Photo of Peter J. Eggers

JAMA Internal Medicine recently published an article finding that the number of homebound adults aged 70 or older more than doubled during the last decade. In 2011, approximately 5% of adults aged 70 or older were homebound compared with 13% in the same age group in 2020. The authors indicate the steep incline in 2020 was likely due to social distancing restrictions and other health precautions taken over the course of the COVID-19 pandemic. But the high number of homebound adults aged 70 and older will likely continue throughout 2021 and have potential lasting effects on the overall health of the individuals and their health care delivery.

While telehealth has become a staple in the lives of many post-pandemic (as discussed in a prior blog post), it may not be reaching this vulnerable population. The JAMA article indicated that, of the survey respondents, 27.8% did not have a cell phone, 50.8% did not have a computer, and more than 50% did not email, text or go online in the last month. This means those in this population that need assistance with health care services may need to rely on in-person home care.

On June 24, 2021, New York Governor Andrew Cuomo issued Executive Order 210, which officially declared the end of the New York State of Emergency caused by the COVID-19 pandemic effective June 25, 2021. The issuance of the Executive Order marked an important milestone for life post-pandemic and a welcome result for small businesses barely treading water trying to comply with the COVID-19 restrictions. However, the abruptness of the announcement, the limited carve-outs for health care professionals and the organizations that employ or contract with them, and the lack of permanent alternative solutions will create a tumultuous few weeks for those parties.

Many of us have been waiting to hear the final word about what’s next from CMS for the Next Generation ACO Model. On May 21, 2021, CMS’s Innovation Center (“CMMI”) confirmed that the Next Generation ACO Model would not be extended and will conclude at the end of this year as planned. The Next Generation ACO Model has been the most advanced value-based contracting model offered by CMS with participating risk-bearing entities taking between 80%-100% upside and downside risk.  However, according to reports, the model didn’t achieve sufficient savings to justify making it a permanent CMMI program.

As is the case with most new technologies or significant industry innovations, companies embracing and driving the disruptions often move very fast in a legal and political landscape that is always playing catch-up. This is very true for the fast-growing telemedicine and digital health industries. However, likely motivated by COVID-19, state governments are moving faster than they traditionally do to pass new regulations and to extend certain regulatory waivers.

COVID-19 required a shift in the delivery of medical care with the state and local lockdowns. During the pandemic, the United States Department of Health and Human Services (HHS) has issued guidance on various compliance waivers and enhanced flexibility. Governors across the country issued executive orders to help address the requirements of providing ongoing medical care while maintaining proper social distancing (e.g., New Mexico, Texas, etc.). The result was more people receiving medical care remotely. Similar to the realization by many that working from home was not only feasible but in some cases preferable, many also came to the conclusion that a trip to the doctors’ office was not necessary for the treatment of certain conditions.

A recent Fourth Circuit decision, United States v. Mallory (988 F.3d 730), upheld damages and penalties for more than $100 million for violations of the Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)) (the “AKS”) and the False Claims Act (31 U.S.C. § 3729) by a blood testing laboratory and its contracted sales agents.  The Court held that commission payments made by the laboratory to its sales agents (sales companies that, in turn, hired and contracted salespeople to sell the laboratory blood tests), which were based on the percentage of revenue the sales agents generated for the laboratory through marketing services, constituted improper “remuneration” that intended to induce the sales agents to sell as many laboratory tests as possible. The defendants failed to show that the arrangements fit within an AKS Safe Harbor.