In November 2018, I had the honor and pleasure of speaking at the AHLA Fundamentals of Health Law program in Chicago. This is a conference that is designed for attorneys (and others) who are relatively new to health law. I spoke on the exciting topic of “Medicare Parts A and B.” As I prepared for…… Continue reading this entry

Virginia lawmakers have taken new steps to expand the use of remote patient monitoring among the State’s residents, with both the House and Senate unanimously passing bipartisan legislation ensuring that commercial health plans and the Virginia Medicaid program will cover remote patient monitoring services. The bill now heads to the office of Governor Ralph Northam…… Continue reading this entry

Last week, the federal HHS Office of Inspector General (OIG) gave the greenlight to allow a virtual care company and pharmaceutical manufacturer to loan patients free smartphones, so the patients (which include Medicare beneficiaries) could use the smartphones to track their drug therapy adherence via a mobile digital health app. The OIG’s recent Advisory Opinion…… Continue reading this entry

On January 9, 2019, the American Telemedicine Association (ATA) issued a policy comment letter to the U.S. Drug Enforcement Administration (DEA), advocating for provider-friendly changes to federal controlled substance prescribing rules. Note: the firm’s Telemedicine & Digital Health Industry Team participated in the ATA’s special workgroup to develop the recommendations. The letter offers recommendations for DEA’s…… Continue reading this entry

The U.S. Department of Health and Human Services (DHHS) recently released Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients (HICP). DHHS states that the purpose of the HICP is to: Raise awareness of cybersecurity; Provide vetted cybersecurity practices; Move organizations towards consistency in mitigating cybersecurity threats to the sector; Aid health care and public…… Continue reading this entry

On December 11, 2018, U.S. EPA Acting Administrator Andrew Wheeler signed a new hazardous waste pharmaceutical rule. The final rule retains a proposed requirement, opposed by industry, that prescription pharmaceuticals sent from health care facilities to reverse distributors first be considered “disposed of,” regulated as solid waste and evaluated for hazardous classification at the health…… Continue reading this entry

Last week, a federal district court held that the Secretary of the Department of Health and Human Services (HHS) exceeded his authority when he reduced Medicare outpatient prospective payment system (OPPS) reimbursement to hospitals for most separately payable drugs purchased under the 340B program by almost 30%. The court—hearing the case for the second time…… Continue reading this entry

The Centers for Medicare and Medicaid Services (CMS) issued a final rule (the Rule) on December 21, 2018, which reshapes the Medicare Shared Savings Program (MSSP).  Termed “Pathways to Success,” the Rule, among other things, Redesigns the options for participation in the MSSP, Requires accelerated movement to downside risk, Is designed to increase savings for…… Continue reading this entry

As noted in previous Health Care Law Today blog posts, we have seen an uptick in private equity recapitalization transactions in orthopedics. We expect this trend to continue, and to pick up pace, as the economy remains robust and the appetite for the most lucrative physician practices increases. When coupled with an increasing maturation of…… Continue reading this entry

Justice Reed O’Connor’s recent decision, Texas et al. v. U.S. et al., No. 4:18-cv-00167-O (E.D. Tex. Dec. 14, 2018), to strike down the entire Patient Protection and Affordable Care Act, 42 U.S.C. § 18001 et seq. (2010) (the ACA) as unconstitutional not only threatens to dismantle health coverage for millions of Americans and protections for…… Continue reading this entry