Back to School: No Religious Exemption for Immunizations in New York
July 29, 2019 | Legislation and Public Policy | Litigation

As parents and healthcare providers prepare for the start of the new school year, there are now more than 26,000 students who will need to get vaccinated as New York has eliminated exemptions from vaccinations due to religious beliefs. New York Public Health Law §§ 2164 and 2165 require students to be immunized against diphtheria,

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Marijuana Legalization Bills Introduced in Congress
July 26, 2019 | Behavioral Health | Cannabis | FDA | Legislation and Public Policy

On July 23, companion legislation was introduced in the House and Senate by Senator Kamala Harris of California and New York Congressman Jerrold Nadler to legalize and tax marijuana at the federal level. The tax revenue from this legislation would support job training, substance abuse treatment, literacy programs, and other services for communities that have been

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OIG Audit Reveals NY Medicaid Eligibility Errors
July 25, 2019 | Margarita Christoforou | Affordable Care Act | Legislation and Public Policy | Medicare and Medicaid

Based on a recent audit of payments under New York’s Medicaid program, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) estimated in a report that the state made hundreds of millions of dollars in payments to ineligible or “potentially ineligible” beneficiaries.

The audit examined payments to “non-newly eligible” beneficiaries, meaning

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LabCorp Offers Self-Directed Blood Testing (but not in NY/NJ)
July 24, 2019 | Eric D. Fader | Home Health | Medical Devices and Wearables

LabCorp announced on July 22 that it is now offering blood tests directly to consumers online. The clinical lab giant’s “Pixel by LabCorp” platform previously offered self-directed test kits for colorectal cancer and diabetes screening, as well as lipid panels. The service is not currently offered in New York, New Jersey, Maryland or Rhode Island.

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CVS Announces Home Dialysis Machine Trials
July 22, 2019 | Eric D. Fader | FDA | Home Health | Medical Devices and Wearables | Pharmaceuticals | Private Insurers

On July 17, CVS Health Corp. announced the beginning of human trials of a new home dialysis machine called the HemoCare Hemodialysis System. The company’s CVS Kidney Care unit hopes to shift some of the $35 billion market for end-stage kidney care from outpatient dialysis clinics to patients’ homes.

The HemoCare device was designed by

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FDA Warns on CBD Dietary Supplements
July 17, 2019 | Marc S. Ullman | Cannabis | FDA | Legislation and Public Policy | Pharmaceuticals

In a July 9 Warning Letter to Ceba-Tek, Inc. focused mainly on issues relating to failure to comply with regulations on Good Manufacturing Practices for Dietary Supplements, the U.S. Food and Drug Administration (FDA) again commented on the issues confronting companies producing and marketing CBD as an ingestible: “It is a prohibited act to introduce

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OCR Releases New HIPAA FAQs on Care Coordination
July 16, 2019 | Ada Janocinska | HIPAA | Legislation and Public Policy | Private Insurers

The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) recently issued new guidance on its HIPAA FAQs webpage regarding permissible use and disclosures of protected health information (PHI) by health plans for purposes of care coordination and continuity of care. Health plans are covered entities under HIPAA.

The guidance explains that,

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States Pick Up ACA Slack
July 12, 2019 | Eric D. Fader | Affordable Care Act | Legislation and Public Policy | Private Insurers

With the political battle over the future of the Affordable Care Act (ACA) dragging on in Washington, a number of states have recently taken steps to protect their residents from potential instability in the health insurance market. New Jersey is setting up its own state health insurance exchange to replace the federally run marketplace,

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Anesthesiologist Charged with Telemedicine Fraud
July 11, 2019 | Eric D. Fader | Fraud and Abuse | Litigation | Medicare and Medicaid | Pharmaceuticals | Telehealth

A New York anesthesiologist was indicted on July 9 for conspiring with pharmacies and medical equipment suppliers to defraud the Medicare program and other insurers. Anna Steiner, also known as Hanna Wasielewska, allegedly wrote prescriptions for drugs and durable medical equipment for patients supposedly seen via telemedicine without ever having actually examined or evaluated the

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Drug Price Disclosure Rule Vacated
July 10, 2019 | Eric D. Fader | Legislation and Public Policy | Medicare and Medicaid | Pharmaceuticals

A new federal regulation that would have required companies to disclose wholesale prices of prescription drugs in television advertisements was rejected by a federal court on July 8, one day before the rule would have taken effect. Amgen Inc., Eli Lilly & Co. and Merck & Co. Inc. had filed suit challenging the rule, claiming

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