Written By Chris Emper, JD, MBA, government affairs advisor, NextGen Healthcare, Inc. for STAT News
Since the start of the Covid-19 pandemic last year, physicians have been forced to deal with constant regulatory changes. Some of those changes have been minor and fairly inconsequential, while others have been major and disruptive. The changes have come from every level of government — federal, state, and local. Overall, this dynamic has added to an already very challenging environment for physicians and other healthcare providers.
Now, as the calendar flips to November and we find ourselves officially 20 months into the pandemic and ten months into a new presidential administration, there are no signs that the pace of regulatory change is slowing. Conversely, as we look ahead to the new year, the pace of regulatory change seems poised to accelerate. For providers struggling to keep up with all of the changes and wondering what to expect in 2022, here are three key issues to watch:
Early in the pandemic, the Centers for Medicare and Medicaid Services (CMS) issued a series of regulatory waivers to expand access to telehealth services in Medicare. Statutory requirements for a patient to be located in a rural area and physically present at a healthcare facility were relaxed to allow the delivery of telehealth services to patients anywhere geographically and physically, including at a patient’s home. Reimbursement amounts were also increased to the same level as for in-person visits.
While these rule changes have been game-changing for telehealth, they are only temporary, lasting as long as the duration of the federal public health emergency declaration. In response, bipartisan efforts in Congress are underway to pass legislation to extend some of these policies beyond the end of the emergency. While we currently don’t know when the emergency will end, or when and how Congress will act on telehealth, sometime in 2022 seems likely. Likewise, states that did not enact laws in 2021 to permanently change Medicaid and commercial payer telehealth policies are likely to do so in 2022.
In 2020, the Office of the National Coordinator for Health Information Technology (ONC) released a final rule that implements the interoperability requirements of the 2016 21st Century Cures Act law. As a result of that rule, new federal information blocking mandates went into effect on April 5, 2021. The mandates require healthcare providers — in addition to certified health IT developers, networks, and exchanges — to respond to data exchange requests and generally refrain from actions that are likely to “interfere with access, exchange, or use of electronic health information”.
Even though the rules went into effect in April, HHS is not enforcing them and has yet to even define what the penalties will be for providers who violate them. The industry is actively awaiting the release of those details, which will likely come at some point next year. The scope of electronic health information covered by the rules is also set to expand on October 6, 2022, creating another regulatory hurdle for providers and health IT developers.
Value-based payment models
During the pandemic, the transition to value-based reimbursement stalled as CMS exempted providers from both the reporting requirements and financial penalties of key programs such as the Medicare Shared Savings Program (MSSP) and Merit-Based Incentive Payment System (MIPS.) This followed CMS’s moves under the direction of the Trump Administration to transition MIPS into MIPS Value Pathways, accelerate the transition to risk for ACOs under the Pathways to Success program redesign, and introduce new advanced risk models such as Primary Care First.
Before the start of the 2022 performance period in January, the Biden Administration’s newly installed leadership team at CMS will be forced to decide whether to continue forward with these reforms, reverse course, or head in a different direction. Given the importance of these programs both clinically and financially, providers are actively awaiting these decisions and hoping to get some clarity from CMS as soon as possible.
Beyond these issues, providers should also be on the lookout for additional regulatory changes tied to the Covid-19 pandemic, including those related to federal aid programs. The Democratic-led Congress and Biden Administration are also pushing to pass into law expansions of Medicare, Medicaid, and the Affordable Care Act, each of which could have an impact on insurance coverage, payer mix, and reimbursement for providers.
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