We follow up on our previous blog post concerning the U.S. Supreme Court’s unanimous ruling in favor of 340B hospitals. The Supreme Court previously held that “absent a survey of hospitals’ acquisition costs, HHS may not vary the reimbursement rates for 340B hospitals” and therefore, that HHS exceeded its statutory authority by varying the 2018 and 2019 rates for 340B hospitals without first conducting such survey.
Hospitals
Supreme Court Decides in Favor of 340B Hospitals Regarding Medicare Reimbursement Methodology
On June 15, 2022, the U.S. Supreme Court unanimously ruled in favor of “340B” hospitals in a notable statutory interpretation case concerning how the federal Medicare program reimburses hospitals for prescription drugs. The case, which was brought by the American Hospital Association, arises from reimbursement reductions imposed by the Department of Health and Human Services (HHS) in 2018 and 2019 on hospitals participating in the 340B program (which the Court noted are hospitals that “generally serve low-income or rural communities”). In those years, HHS sought to impose reductions in reimbursement due to favorable pricing available to 340B hospitals under that program. The hospitals challenged those reductions based on the process HHS followed when setting the reimbursement rates, claiming that HHS’s failure to conduct a survey of hospitals’ average acquisition costs for the drugs prevented HHS from varying reimbursement rates for this distinct group. Therefore, according to the hospitals, HHS was required to pay them based on the average sales price charged by manufacturers for the drugs.…
FTC Takes Action to Block Hospital Transactions in Utah and New Jersey
On June 2, 2022, the Federal Trade Commission announced a pair of antitrust enforcement actions to block pending health system transactions that, according to it, would harm competition in the provision of inpatient general acute care hospital services.…
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Connecticut Enacts Legislation Making Various Changes to Public Health Laws
Connecticut Governor Ned Lamont recently signed into law Public Act No. 22-58, “An Act Concerning the Department of Public Health’s Recommendations Regarding Various Revisions to the Public Health Statutes” (the Act). The Act is an omnibus bill that includes a number of notable updates to state laws concerning health care and hospitals, certain of which are summarized below.…
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NOTICE TO PROVIDERS: CMS Phasing Out Certain COVID-19 Regulatory Waivers in Long-Term Care Facilities, Hospices, and ESRD Facilities
Certain COVID-19 emergency declaration blanket waivers are being phased out by the federal government, and health care providers should take steps to determine whether current arrangements are compliant. As background, in response to the COVID-19 public health emergency CMS previously enacted extensive temporary COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers. However, the Centers for Medicare and Medicaid Services (CMS) have now determined that various regulatory requirements must be restored in order to protect the health and safety of residents in long-term care facilities.…
CMS Issues Memorandum Stating It Will Not Enforce Its COVID-19 Vaccine Mandate While There are Court-Ordered Injunctions in Place
By Conor Duffy, Michael Lisitano & Robinson+Cole's Health Law Group on
On December 2, 2021, the Centers for Medicare and Medicaid Services (CMS) issued a memorandum to state survey agencies indicating that it will not enforce its Interim Final Rule (the “Rule”) regarding health care worker vaccinations while there are court-ordered injunctions against the Rule in place.
Continue Reading CMS Issues Memorandum Stating It Will Not Enforce Its COVID-19 Vaccine Mandate While There are Court-Ordered Injunctions in Place
CMS Issues Emergency Regulation Requiring COVID-19 Vaccination for Health Care Facility Workers
By Conor Duffy, Michael Lisitano & Robinson+Cole's Health Law Group on
Posted in Academic Medical Centers, Accountable Care Organizations, Ambulatory Surgical Centers (ASC), Americans With Disabilities, COVID-19, Home Health Agencies, Hospice, Hospitals and Health Systems, Long Term Care and Nursing Homes, Medicare and Medicaid, Physicians and Allied Health Professionals
On November 4, 2021, the Centers for Medicare & Medicaid Services (CMS) issued heavily anticipated emergency regulations requiring COVID-19 vaccination of eligible staff at health care facilities that participate in the Medicare and Medicaid programs. CMS issued an Interim Final Rule (IFR) in response to the COVID-19 “Path out of the Pandemic” Action Plan announced by President Biden on September 9, 2021, that per CMS is intended to protect the health and safety of residents, patients and staff at health care facilities. See our previous analysis of the Plan here.
Below please find key takeaways regarding the new COVID-19 vaccination requirements for health care facilities and staff:…
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New Legislation Updates Laws Related to Hospital Admission and Discharge Practices
By Michael Lisitano, Conor Duffy & Guest Contributor on
On June 7, 2021, Connecticut Governor Ned Lamont signed into law Public Act 21-26 “An Act Concerning Various Revisions to the Public Health Statutes” (the “Act”). This Act makes notable changes to laws affecting hospital and health system practices, including the following:
Hospitals Required to Give Patients Option to Contact Family or other …
Warning to Hospitals of Imminent Threat Released by U.S. Government
By Linn Foster Freedman on
Posted in Privacy and Security
On October 27, 2020, the FBI and the Department of Homeland Security (DHS) warned the health care industry about “an imminent cybercrime threat to U.S. hospitals and healthcare providers.”
According to the warning, which was shared during a conference call, the government has received “credible information of an increased and imminent cybercrime threat to U.S. hospitals and healthcare providers.” The information was being shared with participants so that they can take timely precautions to protect their networks from the threat.
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New York State Department of Health Publishes Emergency Rule to Clarify Authority to Prevent Spread of Communicable Disease
By Robinson+Cole's Health Law Group on
On June 24, 2020 the New York State Department of Health (DOH) published formal notice of its June 5th emergency rule “necessary to clarify and strengthen the Department’s authority and that of the local health departments to take specific actions to control the spread of disease, including actions related to investigation and response to…