Legislation and Public Policy

This week, the U.S. Food and Drug Administration (FDA) issued Warning Letters that effectively declare that the presence of cannabidiol (CBD) as an inactive ingredient in topical over-the-counter (OTC) drug products is a  violation of the federal Food, Drug, and Cosmetic Act (FD&C Act).

In a news release issued on March 22, 2021 the FDA…

A March 11 article in the Health Care Compliance Association’s Report on Patient Privacy, “In Wake of 16th OCR Settlement, Time For CEs, BAs to Take Right of Access Seriously,” discussed the Right of Access Initiative that the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) has been pursuing since…

For those providers who somehow missed or ignored the first 15 settlements in the series, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) recently announced that Sharp HealthCare, doing business as Sharp Rees-Stealy Medical Centers, agreed to pay a $70,000 fine for failing to provide a patient with timely access…

On January 28, the U.S. Department of Health and Human Services (HHS) announced that it has amended the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to expand the types of providers that are qualified to prescribe, dispense and administer COVID-19 vaccines. Under the amendment, any healthcare provider that is licensed or…

The Centers for Medicare & Medicaid Services (CMS) recently released corrections to its 2021 Physician Fee Schedule final rule that was published on December 28. Some of the corrections clarify reimbursement requirements for remote patient monitoring (RPM), which entails gathering and interpreting physiologic data from patients at home.

The December 28 final rule had stated…

The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) announced the 14th settlement in its ongoing HIPAA Right of Access Initiative. Banner Health, a Phoenix-based health system that operates 30 hospitals and many other healthcare facilities, agreed to pay $200,000 for failing to provide patients with timely access to their medical…

On January 12, the U.S. Department of Health and Human Services (HHS) released a final rule on “Transparency and Fairness in Civil Administrative Enforcement Actions.” The rule, which was effective immediately, states that HHS can rely only on statutes and regulations in bringing civil enforcement actions. Standards set forth in agency guidance documents…

In his 2021 State of the State Address on January 10, New York Governor Andrew Cuomo announced legislation to expand access to telehealth. The proposals will adjust reimbursement incentives to encourage telehealth, relax or eliminate outdated regulatory restrictions on the delivery of telehealth services, and establish training programs for patients and providers and other programs…