After setting foot in the Oval Office, President Joe Biden made moves to review his predecessor's final regulatory actions. In the flurry of initial executive orders, one halted any regulations finalized in the waning days of the Trump administration. Since then, he has started to set his own policy agenda.
Modern Healthcare is keeping an eye on the status of the rules most salient to the industry.
Check back daily for status updates.
Setting CMS pay rules
The Biden administration is reviewing four Medicare payment rules affecting inpatient hospital care, skilled nursing facilities, inpatient psychiatric care and inpatient rehab facilities. CMS will publish the proposed rules for notice and comment later this year.
Status On review at the Office of Management and Budget on Feb. 25.
Barring PBMs from keeping Medicare Part D drug rebates
The rule would replace the current system, which bases rebates on a drug's list price, with fixed administrative fees. The Trump administration hoped the regulation would lower drug prices by cutting into the profits of pharmacy benefit managers. The Pharmaceutical Care Management Association sued earlier this month to block the rule from taking effect.
Status: On pause, Feb. 1. The rule now won't fully take effect until at least Jan. 1, 2023. The Biden administration had originally delayed the regulation's effective date until March 22.
Cutting 340B drug discounts
HHS in December finalized a rule forcing community health centers to pass 340B drug discounts along to their patients, a move the Trump administration hoped would lower out-of-pocket drug costs. It faced staunch opposition from providers and patient advocates, who worried it could hamper access to care and cut already razor-thin operating margins for community health centers.
Status: On pause, Jan. 21. The rule was slated to take effect Jan. 22, but the Biden administration delayed until March 22. The rule could be withdrawn before then.
Covering dialysis treatments
The Trump administration wanted to permanently require dialysis centers to tell patients about their coverage options and premium assistance programs. It was an updated version of an Obama-era rule, which went into effect in January 2017.
Status: On pause, Jan. 26
Increasing oversight on accreditation organizations
CMS has long worried about accrediting organizations' potential conflicts of interest, as many sell consulting services. The Trump administration was working on a rule to address them.
Status: On pause, Jan. 26
Revising Social Security and Medicare Part A relationship
Under the current rules, a person age 65 or older automatically applies for Part A coverage when they file to collect Social Security benefits. The Trump administration was working on a proposal to allow seniors to collect Social Security retirement benefits if they chose not to accept Medicare coverage for inpatient services.
Status: On pause, Jan. 26
Altering the Affordable Care Act exchanges
Just days before Biden took office, CMS said states could waive some requirements for their ACA exchanges via Section 1332 waivers and allow web-based brokers to sell plans starting as soon as 2023. The move could have increased competition on the exchanges, but industry groups said this would essentially privatize those markets and could lead consumers to purchase less comprehensive coverage without understanding all their options.
Status: No action yet.
Sunsetting old regulations
Earlier in January, HHS finalized a rule requiring it to review all of its regulations every 10 years to see if they're having their desired impact, and sunsetting any rules that aren't reviewed. The review process wouldn't apply to food and drug regulations or payment rules.
Status: No action yet.
Requiring insurer price transparency
In another controversial rule, the Trump administration in October said it would require nearly all health insurers and self-insured plans to disclose in-network and out-of-network rates in an effort to increase price transparency. The changes would shed light on insurer-provider pricing negotiations and create consumer tools that give cost-sharing information. Insurers and provider groups united to oppose the rule and said it wouldn't help lower healthcare costs. Providers' own price transparency requirements were set to go into effect in January.
Status: No action yet.
Changing outpatient drug prices
A federal court already paused a Trump-era pilot to tie Medicare outpatient drug prices to foreign countries' prices, but the demonstration was slated to take effect in January. The demonstration would put the onus on providers to negotiate drugmakers' prices down to their new reimbursement levels. If they were unsuccessful, they might stop offering the drugs to Medicare beneficiaries.
Status: No action yet.
Shifting Medicare Advantage payment calculations
The latest Medicare Advantage pay rates included a controversial new payment methodology that would adjust plan payments based on encounter data, a move long opposed by insurers.
Status: No action yet.
Expanding value-based drug pricing
CMS in January overhauled regulations preventing private insurers, state Medicaid programs and prescription drug manufacturers from creating value-based payment arrangements tied to clinical outcomes. The agency hoped this would increase access to new, high-cost drugs, including gene therapies. The rule was rushed through, according to industry members, and they worried it could cause administrative headaches or alter drug prices.
Status: No action yet.
Easing prior authorization requirements
CMS in Trump's last week greenlit a plan to make it easier for providers to send prior authorization requests electronically through their EHR platforms. Under the changes, Medicaid and CHIP fee-for-service and managed-care plans would have up to 72 hours to make prior authorization decisions on urgent requests and seven calendar days for non-urgent requests. Providers and insurers had only a few weeks to review the changes before the final rule came down.
Status: No action yet.
Easing up on guidance violation penalties
In January, HHS made it more difficult for regulators to penalize organizations and individuals who violate standards from guidance documents rather than rules or laws. It also created a new process for civil enforcement actions.
Status: No action yet.
Covering breakthrough medical devices
Medicare will be allowed to cover medical devices designated as "breakthrough" technology by the Food and Drug Administration. Under the rule issued in January, Medicare can cover those devices for four years after it receives FDA market authorization, circumventing Medicare's previous coverage determination process.
Status: No action yet
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