Health Care Law Today

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The U.S. Department of Health and Human Services (HHS) recently proposed two new rules designed to increase patient and provider access to health records. As stated by HHS in its press release, the proposed rules “will support seamless and secure access, exchange, and use of electronic health information.” These proposed rules stem from two separate components within HHS – the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health…
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 this session, the first thought I had was that it was too hard a topic, even though I have been…
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 will cover remote patient monitoring services. The bill now heads to the office of Governor Ralph Northam for signature.…
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 marks the sixth favorable telemedicine/digital health advisory opinion issued by OIG to date. This article describes the drug and digital…
On January 25, 2019, the Illinois Supreme Court handed down a key ruling that will make it significantly easier for consumers and workers to sue and recover damages for mere non-compliance with the requirements of the state’s Biometric Information Privacy Act, 740 ILCS 14/1 et seq. (BIPA or Act). In its highly anticipated decision in Rosenbach v. Six Flags Entertainment Corp., the state’s high court unanimously held that actual harm is not required…
On January 31, 2019, the United States Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) announced a proposed rule, which would eliminate certain drug rebates and encourage direct discounts for federal beneficiaries.  Specifically, the rule would:…
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 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 health organizations to develop meaningful cybersecurity objectives and outcomes.…
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 care facility. This rule will impose significant new obligations on health care providers, including pharmacies and long-term care providers,…
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 after the first lawsuit was dismissed for being premature—decided that it now had subject matter jurisdiction because a claim…