CMS Announces New Ambulance Emergency Triage, Treat and Transport Payment Model

On February 14, 2019, the U.S. Department of Health and Human Services (HHS) Center for Medicare and Medicaid Innovation, announced the launch of an innovative payment model with new treatment and transport options to more appropriately and effectively meet Medicare beneficiaries’ emergency needs.   The Emergency Triage, Treat and Transport (ET3) Model is a voluntary, five-year payment model that aims to allow Medicare Fee-For-Service (FFS) beneficiaries to receive the most appropriate level of care at the right time and place. Continue reading

Texas Judge Rules Obamacare (ACA) Invalid

A ruling from the federal district court in the Northern District of Texas, penned by Judge Reed O’Connor, held a part of the Patient Protection and Affordable Care Act (“ACA”) (commonly referred to as Obamacare) unconstitutional, and the remaining parts invalid. Unsurprisingly, this decision has attracted much attention and quickly become one of the most watched cases. Continue reading

DOJ Announces Settlement with Physicians Based on Pre-Signed Blank Prescriptions for Controlled Substances

On August 8, 2018, the U.S. Attorney’s Office for the District of Massachusetts announced that two physicians had agreed to settle allegations of improper dispensing of controlled substances and improper billing. According to this press release, a physician and his addiction treatment clinic, H.K.D. Treatment Options, agreed to pay $23,000 to settle claims of improper billing of medical services under the Controlled Substances Act and the False Claims Act. A physician employed by the pain treatment clinic also agreed to pay a $12,500 civil penalty for issuing invalid prescriptions for controlled substance under the Controlled Substance Act.

The government alleged that under the direction of the physician-owner of the pain management clinic, another physician signed hundreds of blank prescriptions for use by unsupervised non-physician staff while the physician signing the prescriptions was on vacation. The non-physician staff issued over 600 prescriptions for controlled substances using the pre-signed blank prescriptions. The government also alleged that the pain treatment center billed Medicare improperly for services related to the prescriptions that non-physician staff provided in the other physician’s absence and that the physician-owner falsely reported to Medicare that the physician on vacation had supervised the services by the non-physician practitioners. A copy of the press release on the settlement can be found here.

Written by: Clay J. Countryman

Countryman, Clay headshot

Justice Department Files Brief in Texas Lawsuit Supporting Challenge to the Constitutionality of the ACA

Co-authored by Cecilia G. Vazquez, Summer Law Clerk, Breazeale, Sachse & Wilson, L.L.P.

Depending on how a Texas federal court rules in a lawsuit filed February 2018, by 20 state attorneys general (including Louisiana), all or part of the Affordable Care Act (ACA) could be declared unconstitutional. On June 7, 2018, the Justice Department filed a brief in Texas v. the United States (N.D. Texas 2018) (the “Texas lawsuit”) that largely supported the challenge to the constitutionality of the Individual Mandate in the ACA requiring individuals to maintain essential health insurance coverage. Continue reading

CMS Requests Feedback on Regulatory Burden of the Stark Law

The Centers for Medicare & Medicaid Services (“CMS”) is seeking public feedback regarding the regulatory impact and burdens of the Physician Self-Referral Law (commonly known as the “Stark Law”). On Monday, June 25th, CMS published in the Federal Register a Request for Information Regarding the Physician Self-Referral Law (the “RFI”). According to the RFI, CMS has identified some aspects of the Stark Law as a potential barrier to coordinated care and is seeking public comment on the impact and burden of the Stark Law and whether the Stark Law prevents or inhibits care coordination.

CMS plans to issue guidance or revise regulations to address obstacles such as certain portions of the Stark Law, as well as to encourage and incentivize coordinated care. In the RFI, CMS has asked for stakeholders’ comments on the following areas:

  • The structure of arrangements between parties that participate in alternative payment models or other novel financial arrangements;
  • The need for revisions or additions to exceptions to the Stark Law; and
  • Certain terminology used in the context of healthcare delivery, payment reform, and the Stark Law.

In the RFI, CMS asked for public feedback on 20 questions that address the above areas. Some of the areas and questions include:

  1. What existing or potential arrangements involving alternative payment models do you participate in that involve a designated health services entity and referring physician under the Stark Law;
  2. What, if any, additional exceptions to the Stark Law are necessary to protect financial arrangements that involve integrating and coordinating care outside of an alternative payment model;
  3. Whether the current exception at 42 CFR 411.357(n) for risk-sharing arrangements is effective;
  4. Whether the special rule for compensation under a physician incentive plan within the exception for personal services arrangements is useful;
  5. Comments on possible approaches to addressing the application of the Stark Law to financial arrangements with participants in alternative payment models.
  6. How should the CMS define commercial reasonableness in the context of the Stark Law;
  7. Whether the CMS should modify the definition of “fair market value”;
  8. When compensation should be considered to “take into account the volume or value of referrals” by a physician or “take into account business generated” between parties to an arrangement;
  9. Whether barriers exist to qualifying as a “group practice”;
  10. Whether transparency about physician’s financial relationships, price transparency or the availability of other data necessary for informed consumer purchasing could reduce or eliminate the harms to the Medicare program and its beneficiaries that the Stark Law is intended to address; and
  11. What are the compliance costs for regulated entities, such as physician practices and hospitals.

Any comments and feedback to CMS in response to the Request for Information on the Stark Law must be received by CMS by 5:00 p.m. on August 24, 2018. A copy of the CMS RFI is available here.

Written by: Clay Countryman

Countryman, Clay headshot