Legislation and Public Policy


NYS Legalizes Gestational Surrogacy: Changes for Health Care Providers
April 7, 2021 | Wendy Hoey Sheinberg | Cassandra Rivais DiNova | Legislation and Public Policy
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 surrogate …
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Free Drug Program Avoids Sanctions Under AKS
April 6, 2021 | Ada (Kozicz) Janocinska | FDA | Fraud and Abuse | Legislation and Public Policy | Medicare and Medicaid | Pharmaceuticals
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 the …
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Pandemic response, fraud and abuse top Biden’s enforcement priorities
March 31, 2021 | Rivkin Rounds Staff | COVID-19 | False Claims Act | Fraud and Abuse | HIPAA | Hospitals | Legislation and Public Policy | Litigation
A March 24 article in Wolters Kluwer’s Health Law Daily, “STRATEGIC PERSPECTIVES: Pandemic response, fraud and abuse top Biden’s enforcement priorities,” quoted healthcare industry experts who predict increased enforcement in the areas of fraud and abuse, False Claims Act (FCA) cases, and pandemic-related waivers. Rivkin Radler’s Robert Hussar was quoted in the article. Among Bob’s …
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Shapiro Quoted on CBD Warning Letters in Vitamin Retailer
March 31, 2021 | Rivkin Rounds Staff | Cannabis | FDA | Legislation and Public Policy
A March 26 article in Vitamin Retailer, “FDA Warns Selling of Topical CBD Products Violates FD&C Act,” discussed the two warning letters recently issued by the U.S. Food and Drug Administration (FDA) to two companies for selling topical pain relief products containing CBD. The FDA claims that the sale of the products violates the Federal …
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FDA Warns that Topical Pain-Relief Products Containing CBD Violate FD&C Act
March 25, 2021 | Steven Shapiro | Marc S. Ullman | Cannabis | FDA | Legislation and Public Policy | Pharmaceuticals
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 announced that …
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Time For CEs, BAs to Take Right of Access Seriously
March 18, 2021 | Rivkin Rounds Staff | Electronic Health Records | Employer/Employee | HIPAA | Hospitals | Legislation and Public Policy | Litigation
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 2019. …
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HIPAA Right of Access Initiative Marches On
February 26, 2021 | Eric D. Fader | Electronic Health Records | HIPAA | Hospitals | Legislation and Public Policy | Litigation
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 …
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Provider Relief Fund Audits Coming
February 23, 2021 | Rivkin Rounds Staff | COVID-19 | Legislation and Public Policy | Medicare and Medicaid
A February 15 article in Part B News, “Provider Relief Fund audits coming; pick your method and keep good records,” discussed the Provider Relief Fund (PRF) authorized under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). Rivkin Radler’s Bob Iseman was quoted in the article. Healthcare providers who received PRF funds were required …
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HHS Relaxes Rules on Administering COVID-19 Vaccines
February 5, 2021 | Ada (Kozicz) Janocinska | COVID-19 | Legislation and Public Policy | Pharmaceuticals
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 …
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CMS Clarifies RPM Reimbursement
January 28, 2021 | Eric D. Fader | Home Health | Legislation and Public Policy | Medical Devices and Wearables | Medicare and Medicaid | Telehealth
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 …
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