Health Industry Washington Watch

Updates by Reed Smith on U.S. legislative & regulatory developments affecting the health care industry

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Debra A. McCurdy

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Latest from Health Industry Washington Watch

Health Industry Washington Watch

Reliance on telehealth ramps up during COVID-19, and may be here to stay

By Kelly Kearney & Andrew Lu

June 25, 2020

As technology has advanced over the years, there has been a corresponding push for virtual visits with health care providers. In fact, many state boards of medicine and other regulatory agencies have sought to amend regulations and guidances to make telehealth a reality for patients across the U.S. However, despite the technical allowance for telehealth, many regulatory, privacy, and financial barriers have stood in the way of allowing telehealth to be the norm — that…

Health Industry Washington Watch

FDA issued guidance on statistical considerations for clinical trials during the COVID-19 public health emergency

By John D. Kendzior & Ryan Pate

June 19, 2020

On June 17, the Food and Drug Administration (FDA) continued its efforts to mitigate COVID-19’s disrupting impact on clinical trials by issuing guidance on statistical considerations for changes to trial conduct (FDA previously relaxed restrictions on protocol modifications). As expected, public health measures designed to control COVID-19’s rapid emergence as a global pandemic—social distancing, travel restrictions, site closures, etc.—have impeded drug and device industry innovation. Many clinical trials have been delayed; others cannot get up…

Health Industry Washington Watch

HHS announces another round of CARES Act funding for Medicaid and CHIP providers as well as Safety Net Hospitals

By Carrie Gorner

June 11, 2020

On June 9, 2020, the U.S. Department of Health and Human Services (HHS) announced additional distributions from the CARES Act Provider Relief Fund to several groups of providers, totaling approximately $25 billion. $15 billion of these funds is targeted towards eligible Medicaid and Children’s Health Insurance Program (CHIP) providers participating in state Medicaid and CHIP programs. Another $10 billion is allocated to “safety net hospitals,” serving more vulnerable individuals and can come as soon as…

Health Industry Washington Watch

CMS announces increased penalties and oversight for states and nursing homes during COVID-19 emergency

By James F. Hennessy & Taylor Grant

June 5, 2020

On June 1, 2020, the Centers for Medicare & Medicaid Services (CMS) unveiled new measures designed to enhance enforcement and oversight of nursing homes and related state survey agencies. CMS announced the new policies concurrently with the release of federal data detailing the incidence of nursing home COVID-19 infections, which was also made available on the agency’s Nursing Home Compare website on June 4, 2020. The new policies include potential civil monetary penalties (CMPs) for…

Health Industry Washington Watch

OIG releases strategic plan for oversight of COVID-19 response

By Vicki Tankle

June 1, 2020

Following the distribution of billions of relief aid to healthcare providers and amidst the guidance issued around reopening of nursing homes throughout the country, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) unveiled a COVID-19 Response Strategic Plan on May 26, 2020 after updating its Workplan a few days earlier. The 2020 OIG Workplan has been updated to account for an audit of the $50 billion in payments to healthcare…

Health Industry Washington Watch

CARES Act Relief Funds: HHS continues rolling updates to FAQs and extends attestation deadline by another 45 days

By Daniel Fundakowski

May 26, 2020

On May 21, 2020, the U.S. Department of Health and Human Services (HHS) issued additional guidance, by again updating its FAQs, for Medicare providers and suppliers (collectively, providers) receiving relief from the Public Health and Social Services Emergency Fund. Of the $175 billion appropriated by Congress, HHS has allocated $50 billion for general distribution to providers impacted by COVID-19, $12 billion for hospitals in COVID-19 high-impact areas, $10 billion for rural providers, and $4.9…

Health Industry Washington Watch

HHS Office of General Counsel advises that the PREP Act preempts state and local requirements that prevent pharmacists from testing for COVID-19

By Megan Engel & Jessica Christensen

May 21, 2020

Earlier this week, the Department of Health and Human Services (HHS) Office of General Counsel issued Advisory Opinion 20-02, which declared that the Public Readiness and Emergency Preparedness Act (PREP Act), combined with the HHS Secretary’s March 10, 2020 declaration, preempts state or local requirements that would prevent pharmacists from ordering or administering COVID-19 tests approved for diagnostic purposes by the Food and Drug Administration (FDA). The Advisory Opinion concluded that the PREP Act makes…

Health Industry Washington Watch

Nursing homes face increased scrutiny by attorneys general during COVID-19

By Divonne Smoyer, Paul Connell & Christine Cogbill Noonan

May 20, 2020

Pennsylvania Attorney General Josh Shapiro announced on May 12, 2020, that his office is investigating several nursing homes in the Commonwealth for neglect of patients and residents: “We will hold nursing facilities and caretakers criminally accountable if they fail to properly provide care to our loved ones … we will not tolerate those who mistreat our seniors and break the law.” Shapiro has also launched a public portal for citizens to email reports of neglect…

Health Industry Washington Watch

CMS Issues Nursing Home Reopening Recommendations for State and Local Officials

By Megan Engel & Jessica Christensen

May 20, 2020

With portions of the country beginning to reopen, on May 18, 2020, the Centers for Medicare & Medicaid Services (CMS) issued its recommendations to state and local officials for best practices regarding the reopening of nursing homes. Because nursing homes have been severely impacted by COVID-19, CMS issued a memorandum to state officials regarding the “level of mitigation needed to prevent the transmission of COVID-19 in nursing homes.” The recommendations cover a phased approach for…

Health Industry Washington Watch

CMS releases additional COVID-19 blanket waivers for health care providers

By Daniel Fundakowski

May 18, 2020

On May 11, 2020, the Centers for Medicare & Medicaid Services (CMS) released a new suite of blanket waivers for hospitals and other health care providers in response to the COVID-19 public health emergency.[1] The blanket waivers have a retroactive effective date of March 1, which extends through the end of the public health emergency declaration and, in CMS’s view, “provide the flexibilities needed to take care of patients during the COVID-19 public health…