Regs & Turkey Legs: The Regs We’re Thankful For - McDermott+Consulting

REGS & TURKEY LEGS: The Regs We’re Thankful For

McDermottPlus is pleased to bring you Regs & Eggs, a weekly Regulatory Affairs blog by Jeffrey Davis.

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November 22, 2023 – It’s Thanksgiving week, so instead of eating eggs with your regs, you should sit back, relax and reflect on the regs you are thankful for as you eat your turkey legs (or whatever you enjoy on Thanksgiving). Many of the policies that federal agencies enact are welcomed by different stakeholders and take into account input from the public. While there are others that we may have concerns with (and which I’ve written about in previous Regs & Eggs), from time to time it’s useful to focus just on the positive—and what better time to do so than Thanksgiving. To share in the spirit of thanks, I’m bringing in other team members from McDermottPlus (and one from McDermott Will & Emery) to highlight the regulatory policies they truly appreciate.

  • Jeffrey Davis: I’ll start with what I’m thankful for. In the No Surprises Act independent dispute resolution (IDR) proposed reg, the US Departments of Health and Human Services (HHS), Labor and the Treasury really listened to providers’ feedback about operational improvements that should be made to the federal IDR process, including providers’ need for more information from health plans to help determine if a service is subject to that process. The Departments proposed to require health plans to disclose additional information to clinicians and facilities at the time of the initial payment and notice of denial for out-of-network services. These new disclosures would make it easier to determine whether services are eligible for the federal IDR process and would make the whole process run more efficiently.
    • Read our full analysis of the IDR Operations proposed rule here.
  • Paul Radensky: In the calendar year (CY) 2024 Medicare Physician Fee Schedule (PFS) final reg, the Centers for Medicare & Medicaid Services (CMS) finalized numerous proposals to help improve diabetes care. One in three US seniors has diabetes, as stated by Dr. Meena Seshamani, director of the Center for Medicare at CMS, in a recent webinar. One of the reg’s finalized policies is to add the Hemoglobin A1c (HbA1c) test as a nationally covered diabetes screening test under Medicare since it is well established, easy to perform and can help identify more patients who need treatment.
    • Read our full analysis of the CY 2024 PFS final rule here.
  • Kayla Holgash: Sticking with the CY 2024 PFS final reg, Kayla is thankful that CMS is allowing coding and payment for community health integration services, which are proven to advance health equity. The payment will cover person-centered planning and health system coordination, and will promote patient self-advocacy and facilitate access to community-based resources to address unmet social needs. This is the first time coverage will be available for PFS services that are designed specifically to include community health workers, who are critical in connecting communities with healthcare and social services and are proven to improve equitable access to care and outcomes.
  • Kristen O’Brien: Kristen is also thankful for these new payments under the CY 2024 PFS final reg. In addition to what Kayla highlights above, the reg includes payments for principal Illness navigation services and social determinate of health (SDOH) risk assessments. For many people with complex medical conditions, such as cancer or serious mental health conditions, quality healthcare requires coordinating services with non-traditional providers. The new payments account for resources when clinicians coordinate with healthcare support staff and will likely improve access to patient navigation services. The coding and payment for social risk assessments will encourage providers to spend time and resources evaluating social factors that may impact patient care. Practitioners can use this code to bill for an SDOH risk assessment that includes food insecurity, housing insecurity, transportation needs and utility difficulties.
  • Parashar Patel: Parashar will also add his name as someone who is thankful for these new PFS payments (they are very popular). As Parashar states, “Anyone who has helped a family member or friend with a chronic illness navigate our health care system understands the importance of identifying the care that’s needed, making appointments, ensuring that reports are sent to the primary care provider, removing barriers to receiving timely care and providing other coordination necessary to receive optimal care and services. Such assistance and support are especially important for those with chronic conditions. Unfortunately, many patients may not have the support of family members or friends who can provide such navigation, which can be a full-time job. This policy will now recognize, and pay, providers who deliver such services to chronically ill beneficiaries. In the long run, beneficiaries will benefit from improved quality of care, improved outcomes and lower costs.”
  • Leigh Feldman: Along the same lines, Leigh is thankful for the new PFS payments for caregiver training services. As those of us who have helped a loved one navigate care know, family members often serve as critical members of the care team. These new payments recognize that role by compensating clinicians for their time training and involving caregivers in carrying out a patients’ care plan.
  • Deborah Godes: Deborah is thankful for the clarifications that CMS issued in the CY 2024 PFS final reg regarding remote physiological monitoring and remote therapeutic monitoring devices. Particularly since the COVID-19 public health emergency (PHE), these types of devices have been an important way for providers to monitor their patients between visits and allow for more timely responses and adjustments to treatment based on real-time information on patient conditions. As we continue to see innovation in these types of technologies, the additional clarity is important for companies currently offering these solutions and new market entrants seeking to bring the latest capabilities to Medicare beneficiaries.
    • Read more about remote monitoring coverage and payment policies here.
  • Amy Kelbick: Similarly, Amy is grateful for a request for information (RFI) included in the CY 2024 PFS proposed reg on cognitive digital therapy, including digital cognitive behavioral therapy. Digital therapeutics are promising new medical technologies that deliver clinically validated treatments through artificial-intelligence-backed software. Digital therapeutics can help treat insomnia, depression, anxiety, and many other mental and physical health conditions. Medicare currently does not cover most of the available evidence-based digital therapeutics. This RFI was an important step forward, as it showed that the agency is interested in these technologies and wants to better understand how coverage for them could fit into existing benefit categories. Coverage for digital therapeutics would give Medicare beneficiaries access to a growing field of clinically proven treatments, including many that treat mental health conditions during a time when there is a significant need for mental health services and providers.
  • Rachel Stauffer: Rachel is grateful for CMS’s discussion in the CY 2024 PFS final reg around coverage and payment for telehealth services. This was the first rulemaking from the agency after the COVID-19 PHE ended. The agency clearly laid out its limitations in making policies permanent or opining beyond December 31, 2024, the date when many of the current flexibilities expire. This discussion helps us understand what falls under CMS authority and where Congress will need to step in to change statute. Stakeholders can use this information to drive advocacy over the next year.
  • Debbie Curtis: Speaking of telehealth, Debbie is thankful that CMS is changing the way that it covers telehealth services on a temporary basis. Instead of time-limiting those services, CMS created a new “provisional” category in the CY 2024 PFS final reg. Telehealth services in this category will continue to be covered while CMS collects data to decide whether that coverage should be made permanent. This change is significant because it will eliminate the arbitrary pulling of particular services from the telehealth arena simply because they met the end of a similarly arbitrary temporary coverage period. Congress still must take action to actualize Medicare’s coverage of telehealth services going forward, but this move is an important step towards enabling people who may not live near a brick-and-mortar facility, or who face other barriers to in-person care, to continue to receive vital healthcare services via telehealth.
  • Lauren Knizner: Lauren has another shout-out for CMS’s work on telehealth, this time with respect to protecting the privacy and security of providers’ information. Because many healthcare providers began working from home during the COVID-19 pandemic, CMS allowed providers to deliver telehealth services without reporting their home addresses on their Medicare enrollment, while continuing to bill from their currently enrolled location. This important policy, which provided efficiency and protected the privacy and safety of physicians and other healthcare providers while increasing patient access to services, was previously set to expire at the end of 2023. CMS extended the current flexibilities for another year in the CY 2024 PFS final reg, ensuring that providers can safely bill from other locations and remain available to patients who wish to continue having the flexibility of being treated remotely.
  • Karen Sealander: The CY 2024 PFS final reg took another important step forward for Medicare beneficiaries and oral systemic health. Last year, CMS took the first step when it clarified in the CY 2023 PFS final reg that Medicare payment is available for dental services that are inextricably linked to and substantially related and integral to the clinical success of Medicare-covered medical services. CMS also established an annual process for stakeholders to nominate additional clinical scenarios for Medicare payment. This process yielded clarification in the CY 2024 PFS final reg around Medicare payment of medically necessary dental care for beneficiaries with cancer. Submissions for consideration in the CY 2025 PFS are due to CMS by February 10, 2024. Increasing Medicare beneficiaries’ access to medically necessary oral and dental therapies will improve older Americans’ oral health, an essential element of overall health and general well-being.
  • Priya Rathakrishnan: Turning to the CY 2024 Outpatient Prospective Payment System (OPPS) final reg, Priya is thankful that CMS finalized the payment and program requirements to implement the intensive outpatient program benefit under Medicare. This new benefit category was created for individuals with acute behavioral health needs, including depression, schizophrenia and substance use disorders. CMS established payment and program requirements for the benefit across various settings, including hospital outpatient departments, community mental health centers, federally qualified health centers and rural health clinics, effective January 1, 2024. CMS further extended coverage for intensive outpatient services in opioid treatment programs for the treatment of opioid use disorder. In all, the provision helps address the nation’s behavioral health crisis by expanding access to crucial behavioral health services across multiple settings and levels of care.
    • Read our full analysis of the CY 2024 OPPS final rule here.
  • Christopher Salmen: In the CY 2024 home health final reg, CMS implemented the Lymphedema Treatment Act and, in doing so, added 78 new Healthcare Common Procedure Coding System (HCPCS) codes describing head, neck, chest, torso, genital and other compression treatment items, as well as three daytime garments per affected body part every six months, and two nighttime garments per affected body part every two years. Christopher is grateful that patients suffering from lymphedema will begin to have access to these medically necessary items.
  • Eric Zimmerman: Last, but not least, Eric is grateful for how CMS decided to calculate the Hospital Wage Index. Legislation enacted in 1999 permitted certain urban hospitals meeting specified criteria to be considered “rural” for various Medicare payment purposes, including most notably for the wage index. CMS implemented this policy at 42 C.F.R. § 412.103. From the start, CMS disfavored this policy and established several obstacles intended to limit access and blunt the effects of urban hospitals reclassifying to rural areas on calculation of the wage index. Following years of lawsuits, which were nearly universally won by the hospitals challenging CMS’s hurdles, CMS determined to treat all hospitals undergoing urban-to-rural reclassification under § 412.103 the same as geographically rural hospitals for the wage index calculation. This policy change substantially alters how CMS calculates and applies the wage index. The change is causing disturbances in the wage index that affect all hospitals, but the change also will (hopefully) put an end to inefficient litigation and simplify CMS’s wage index and reclassification rules. Eric is all for efficiency and simplification! He says thank you to CMS.

As a former HHS employee, I know that federal departments like HHS don’t hear the word “thanks” enough—and while public stakeholders may not agree with every policy they put out, their commitment to improving the healthcare system should rarely be questioned.

So, thank you, federal agencies, for all the work you do.

And with that, I wish you all a very happy Thanksgiving! Until next week, this is Jeffrey (and everyone from McDermottPlus) saying, enjoy reading regs with your TURKEY LEGS.

For more information, please contact Jeffrey Davis. To access the full archive of Regs & Eggs, visit the American College of Emergency Physicians.

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