Where Trump’s last-minute healthcare regulations stand under Biden

During the waning weeks of President Donald Trump’s single term last December, the Health and Human Services Department announced a slew of policies ranging from phasing out a list of procedures that could only be performed at inpatient facilities to proposing changes to patient privacy rules.

When President Joe Biden took office, his administration froze or delayed many Trump-era policies to reevaluate them.

Here’s a look at some of those HHS initiatives and where they stand now:

Dec. 1, 2020: CMS released the physician fee schedule for 2021, which authorized Medicare reimbursement for telehealth services such as at-home evaluation and management and visits for patients with cognitive impairments. Accountable care organizations also got an extra year before they needed to align their quality measures with those in Medicare’s Quality Payment Program. ACOs appreciated the delay but didn’t want CMS to move forward with the quality changes in the first place.

The telehealth codes are still in effect. But in the 2022 fee schedule, CMS gave ACOs an extra three years to modify their quality measure reporting.

Dec. 2, 2020: The 2021 outpatient prospective payment system phased out the inpatient-only procedure list and allowed physician-owned hospitals to expand if they treat large numbers of Medicare beneficiaries.

CMS reversed its decision to get rid of the inpatient-only list in its 2022 outpatient prospective payment rule, but the policy on physician-owned hospital expansion is still in effect.

Dec. 3, 2020: CMS published its geographic direct contracting model through the Center for Medicare and Medicaid Innovation. The program would allow participating providers to accept full financial risk for all traditional Medicare enrollees in their regions.

CMS paused the geographic direct contracting model in March. The agency’s website still says it will share additional information on the model in the future.

Dec. 10, 2020: CMS unveiled a proposed rule that sought to require Medicaid, Children’s Health Insurance Program and health insurance exchange plans to build application interfaces that support data exchange and prior authorizations. The proposal also aimed to reduce the time insurers have to inform providers of prior authorization decisions.

The rule has not been finalized but the Health and Human Services Department’s 2022 regulatory agenda includes a new proposed rule that would require different types of public payers to improve electronic exchange of healthcare data and streamline prior authorization processes. The rule is expected in February.

Dec. 10, 2020: Another proposed rule would have changed Health Insurance Portability and Accountability Act rules to allow caregivers and family members greater involvement in patients’ emergency care. The proposal also would have created flexibilities for information disclosures during emergency circumstances and cut administrative burdens for providers and health plans.

This year, the HHS Office for Civil Rights extended the comment period for the regulation until May. The final rule is listed on the regulatory agenda and expected to come out in October.

Dec. 10, 2020: HHS approved an administrative dispute resolution process for the 340B drug discount program that was originally proposed in 2016.

HHS’ 2022 agenda lists a replacement administrative dispute resolution process, scheduled to be released in January.

Dec. 21, 2020: A CMS final rule made it easier for private payers, state Medicaid programs and pharmaceutical manufacturers to create value-based drug pricing arrangements.

Last month, CMS delayed part of the rule that required drug makers to figure out the best price for drugs under Medicaid’s drug rebate program using their patient discounts until July 1, 2022. CMS also delayed the start date when U.S. territories are permitted to enter the drug rebate program.

Dec. 22, 2020: The Health Resources and Services Administration approved a final rule that requires federally qualified health centers participating in the 340B prescription drug discount program provide insulin and Epi-Pens to patients at or below cost.
HRSA froze the regulation in January and delayed its implementation again in March. HHS proposed getting rid of the rule in June.

HHS paused several other Trump administration initiatives this year, including a policy that would have canceled HHS regulations if they aren’t reviewed within five years, a rule to mandate Medicare Part D plans support a new electronic prior authorization standard for e-prescribing plans and a drug rebate rule for Part D.

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