December 2022 Advocacy Recap

Alec Bose:

Hello and welcome to the CAP Advocacy Recap, a monthly podcast dedicated to catching you up on the top news for pathologists. I'm Alec Bose here with your December recap. This month we'll look at updates for good faith estimates requirements, as well as important legislative priorities that were passed in the year in legislation by Congress.

The CMS published an FAQ announcing that the agency further delayed enforcement on the good faith estimate requirements for uninsured or self-pay individuals. The FAQ clarified that the HHS is extending enforcement discretion pending future rulemaking for situations where GFEs for uninsured or self-pay individuals do not include expected charges from co-providers or co-facilities. According to the HHS, they have received feedback that "compliance with this provision is likely not possible by January 1st, 2023, given the complexities involved." Importantly, they explained that any rulemaking to fully implement the GFE requirements related to uninsured or self-pay individuals will include a perspective applicability date that gives providers and the facilities a reasonable amount of time to comply with any new requirements. The CAP met with the CMS to try and obtain clarification and further guidance around these requirements. For more FAQs on good faith estimates, be sure to visit our website.

We turn now to MIPS. The CMS announced that it plans to act within its regulatory authority to randomly audit MIPS eligible clinicians and groups on a yearly basis. Suppose an eligible clinician or group is selected for an audit. In that case, they will have 45 days from the date of the notice to provide the requested information of substantive primary source documents. It is unclear whether pathology practices will be included in these audits. Under MIPS, pathologists are included if they are an eligible clinician type and meet the low volume threshold, which is based on allow charges recovered professional services under the Medicare physician fee schedule and the number of Medicare Part B patients who are furnished, covered professional services under the Medicare physician fee schedule. If you have any questions, you can contact us by emailing mips@cap.org.

And finally, we go to Congress where a government shutdown was averted by passing an omnibus spending bill, which included several key priorities the CAP has advocated for. The bill included a reduction in Medicare cuts for 2023 and 2024 after a strong lobbying effort by the CAP and a coalition of physician groups led by the AMA. The CAP and the physician groups lobbied lawmakers to prevent the entire 4.5 Medicare cuts stemming from the program's policy to increase payment for E&M services.

Congress also included the Prevent Pandemics Act in the bill, which would expand genomic sequencing and advanced molecular detection, enhanced public health surveillance of pathogens, improve recruitment and retention of the public health workforce, and modernize the supply chain for vital medical products.

In addition, Congress added provisions to the omnibus bill that are intended to increase diversity in clinical trials. This would require the HHS Director to promote diversity in clinical trials via diversity action plans, use of decentralized clinical studies, modernize clinical trials using new digital health technologies, and promote the seamless and concurrent expansion of clinical trials to better capture evidence on a variety of patients.

There were several priorities that did not make it into the end of year legislation. For example, the VALID Act, which would ensure quality laboratory testing for patients and minimize the regulatory burden on laboratories while allowing for continued innovation in laboratory testing was not included as lawmakers could not come to an agreement on it. However, the FDA is expected to step in and use its authority to regulate laboratory developed tests in the absence of a newly enacted statute.

Congress also did not pass the Saving Access to Laboratory Services Act or SALSA. The bill would stop a 15% Medicare cut to laboratory fees, reduce administrative burden on laboratories, and ensure accurate collection of private market data through statistically valid sampling from all laboratory segments. Instead, Congress decided to delay cuts that were set to take effect in 2023 by one year. Reporting requirements where certain applicable laboratories must send the CMS data on private payer rates for clinical laboratory services were also delayed by one year.

That's all for this edition of the Advocacy Recap. Thank you so much for listening. For more information on any of the stories you heard today, be sure to subscribe to our weekly advocacy newsletter and follow us on Twitter at CAP DC Advocacy. Once again, we're CAP Advocacy Communications, I'm Alec Bose and we'll see you next month.

Download Transcript