A Healthcare Regulatory Year in Review

Federal oversight of healthcare is changing, with a greater emphasis on equity and consumer rights.

In this first year of the new administration, we saw some policy shifts in the area of federal health regulation. At the same time, the COVID-19 Public Health Emergency (PHE) continued to delay some expected new programs.

For one thing, the administration introduced the idea of “health equity” into the mainstream of its regulatory programs. While asking for public comment in a number of areas, the Centers for Medicare & Medicaid Services (CMS) revised some quality measures and introduced some new pilot programs to achieve better health equity in the Medicare and Medicaid programs. 

We also continued to see the coverage of telehealth being expanded from pre-pandemic levels, although it appears that some commercial plans are not following suit. The usual coding updates for CPT and ICD-10 occurred, with new codes for COVID-19 and for dealing with the social determinants of health (SDoH) to help achieve equity. There were some payments increased for institutional providers. Physician Part B payments were somewhat reduced, but with a revision to help increase payments for primary care.

Price transparency, especially under the No Surprises Act regulations, continues to be important – as indicated by the recent increase in penalties for hospitals not publishing their contracted rates as required. The No Surprises Act regulations, effective Jan. 1, 2022, eliminate out-of-network charges for emergency room visits and most in-network hospital visits for commercial health plans. The regulations also will require providers to give uninsured patients price estimates for scheduled services within a few days of scheduling them. Requirements under the Act to provide insured patients with advance estimates of their costs are expected soon; but these will not be effective on Jan. 1.

And in recent regulatory news, a new interim final rule requires health plans, health insurance issuers offering group or individual coverage, and health benefit plans offered to federal employees to submit key data to several government departments, which will work through the U.S. Department of Health and Human Services (HHS) Assistant Secretary for Planning and Evaluation (ASPE) to publish a report on prescription drug pricing trends and rebates, as well as their impact on premiums and consumers’ out-of-pocket costs. Plans and issuers must now provide an annual overview of their top 50 drugs across key areas of concern, including the following:

• The most frequently dispensed brand prescription drugs;
• The costliest prescription drugs; and
• The prescription drugs that had the greatest increase in total annual plan spending over the previous year.

The new data submission requirements will apply starting with data from the 2020 calendar year. However, the Departments are deferring enforcement of the new requirements until Dec. 27, 2022, to give regulated entities time to come into compliance. This means the required information for 2020 and 2021 is due by then, although it may be submitted sooner.