Earlier this month, the Office for Civil Rights issued a bulletin outlining guidance for online tracking technologies. The bulletin sets a regulatory framework for the use of tracking technologies by regulated entities and states that regulated entities are not permitted to use tracking technologies in a manner that would result in impermissible disclosures of PHI to tracking technology vendors or any other violations of the HIPAA Rules.

The U.S. Food and Drug Administration (“FDA”) recently announced that its Vaccines and Related Biological Products Advisory Committee (“VRBPAC”) will hold a meeting on January 26, 2023 to consider the future vaccination regimens addressing COVID-19.

The Centers for Medicare & Medicaid Services (“CMS”), on behalf of, the U.S. Department of Health and Human Services (“HHS”) has issued a proposed rule, “Adoption of Standards for Health Care Attachments Transactions and Electronic Signatures, and Modification to Referral Certification and Authorization Transaction” (the “Proposed Rule”). The Proposed Rule seeks to adopt standards for “health care attachments” transactions. Health care attachments include medical charts, x-rays, and provider notes that document physician referrals. The comment period will close March 21, 2023.

On November 23, 2022, the Court of Appeals of Indiana unanimously agreed that blood test results of a minor, L.W., were obtained in violation of her federal and state constitutional rights against unreasonable search and seizure. L.W. v. State, No. 22A-JV-1138, 2022 WL 17172059 (Ind. Ct. App. Nov. 23, 2022). Read more here!

The Centers for Medicare and Medicaid Services (CMS) is once again engaging with the payer and provider communities on healthcare interoperability. This is being done through the issuance of a new proposed rule that is set to create new burdens for payers but frees up providers to focus more on clinical care.

Historically, emergency preparedness programs in long-term care facilities have been less prioritized, with facilities understandably focusing on patient care and operations. 

But with the pandemic and President Biden’s nursing home reform plan, a focus on emergency preparedness is key, and facilities should concentrate on, and perfect, their emergency preparedness programs now.  And we don’t mean just on paper.

The twenty-first century ushered significant advances in medical treatment for preserving health and combating diseases. Through these medical advances, healthcare providers have successfully reduced morbidity and mortality, while improving public health and safety. However, advances in patient health and safety present new areas of moral trepidation among health care providers concerning their ability to ethically render patient care. Healthcare delivery and patient safety could be compromised resulting in two potential outcomes: 1) healthcare providers might refuse to deliver adequate care out of fear of criminal liability and revocation of their license, or 2) healthcare providers might be sanctioned or prosecuted for rendering care that is prohibited by the rule of law. Thus, the delivery of healthcare could be compromised due to reduced access to healthcare and healthcare providers thereby compounding health disparities for patients already suffering from limited access to healthcare.

The Health & Life Sciences Section is pleased to announce it is offering a scholarship for the American Health Lawyers Association Fundamentals of Health Law Conference, November 9-11, 2022, in Chicago. 

On June 15, 2022, after many years of ongoing litigation1, the U.S. Supreme Court unanimously overturned a substantial Medicare Part B payment reduction to many 340B Program participating hospitals related to certain outpatient prescription drugs provided to Medicare patients for fiscal years 2018 and 2019, totaling an estimated $1.6 billion across all affected entities.

PhRMA, the pharmaceutical industry group, recently won a court order striking down the so-called "Patient Assistance Rule," which affects the Best Price pharmaceutical manufacturers must report to CMS for discounts under the Medicaid Drug Rebate Program and the 340B Drug Discount Program. The rule was meant to help curb the practice of "accumulator adjustment programs" used by insurance companies to divert pharmaceutical rebates from the patient to the insurer.