Modern Healthcare 
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.
Medicaid work requirements
The Biden administration has started to undo a controversial Trump-era policy that allows states to force low-income residents to work, volunteer or take part in other so-called “community engagement” activities to enroll in Medicaid coverage. Starting in February, the Biden administration began repealing approvals for states’ work requirement waivers. Federal officials had prepared to defend CMS’ approval of work requirement waivers before the Supreme Court in March. But the Biden administration stopped defending the policy and asked the high court to cancel the federal government’s appeal.
Status: As of April 7, CMS had rescinded Medicaid work requirements in Arkansas, Michigan, New Hampshire and Wisconsin—Arkansas is disputing the decision. But the Biden administration hasn’t decided whether to pull work requirements in other GOP-led states like Georgia, which promised to fight to keep its policy in place. The Supreme Court hasn’t decided whether to hear the Trump-era defense of the policy.
HIPAA updates
HHS’ Office for Civil Rights extended the comment period for its proposed changes to Health Insurance Portability and Accountability Act rules by 45 days. Comments are now due May 6. The Trump administration designed the changes to give patients more control over their health data and make it easier for clinicians to share patient data with other providers, insurers and social service agencies for coordinating patient care.
Encouraging primary-care coordination for seriously ill Medicare beneficiaries
CMS’ Center for Medicare and Medicaid Innovation delayed the start of the Primary Care First model’s option for seriously ill populations, saying the model is now under review. The model was set to kick off on April 1. The payment option for seriously ill populations was supposed to encourage advanced primary care practices, including providers that deliver hospice or palliative care services, to provide primary care services and care coordination for seriously ill Medicare beneficiaries.
Status: Delayed, March 8
Kidney-care pay model
CMS’ Center for Medicare and Medicaid Innovation delayed the start of its Kidney Care Choices model. The model’s first performance year now kicks off on Jan. 1. It builds on existing kidney-care models and adds financial incentives for providers to manage patient care. CMS hopes the model will help chronic kidney disease patients stay off dialysis or get kidney transplants instead.
Status: Delayed, March 8.
Alternative payment model for rural health
CMS extended the application deadline for the Community Transformation track of its Community Health Access and Rural Transformation model. The new deadline is May 11. Interested applicants told CMS they needed more time to apply due to COVID-19.
On Mar. 30, the agency delayed its request for applications for CHART’s accountable care organization transformation track until spring 2022.
Boosting funding for exchange plan marketing
CMS is boosting federal funding for marketplace navigators by $2.3 million for the special enrollment period that runs through May 15. The move is a dramatic shift from the Trump administration, which cut the ACA’s advertising budget by 90%, and delivers on a campaign promise made by President Joe Biden. California and other states have already announced plans to increase their marketing budgets for the special enrollment period.
“Navigators help Americans understand their health insurance options, connecting consumers with financial help, and help them enroll in Marketplace plans, Medicaid or CHIP,” CMS Acting Deputy Administrator Jeff Wu said in a statement.
Geographic direct contracting pay model
CMS’ Center for Medicare and Medicaid Innovation isn’t moving forward with the Geographic Direct Contracting Model at this time. The agency said it’s reviewing the model and will share additional information with the public when it becomes available.
Experts had worried that the so-called “Geo” model is too complicated to put into practice, which could frustrate Medicare beneficiaries and make it more difficult to coordinate and manage care. President Joe Biden’s administration paused all rules and other agency activities that had yet to take effect to give his team time to review them.
Status: On pause, March 1.
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, Mar. 19. The rule was slated to take effect Mar. 22. But the Biden administration delayed its effective date until July 20.
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: Several organizations, including the American Lung Association and the National Association of Pediatric Nurses, sued HHS on Mar. 9 to stop the so-called “Sunset Rule” from taking effect on Mar. 22.
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: The rule was supposed to take effect on March 15, but CMS delayed the start date until May 15. The agency will accept comments on the interim final rule until April 17. The Biden administration could rework or withdraw the Trump-era regulation before it takes effect.
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