Please join us as Rivkin Radler Associate Ashley Algazi presents the September Lunch and Learn. The program will:

• Review HIPAA breach definition
• Discuss the analysis and investigation process to determine if a breach has occurred
• Review exceptions to the definition of ‘breach’
• Discuss covered entity vs business associate

On July 13, the Office of Medicaid Inspector General (OMIG) published proposed regulations implementing 2020 changes to law relating to provider compliance programs, Medicaid managed care fraud, waste and abuse prevention programs, and OMIG’s self-disclosure program. The proposed changes will significantly impact both payers and providers alike.

Hear from Robert Hussar, a compliance professional and

On September 28, 2022, Jeff Kaiser will be a panelist at the Practising Law Institute’s program, Life Sciences 2022: Navigating Legal Challenges in Drug and Device Industries. The program is designed for attorneys and allied professionals who counsel pharmaceutical and life sciences companies.

Entitled “Enforcement Trends Impacting the Drug and Device Industries,” Jeff’s panel will

Marc Ullman spoke with Natural Products INSIDER for the article, “FDA hoping to shrink pool of noncompliant ingredient notifications.”

The story discusses the U.S. Food & Drug Administration’s recent guidance that it is providing a 180-day amnesty to manufacturers of nutritional products that failed to file a New Dietary Ingredient (NDI) notification.

Marc is not convinced

Marc Ullman was cited in the Natural Products Insider article “NDI warning letters fuel criticism of FDA enforcement approach—again.”

In May, the FDA issued warnings to several companies who sell dietary supplements. The warning letters indicated that some of the supplements “could potentially harm consumers,” according to a constituent update. Targeting six supplements specifically, the

Please join us for the June lunch and learn, presented by Partners Frank Izzo and Wendy Sheinberg. The program will discuss:

Article 9 (mental health)
The FHCDA
Article 81 (guardianships)
HIPAA issues

The program will be moderated by Robert Hussar, a partner in Rivkin Radler’s Compliance, Investigations & White Collar and Health

The prestigious Chambers USA Directory has once again included Rivkin Radler LLP in its New York rankings. The firm’s Insurance Coverage Practice Group is ranked in Band 3 in the Insurance: Dispute Resolution: Insurer category. Insurance Practice Group Partner William M. Savino is a Ranked Lawyer in Band 3. The firm’s Health Services Practice Group

Eric Fader explained that certain steps can be taken in preparation of a medical tourist patient in the PartB News article, “Prepare and monitor: Take extra steps when the patient’s a medical tourist.”

If a patient plans on getting medical treatment in another country, make him or her aware of the risks involved and and

Eric Fader was quoted in the PartB News article, “Did your practice get burned online? Reach out — and redirect.”

The article examines what providers should do when they receive a negative review. Responding can make matters worse or even violate HIPAA.

Even if a patient discloses much of his or her own private health

Marc Ullman commented on the FDA’s recent announcement that it will exercise enforcement discretion on the use of NAC in the NutraIngredientsUSA article, “FDA formally announces NAC enforcement, but legal handover remains.”

The draft guidance came in response to two petitions, one referencing the DSHEA grandfather date of 1994. The FDA rejected the grandfather date