Monitoring the Pulse of Health Care and Life Sciences
This post is co-authored by Seth Orkand, co-chair of Robinson+Cole’s Government Enforcement and White-Collar Defense Team.
On June 1, 2023, the U.S. Supreme Court issued a unanimous opinion in the highest-profile False Claims Act (FCA) case for many years, concluding that a party’s subjective belief as to whether it overcharged Medicare and Medicaid…
On May 9, 2023, the Drug Enforcement Administration (DEA) issued a temporary rule that extends pandemic-era flexibilities allowing prescribing of controlled substances based on a telehealth relationship, after receiving in excess of 38,000 comments on its March 1, 2023 proposed rules (previously discussed here) to extend certain of those flexibilities but allow others to end upon expiration of the COVID-19 public health emergency on May 11, 2023. The Temporary Rule provides the DEA with additional time to assess feedback on its proposed rules for post-pandemic tele-prescribing, and provides practitioners and patients with additional time to utilize pandemic-era flexibilities and to transition away from such flexibilities once final rules are issued.Continue Reading DEA Extends Pandemic Telehealth Prescribing Flexibilities For Up To 18 Months
On April 12, 2023, the U.S. Department of Health & Human Services (HHS) released a Notice of Proposed Rulemaking (Proposed Rule) that seeks to enhance safeguards of reproductive health care information through changes to the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. The proposal is intended to align with President Biden’s Executive Order…
On December 27, 2022, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule (Proposed Rule) which proposes certain policy and technical changes to Medicare regulations, including a notable change to the current standard under the “60-Day Rule” for identifying a Medicare overpayment. Specifically, CMS indicated that it is proposing to (i) “adopt by reference” the federal False Claims Act’s (FCA) definitions of “knowing” and “knowingly” as governing when an overpayment is identified, and (ii) eliminate the “reasonable diligence” standard that has been in place, but subject to challenges, for a number of years.Continue Reading No More Reasonable Diligence? CMS Proposes to Change Standard for Identifying Medicare Overpayments to Align with False Claims Act
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.Continue Reading FTC Takes Action to Block Hospital Transactions in Utah and New Jersey
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.Continue Reading Connecticut Enacts Legislation Making Various Changes to Public Health Laws
Effective February 3, 2022, the Massachusetts Board of Registration in Medicine (BoRM), which oversees physician licensure and the practice of medicine, updated its “Policy on Telemedicine in the Commonwealth” (Policy) to provide more guidance for licensed physicians on utilization of telemedicine in practice. BoRM initially issued this Policy in 2020 in connection with the onset of COVID-19 and the significant corresponding expansion of telemedicine and other telehealth care delivery models for patients and providers.
Continue Reading Massachusetts Updates State Telemedicine Guidance for Physicians
On February 28, 2022, the Office of the National Coordinator for Health Information Technology (ONC) issued data on information blocking claims received since April 5, 2021, the effective date of information blocking regulations enacted under the 21st Century Cures Act (Cures Act). As a reminder, in accordance with the Cures Act’s prohibition on certain information blocking practices, in 2020 ONC issued a pair of rules (available here and here) to implement information blocking regulations (now found at 45 CFR Part 171). Due to COVID-related delays, ONC ultimately set a compliance date for such regulations of April 5, 2021. ONC is now sharing preliminary data on the information blocking claims received for the first time.
Continue Reading ONC Information Blocking Data Show Majority of Claims Against Health Care Providers
On November 12, 2021, the Centers for Medicare & Medicaid Services (CMS) issued finalized guidance (“Guidance”) clarifying that hospitals can share space, services, or personnel with another hospital or health care provider so long as they demonstrate independent compliance with the Medicare Conditions of Participation (CoPs). This Guidance, which finalizes the prior draft guidance issued on May 3, 2019, explains how CMS and state agency surveyors will evaluate a hospital’s space sharing or contracted staff arrangements when assessing the hospital’s compliance with the Medicare CoPs. The Guidance took effect immediately upon publication on November 12, 2021.
As relayed by CMS, hospitals have increasingly co-located with other hospitals or other healthcare entities as they seek efficiencies and develop different delivery systems of care. Co-location occurs when two Medicare certified hospitals or a Medicare certified hospital and another healthcare entity are located on the same campus or in the same building and share space, staff, or services.
Continue Reading CMS Finalizes Guidance on Hospital Co-Location
To ensure the continued availability of health care workers, on November 12, 2021, the Massachusetts Department of Public Health (DPH) issued Order 2021-13 (COVID-19 Public Health Emergency Order No. 2021-13), extending licensure reciprocity for certain out-of-state providers to provide services (in person or via telemedicine) to patients in Massachusetts. Order 2021-13 extends prior DPH orders which authorized issuance of temporary licenses for certain health care providers and renewal or reactivation of certain temporary licenses.
Continue Reading Massachusetts DPH Issues Two Orders To Ensure Continued Availability of Health Care Provider Workforce
