The Centers for Medicare & Medicaid Services (CMS) has been busy. Here is a roundup of the agency’s recent news and actions.
Issues notice to postpone the final RADV audit rules
CMS has extended the timeline for publication of the Medicare Advantage Risk Adjustment Data Validation regulations for one year to November 1, 2022. The November 1, 2018 proposed rule discussed the agency’s authority to extrapolate in the recovery of RADV overpayments, starting with payment year 2011 contract-level audits and without the use of a fee-for-service (FFS) adjuster to the RADV overpayment determinations.
The final rule was supposed to be published by Nov. 1, 2021, but CMS said it was unable to meet the three-year timeline publication due to “exceptional circumstances.” Those circumstances involve the FFS Adjuster Study, which was published a few days before the RADV proposed rule. The agency had extended the comment period for the proposed RADV propositions of the rule until April 2019 with a plan to release data underlying the FFS Adjuster study. Although it had released the data underlying the FFS Adjuster Study in March 2019, CMS later announced an additional extension of the RADV provision until August 2019 as well as additional material related to the FFS Adjuster Study and again sought public comment.
“Based on extensive public comments received on the proposed rule and subsequent FFS Adjuster study and related data along with delays resulting from the agency's focus on the COVID-19 public health emergency, we determined that additional time is needed to address the complex policy and operational issues that were raised,” CMS said in the decision to delay the final rule.
Publishes ESRD final rule
CMS’s final rule aims to encourage dialysis facilities and health care providers to decrease disparities in rates of home dialysis and kidney transplants among End-Stage Renal Disease (ESRD) patients with lower socioeconomic status. The action, CMS announced, makes the model one of its first CMS Innovation Center models to directly address health equity.
The rule is a decisive step to ensure people with Medicare with chronic kidney disease have easy access to quality care and convenient treatment options, said CMS Administrator Chiquita Brooks-LaSure. “Enabling dialysis providers to offer more dialysis treatment options for Medicare patients will catalyze better health outcomes, greater autonomy and better quality of life for all patients with kidney disease.”
Disadvantaged people with Medicare have higher rates of ESRD, are more likely to experience higher hospital readmissions and costs, and are more likely to receive in-center hemodialysis (vs. home dialysis), according to CMS Office of Minority Health studies on racial, ethnic and socioeconomic factors. Studies also indicate non-white ESRD patients are less likely to receive pre-ESRD kidney care, become waitlisted for a transplant, or receive a kidney transplant.
The rule finalizes changes to test a new payment incentive that rewards ESRD facilities and clinicians who manage dialysis patients for achieving significant improvement in the home dialysis rate and kidney transplant rate for lower-income beneficiaries. In addition, the agency said it is approving the first ever technology under a recently established policy that allows for enhanced payments for innovative technologies that represent a substantial clinical improvement relative to existing options. This approval will help ESRD facilities offer an additional option to beneficiaries for home dialysis at this critical time in the pandemic.
Enacts emergency regulation for COVID-19 vaccinations
CMS issued an emergency regulation on Thursday that requires vaccination of eligible staff at health care facilities that participate in the Medicare and Medicaid programs. The regulation aims to protect those who are fighting the virus on the frontlines while also ensuring that individuals and their families will be protected when seeking care.
The regulation requires facilities to establish a policy ensuring all eligible staff have received the first dose of a two-dose COVID-19 vaccine or a one-dose COVID-19 vaccine prior to providing any care, treatment, or other services by December 5. All eligible staff must have received the necessary shots to be fully vaccinated–either two doses of Pfizer or Moderna or one dose of Johnson & Johnson–by January 4, 2022. The regulation also provides for exemptions based on recognized medical conditions or religious beliefs, observances, or practices. Facilities must develop a similar process or plan for permitting exemptions in alignment with federal law.
CMS said it will ensure compliance with the requirements through established survey and enforcement processes.
Releases info on possible risk adjustment model changes for ACA marketplace
CMS has also released a technical paper on possible model changes for HHS-operated risk adjustment. The 84-page document offers a historic look at the risk adjustment program established by the Affordable Care Act (ACA) to help minimize the negative effects of adverse selection and help level the playing field in the commercial marketplace. The risk adjustment program is intended to achieve this goal by mitigating the effect of risk selection on premiums by transferring funds from issuers that enroll lower-than-average risk populations to issuers that enroll higher-than-average risk populations.
Most recently, the Department of Health & Human Services (HHS) proposed, but did not finalize, several updates to the HHS risk adjustment models in the 2022 Payment Notice. HHS noted it would continue to consider potential changes that could increase the current models’ predictive accuracy. The technical paper provides additional detail and analyses on the model updates proposed in the 2022 Payment Notice. It also includes information on HHS’ ongoing evaluation of the state payment transfer formula’s current cost-sharing reduction induced demand factors.
Publishes the 2022 physician payment final rule
CMS has also released the 2022 Physician Fee Schedule (PFS) final rule, which promotes greater use of telehealth and other telecommunications technologies to provide behavioral health care services, encourage growth in the diabetes prevention program, and boost payment rates for vaccine administration. The final rule also advances programs to improve the quality of care for people with Medicare by incentivizing clinicians to deliver improved outcomes.
Here are eight things to know about the rule:
1. Expands use of telehealth for behavioral health: The final rule expands access to behavioral health care—especially for traditionally underserved communities—by harnessing telehealth and other telecommunications technologies. CMS has eliminated geographic barriers and will allow patients in their homes to access telehealth services for diagnosis, evaluation, and treatment of mental health disorders.
It will also pay for audio-only telephone calls for certain mental and behavioral health services, such as counseling and therapy, including treatment of substance use disorders and services provided through opioid treatment programs.
2. Improves Medicare Diabetes Prevention Program (MDPP): The rule expands the MDPP model, which was developed to help people with Medicare with prediabetes from developing type 2 diabetes.
CMS will waive the Medicare enrollment fee for all organizations that apply to enroll as an MDPP supplier on or after January 1, 2022. It will also shorten the MDPP services period to one year instead of two years. This change will make delivery of MDPP services more sustainable, reduce the administrative burden and costs to suppliers, and improve patient access by making it easier for local suppliers to participate and reach their communities.
3. Increases access to medical nutrition therapy services: The rule will also streamline access to Medical Nutrition Therapy (MNT), which includes services provided by registered dietitians or nutrition professionals to help people with Medicare better manage their diabetes or renal disease.
CMS has removed a requirement that limited who could refer people with Medicare to MNT services, allowing any physician (M.D. or D.O.) to do so. This change should particularly benefit people living in rural areas as the MNT services are provided to eligible individuals with no out-of-pocket costs and may be provided via telehealth.
4. Increases payment for proven vaccines to protect against preventable illnesses: CMS will maintain the current payment rate of $40 per dose for the administration of the COVID-19 vaccines through the end of the calendar year in which the ongoing PHE ends. However, effective January 1 of the year following the year in which the PHE ends, the payment rate for COVID-19 vaccine administration will be set at a rate to align with the payment rate for the administration of other Part B preventive vaccines. CMS will also continue to facilitate vaccinations for common diseases such as influenza, pneumonia, and hepatitis B.
The final rule will nearly double Medicare Part B payment rates for influenza, pneumococcal, and hepatitis B vaccine administration from roughly $17 to $30. CMS hopes this change will increase access to these potentially life-saving injections and lead to greater vaccination uptake.
5. Expands pulmonary rehabilitation coverage under COVID: CMS also finalized expanded coverage of outpatient pulmonary rehabilitation services, paid under Medicare Part B, to individuals who have had confirmed or suspected COVID-19 and experience persistent symptoms that include respiratory dysfunction for at least four weeks. CMS also finalized a temporary extension of certain cardiac and intensive cardiac rehabilitation services available via telehealth for people with Medicare until the end of December 2023.
6. Advances the Quality Payment Program (QPP) and MIPS Value Pathways: The final rule makes several key changes to CMS’ QPP, a value-based payment program that promotes the delivery of high-value care by clinicians through a combination of financial incentives and disincentives.
For example, CMS said it finalized a higher performance threshold that clinicians will be required to exceed in 2022 to be eligible for positive payment incentives. This new threshold was determined in accordance with statutory requirements for the QPP’s Merit-based Incentive Payment System (MIPS).
7. Updates clinical labor rates: For the first time in nearly 20 years, CMS said it is updating the clinical labor rates that are used to calculate practice expense under the PFS. As a result, payments to primary care specialists that involve more clinical labor, such as family practice, geriatrics, and internal medicine specialties, are expected to increase. There will be a four-year transition period to implement the clinical labor pricing update, which will help maintain payment stability and mitigate any potential negative effects on health care providers by gradually phasing in the changes over time.
8. Increases access to physician assistants’ (PA) services: CMS will also make direct Medicare payments to PAs for professional services they furnish under Part B. For the first time, beginning January 1, 2022, PAs will be able to bill Medicare directly.