On May 19, 2023, Novitas Solutions and First Coast Options sent an email to certain interested parties, with whom they had engaged following the multijurisdictional contractor advisory committee (CAC) meeting, explaining that they have decided to not pursue at this time a local coverage determination for remote physiological monitoring (RPM) and remote therapeutic monitoring (RTM).
What does this communication mean for RPM/RTM service providers?
The US Department of Health and Human Services Office for Civil Rights (OCR) recently announced a settlement with a community hospital resolving an investigation under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) privacy and security rules. While the settlement involved a medical provider, it offers some important lessons for other HIPAA-covered entities, including employer-sponsored group health plans.
The settlement involved impermissible data breaches by non-medical staff who, allegedly, used their login credentials to access patient medical records maintained in the hospital’s electronic medical record system without a job-related purpose. The lesson here is straightforward: all HIPAA-covered entities must “protect the privacy and security of health information.”
The HIPAA privacy and security rules are complex, and full compliance requires substantial resources that are, as a practical matter, beyond the reach of many organizations. While OCR routinely refers to these rules as “scalable,” that claim is difficult to square with our experience. Full compliance with the particulars of the rule is costly and time-consuming, and it requires no shortage of expertise. Thankfully, in practice, OCR tends to focus its investigative resources on certain features of these rules. These features include the following items which covered entities must perform to comply:
Where group health plans are concerned, fully insured plans routinely rely on their carriers for HIPAA compliance, which requires that plan sponsors get only “summary” health information at renewal. This option is not available to self-funded plans, however, even those that contract with a carrier for administrative services. Employers in this latter category should be reasonably confident of surviving an OCR audit or investigation only, at a minimum, by taking the actions listed above.
The US Drug Enforcement Administration (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) are extending telehealth flexibilities that allow providers to prescribe controlled substances. While the extension is in place, the DEA indicated that it will be further evaluating its recently proposed rules for post-COVID-19 public health emergency telemedicine prescription of controlled substances.
US lawmakers recently advanced a broad healthcare bill during a US House Energy & Commerce Health Subcommittee markup. In this Health Policy Breakroom podcast episode, McDermott+Consulting’s Debra Curtis and Rodney Whitlock break down the markup and address extenders, PBMs, site-neutral policies and the timing of this bill.
At a recent open Commission meeting, the Federal Trade Commission (FTC) voted unanimously to issue a Notice of Proposed Rulemaking to amend the Health Breach Notification Rule (HBNR). The FTC’s proposed amendment aims to codify the HBNR’s application to digital health and mobile technologies. However, several aspects of the proposed amendment lack clarity and are likely to cause confusion unless further clarified through the ongoing rulemaking process.
The US Department of Health and Human Services Office of the Inspector General (HHS OIG) recently unveiled a new toolkit that seeks to help analyze telehealth claims for federal healthcare program integrity risks. It is based on methodologies highlighted in OIG’s September 2022 data brief; the data brief identified billing practices by Medicare providers that OIG was concerned posed a high risk to program integrity. OIG intends for the toolkit to be used by public and private parties—including Medicare Advantage plan sponsors, private health plans, State Medicaid Fraud Control Units and other federal healthcare agencies—to assess program integrity risks and identify providers whose billing may warrant further scrutiny.
Members of Congress could call for more transparency about how hospitals use their federal drug discount program savings. According to this Bloomberg Law article, a study found that the Health Resources and Services Administration’s oversight of the 340B program could be improved. McDermott Partner Emily Jane Cook said there is interest in Congress overseeing aspects of hospitals, including the 340B program.
“I wouldn’t be surprised to see a bill being introduced that imposes more explicit oversight requirements,” Cook said.
Reproduced with permission. Published May 15, 2023. Copyright 2023 by Bloomberg Industry Group, Inc. (800-372-1033) http://www.bloombergindustry.com.
Medicare Advantage (MA) plans are facing both regulatory and business risks following the conclusion of the COVID-19 Public Health Emergency (PHE). What are the major MA flexibilities and requirements related to the pandemic, and have they ended along with the PHE?
The Internal Revenue Service (IRS) recently issued a Chief Counsel Advice memorandum to remind sponsors of health and dependent care flexible spending arrangements (FSAs) about their responsibility to adequately substantiate claims in order to receive favorable tax treatment under Section 125 of the Internal Revenue Code (the Code). The IRS emphasizes that the standards for substantiation are stringent, and employers who fail to comply will face significant and undesirable consequences. The memorandum also provides a helpful overview of the relevant laws, illustrated through six examples of claims practices.
For decades, promoters have marketed programs to employers seeking to leverage the favorable tax treatment accorded employer-provided medical benefits. These programs are variously described as “wellness” or “preventive services” arrangements, and they are usually wrapped in or offered with hospital indemnity policies. While varying in their design features and terminology, these programs all hold out the promise of outsized income and/or payroll tax savings. But can these programs deliver on that promise?
In a new article published by the American Staffing Association, McDermott’s Alden J. Bianchi and American Staffing Association Senior Counsel Edward Lenz express their view that any such health program that claims to achieve material payroll tax savings exposes adopting employers to a significant risk of violating federal tax and other laws.
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