Regulatory sprint to coordinated care: New Stark and Anti-Kickback rules
Michael A. Cassidy, Esq.

On Oct. 22, 2019, the Centers for Medicare & Medicaid Services (CMS) and OIG (Office of Inspector General) released new proposed rules regarding Stark Law Exceptions and Anti-Kickback Safe Harbors in response to what has universally been christened as the “Regulatory Sprint to Coordinated Care,” first announced by the U.S. Department of Health and Human Services (HHS) in June 2018.
As background, please remember that, although the Anti-Kickback Safe Harbors and the Stark Law Exceptions are confusingly similar with respect to their intended purpose, they serve the following different functions:
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As suspicion – or acknowledgement – that many cases of opioid use disorder (OUD) were iatrogenic and the opioid crisis grew, both federal and state governmental health agencies sought to develop and issue guidance for physicians. Having been fed misinformation by pharmaceutical companies for years, physicians needed evidence-based guidelines to appropriately treat their non-cancer chronic pain patients. The Centers for Disease Control and Prevention (CDC) responded definitively by issuing guidelines after seeking input from experts and stakeholders and combing through the evidence and responses. In addition, legislatures put strict limitations on prescribing in certain situations. It is clear that compliance with opioid prescribing legislation is mandatory, but what about compliance with guidelines?

“History does not repeat itself, but it rhymes,” according to a popular proverb misattributed to Mark Twain. Healthcare trends tend to be cyclical, and the 1990s trend of publicly traded physician practice management (PPM) companies infusing investor capital into medical practices has returned from oblivion in the form of private equity (PE) transactions. Like the ill-fated PPMs, PE deals offer physicians cash up front and ownership in management companies that are designed to be sold in the future at a profit, and like PPMs, PE deals claim to be in a position to consolidate physician groups to achieve greater profitability. The results may not be in for a few years, but PE firms hope to avoid falling prey to the mistakes which led to the meteoric rise and fall of the PPM industry.

On July 29, 2019, the Centers for Medicare and Medicaid Services (CMS) issued the proposed Medicare Physician Fee Schedule (PFS) changes for the 2020 calendar year. 

A. Payment for evaluation and management (E/M) services

The E/M proposals will probably be the most complicated and will impact the most physicians. I will outline them here and then present a later Bulletin article dedicated specifically to E/M Services.

• The CPT coding changes retain five levels of coding for established outpatient, but reduce the number of levels to four levels of E/M visits for new patients.
• The code definitions are revised, as well as the times and medical decision-making process for all codes.

Scenario #1. Your nurse is teaching an incontinent male patient to self-catheterize. His wife wants to record the encounter on her cell phone to “help” her husband perform the task in the future. The male nurse does not want to be recorded; he is concerned with his own privacy. Moreover, he is not sure that the patient actually wants his wife to film this. The wife is adamant that filming is necessary. The practice has plenty of other resources to assist the patient in completing this self-care task.

Scenario #2. You operate an OB/GYN practice. In your waiting room, a 12-year-old girl, whose mother is a patient of the practice, covertly snaps a photo of a 13-year-old patient when she is called back to the treatment area.

The legal landscape for non-compete restrictions has been undergoing change. Legislatures and courts have been taking a renewed look at these restrictions, and in some cases aggressively limiting the type and scope of non-competes including those for physicians. While limitations are springing up, non-competes continue to be valid in most states. As a result, physicians must still be mindful and strategic when entering into contracts containing non-compete clauses. 

What is a non-compete?

Non-competes are a type of contract provision known as a restrictive covenant which can apply during employment and after employment ends.¹ Non-competes are designed to restrict physicians from competing by precluding them from working for a competitor, or setting up a competing medical practice, usually for a specified time period after employment ends within a designated geographic area.

A Federal law enacted nearly six decades ago to combat interstate organized crime has become the latest weapon in the government’s arsenal against healthcare fraud. The Travel Act, signed by President John F. Kennedy in 1961, prohibits interstate or foreign travel, or use of the mails or any facility in interstate or foreign commerce, for the purpose of distributing the proceeds of an unlawful activity, committing a crime of violence in furtherance of an unlawful activity, or to promote, manage, establish, or carry on an unlawful activity. It makes travel or the use of the mails or other interstate facilities in furtherance of a state or federal crime a separate federal offense.