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Insights on Health Care

1199 total results. Page 21 of 48.

Health Care Counsel Blog
Searching for Safe Harbors? CMS-Sponsored Model Participants Receive Anti-Kickback Statute Protection
January 13, 2021

Enrolling in such a CMS-sponsored innovation model now has an added benefit: a new Anti-Kickback Statute (AKS) safe harbor.

Press Release
Healthcare GPO Response to COVID-19 Pandemic Documented in Accountability Report
January 13, 2021

The Healthcare Group Purchasing Organization sector has played a critical role in assisting health systems respond to supply disruptions during the pandemic.

Investigations Blog
New York Pharmacy Owners Charged in $30 Million COVID-19 Health Care Fraud and Money Laundering Case
January 8, 2021
D. Jacques Smith, Randall A. Brater, Alexander S. Birkhold, Michael F. Dearington, Rebecca W. Foreman, Nadia Patel, Laura Zell

Headlines that Matter for Companies and Executives in Regulated Industries

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Health Care Counsel Blog
Revisions to Stark Law Rules Covering Physician Profit Sharing and Bonuses
January 7, 2021
Jill A. Steinberg

The Centers for Medicare & Medicaid Services (CMS) published a Final Rule in the Federal Register on December 2, 2020, overhauling the regulations governing the federal Physician Self-Referral Law (Stark Law).

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Health Care Counsel Blog
Changes to Stark Law Definitions Impact Innovative Relationships and “Commercially Reasonable” Considerations
January 5, 2021

The Final Rule of the Stark Law revises the definitions of Fair Market Value and includes a definition of General Market Value to better align with actual practices without unduly restricting innovative relationships between physicians and entities providing designated health services.

Health Care Counsel Blog
Second Judge Grants Temporary Injunction Against Favored Nation Rule
December 29, 2020
Stephanie Trunk

On December 28, 2020, Judge Vince Chhabria of the US District Court for the Northern District of California joined Judge Catherine Blake of the US District Court of the District of Maryland in enjoining the application of the Medicare Part B Most Favored Nations Reimbursement Rule.

Health Care Counsel Blog
Early Christmas Presents for Pharmaceutical Manufacturers: Court Grants Temporary Ban on Medicare Part B Most Favored Nations Reimbursement Rule
December 24, 2020
Stephanie Trunk

On December 23, 2020, Judge Catherine Blake of the US District Court for the District of Maryland put in place a 14-day restraining order while she considers whether to issue a preliminary injunction. She plans to consider whether the Centers for Medicare & Medicaid Services rulemaking was adequate

Health Care Counsel Blog
Supreme Court Holds Arkansas Statute Regulating PBMs Not Preempted By ERISA
December 18, 2020
Caroline Turner English, Alison Lima Andersen, Rebecca W. Foreman

States seeking to regulate pharmacy benefit managers (PBMs) and prescription drug pricing received a win from the Supreme Court, which reversed an Eighth Circuit decision that had invalidated an Arkansas law governing pharmacy and PBM conduct on ERISA preemption grounds.

Investigations Blog
First Circuit Upholds Whistleblower Retaliation Verdict
December 18, 2020
D. Jacques Smith, Randall A. Brater, Alexander S. Birkhold, Michael F. Dearington, Rebecca W. Foreman, Nadia Patel, Laura Zell

Headlines that Matter for Companies and Executives in Regulated Industries

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Health Care Counsel Blog
Proposed HIPAA Regulations Would Improve Individual Patient Care and Expand Patient Rights
December 17, 2020
Thomas E. Jeffry, Jr., Michele L. Gipp

Nearly two years after soliciting public suggestions to modify HIPAA rules to improve the coordination of care, the Department of Health and Human Services (DHHS) issued a Proposed Rule.

Investigations Blog
HHS Announces Formation of FCA Working Group
December 11, 2020
D. Jacques Smith, Randall A. Brater, Alexander S. Birkhold, Michael F. Dearington, Rebecca W. Foreman, Nadia Patel, Laura Zell

Headlines that Matter for Companies and Executives in Regulated Industries

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Health Care Counsel Blog
New Stark Law and Anti-Kickback Reforms Aimed at Value-Based Care
December 8, 2020
Anne M. Murphy

OIG and CMS, through a coordinated effort, have issued sweeping and much-anticipated final changes to the Anti-kickback and Stark rules. These changes are generally industry-friendly.

Investigations Blog
HHS Announces Final Rules Amending Stark Law Regulations and Anti-Kickback Statute
December 4, 2020
D. Jacques Smith, Randall A. Brater, Alexander S. Birkhold, Michael F. Dearington, Rebecca W. Foreman, Nadia Patel, Laura Zell

Headlines that Matter for Companies and Executives in Regulated Industries

Events
CTeL Digital Health Virtual Summit
December 3, 2020
Douglas A. Grimm, Hillary M. Stemple

Health Care Practice Co-Leader Douglas Grimm and Law Clerk Hillary Stemple presented at the Center for Telehealth & e-Health Law (CTeL) Digital Health Virtual Summit on December 3.

Health Care Counsel Blog
Drug Manufacturers Take Note: Upcoming Public Meeting in Nevada
November 30, 2020

The Nevada Division of Public and Behavioral Health will hold an open public meeting to discuss proposed amendments to current regulations impacting the State’s drug transparency program. The meeting will take place on December 9, 2020, at 1 pm PST.

Health Care Counsel Blog
Discount Safe Harbor Final Rule Released: OIG Seeks to Adopt Major Changes
November 25, 2020
Stephanie Trunk

Final Rule largely tracks prior proposal to make significant changes to the Discount Safe Harbor and other regulatory safe harbors to the Federal Anti-Kickback Statute.

Health Care Counsel Blog
CMS Releases Interim Final Rule Establishing Reimbursement for Part B Drugs Based on International Pricing
November 24, 2020
Stephanie Trunk

Most Favored Nations Model will alter how certain Medicare Part B drugs are reimbursed.

Health Care Counsel Blog
With the Upcoming Holidays, CMS Reminds Nursing Homes to Follow COVID Guidelines
November 20, 2020
Michele L. Gipp

On November 18, the Centers for Medicare & Medicaid Services (CMS) released an alert urging nursing homes to follow established COVID guidelines for visitation and infection prevention during the upcoming holidays.

Investigations Blog
Seven Individuals Charged in $16 Million COVID-Relief Fraud Scheme
November 20, 2020
D. Jacques Smith, Randall A. Brater, Alexander S. Birkhold, Michael F. Dearington, Rebecca W. Foreman, Nadia Patel, Laura Zell

Headlines that Matter for Companies and Executives in Regulated Industries

Events
Medicare Pricing and Rebate Essentials and Advanced CMS Pricing and Rebate Topics
November 19, 2020
Stephanie Trunk

Health Care Partner Stephanie Trunk will speak at the American Conference Institute’s Proficiency Series on Rx Drug Pricing & Rebate Fundamentals on November 19.

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Health Care Counsel Blog
OIG Issues Fraud Alert: Should Pharma and Device Companies Cease Speaker Programs?
November 18, 2020
Stephanie Trunk

The Department of Health and Human Services Office of the Inspector General (OIG) published a Special Fraud Alert on November 16, 2020 (the Alert) regarding a common practice within the pharmaceutical and medical device industry known as “speaker programs.” 

Health Care Counsel Blog
11th Circuit Upholds Rights of Medicare Advantage ‘Downstream Actors’ to File Suit under the Medicare Secondary Payer Act
November 17, 2020
David S. Greenberg

Calling it a “straightforward inquiry,” the US Court of Appeals for the 11th Circuit recently opted to expand access to the Medicare Secondary Payer Act (the MSP Act) private right of recovery to Medicare Advantage “downstream actors.” 

Investigations Blog
House Committee Chairs Direct White House and Federal Agencies to Preserve Documents during Transition Period to the Biden Administration
November 13, 2020
D. Jacques Smith, Randall A. Brater, Alexander S. Birkhold, Michael F. Dearington, Rebecca W. Foreman, Nadia Patel, Laura Zell

Headlines that Matter for Companies and Executives in Regulated Industries

Health Care Counsel Blog
California Department of Consumer Affairs Continues Issuing Healthcare Professional Licensing Waivers
November 12, 2020

The Department of Consumer Affairs (DCA) continues to issue and extend waivers under Governor Newsom’s March 30, 2020 Executive Order, which authorized the DCA to temporarily modify licensing and staffing requirements for healthcare professionals licensed under the California Business and Profession

Press Release
US News and Best Lawyers Name 24 Arent Fox Practices Among Nation’s Best
November 8, 2020

Twenty-four Arent Fox LLP practices have been recognized in the 2021 “Best Law Firms” rankings that are published annually by US News & World Report and Best Lawyers.

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