Earlier this month, in response to the end of the COVID-19 public health emergency, the Department of Health and Human Services (“HHS”) issued the Eleventh Amendment to the declaration under the Public Readiness and Emergency Preparedness Act (“PREP Act”) for medical countermeasures against COVID-19. The PREP Act allows the Secretary of HHS to provide liability
Health Industry Washington Watch
Updates by Reed Smith on U.S. legislative & regulatory developments affecting the health care industry
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CMS proposes Medicaid changes that are likely to have significant impact on beneficiaries and Medicaid MCO payments
The Centers for Medicare and Medicaid Services (CMS) released a pair of proposed rules on April 27, 2023 that make substantial changes to the structure of Medicaid and the Children’s Health Insurance Program (CHIP), both in the traditional fee-for-service setting and for services provided through managed care organizations (MCOs), and incorporate feedback from stakeholders in…
HHS Proposes Bridge Access Program for COVID-19 Vaccines and Treatments
On April 18, 2023, the U.S. Department of Health and Human Services (“HHS”) announced its plan to maintain access to COVID-19 vaccines and treatment following the end of the Public Health Emergency on May 11, 2023. The “HHS Bridge Access Program for COVID-19 Vaccines and Treatments” is a $1.1 billion public-private partnership between HHS, pharmacy…
MACs Consider Guidance on Remote Patient Monitoring Amid Exploding Utilization
On February 28, 2023, six of the seven Medicare Administrative Contractors (MACs), who administer Medicare reimbursement on behalf of the Centers for Medicare and Medicaid Services (CMS), came together for a multijurisdictional contractor advisory committee (CAC) meeting. The purpose of the CAC meeting was to discuss remote physiologic monitoring (RPM) and remote therapeutic monitoring…
FCA enforcement going strong in 2022, particularly in declined health care qui tams
On February 16, 2023, the Federal Bar Association (FBA) kicked off its sixth annual Qui Tam Conference with its customary “Year in Review” panel, which spotlighted the key False Claims Act (FCA) decisions and developments from 2022. Consistent with the annual press release and FCA recovery statistics issued by the U.S. Department of Justice (DOJ) earlier…
CMS issues guidance for rural emergency hospital eligibility requirements
On January 26, 2023, the Centers for Medicare and Medicaid Services (CMS) issued guidance for Rural Emergency Hospitals (REHs), through which CMS outlined requirements on eligibility, the conversion process for eligible facilities, and other related information. The guidance clarifies the final rule CMS issued in November that established REHs as a new Medicare provider type,…
Administration may end public health emergencies in May 2023
The Biden Administration plans to put an end to the COVID-19 health emergencies on May 11, 2023, according to a Statement of Administration Policy submitted to the Rules Committee of the House of Representatives today.
The statement was presented in opposition to two items that the committee was considering for submission to the full House:…
Telehealth Under Scrutiny: OIG Special Fraud Alert and DOJ Enforcement Highlights Suspect Characteristics Associated with High-Risk Telemedicine Arrangements
The Department of Health and Human Services Office of Inspector General (HHS-OIG) recently published a Special Fraud Alert warning health care providers (e.g., prescribers, pharmacies, durable medical equipment providers, clinical laboratories) to steer clear of certain telemedicine arrangements and outlining seven “suspect” characteristics that may present heightened risk of fraud and abuse.
The alert coincides…
Biden administration announces efforts to combat “Long COVID”
By Megan K. Ali
On April 8, 2022, President Biden issued a memorandum ordering his executive departments to take steps to combat the long term effects of COVID-19.
In particular, the memorandum focused on efforts to address the effects of “Long COVID.” The memorandum noted that “Long COVID” symptoms “can include anxiety and depression, fatigue, shortness of breath, difficulty…
HRSA asks for comment on provider relief fund and ARP rural reporting requirements
In a notice published on April 7, 2022, the Health Resources and Services Administration (HRSA), the division of HHS that manages the distribution and oversight of CARES Act Provider Relief Funds (PRFs), requested comments from stakeholders on proposed changes to its Information Collection Request (ICR) Form that it will be submitting to the Office of…