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Tick-Tock: CMS Overpayment Refund Final Rule and Practical Implications

The Centers for Medicare & Medicaid Services issued its long-anticipated final rule clarifying the 60-day overpayment refund obligation (the 60-Day Rule) first established in a 2016 regulation for Medicare Part A and B...more

CMS Proposes Additional Revisions to the 60-Day Rule

The Centers for Medicare & Medicaid Services has issued its Calendar Year 2025 Medicare Physician Fee Schedule Proposed Rule, scheduled for publication in the Federal Register on July 31, 2024. In response to industry...more

Medicaid Unwinding: CMS to Withhold Federal Medicaid Funding from Noncompliant States

Since our publication on disenrollments caused by the “unwinding” of Medicaid’s continuous enrollment condition, the Centers for Medicare and Medicaid Services (CMS) issued an interim final rule on December 6, 2023...more

Medicaid Changes Now and Later: What to Expect at the End of the PHE and Beyond

Medicaid enrollment grew significantly during the public health emergency (PHE). States implemented expanded eligibility and enrollment as well as reduced cost sharing and premiums based on Medicaid program regulatory...more

How the End of the PHE Will Impact the Healthcare Industry

The Biden administration announced on January 30, 2023 that the COVID-19 Public Health Emergency (PHE) would officially end on May 11, 2023. The PHE declaration, which first was issued by the Secretary of the US Department of...more

End of the PHE: Preparing for Return to Normal for Stark Law and Anti-Kickback Statute

Concurrent with the termination of the COVID-19 Public Health Emergency, various regulatory flexibilities will also come to an end, including the blanket waivers to the Stark Law and related enforcement discretion under the...more

CMS Proposes Small but Significant Change to 60-Day Overpayment Refund Rule

In a proposed rule issued on December 27, 2022 to make technical changes to the Medicare Advantage Program, the Centers for Medicare and Medicaid Services (CMS) buried in the regulatory arcana a material legal change to the...more

CMS Releases Physician Fee Schedule Proposed Rule, Continuing Emphasis on Equity and Value-Based Care

The Centers for Medicare & Medicaid Services on July 7 released its proposed rule for the Medicare physician fee schedule for Calendar Year 2023. Among other updates, the proposed rule contains significant programmatic...more

HHS Regulatory Sprint Crosses the Finish Line: New Stark and Anti-Kickback Rules Forecast Big Changes for Patients and Value-Based...

Powerfully illustrating the efforts of the US Department of Health and Human Services (HHS) to transform the US healthcare system to a value-based model, the Office of the Inspector General (OIG) and the Centers for Medicare...more

DC Circuit Court: CMS Rule on Drug Pricing Disclosure Exceeds Statutory Authority

In an informative decision for challenging rules that portend government overreach, the US Court of Appeals for the District of Columbia Circuit upholds the invalidation of the Centers for Medicare and Medicare Services’ drug...more

CMS and OIG Offer Additional Details on Blanket Waivers and AKS Policy Statement

The Centers for Medicare & Medicaid Services and the US Department of Health and Human Services Office of Inspector General have provided additional guidance and clarification on the application of Stark Law blanket waivers...more

Stark Law and Anti-Kickback Statute Enforcement: For HHS, It’s Not Business as Usual

The US Department of Health and Human Services recently announced the use of blanket waivers for healthcare providers under the Stark Law, and its Office of Inspector General noted it will exercise enforcement discretion in...more

Retail Pharmacies Are Rising to the COVID-19 Challenge

Aided by ingenuity and growing regulatory flexibility, retail pharmacies across the country are finding ways to serve their customers while reducing face-to-face contact. Protocols may vary by state. ...more

OIG and CMS Coordinate Seismic Change to Fraud and Abuse Laws—What It Means for the Health Industry

Highlighting the US Department of Health and Human Services’ (HHS) efforts to transform the US healthcare system to a value-based model, the Office of the Inspector General (OIG) and the Centers for Medicare and Medicaid...more

Is Stark Law Reform or Repeal in the Offing?

The Centers for Medicare & Medicare Services has issued a request for information seeking public comment on how to address the undue regulatory impact and burden of the physician self-referral law, commonly known as the Stark...more

CMS Publishes Six Proposed Medicare Payment Rules: What It All Means

Key themes emerging from the hundreds of pages of proposed Medicare payment and policy rules impacting hospitals and post-acute providers include encouraging price transparency, promoting exchange of healthcare data, and...more

Hurricane Recovery Client Alert: Regulatory Relief for Healthcare Providers in Disaster Areas

Hurricanes Harvey and Irma have led to the declaration of a public health emergency in various affected areas across the country. As healthcare providers continue to provide essential disaster response operations, CMS and HHS...more

Provider-Based Rule and Stark—Is Joint Compliance Impossible in 2017?

The Centers for Medicare & Medicaid Services (CMS) will be putting hospitals in an untenable position if recent proposed rulemaking is implemented as is. In its proposal for acting on legislation reducing payments to new,...more

The 60-Day Rule Is Final: Assessing Your Organization’s Safeguards

Follow these tips to ensure compliance in the wake of the new 60-Day Rule. On February 12, the CMS finalized the 60-Day Overpayment Report and Refund rule (60-Day Rule) for Medicare Parts A and B. This long-awaited rule...more

CMS Finalizes 60 Day Overpayment Rule

The final rule relaxes the requirements on “identification” and look-back period. The Centers for Medicare & Medicaid Services (CMS) has released its long-awaited final rule related to the reporting and refunding of...more

Stark Law Clarifications Bring Both Benefits and Potential Challenges - Hospital Industry Viewpoint

The new clarifications suggest a more lenient CMS, but providers shouldn’t compromise their compliance standards. Throughout the halls of hospitals’ legal and compliance departments, people have been talking....more

CMS Releases 2016 Physician Fee Schedule

Major changes to Stark law are ahead, including new exceptions for timeshare arrangements and employment of NPPs. The Centers for Medicare & Medicaid Services (CMS) released a proposed rule on July 8 for the 2016...more

Protections to Be Extended for Electronic Health Record Donations

CMS and OIG issue similar proposed rules to modify the electronic health record exception and safe harbor. On April 10, the Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) of...more

Final Sunshine Act Arrives: Now the Hard Part

The Centers for Medicare and Medicaid Services (CMS) issued the final regulations on the U.S. Sunshine Act on February 8, 2013. Transparency Reports and Reporting of Physician Ownership or Investment Interests, 78 Fed. Reg....more

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