This week in Washington: Senate hearing on safely getting back to work and school, House hearing on protecting scientific integrity in the COVID-19 response.

Upcoming Hearings/Markups

Congress

House

• Schakowsky Introduces Bill to Oversight, Infection Control in Nursing Homes

Senate

• Wyden, Casey Want CMS to Release Nursing Home COVID-19 Data

Administration

• FDA Cuts Plan to Approve Medical Devices for Use with Certain Drugs

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

• CMS: Final Payment Notice for 2021 Coverage Year
• FDA Requires Device Manufacturers to Notify of Shortages during Pandemic
• FDA Gives Serology Test Makers 10 Business Days to Submit EUAs

Courts

• Trump Administration Will Urge Supreme Court to Overturn ACA

Upcoming Hearings/Markups

Tuesday, May 12, 2020

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

The Senate HELP committee will hold 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 as they become available here.

Thursday, May 14, 2020

House Committee on Energy and Commerce: “Protecting Scientific Integrity in the COVID-19 Response”

The Subcommittee on Health of the Committee on Energy and Commerce will hold a hearing on protecting scientific transparency and support during the ongoing coronavirus pandemic.

Find more details on the hearing as they become available here.

House

Schakowsky Introduces Bill to Oversight, Infection Control in Nursing Homes

On May 7, Rep. Jan Schakowsky (D-IL) introduced a bill, with a Senate companion bill to be introduced by Sens. Cory Booker (D-NJ) and Richard Blumenthal (D-CT), that seeks to improve care quality, worker safety, infection control and resident rights in nursing homes during the coronavirus pandemic. The Quality Care for Nursing Home Residents and Workers During COVID-19 Act (H.R. 6698) requires each facility to have a full-time infection preventionist with a certain level of experience, blocking a 2019 proposal by the Centers for Medicare and Medicaid Services (CMS) to roll back infection preventionist requirements.

Find the full bill here.

Senate

Wyden, Casey Want CMS to Release Nursing Home COVID-19 Data

On May 6, Senate Finance Committee ranking member Ron Wyden (D-OR) and Senate Aging Committee ranking member Bob Casey (D-PA) released a statement asking the Trump administration, for a second time, to commit to a timeline and process for releasing information on COVID-19 infections and deaths in nursing homes. The senators added in their statement that no public data has been released from the Centers for Medicare and Medicaid Services (CMS) thus far, and the information should be readily available by now, and updated in real time.

Find the statement here.

Administration

FDA Cuts Plan to Approve Medical Devices for Use with Certain Drugs

On May 7, the Food and Drug Administration (FDA) announced it is ending a proposed plan to allow medical device companies to submit devices for authorization that would be labeled for use with approved drugs, even without the cooperation of the manufacturers that own the drugs.

Find more information 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: 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

CMS: Final Payment Notice for 2021 Coverage Year

On May 7, the Centers for Medicare and Medicaid Services (CMS) issued a final rule in response to the coronavirus disease 2019 (COVID-19) pandemic, for a one-week extension of the qualified health plan (QHP) certification and rate review timelines. The final Notice of Benefit and Payment Parameters for the 2021 benefit year maintains the lower user fee rates on issuers participating on the federal exchange platform that was set in the 2020 Payment Notice. The rule also includes special enrollment periods (SEPs), such as being able to make coverage effective sooner under certain SEPs starting in January 2022. CMS is providing state-based exchanges (SBEs) that operate their own eligibility and enrollment platforms with display quality rating data provided by CMS or quality rating data from their state.

Find the final rule here.

FDA Requires Device Manufacturers to Notify of Shortages during Pandemic

On May 6, the Food and Drug Administration (FDA) released a temporary guidance requiring that manufacturers notify the FDA of any significant disruption in the medical device supply chain during a public health emergency, in an effort to mitigate device shortage amid the COVID-19 crisis. The guidance lays out which manufacturers should notify the FDA’s device center of potential disruptions, when and how they should send the alert and the information that should be included. FDA considers permanent discontinuance, interruption in manufacturing and an uptick in demand as potential meaningful disruptions.

Find the temporary guidance here.

FDA Gives Serology Test Makers 10 Business Days to Submit EUAs

On May 4, the Food and Drug Administration (FDA) revised a serology test policy and gave commercial manufacturers of currently marketed COVID-19 serology tests 10 business days to submit Emergency Use Authorization (EUA) requests. Similarly, all other test developers that want to market serology tests will need to submit EUA requests 10 business days from the day they notify the FDA of their marketing plans. The FDA will publicly share information about any test that does not have an EUA submitted within the timeframe.

Find more information here.

Courts

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

Trump Administration Will Urge Supreme Court to Overturn ACA

On May 6, President Trump announced that his administration would continue to urge the Supreme Court to overturn the Affordable Care Act (ACA), meeting a deadline for the Department of Justice (DOJ) to change its position in the Supreme Court case. The Trump administration will maintain the legal battle against the ACA during the COVID-19 pandemic, despite Attorney General William Barr’s warning against the decision. The DOJ has not yet commented on the announcement.