Regulatory agenda lays out timetable for major rules on drug pricing, interoperability

The Trump administration estimates it will release rules on drug prices and information blocking this month but punted finalizing a rule on interoperability until as late as 2022.

The White House Office of Management and Budget released on Wednesday the unified regulatory agenda for fall 2019, which gives estimates for regulations the administration is planning to release in the coming year. 

The agenda said that a major rule that would outlaw information blocking among providers is estimated to be released this month. The rule, released back in February, also modifies the health IT certification criteria to advance interoperability.

The rule published by Health and Human Services’ Office of the National Coordinator for Health IT outlines the fines for the practice of blocking patient access to their medical information.

RELATED: HHS delivers first fine under new information blocking initiative to Florida hospital

But another major interoperability rule won’t be finalized any time soon. The unified agenda moved a rule from CMS to foster greater adoption of interoperability to its long-term actions list, giving it a deadline of March 2022 to finalize it.

However, the rule could be published earlier. Federal law requires Medicare final rules to be published three years after they were proposed and the rule was published in February 2019, so March 2022 would likely be the final deadline.

The CMS proposed rule would require Medicaid, the Children’s Health Insurance Program, Medicare Advantage and qualified health plans sold on the Affordable Care Act’s exchanges to ensure patient data can be accessed via application programming interfaces by next year.

The delay would likely make providers and insurers happy. America’s Health Insurance Plans, the top insurance lobbying group, said in comments on the rule that CMS should phase in the requirements by 2022.

The unified agenda also gives an update on key regulations addressing high drug prices.

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One such proposal is a demonstration model that would tie the price of physician-administered drugs paid by Medicare Part B to an index made up of cheaper prices paid by other countries.

HHS released an advanced notice of a proposed rule back in October 2018 on the model, but so far no proposed rule has emerged. Now, the unified agenda estimates the proposal to be released this month.

The agenda also provides an estimated release date of January 2020 for a proposed rule to allow the importation of drugs from Canada. The proposed rule would create a pilot project to allow states, wholesalers and pharmacists to import drugs from Canada at a cheaper price than in the U.S.

Another key regulation to watch out for is a proposed rule outlining new conflict of interest rules for accrediting organizations such as The Joint Commission. The rule—estimated to go out in March 2020—comes as The Joint Commission, the largest accreditor of hospitals, received scrutiny over also providing consultants to the hospitals it inspects.