Legislation and Public Policy

In an April 15 notice on its COVID-19 portal, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) reminded healthcare providers that COVID-19 vaccines must be administered at no out-of-pocket cost to patients. OIG has received complaints from patients that their providers charged them for COVID-19 vaccines.

Under the Centers for

On February 16, 2021, the Governor enacted the Child-Parent Security Act (“the Act”) through emergency regulations, legalizing compensated gestational surrogacy in New York State.

With gestational surrogacy, a surrogate gestates an embryo for the intended parents. The embryo may contain the genetic material of the intended parents or donor gametes. Traditional surrogacy, where the

In a recent advisory opinion, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) determined not to impose sanctions under the federal Anti-Kickback Statute (AKS) on a drug manufacturer program that offers a free drug to certain eligible patients. The manufacturer uses personalized medicine technology to make the drug from

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

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