Klobuchar, Grassley Push Implementation of Rural Emergency Hospital Designation

Sens. Amy Klobuchar (D-Minn.) and Charles Grassley (R-Iowa) are urging the Centers for Medicare and Medicaid Services (CMS) to prioritize implementation of the new Rural Emergency Hospital designation to prevent more hospital closures. This provision, which was sponsored by Sen. Grassley and included in the coronavirus stimulus package passed late last year, would provide increased funding to small rural hospitals that decide to close their in-patient operations and revamp as standalone emergency rooms that offer some outpatient services. Hospitals in rural areas with fewer than 50 beds can apply for the designation, which goes into effect in 2023. “If nothing is done, more hospitals and rural Americans will continue losing access to essential medical services resulting in poorer outcomes and higher costs for patients and taxpayers,” their letter states.

House of Representatives Changes Rules on Masks

New guidance from the House Attending Physician will permit fully vaccinated House lawmakers, staff, and visitors to move about the Capitol, including committee rooms and the floor, without masks or face coverings. Masks are still required for those who are unvaccinated or not fully vaccinated. The Capitol Hill complex currently has a vaccination rate of 85%.

States Move to Make COVID Scope of Practice Changes Permanent

States across the nation are considering permanent, legislative changes to their scope of practice laws that were loosened during the COVID-19 pandemic to allow nurse practitioners and physician assistants to operate independently. Over the last year, 21 states expanded scope of practice for these providers. Four states – Arkansas, Utah, Virginia, and West Virginia – have enacted eight laws making such expansions permanent. The Michigan House also passed legislation that would allow nurse anesthetists to practice without physician supervision; the bill is awaiting action in the state Senate.

Warren Requests Details about Potential Future Vaccine Price Hikes

Sen. Elizabeth Warren (D-Mass.) has sent a letter to Pfizer CEO Albert Bourla questioning the company about possible future price increases for its COVID-19 vaccine. Warren cites comments made by the company’s CFO during an earnings call in February during which investors were told that Pfizer was “obviously...going to get more on price” for its COVID-19 vaccine. She requests information on how Pfizer will determine its pricing for the vaccine moving forward. The letter was also signed by Sen. Chris Murphy (D-Conn.) and Reps. Katie Porter (D-Calif.) and Mark Pocan (D-Wis.).

CMS Increases Payment for At-Home COVID Vaccination

The Centers for Medicare and Medicaid Services (CMS) announced that Medicare will pay an additional $35 per dose for COVID-19 vaccine administration in a beneficiary’s home. The move aims to increase access to vaccinations for those who have difficulty leaving their homes or accessing vaccines in a community setting – a population CMS estimates at approximately 1.6 million adults age 65 or older. The additional payment increases the cost per vaccine dose from $40 to $75 to account for the unique challenges of vaccinating hard-to-reach individuals, the clinical time needed to monitor the patient after the vaccine is administered, and the upfront costs of administering the vaccine in a beneficiary’s home. The in-home payment amount will be geographically adjusted based on where the service is furnished.

In related news, U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra has sent a letter to insurers and providers following reports of Americans facing costs associated with COVID-19 vaccines and testing. The Secretary underscores that these services must be free for patients, reminding “health care providers of their signed agreements to cover the administration of COVID-19 vaccines free-of-charge to patients, and group health plans and health insurers of their legal requirement to provide coverage of COVID-19 vaccinations and diagnostic testing without patients shouldering any cost.” COVID-19 vaccines and their administration are free to anyone living in the U.S., per the Centers for Disease Control and Prevention’s (CDC) COVID-19 Vaccination Program Provider Agreement. Group health plans and health insurers are also required to cover COVID-19 diagnostic testing without cost-sharing. Secretary Becerra notes that failure to comply with these legal requirements should be reported to CMS or the Department of Labor.

OSHA Releases Emergency Temporary Standard for Health Care Employers

The Occupational Safety and Health Administration (OSHA) has released a long-awaited emergency rule outlining workplace safety standards for the health care services and support industry for the duration of the coronavirus pandemic. The emergency temporary standard (ETS) details what health care employers must do to protect their workers from COVID-19. The rule requires social distancing protocols, proper patient screening, paid time off for vaccination, and encouraging employees to get the vaccine. Workplaces where all workers are fully vaccinated and where people who may have COVID-19 are barred are carved out of the regulation. The ETS will take effect on the date that it is published in the Federal Register, which remains unknown. Once the ETS is in effect, employers must comply with most provisions within 14 days and with the remaining provisions within 30 days. To help employers assess whether the ETS is applicable to their worksites, OSHA has provided a flowchart, available here. OSHA also issued voluntary guidelines providing information to employers outside of the health care space about how they can protect their unvaccinated employees and mitigate and prevent the spread of COVID-19 in the workplace.

FDA Rules on Emergent J&J Vaccine Doses

The Food and Drug Administration (FDA) has instructed Johnson & Johnson to discard 60 million doses of its COVID-19 vaccine made in Emergent BioSolutions’ Baltimore plant that are “not suitable for use,” while releasing two other batches of the vaccine totaling around 10 million doses. The agency had previously ordered Emergent to stop producing coronavirus vaccines after the company contaminated 15 million doses of J&J’s vaccine with the active ingredient from AstraZeneca’s vaccine. The FDA has not yet cleared the Emergent plant to resume making the vaccines.

Hart Health Strategies COVID-19 Resources

Hart Health Strategies Inc. continues to update the following resources related to the coronavirus pandemic. Please remember to clear your cache to ensure you download the most recent documents.

Upcoming Congressional Hearings and Markups

Senate Committee on Finance hearing “Mental Health Care in America: Addressing Root Causes and Identifying Policy Solutions;” 10:00 a.m.; June 15

Senate Judiciary Committee hearing “H.R. 6, American Dream and Promise Act of 2021;” 10:00 a.m.; June 15

House Energy and Commerce Subcommittee on Health legislative hearing “Booster Shot: Enhancing Public Health through Vaccine Legislation;” 10:30 a.m.; June 15

House Homeland Security Committee hearing “Cyber Threats in the Pipeline: Lessons from the Federal Response to the Colonial Pipeline Ransomware Attack;” 2:30 p.m.; June 15

House Committee on Education and Labor hearing “Examining the Policies and Priorities of the U.S. Department of Health and Human Services;” witness: Secretary Becerra; 9:00 a.m.; June 16

Senate Homeland Security & Governmental Affairs business meeting to consider the nominations of Jen Easterly to be Director of Cybersecurity and Infrastructure Security Agency (CISA) and Chris Inglis to be National Cyber Director; 9:30 a.m.; June 16

Senate Committee on Health, Education, Labor, and Pensions business meeting to consider the nominations of Dawn Myers O’Connell, of the District of Columbia, to be Assistant Secretary for Preparedness and Response, and Miriam E. Delphin-Rittmon, of Connecticut, to be Assistant Secretary for Mental Health and Substance Use, both of the Department of Health and Human Services; 12:00 p.m.; June 16

Senate Judiciary Subcommittee on The Constitution hearing “Women’s Health Protection Act;” 2:30 p.m.; June 16

House Homeland Security Committee hearing “A Review of the Fiscal Year 2022 Budget Request for the Department of Homeland Security;” 8:30 a.m.; June 17

Senate Aging Committee hearing “21st Century Caregiving: Supporting Workers, Family Caregivers, Seniors and People with Disabilities;” 9:30 a.m.; June 17

Senate Homeland Security & Governmental Affairs Subcommittee on Emerging Threats & Spending Oversight hearing “Addressing Emerging Cybersecurity Threats to State and Local Government;” 10:15 a.m.; June 17

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