo study or an adaptive or pragmatic design.

CMS Requires Nursing Homes to Directly Report COVID-19 Cases to CDC

On April 19, the Centers for Medicare and Medicaid (CMS) announced a requirement for nursing homes to report suspected or confirmed COVID-19 cases directly to the Centers for Disease Control and Prevention (CDC), as well as notify families and patients. Prior guidance only required nursing homes to notify state or local health authorities of cases, and CMS, CDC or the Federal Emergency Management Agency (FEMA) were not collecting the data.

CMS: Guidance on Reopening Facilities to Provide Nonemergent Non-COVID-19 Health Care – Phase I

On April 19, the Centers for Medicare and Medicaid Services (CMS) released guidance for health care providers to begin the process of reopening for nonemergent, non-COVID-19 services. Most nonessential surgeries and procedures have been on hold since at least March 18. CMS now says health facilities may resume some procedures if they are located in regions or states that have satisfied the criteria announced by the Trump administration last week as part of a plan for businesses to reopen. Those criteria include a two-week downward trajectory of COVID-19 cases in a state or region.

Find the guidance here.

Courts

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

Supreme Court Rules for Commercial Health Insurers in $12B Risk Corridors Case

On April 27, the Supreme Court ruled in favor of commercial health insurers arguing they are owed $12 billion under the Affordable Care Act’s (ACA) risk corridor program. The 8-1 decision found that the ACA “established a money-mandating obligation that Congress did not repeal this obligation.”

Find the opinion from Maine Community Health Options v. U.S. here.

Video Hearing on Hospital Price Transparency Rule Set for May 7

As of April 22, U.S. District Judge Carl Nichols postponed hearing American Hospital Association v. Azar in light of the coronavirus pandemic. Judge Nichols rescheduled the hearing for May 7 of this year and specified that it would be held over video. The Centers for Medicare and Medicaid Services’s (CMS) rule in question requires hospitals to post online various types of pricing information for the services they provide, including the rates they negotiate with private insurers. Hospitals are asking the courts to strike down the rule, arguing that it exceeds CMS’s authority and violates the First Amendment. The rule is scheduled to take effect Jan. 1, 2021.

Reports

GAO: Immigration Detention – Care of Pregnant Women in DHS Facilities

On April 21, the Government Accountability Office (GAO) released a report analyzing data from the U.S. Immigration and Customs Enforcement (ICE) on the detainment of pregnant women more than 4,600 times from 2016-2018. Most detentions lasted one week or less. ICE has policies and standards related to the care for pregnant women that vary by facility type, with some having more requirements than others. ICE is updating its policies and standards to address gaps. GAO’s analyses of inspections and complaint mechanisms determined that at facilities it inspected, ICE generally found at least 79 percent compliance with inspection measures related to pregnancy care. Most ICE detentions started with U.S. Customs and Border Protection arrests (CBP). CBP mostly relies on off-site pregnancy care, but plans to enhance medical support at select facilities.

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

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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