Albert Shay at Morgan Lewis

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

7/25/2024 / Centers for Medicare & Medicaid Services (CMS) , Health Care Providers , Medicare , Physician Fee Schedule , Physicians

OIG Approves Consultant’s Provision of Gift Cards to Physician Practices

The US Department of Health and Human Services Office of Inspector General (OIG) published favorable Advisory Opinion No. 23-15 on January 3, which concluded that a consultant’s proposal to provide gift cards to existing...more

1/19/2024 / Anti-Kickback Statute , Client Referrals , Department of Health and Human Services (HHS) , Gift-Cards , Health Care Providers , Medicare , OIG , Physicians

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

12/20/2023 / Centers for Medicare & Medicaid Services (CMS) , Health Care Providers , Interim Final Rules (IFR) , Medicaid

Medicaid’s Unwinding: Significant Disenrollments Will Affect Plans, Providers, and Patients

Estimates show that Medicaid enrollment grew by more than 20 million (approximately 31%) during the public health emergency (PHE) and the top Medicaid managed care organizations (MCOs) experienced a 44.1% increase in managed...more

12/6/2023 / Consolidated Appropriations Act (CAA) , Department of Health and Human Services (HHS) , Families First Coronavirus Response Act (FFCRA) , Medicaid , Public Health Emergency

OIG Approves Net Profit–Based Bonuses for Employed Physicians

The US Department of Health and Human Services Office of Inspector General (OIG) recently released Advisory Opinion No. 23-07, in which OIG approved a proposed arrangement to pay employed physicians bonuses based on net...more

10/27/2023 / Ambulatory Surgery Centers , Anti-Kickback Statute , Health Care Providers , OIG , Physicians

OIG Rejects the Formation and Operation of Surgeon-Owned IONM Businesses

The US Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently evaluated the risks associated with certain intraoperative neuromonitoring (IONM) services arrangements in its release of...more

8/30/2023 / Ambulatory Surgery Centers , Anti-Kickback Statute , Department of Health and Human Services (HHS) , Health Care Providers , Hospitals , OIG

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

5/11/2023 / Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Families First Coronavirus Response Act (FFCRA) , Medicaid , Public Health Emergency , Telehealth

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

5/11/2023 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Life Sciences , Medicare , OCR , Public Health Emergency , Telehealth

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

4/14/2023 / Anti-Kickback Statute , Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Health Care Providers , OIG , Public Health Emergency , Stark Law

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

1/18/2023 / Centers for Medicare & Medicaid Services (CMS) , False Claims Act (FCA) , Health Care Providers , Medicare Advantage , Medicare Part A , Medicare Part B , Prescription Drugs

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

7/12/2022 / Centers for Medicare & Medicaid Services (CMS) , Health Care Providers , Medicare , Medicare Shared Savings Program , Physician Fee Schedule , Physicians , Proposed Rules

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

11/25/2020 / Anti-Kickback Statute , Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Fraud and Abuse , Health Care Providers , Healthcare Fraud , Healthcare Reform , OIG , Rulemaking Process , Safe Harbors , Stark Law , Value-Based Care

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

6/22/2020 / Centers for Medicare & Medicaid Services (CMS) , Disclosure Requirements , Drug Pricing , Medicare , Pharmaceutical Industry , Prescription Drugs , Transparency

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

5/19/2020 / Anti-Kickback Statute , Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Health Care Providers , OIG , Stark Law , Waivers

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

4/16/2020 / Anti-Kickback Statute , Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Health Care Providers , Physicians , Relief Measures , Stark Law , Waivers

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

3/23/2020 / Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Medicaid , Pharmacies , Pharmacist , Pharmacy Benefit Manager (PBM) , Social Distancing

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

10/10/2019 / Anti-Kickback Statute , Centers for Medicare & Medicaid Services (CMS) , Civil Monetary Penalty , Department of Health and Human Services (HHS) , OIG , Stark Law

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

6/29/2018 / Centers for Medicare & Medicaid Services (CMS) , Physicians , Request For Information , Self-Referral , Stark Law

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

5/14/2018 / Centers for Medicare & Medicaid Services (CMS) , Health Care Providers , Hospitals , Inpatient Prospective Payment System (IPPS) , Medicare

Retail Pharmacy: OIG Signals It’s Okay to Reward Again

OIG Advisory Opinion paves the way for expanded retailer reward programs. The US Department of Health and Human Services Office of Inspector General (OIG) issued an advisory opinion on September 7 that provides important...more

10/4/2017 / Civil Monetary Penalty , Department of Health and Human Services (HHS) , OIG , Pharmaceutical Industry , Retailers

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

9/11/2017 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , EMTALA , FEMA , Health Care Providers , Health Insurance Portability and Accountability Act (HIPAA) , Hospitals , Hurricane Harvey , Hurricane Irma

Preparing for an ACA Rollback: How to Get Paid for Treating the Uninsured - Hospital Industry Viewpoint

Given that Republicans will soon control both Congress and the White House, hospitals may be concerned that expenditures that have helped reduce the ranks of the uninsured will be ratcheted down. However, forward-thinking...more

11/10/2016 / ACOs , Affordable Care Act , CMMI , Healthcare , Hospitals , Life Sciences , Medicaid Expansion , Trump Administration

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

8/9/2016 / Alternative Fee Arrangements , Bipartisan Budget Act , Centers for Medicare & Medicaid Services (CMS) , Fair Market Value , False Claims Act (FCA) , Hospitals , Off-Campus Departments , Physician Fee Schedule , Physicians , Stark Law

Senate Finance Committee Examines Repeal of the Stark Law

A new report suggests that the Stark law is obsolete in new payment models. On June 30, the US Senate Committee on Finance (the Committee) released the report Why Stark, Why Now? Suggestions to Improve the Stark Law to...more

7/7/2016 / Affordable Care Act , AHLA , Alternative Payment Models (APM) , Anti-Kickback Statute , Civil Monetary Penalty , False Claims Act (FCA) , Fraud Abuse and Waste , Health Care Providers , Legislative Agendas , Medicare , Medicare Access and CHIP Reauthorization (MACRA) , Physicians , Repeal , Stark Law

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

2/17/2016 / 60-Day Rule , Centers for Medicare & Medicaid Services (CMS) , Final Rules , Medicare Part A , Medicare Part B , Overpayment , Social Security Act

Albert Shay

Morgan Lewis

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