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This week in Washington: Congress remains in a district work period, while COVID-19 legislative talks continue.
Congress
House
Administration
- FDA Will Hold COVID-19 Vaccine Advisory Committee Meeting Oct. 22
- FDA Authorizes First Diagnostic Test Where Results Can Be Read Directly From Testing Card
- FDA Issues EUA for Use of Convalescent Plasma in COVID-19 Patients
- CMS Pushes Back By a Year Timeline for Finishing Stark Law Reforms
- CMS: Nursing Homes in COVID-19 Hotspots Must Test Staff Twice a Week
- DOJ Seeks Data on Governors’ COVID-19 Nursing Home Policies
Proposed Regulations/Guidance
- FDA Seeks Input on Proposed “Right To Try” Reporting Requirements
- CMS Proposes to Expand Telehealth Benefits Permanently for Medicare Beneficiaries Beyond the COVID-19 Public Health Emergency
- CMS: Calendar Year 2021 Payment and Policy Changes for Home Health Agencies and Calendar Year 2021 Home Infusion Therapy Benefit
Final Regulations/Guidance
Courts
House
E&C Democrats Ask if FDA Chief Hahn is Avoiding Political Pressure From Trump Administration
On Aug. 24, House Energy and Commerce Chair Frank Pallone (D-NJ), Health subcommittee Chair Anna Eshoo (D-CA) and Oversight subcommittee Chair Diana DeGette (D-CO) wrote to Food and Drug Administration (FDA) Chief Stephen Hahn concerned that the Trump administration is putting political pressure on the FDA. The members asked Hahn how he is protecting the FDA’s credibility and wanted to ensure the FDA adheres to rigorous safety and efficacy data standards for any future COVID-19 vaccine authorization or approval.
Find the letter here.
Administration
FDA Will Hold COVID-19 Vaccine Advisory Committee Meeting Oct. 22
On Aug. 27, the Food and Drug Administration (FDA) will hold an advisory committee meeting on Oct. 22, 2020, to discuss general COVID-19 vaccine development and emergency use authorization (EUA) or licensure policies. The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will not discuss any specific application.
FDA Authorizes First Diagnostic Test Where Results Can Be Read Directly From Testing Card
On Aug. 26, the Food and Drug Administration (FDA) issued its first emergency use authorization (EUA) to a COVID-19 antigen test where the results can be read directly from the testing card. The FDA said the test can be made broadly available in point-of-care settings, such as doctors’ offices, emergency rooms and some schools. The test, Abbott Diagnostics’ BinaxNOW COVID-19 Ag Card, will cost $5, and the manufacturer plans to have 50 million tests available per month by the beginning of October. The Department of Health and Human Services (HHS) awarded a $760 million contract to Abbott Diagnostics to produce and deploy 150 million of the BinaxNOW tests.
Find the EUA here.
FDA Issues EUA for Use of Convalescent Plasma in COVID-19 Patients
On Aug. 23, the Food and Drug Administration (FDA) Chief Stephen Hahn announced that the FDA granted emergency use authorization (EUA) to convalescent plasma for use as a COVID-19 therapy. Based on an evaluation of the EUA criteria and the totality of the available scientific evidence, the FDA’s Center for Biologics Evaluation and Research determined that the statutory criteria for issuing an EUA were met.
CMS Pushes Back By a Year Timeline for Finishing Stark Law Reforms
On Aug. 26, the Center for Medicare and Medicaid Services (CMS) delayed by one year its timeframe for finalizing reforms to the physician self-referral rule, but the Department of Health and Human Services (HHS) Office of Inspector General did not mention a similar extension for pending reforms to the anti-kickback statute. While CMS’s rule continues to be reviewed by the Office of Management and Budget (OMB), CMS announced it is continuously working to finalize the physician self-referral changes, even as the new extension says that the complexity of the issue kept CMS from meeting its prior deadline.
CMS: Nursing Homes in COVID-19 Hotspots Must Test Staff Twice a Week
On Aug. 26, the Center for Medicare and Medicaid Services (CMS) issued a memo for nursing homes on how often to test their staff for COVID-19 based on community spread. This memo follows the final interim rule released this week that required nursing homes to immediately test staff or face fines. The memo said that nursing homes in areas with high COVID-19 positivity rates must test staff twice a week. The memo explained that nursing homes should first test staff with symptoms and then test the rest of the staff when there is an outbreak. During an outbreak, testing must be done for all staff, even if they previously tested negative, until no new cases are identified.
DOJ Seeks Data on Governors’ COVID-19 Nursing Home Policies
On Aug. 26, the Department of Justice (DOJ) issued a press release asking Democratic governors of New York, New Jersey, Pennsylvania and Michigan for information on how COVID-19 affected public nursing home residents. The press release mentioned that the DOJ might open investigations under the Civil Rights of Institutionalized Persons Act, arguing that the governors required nursing homes to admit COVID-19 patients to their vulnerable populations, without adequate testing.
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 Proposes to Expand Telehealth Benefits Permanently for Medicare Beneficiaries Beyond the COVID-19 Public Health Emergency
On Aug. 4, the Centers for Medicare and Medicaid Services (CMS) proposed permanently extending the availability of certain telemedicine services after the COVID-19 public health emergency (PHE) ends, giving Medicare beneficiaries access to health care particularly in rural areas where access to health care providers may otherwise be limited. CMS is proposing to permanently allow some telehealth services, including home visits for the evaluation and management of a patient (in the case where the law allows telehealth services in the patient’s home), and certain types of visits for patients with cognitive impairments. CMS is seeking public input on other services to permanently add to the telehealth list.
The billing and coding requirements for Evaluation and Management (E/M) (or office/outpatient visits) make up 20 percent of the spending under the Physician Fee Schedule. Simplified coding and billing requirements for E/M visits will go into effect Jan. 1, 2021. In this rule, CMS is proposing to increase the value of many services that are comparable to or include office/outpatient E/M visits such as maternity care bundles, emergency department visits, end-stage renal disease capitated payment bundles, physical and occupational therapy evaluation services and others.
Find the proposed rule here. Public comments are due by Oct. 5, 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
CMS: Medicare and Medicaid Programs, Clinical Laboratory Improvement Amendments (CLIA), and Patient Protection and Affordable Care Act; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency
On Aug. 25, the Centers for Medicare and Medicaid Services (CMS) released a final interim rule that requires nursing homes to test staff and offer testing to residents for COVID-19. Laboratories and nursing homes using point-of-care testing devices will be required to report diagnostic test results as required by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). The new rules also require hospitals to provide COVID-19 cases and related data to the Department of Health and Human Services (HHS).
Find the final interim rule here. The rule will be published in the Federal Register on Sept. 2, 2020. A public comment period will follow.
Courts
Find a comprehensive look at “Courts and Healthcare Policy in 2020” here.
Supreme Court Expands Oral Argument Time in ACA Case
On Aug. 24, the Supreme Court issued an order expanding the amount of time for oral arguments on Nov. 10, 2020, in its upcoming Affordable Care Act (ACA) case, laying out the time slots in an order issued. The order provides extra time to allow the U.S. Solicitor General and House of Representatives to present their arguments in California v. Texas. The Supreme Court divided the argument as follows: 30 minutes for California, et al.; 10 minutes for the U.S. House of Representatives; 20 minutes for the Solicitor General; and 20 minutes for Texas, et al.
If you have any questions, contact the following individuals atMcGuireWoods Consulting:
Stephanie Kennan, Senior Vice President
Mariam Eatedali, Research Associate
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