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Articles by Robert D. Nauman
HRSA to Test 340B Rebate Model in Pilot Program
On July 31, 2025, the U.S. Department of Health and Human Services Health Resources and Service Administration (HRSA) announced the availability of a new 340B Rebate Model Pilot Program (the Rebate Pilot Program). Under this Rebate Pilot Program, instead of receiving discounts on the purchase price for certain drugs, covered entities will receive a post-purchase rebate reflecting the difference between the higher upfront cost and the drug’s 340B price.
Are you Ready for Washington and Nevada’s Consumer Health Data Laws?
Washington’s My Health My Data Act (“MHMDA”) and Nevada’s SB 370 (“NV CHD Law”) (collectively, “CHD Laws”) went into effect at the end of last month, on March 31, 2024 (as many know, MHMDA’s geofencing prohibition went into effect last summer).
Singapore Updates Data Privacy Rules for Healthcare Sector
Nine years after its initial inception, Singapore’s data protection authority (Commission) published in September 2023 an updated set of advisory guidelines for the healthcare sector (Revised Guidelines).
California Takes Steps Towards a Unified Health Care Financing System
On October 7, 2023, California’s Governor approved Senate Bill (“SB”) 770, which directs the Secretary of the California Health and Human Services Agency (“Secretary”) to take steps towards designing a health care delivery system that provides benefits through a unified health care financing system, such as a single-payer health care system.
Use of Artificial Intelligence in Healthcare Industry in Mainland China
With breakthroughs in artificial intelligence (“AI”), the healthcare industry has experienced rapid development. Since 2016, China has issued a series of relevant policies, including the “Internet+” Artificial Intelligence Three-Year Action and Implementation Plan, Guiding Opinions on Promoting and Regulating the Application and Development of Big Data in Health and Medical Care and the “Healthy China 2030” Blueprint.
Supreme Court Holds Some Provisions of Federal Nursing Home Reform Act are Privately Enforceable under 42 U.S.C. §1983
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.
CMS Blanket Stark Waivers will Terminate Upon End of COVID-19 Emergency
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 terminate on that date.
CMS Blanket Stark Waivers will Terminate Upon End of COVID-19 Emergency
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 terminate on that date.
Individuals that Lose Medicaid Coverage May Enroll in Medicare Part B Nationally and Medicare Supplement Coverage in Some States including Soon in Ohio
Pursuant to federal regulations that took effect on January 1, 2023, individuals who lose Medicaid coverage will be granted a special enrollment right to enroll in Medicare Part B coverage.[1] This special enrollment right was created in part because the COVID health emergency order may soon end, resulting in many people losing Medicaid coverage.
OCR Joins Chorus of Regulators Warning About Health Data Tracking Technology
Key Takeaway: Organizations must conduct a fact-based analysis to determine whether health data collection and tracking technology deployed on their websites and mobile apps complies with the federal Health Insurance Portability and Accountability Act (“HIPAA”) and other applicable laws and guidance.
Court Rejects Vertical Merger Challenge Brought by DOJ
On Monday, September 19, 2022, D.C. District Court Judge Carl J. Nichols rejected the Department of Justice’s (“DOJ”) request to block UnitedHealth’s $13.8 billion acquisition of Change Healthcare. UnitedHealth is the largest health insurer in the United States, while Change Healthcare is a leading data clearinghouse for insurance claims.
Court Rejects Vertical Merger Challenge Brought by DOJ
On Monday, September 19, 2022, D.C. District Court Judge Carl J. Nichols rejected the Department of Justice’s (“DOJ”) request to block UnitedHealth’s $13.8 billion acquisition of Change Healthcare. UnitedHealth is the largest health insurer in the United States, while Change Healthcare is a leading data clearinghouse for insurance claims.
The 2022 Proposed Rule on Section 1557 of the Affordable Care Act Reflects a History of Competing Views on the Definition of Discrimination On the Basis of Sex in Healthcare Programs
On August 4, 2022, the Department of Health and Human Services (“HHS”) issued its proposed rule on Section 1557 of the Affordable Care Act (“ACA”). Section 1557 prohibits discrimination on the basis of race, color, national origin, sex, age or disability in certain health programs or activities, if any part of the program or activity receives Federal financial assistance.
Ohio Amendment HJR 2 And HJR 4 On November Ballot
Ohio voters will have the opportunity to weigh in on two constitutional amendments on the ballot this November. HJR 2 and HJR 4 cleared the Ohio legislature yesterday during marathon sessions as the General Assembly worked to wrap up loose ends prior to disbanding until after the November election. HJR 2, adopted along party lines, requires judges to consider public safety when setting bail. The proposed amendment is in response to a January decision from the Ohio Supreme Court (DuBose v.
Ohio Expands Availability Of Telehealth
United States: Ohio Expands Availability Of Telehealth 04 April 2022 Squire Patton Boggs LLP 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.
Ohio Passes House Bill 122, Expands Telehealth Services
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Ohio Hospitals May Soon Be Subject To License Requirements
United States: Ohio Hospitals May Soon Be Subject To License Requirements 04 June 2021 Squire Patton Boggs LLP To print this article, all you need is to be registered or login on Mondaq.com. Unlike most other states, Ohio does not currently have a hospital licensure system.
Ohio’s New Hospital Licensure Statutes in Current Budget Bill
Monday, May 31, 2021 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 Ohio’s current budget bill are adopted.
CMS Publishes Stark Law Final Rules
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.
CMS Releases Final Rules Implementing Stark Law Changes to Reflect Value-Based Healthcare Delivery and Payment Environment
Legal Disclaimer You are responsible for reading, understanding and agreeing to the National Law Review's (NLR’s) and the National Law Forum LLC's Terms of Use and Privacy Policy before using the National Law Review website. The National Law Review is a free to use, no-log in database of legal and business articles. The content and links on www.NatLawReview.com are intended for general information purposes only.
CMS Releases Final Rules Implementing Stark Law Changes to Reflect Value-Based Healthcare Delivery and Payment Environment
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.
CMS Delays Publication of Final Rule Implementing Stark Law Changes to 2021
Legal Disclaimer You are responsible for reading, understanding and agreeing to the National Law Review's (NLR’s) and the National Law Forum LLC's Terms of Use and Privacy Policy before using the National Law Review website. The National Law Review is a free to use, no-log in database of legal and business articles. The content and links on www.NatLawReview.com are intended for general information purposes only.
CMS Delays Publication of Final Rule Implementing Stark Law Changes to 2021.
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.
HHS OIG says “Ditto” to HHS Blanket Stark Waivers for Purposes of the Anti-Kickback Statute
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 certain arrangements necessary to give hospitals and providers additional flexibility in providing care during the pandemic.
Financial Lifelines, Waivers and Other Support for Hospitals and Healthcare Systems Responding to the Coronavirus Pandemic
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.
Under CARES Act CMS to Expand Advance Payment Program
You are responsible for reading, understanding and agreeing to the National Law Review's (NLR’s) and the National Law Forum LLC's Terms of Use and Privacy Policy before using the National Law Review website. The National Law Review is a free to use, no-log in database of legal and business articles. The content and links on www.NatLawReview.com are intended for general information purposes only.
CMS Expands Accelerated and Advance Payment Program
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).
CMS Issues Blanket Stark Law Waivers in Connection with COVID-19 Emergency
You are responsible for reading, understanding and agreeing to the National Law Review's (NLR’s) and the National Law Forum LLC's Terms of Use and Privacy Policy before using the National Law Review website. The National Law Review is a free to use, no-log in database of legal and business articles. The content and links on www.NatLawReview.com are intended for general information purposes only.
CMS Issues Blanket Stark Law Waivers in Connection with COVID-19 Emergency
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 is permitting certain financial arrangements that would otherwise be prohibited under the Stark Law for entities and physicians...
CMS Issues Blanket Stark Law Waivers in Connection with COVID-19 Emergency
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 is permitting certain financial arrangements that would otherwise be prohibited under the Stark Law for entities and physicians...
US Department of Labor Publishes Further Guidance Concerning Paid Sick Leave and Paid FMLA Leave under FFCRA; Finally Clarifies Small Business Exemption | LexBlog
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 Law Worldview blog.
HHS Expands Coverage for Telehealth in Response to COVID-19
You are responsible for reading, understanding and agreeing to the National Law Review's (NLR’s) and the National Law Forum LLC's Terms of Use and Privacy Policy before using the National Law Review website. The National Law Review is a free to use, no-log in database of legal and business articles. The content and links on www.NatLawReview.com are intended for general information purposes only.
HHS Expands Coverage for Telehealth in Response to COVID-19
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.
Coronavirus Resource Center
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.
Ohio Revises Definition Of Ambulatory Surgical Facilities, Potentially Expanding Application Of Licensure Requirements
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Ohio Revises Definition of Ambulatory Surgical Facilities, Potentially Expanding Application of Licensure Requirements
You are responsible for reading, understanding and agreeing to the National Law Review's (NLR’s) and the National Law Forum LLC's Terms of Use and Privacy Policy before using the National Law Review website. The National Law Review is a free to use, no-log in database of legal and business articles. The content and links on www.NatLawReview.com are intended for general information purposes only.
Ohio Revises Definition of Ambulatory Surgical Facilities, Potentially Expanding Application of Licensure Requirements
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.
CMS “Regulatory Sprint to Coordinate Care” Seeks Input to Lessen the Regulatory Burden of the Stark Law
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.
CMS to Review Stark Law in Connection with Payment Reform
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 improve the quality and efficiency of healthcare.
Bipartisan Budget Act Eliminates Provider-Based Reimbursement for Some HOPDs
Many hospitals may have to reassess their plans to develop new off-campus hospital outpatient departments (HOPDs).
2018 Proposed Changes to the Physician Fee Schedule
On July 21, 2017, the Center for Medicare & Medicaid Services (CMS) published a proposed rule that addresses Part B Medicare payments and policies for calendar year (CY) 2018. The major proposed rule is one of several Medicare payment rules for CY 2018 reflecting a broader strategy to relieve regulatory burdens for providers; support the patient-doctor relationship in healthcare; and promote transparency, flexibility and innovation in the delivery of care.
Ohio Expands Prescriptive Authority for Certain Advanced Practice Registered Nurses
On May 17, the Ohio Board of Nursing (the Board) adopted a new formulary which expands the prescriptive authority for certain of Ohio’s advanced practice registered nurses (APRNs). Specifically, this new “exclusionary” formulary applies to Ohio’s certified nurse practitioners, clinical nurse specialists and certified nurse midwives.
Office of Inspector General Expands Anti-Kickback Statute and Civil Monetary Penalties Protections (Part 2)
As we discussed in a previous post, the Department of Health and Human Services Office of Inspector General (OIG) published a final rule (Final Rule) amending the safe harbors to the Anti-Kickback Statue (AKS) and also amending exceptions to the Civil Monetary Penalties rule (CMP), providing greater protection for certain arrangements with beneficiaries. In this second part of our two-part series, we discuss the Final Rule’s changes to the CMP.
Office of the Inspector General Expands Anti-Kickback Statute and Civil Monetary Penalties Protections
Late last year, the Department of Health and Human Services Office of the Inspector General (OIG) published a final rule (Final Rule) that amends the safe harbors to the federal Anti-Kickback Statute (AKS) by modifying an existing safe harbor, adding new safe harbors and codifying existing statutory provisions that provide further protections from sanctions under the AKS with respect to certain payment practices and business arrangements.
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