With low rates of Medicare reimbursement, complex and unclear regulations, tremendous administrative burden, and the often arbitrary actions of Medicare contractors, a growing number of physicians and healthcare providers may wonder if there is an alternative to participation in Medicare. There is. Some providers have the option to “opt-out” of…
Wachler & Associates Health Law Blog
More Changes to No Surprises Act Final Rule
On Friday, August 26, 2022, the Department of Health and Human Services (HHS) Centers for Medicare and Medicaid Services (CMS), Department of Labor, and Department of Treasury (collectively, the Departments) issued a new Final Rule updating key regulations pertaining to the No Surprises Act. The Final Rule addresses disclosure requirements…
HHS OIG Issues New Advisory Opinion Regarding Speaking Engagements
The Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently issued OIG Advisory Opinion No. 22-14 that applied its November 2020 special fraud alert targeting remuneration associated with speaking arrangements funded by pharmaceutical and medical device companies. The November 2020 special fraud alert addressed potential Anti-Kickback…
OIG Updates Work Plan for August 2022
The Department of Health and Human Services (HHS) Office of Inspector General (OIG) announced several new changes in its Work Plan update in August 2022. The OIG Work Plan forecasts the projects that OIG plans to implement over the foreseeable future. These projects usually include OIG audits and evaluations. Below…
HRSA Starting Audits for COVID-19 Testing
More of the long-promised enforcement actions related to COVID-19 pandemic relief and healthcare programs have started to unfold. This time it is demands from the Health Resources and Services Administration (“HRSA”) that providers repay funds they have received for providing COVID-19 testing to the uninsured during the pandemic. As part…
HHS Issues New Rules for No Surprises Act Dispute Resolution
The Departments of Health and Human Services (HHS), Labor, and the Treasury recently issued new guidance for the dispute resolution process under the federal No Surprises Act. The Departments have made several attempts to implement regulations since the No Surprises Act was enacted in late 2020. Some have been interim…
Appealing Medicare Audits: What to Know
When a Medicare contractor denies a claim, the provider generally has a right to a lengthy appeal process, which is both complex and contains many strict deadlines. In some circumstances, claims can take years to fully progress through the appeals process. However, some limited cases may be eligible for settlement…
HHS and DOJ Release Guidance Regarding Accessibility of Telemedicine Services
The use of telemedicine has exploded over the last few years. The COVID-19 pandemic spurred a shift from in-person services to services provided by telemedicine. As healthcare providers and patients experience the added convenience of telemedicine in some circumstances, some of the large-scale shifts to telemedicine will likely become permanent.…
Commercial Payor Audits of Labs for COVID-19 Growing
As the COVID-19 pandemic continues to recede, efforts by commercial insurance carriers to claw back millions of dollars paid out for COVID-19 testing services are steadily increasing, creating an ongoing audit risk for healthcare providers, especially clinical labs. In many cases, efforts to get people tested, slow the pandemic, and…
Contours of EKRA Still Forming
One of the largest areas of debate in healthcare regulatory compliance is the Eliminating Kickbacks in Recovery Act (EKRA). Despite the many question marks by healthcare providers around how to comply with EKRA, the statute also carries some of the stiffest penalties for failing to do so. Enacted in 2018,…