For more information about this blog post, please contact Khaled J. Klele, Ryan M. Magee, Labinot Alexander Berlajolli, or Daniel J. Parziale.

Time to Repay Medicare Loans Extended

On September 30, 2020, as part of a larger government short-term spending bill, President Trump signed into law a program which relaxes the repayment terms for Medicare loans that hospitals received earlier this year under the Accelerated and Advanced Payment Program. Whereas the loans were originally due 120 days after they were issued, the new law directs the Centers for Medicare & Medicaid Services (“CMS”)  to wait up to one year after the loan was issued to begin withholding Medicare payments to recoup funds.

Insurers Roll Back Telehealth Coverage

On October 1, 2020, Anthem and UnitedHealth Group will implement changes made to virtual health coverage on select plans, scaling back telehealth coverage originally launched in light of COVID-19. Specifically, UnitedHealth updated its cost-sharing for its individual plans and fully insured employer plans regarding non-COVID-19 virtual visits, including those with Medicare Advantage.  Patients enrolled in Anthem's fully insured employer and individual plans will also have cost-sharing for non-COVID-19 virtual visits. Just because these insurers rolled back some coverage does not necessarily mean these changes are effective in New Jersey. To make sure that the rollbacks apply to your patients, please check the various orders in New Jersey that were issued as a result of the pandemic.

Proposed Rule on 340B Program

85 FR 60748 – The Department of Health and Human Services (“HHS”) issued a proposed rule implementing Executive Order 13937, which requires that entities funded under section 330(e) of the Public Health Service Act that also participate in the 340B Drug Pricing Program, must establish practices to provide access to insulin and injectable epinephrine to low-income patients at the price the health center purchased the drugs through the 340B Drug Pricing Program. To qualify under the proposed rule, low-income patients must have (a) a high cost sharing requirement for either insulin or injectable epinephrine, (b) a high unmet deductible, or (c) no health insurance at all. Comments are due October 28, 2020.

HHS Announces New Program to Monitor Health IT

HHS recently announced a new initiative to monitor and measure health information technology (“health IT”) use among office-based physicians across the country. The HHS’s Office of National Coordinated Health Information Technology (“ONC”) awarded a cooperative agreement to the American Board of Family Medicine (“ABFM”) to monitor and measure the use and potential burdens experienced by office-based physicians use of health IT. Under the three-year cooperative agreement, ABFM will: (a) develop key measures related to health IT use and the interoperability of health information; (b) collect data from a nationally representative sample of office-based physicians to support national level progress; and (c) collaborate with the ONC on the analysis and interpretation of the survey results. The ONC expects to utilize the data it collects to impact future federal health IT policies.

Quick-Start Guidance for Clinical Laboratory Improvement Amendments ("CLIA") Certification

CMS recently published guidance for laboratories seeking to apply for CLIA certification. CLIA regulates the quality and safety of U.S. clinical laboratories to ensure the accuracy, reliability, and timeliness of patient results, regardless of where the test was performed. As part of its regulatory oversight, CLIA imposes requirements that all laboratories must meet to obtain certification.  Pursuant to CLIA’s guidance, applicants must: (1) complete Form CMS-116; (2) submit Form CMS-116 to the appropriate state agency; (3) receive a fee coupon; (4) pay applicable fees using the U.S. Treasury online platform; (5) receive a Certificate of Registration; and (6) maintain a valid and current CLIA Certificate in accordance with CLIA’s survey schedule.