HHS Secretary Vows to Reform Privacy and Stark Law Policies

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In a July 26, 2018 speech to the Heritage Foundation, HHS Secretary Alex Azar previewed the agency’s intent to provide new guidance to providers regarding the Federal Stark law and HIPAA, which he said “stand in the way of healthcare providers” and inhibit the transition to value-based care. Azar also addressed pricing of pharmaceuticals, privacy standards for patient records documenting substance use disorder and treatment, Medicaid work requirements, and the Affordable Care Act’s age rating band on health insurance policies.

Azar stated that he plans to extend a free-market approach to the pharmaceutical market, opining that the US lacks “a real market for prescription drugs.” He said HHS will take steps that “may be unexpected” to give private negotiators and consumers more power to bargain with pharmaceutical companies, highlighting the FDA’s announcement last week that it will investigate the price-reducing potential of importing medicines from foreign countries when the sole manufacturer of a drug without patent protection hikes prices.

Azar also promised to take on the enhanced privacy rule for substance use disorder patient records, codified at 42 C.F.R. Part 2, which prevents hospitals and physicians from sharing a patient’s medical record of addiction or addiction treatment with other providers. Azar explained that HIPAA and this enhanced privacy rule applying to addiction are impediments to coordinated efforts against the opioid epidemic.

Azar highlighted the agency’s support for work requirements in Medicaid-expansion States as a key aspect of revamping the program to “avoid work disincentives and income cliffs.” In reference to the Kentucky lawsuit in which a Federal district court judge blocked the State’s work requirements, Azar explained that the administration will “continue to litigate, and take any learnings from that piece of litigation—with which we disagree."

Azar previewed Medicare billing structure reform and admonished so-called Affordable Care Act price controls, particularly the age rating band that requires insurers to charge younger enrollees at least one-third of the premiums that they charge older enrollees. Azar blamed this provision for keeping younger people out of the ACA insurance market.  “Supporting legislation to undo those perverse incentives is a priority for this administration,” he said.

The full speech transcript can be found here.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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