HHS unveils proposals to tweak key regulations  

The proposed changes target the federal Physician Self-Referral Law and the Anti-Kickback Statute.

The U.S. Department of Health and Human Services (HHS) is introducing proposed changes to “modernize and clarify” the regulations that interpret the Physician Self-Referral Law (the “Stark Law”) and the federal Anti-Kickback Statute, officials announced Wednesday.

The moves come as part of HHS’s so-called “Regulatory Sprint to Coordinated Care,” a broader initiative intended to promote value-based care amid the exodus from the legacy fee-for-service model by “examining regulations that impede efforts among providers to better coordinate care for patients,” the Department said in a press release breathtakingly devoid of specifics, pledging that it still intends to maintain strong safeguards against fraud and abuse in the nation’s healthcare system.

“President Trump has promised American patients a healthcare system with affordable, personalized care, a system that puts you in control, provides peace of mind, and treats you like a human being, not a number. But too often, government regulations have stood in the way of delivering that kind of care,” HHS Secretary Alex Azar said in a statement. “Regulatory reform has been a key piece of President Trump’s agenda, not just for faster innovation and economic growth, but also better, higher-value healthcare. Our proposed rules would be an unprecedented opportunity for providers to work together to deliver the kind of high-value, coordinated care that patients deserve.”

“These proposed rules would be a historic reform of how healthcare is regulated in America,” HHS Deputy Secretary Eric Hargan added. “They are part of a much broader effort to update, reform, and cut back our regulations to allow innovation toward a more affordable, higher-quality, value-based healthcare system while maintaining the important protections patients need. (Officials) here at HHS, CMS (the Centers for Medicare & Medicaid Services), and the Office of Inspector General recognized the need for reform and have acted to produce serious and thoughtful sets of proposals.”

The aforementioned press release did not outline details about the proposed changes to the statutes, instead only describing them as intended to “address the longstanding concern these laws unnecessarily limit the ways in which healthcare providers can coordinate care for patients” and offer “flexibility for beneficial innovation and improved coordinated care through, for example, outcome-based payment arrangements that reward improvements in patient health.” Officials said that would mean that healthcare providers could manage to ensure they are complying with the law by offering specific “safe harbors” for such arrangements.

“Any patient can tell you how difficult it is to coordinate their own care. This proposed rule would help patients to focus on their health, enable providers to better coordinate high-quality healthcare, and empower both to achieve improved health outcomes,” acting HHS Inspector General Joanne M. Chiedi said. “We are proposing strong safeguards to protect patients from fraud and abuse by bad actors who might seek to misuse the new flexibilities.”

Wednesday’s announcement also presented the following examples involving “coordinated care, value-based care, data sharing, and patient engagement activities that, depending on the facts, could currently be difficult to fit under existing protections and could potentially be protected by the Stark Law, Anti-Kickback Statute, or Civil Monetary Penalties Law proposals, if all applicable conditions are met:”

• In an effort to coordinate care and better manage the care of their shared patients, a specialty physician practice could share data analytics services with a primary care physician practice.
• Hospitals and physicians could work together in new ways to coordinate care for patients being discharged from the hospital. The hospital might provide the discharged patients’ physicians with care coordinators to ensure patients receive appropriate follow-up care, data analytics systems to help physicians ensure that their patients are achieving better health outcomes, and remote monitoring technology to alert physicians or caregivers when a patient needs healthcare intervention to prevent unnecessary ER visits and readmissions.
• A physician practice could provide “smart” pillboxes to patients without charge to help them remember to take their medications on time. The practice could also provide a home health aide to teach the patient and the patient’s caregiver how to use the pillbox.  The pillbox could automatically alert the physician practice and caregiver when a patient misses a dose, so they could follow up promptly with the patient. 
• A local hospital could improve its cybersecurity and the cybersecurity of nearby providers that it works with frequently. To do so, it could donate, for free, cybersecurity software to each physician that refers patients to its hospital.
• To improve health outcomes for patients with end-stage kidney disease, a nephrologist, dialysis facility, or other provider could furnish the patients with technology that is capable of monitoring the patient’s health and two-way, real-time interactive communication between the patient, facility, and physician. In addition, the facility could equip the physicians with data analytics software to help them monitor patients’ health outcomes.

“We serve patients poorly when government regulations gather dust in the attic: they become ever more stale, and liable to wreak havoc throughout the healthcare system,” CMS Administrator Seema Verma said. “Administrative costs are driving up the cost of healthcare in America – to the tune of hundreds of billions of dollars. The Stark proposed rule is an important next step in President Trump’s healthcare agenda for Americans. We are updating our antiquated regulations to decrease burden for providers and helping bring down these increasingly escalating costs.”

While hundreds of pages in length, it is advisable that providers review the proposals thoroughly before contacting their professional associations to discuss. The comment period will run through the next two months following the publication of the proposals in the Federal Register.

The OIG’s proposed changes can be reviewed in their entirety here: https://www.hhs.gov/sites/default/files/oig-nprm.pdf

The CMS proposed changes can be reviewed in their entirety here: https://www.hhs.gov/sites/default/files/cms-stark-law-nprm.pdf

Programming Note:

Listen to David Glaser report this story live during Monitor Monday, Oct. 14, 10-10:30 a.m. EST