Too Many Regulatory Silos in Patient Care, Says HHS Deputy Secretary

Published February 10, 2020

     On The Heartland Daily Podcast, Hargan discussed his signature project, “Regulatory Sprint to Coordinated Care,” and how it can open the door for more effective care arrangements between health care providers or between providers and patients.

   The initiative is looking closely at four different areas:  the physician self-referral law known as the Stark Law, the anti-kickback statute, privacy protections in the area of substance abuse disorder, known as 42CFR Part 2, and the Health Insurance Portability and Accounting Act (HIPAA).

  “We have a decentralized health care system in the U.S which allows for a lot of achievement, creativity and innovation,” said Hargan. “but it prohibits the coordination of care.” 

Not the Law but the Interpretation

Hargan gave several examples of how well-meaning regulations to protect patients have, instead, interfered with care.

    The Stark Law is one example, says Hargan. Passed in 1989 and named after its sponsor, then-Congressman Pete Stark, the law was intended to eliminate financial self-interest in health care referrals. 

   The pendulum has swung too far the other way, Hargan says. 

   “We have supported value-based care but prohibit it,” Hargan said. “It isolates physicians from every other provider, and so they’re isolated from one another.”   

   The law has created an industry for lawyers, says Hargan. 

   “It’s not really the law, it is just how people have interpreted the law,” Hargan said.

    Hargan says HHS wants to address the Stark Law at the regulatory and educational levels. One way is through promoting value-based health care delivery models, which reimburse outcomes, rather than fee-for-service models, says Hargan. 

Privacy and the Opioid Crisis

Another area where HHS is looking to improve coordination of care is with substance abuse disorders, says Hargan. In 1975, Congress enacted the federal confidentiality law known as “42 CFR Part 2” to encourage patients to seek treatment without fear of discrimination or incrimination.

     “The law was a stand-alone law and interpreted over the course of decades to the point where it now has created significant clinical and safety challenges for providers because they cannot share information with other providers,” Hargan said.

       Hargan says one example is in Huntington, West Virginia, where the state is trying to address the opioid crisis by taking a more holistic approach to care. Patients not only get substance abuse treatment but help in dealing with social and legal issues. One provider told Hargan she had to fill out 11 releases before assisting a patient

    “It slows down care,” Hargan said. “In modern times, information is a critical, critical part of how care is delivered in the health space.” 


AnneMarie Schieber ([email protected]is managing editor of Health Care News.