Private equity’s investment in healthcare has increased rapidly over the past decade, and this is now drawing attention from regulators. Signifying this increased scrutiny is a joint Request for Information (RFI) issued in March by the Department of Justice’s (DOJ) Antitrust Division, Federal Trade Commission (FTC), and Department of Health and Human Services (HHS) seeking … Continue Reading
Last month, the U.S. Supreme Court issued its decision in Health and Hospital Corporation of Marion County v. Talevski, holding that certain provisions of the Federal Nursing Home Reform Act (FNHRA) confer rights that are enforceable by individuals under 42 U.S.C. §1983. The case arises over HHC’s alleged treatment of a resident, Gorgi Talevski. Mr. … Continue Reading
Earlier this year, the U.S. Department of Health and Human Services (“HHS”) announced the expiration of the COVID-19 public health emergency declarations effective May 11, 2023. As a result, many of the regulatory waivers and flexibilities available to health care providers, including the blanket waivers applicable to many Stark Law requirements (the “Stark Waivers”), will … Continue Reading
Since the beginning of the COVID-19 pandemic, policymakers at both the federal and state level have worked to expand the availability of telehealth services. Since telehealth , in many cases, is viewed to provide a convenient, accessible and safe alternative to in-person visits with healthcare providers, it has been considered an effective tool to maintain … Continue Reading
Unlike most other states, Ohio does not currently have a hospital licensure system. While Ohio hospitals are subject to registration and information reporting requirements, as well as licensure requirements for certain discrete hospital services, Ohio does not require hospitals to obtain a state license in order to operate. That may change if certain provisions in … Continue Reading
In follow up to our post last month, on Wednesday, December 2, The Centers for Medicare and Medicaid Services (CMS) published final rules implementing many of the Stark Law changes first proposed in October 2019 (the Final Rules). These changes have been adopted to address the shift to a value-based and coordinated healthcare environment. The … Continue Reading
On Friday, November 20, CMS released final rules implementing many Stark Law changes first proposed in October 2019 (the “Final Rules”). This release comes despite earlier suggestions that these Final Rules may be delayed until sometime in 2021. Developed as part of the Regulatory Sprint to Coordinated Care program, the Final Rules represent CMS’s recognition … Continue Reading
As we reported last October, CMS and the OIG issued proposed rules aimed at updating the Stark Law, Anti-Kickback Statute, and Civil Monetary Penalties Law as part of HHS’ Regulatory Sprint to Coordinated Care. In part, the proposed rules seek to address the current value-based and coordinated healthcare environment. While publication of final rules concerning … Continue Reading
On April 3, the Department of Health and Human Services Office of the Inspector General (HHS OIG) released a policy statement to align its enforcement of the federal Anti-Kickback Statute (AKS) with HHS’s recent Blanket Waivers of Stark (Blanket Waivers) during the COVID-19 pandemic. As previously reported, HHS issued the Blanket Waivers to allow for … Continue Reading
In just the past week, the federal government has issued a flurry of legislative and regulatory aid packages, programs and rule changes for hospitals and health systems responding to the COVID-19 pandemic. These measures are designed to give emergency financial support and to cut through regulatory roadblocks to delivering care during the crisis. The federal … Continue Reading
On March 28, 2020, the Centers for Medicare & Medicaid Services (CMS) announced an expansion of its Accelerated and Advance Payment Program (the Program). The Program is designed to help providers with “significant cash flow problems resulting from…unusual circumstances of the hospital’s operation.” 42 U.S.C. § 1395g (e)(3). Usually deployed during times of natural disasters, … Continue Reading
On March 30, in connection with the national COVID-19 emergency, the Centers for Medicare and Medicaid Services (“CMS”) issued waivers (the “Waivers”) for certain provisions of the federal physician self-referral law, commonly referred to as the “Stark Law.” To ensure there will be sufficient capacity to handle the unique challenges of the COVID-19 pandemic, CMS … Continue Reading
Since the Families First Coronavirus Response Act (FFCRA) became law last week, the US Department of Labor (DOL) has been publishing and updating guidance concerning the public health emergency paid sick leave and emergency Family and Medical Leave Act (FMLA) leave required under the law. See a summary here by Daniel Pasternak in our Employment … Continue Reading
On March 17, 2020, in response to the national COVID-19 public health emergency, divisions of the Department of Health and Human Services (HHS) outlined a series of policy changes regarding telehealth services. In an effort meant to expand the capacity of the healthcare system and protect seniors who are the most vulnerable to COVID-19, the … Continue Reading
In December 2019, a new strain of coronavirus emerged in Wuhan, China. The World Health Organization (‘WHO’) has named this strain COVID-19. WHO declared the outbreak a Public Health Emergency of International Concern on 30 January 2020. The Organization for Economic Cooperation and Development said on 3 March 2020 that while the world economy is … Continue Reading
Ohio recently revised the definition of an Ambulatory Surgical Facility (ASF), as part of the new 2020/2021 general operating budget legislation. The change expanded the ASF definition, potentially triggering ASF licensing requirements for some facilities not previously subject to such requirements. Under the revised definition, an ASF includes (1) all facilities that provide outpatient surgical … Continue Reading
On October 9, the Department of Health and Human Services (HHS) released proposed rules (the Proposed Rules) aiming to update the Anti-Kickback Statute (the AKS), Stark Law and Civil Monetary Penalties Law (CMPL) to address today’s value-based and coordinated healthcare environment. The proposals reflect a recognition on HHS’s part that the healthcare landscape of today … Continue Reading
On February 6, 2019, the Department of Health and Human Services (HHS) published a Proposed Rule modifying the Anti-Kickback Statute safe harbor protection with the aim of lowering prescription pharmaceutical product prices and out-of-pocket costs for (primarily Medicare Part D and Medicaid Managed Care Plan) consumers. With the Proposed Rule, HHS hopes to encourage medication … Continue Reading
On December 27, 2018, the provider community scored a major victory when the U.S. District Court for the District of Columbia held that the Medicare statute did not authorize the Department of Health and Human Services (“HHS”) to impose a nearly 30% reduction in 340B Reimbursement rates. The legal implications of this decision may be … Continue Reading
Along with the Federal Association of the Pharmaceutical Industry (BPI), the American Chamber of Commerce in Germany and the Federal Association of German In-house Lawyers (BUJ), we cordially invite you to attend our Life Sciences Day on 20 September 2018 in Frankfurt. The trend for public and private healthcare systems over the past few years … Continue Reading
Late last month, the Centers for Medicare & Medicaid Services (“CMS”) issued a request for information (“RFI”) seeking input regarding the Medicare physician self-referral law and its implementing regulations (“Stark Law”) and how it may prevent or inhibit care coordination amongst healthcare providers. As part of CMS’s broader “Regulatory Sprint to Coordinated Care” initiative, the … Continue Reading
CMS has recently signaled its intention to review the Stark Law and its impact on providers. During a January, 2018 American Hospital Association webinar, CMS Administrator Seema Verma announced the development of an inter-agency group to review the Stark Law in light of provider complaints that the law acts as a barrier to their ability to … Continue Reading
On November 13, CMS published the final rule revising the Medicare hospital Outpatient Prospective Payment System for 2018. Among a number of changes, the final rule dramatically reduces Medicare Part B payments to hospitals for separately payable drugs purchased through the 340B Program. Currently, Medicare pays hospitals the Average Sales Price (ASP) plus 6% for … Continue Reading
In recent weeks, we’ve highlighted provisions of the House and Senate tax bills that impact tax-exempt bonds. However, the bills contain other provisions which may have a significant impact on tax-exempt organizations, including hospitals and other tax-exempt health care providers. Specifically, provisions in the bills regarding charitable giving, tax-favored financing, governance and compensation, political activity, unrelated … Continue Reading
