Author: Alissa Smith

Alissa represents health systems, hospitals, pharmacies, long-term care providers, home health agencies and medical practices, as well as nonprofit and municipal organizations. Alissa’s transactional practice includes contracts, leases, mergers, acquisitions and joint ventures. Alissa’s regulatory practice includes the interpretation and application of state and federal fraud and abuse laws, Medicare and Medicaid rules, tax-exemption laws, HIPAA and privacy laws, EMTALA laws, licensing matters, employment laws, governmental audits and open records and open meetings matters. She also assists with corporate and health system governance issues, including the revision and negotiation of medical staff bylaws.

Naughty or Nice: Feds Hand Out More Than Lumps of Coal When it Comes to Healthcare Fraud

The United States government has an arsenal of agencies and civil and criminal statutes at its disposal to choose from in investigating and combating healthcare fraud.  A recent federal indictment discussed below exemplifies just how multifaceted government investigations and prosecutions can be.  And organizations need to be prepared to respond to such investigations. Last week,...

CMS Finalizes Changes to the Stark Advisory Opinion Regulations; 2020 DHS Code List and CPI-U Updates

In the calendar year 2020 Medicare physician fee schedule final rule (“PFS”), which was published in the Federal Register on November 15, 2019 (available here), CMS finalized changes to the advisory opinion process under the federal physician self-referral law (“Stark Law” or “Stark”).  CMS also published its annual update to CPT/HCPCS codes used to identify...

Settlement Reached in the First Federal Opioids Trial

This post is an update from our earlier blog post, available here, on the bellwether federal opioids trial in the Northern District of Ohio.  Just hours prior to the start of the trial in a consolidated case involving two plaintiff counties in Ohio, all of the remaining defendants in the case, except Walgreens, reached a...

A Massive Number of New Health Law Regulatory Proposals as Part of the “Regulatory Sprint to Coordinated Care”: Proposed Changes to the Stark Law, Anti-Kickback Statute, Beneficiary Inducement CMP, Privacy Laws Governing Substance Use Disorder Records, and the Stark Law Advisory Opinion Process

Today, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) Office of Inspector General (OIG) each released their long-anticipated proposed rules to revise the federal self-referral law (or “Stark Law”) regulations, the safe harbors under the federal anti-kickback statute (AKS), and the civil monetary penalty law (CMP)...

Proposed Drug Rebate and PBM Service Fee Regulations Abandoned by Administration

As reported here in February, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released two new significant proposed regulations that would have had a transformative effect on the drug discount and rebate arrangements that are commonplace between pharmaceutical manufacturers and Medicare Part D Plans and Medicaid Managed Care Organizations (and...

The Eliminating Kickbacks in Recovery Act of 2018 (EKRA): A New Federal Kickback Law Applicable to All Payors

The Eliminating Kickbacks in Recovery Act of 2018 (EKRA) became law on October 24, 2018, and is codified at 18 U.S.C. § 220.  As part of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, EKRA was enacted in response to a concern that the federal Anti-Kickback Statute...

Court Invalidates Final Rule Requiring Advertisements to List Drug Prices Finding that CMS Exceeded Its Statutory Authority

In a much anticipated decision, a federal judge ruled this week that the Trump Administration’s rule requiring drug manufacturers to list drug prices in television advertisements exceeds the agency’s authority. Back in May 2018, the Trump administration spoke on drug pricing and published its “Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs”. One of...

At Long Last, CMS Issues Proposed Guidance on Hospital Co-Locations

For years, CMS has informally applied restrictions for hospitals which share space, equipment, staff or services in the same physical location (i.e., “co-locate”) with other hospitals or health care entities.  Although these sub-regulatory interpretations by CMS were not formal guidance, the penalties were so severe that many hospitals unwound the co-location or shared services arrangements...

CMS’s New “Primary Cares Initiative” Places Primary Care at the Center of the Shift to Value-Based Care

On April 22, 2019, the Centers for Medicare and Medicaid Services (CMS) announced two sweeping new payment innovation models under the Primary Cares Initiatives. The models will seek to incentivize primary care and other providers to take on greater responsibility and risk for the lives of covered beneficiaries. Both new models are scheduled to be...

Federal Government’s Charges against 60 Medical Personnel for Illegal Prescribing and Distributing of Opioids Demonstrates Continued Focus on Compliance throughout Supply-Chain

Today, the Federal Government announced enforcement actions against 60 defendants in eleven federal districts, including 31 doctors, seven pharmacists, eight nurse practitioners, and seven other licensed medical professional for allegedly prescribing and distribution opioids and other dangerous narcotics and for health care fraud schemes. (DOJ Press Release, April 17, 2019). The charges involve over 350,000...