Legal Insights and Perspectives for the Healthcare Industry

We invite you to join us on Wednesday, November 20, for our second installment of the Fast Break: Regulatory Sprint series. In a recent Health Law Scan post, we discussed the two proposed rules by the Office of the Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) that seek to alter the landscape of healthcare program integrity and fraud and abuse regulation, as part of what the US Department of Health and Human Services (HHS) calls the “Regulatory Sprint to Coordinated Care Initiative.”

Last month, we held Part 1 of the series, which highlighted CMS’s proposed rule on Stark Law Changes. This month, Katie McDermott, Matthew Hogan, and Jake Harper will discuss the OIG’s proposed rule on the Anti-kickback and beneficiary inducement Civil Money Penalty changes.

Register for the webinar now.

You can also check out a recent Bloomberg Law article the presenters wrote on “OIG Proposed AKS Safe Harbors For Patient Incentives – Getting Patients Involved.”

In Part 2 of a two-part Morgan Lewis series for Bloomberg Law on the proposed Stark Law and anti-kickback statute (AKS) rules, Kathleen McDermott, Matt Hogan, and Jacob Harper examine the safe harbors and exceptions aimed at empowering patients to manage their healthcare. Noting that value-based care can only be achieved when patients no longer sit on the sidelines, the authors ask whether the proposed AKS safe harbors are bold enough, and conclude there may be more that the Office of the Inspector General and the Centers for Medicare & Medicaid Services could do.

Read the full Bloomberg Law article >>

The Office of the Inspector General and the Centers for Medicare and Medicaid Services recently published a pair of proposed rules aimed at encouraging the adoption of value-based payment and care. In Part 1 of a two-part Morgan Lewis series for Bloomberg Law, Al Shay, Donna Clark, and Banee Pachuca unpack the proposed Stark Law exceptions and anti-kickback statute safe harbors that share similarities but differ in design when it comes to protecting physician compensation arrangements that advance value-based care. Potential challenges presented by the proposed rules with respect to obtaining safe harbor protection, encouraging payor participation, and absorbing downside financial risk are also addressed.

In addition, Al and Donna will be joining Jake Harper to talk about the Stark Law changes in more detail during our October 30 Fast Break—make sure to register!

Read the full Bloomberg Law article >>

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 Services (CMS) have issued two proposed rules that seek to alter the landscape of healthcare program integrity and fraud and abuse regulation, as part of what HHS calls the “Regulatory Sprint to Coordinated Care Initiative.”

The HHS Regulatory Sprint identifies four lanes to better coordinate care:

  • Improving a patient’s ability to understand his/her treatment plans and be empowered to make decisions
  • Increasing providers’ alignment on end-to-end treatment
  • Providing incentives for providers to coordinate and collaborate care with their patients
  • Encouraging information sharing among providers, facilities, and other stakeholders in a manner that facilitates efficient care while preserving and protecting patient access to data

In a March 19 letter to CMS and HHS-OIG, Senators Chuck Grassley (R-IA) and Ron Wyden (D-OR) continued their oversight efforts regarding physician-owned distributorship (POD) relationships by raising questions about US Sunshine compliance by PODs. PODs involve the ownership of medical device distributorships by surgeons who use or recommend those products in their surgical procedures. The senators are critical of CMS and OIG efforts to expose and deter POD arrangements, citing long-held concerns that POD arrangements are, as the OIG has suggested in a prior Fraud Bulletin, "inherently suspect” and abusive arrangements that promote medically unnecessary services. The March letter raises an often debated question regarding POD compliance with Physician Sunshine Rules and whether CMS or the OIG have taken sufficient steps to assure transparency compliance with these particular arrangements.

Emerging as an industry disrupter, the Office of Inspector General for the US Department of Health and Human Services (OIG) has waded knee-deep into health policy and economics in proposing dramatic changes to the anti-kickback discount safe harbor protection. Its latest move targets certain industry sectors, proposing to remove their protection from administrative and criminal prosecution in connection with rebates and price reductions for prescription drugs.

Under the proposed rule issued February 6, the OIG proposes to amend the language of the existing discount safe harbor to no longer protect price reductions from prescription drug manufacturers to sponsors, MA plans, or Medicaid managed care organizations (MCOs), or to pharmacy benefit managers (PBMs) under contract with those entities, in connection with the sale or purchase of prescription drugs (unless the price reduction is otherwise required by law). The proposal is elegant and simply excludes from the definition of a “discount” price reductions or other remuneration paid from a drug manufacturer to sponsors and MA plans, Medicaid MCOs, and PBMs. If a price reduction is not a discount, it is not excepted or protected and can be subject to enforcement. No other health industry sector is apparently targeted for this administrative rule change.