Judith A. Waltz

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No Fraud Waivers Contemplated On February 14, 2019, CMS’ Innovation Center announced its Emergency Triage, Treat, and Transport (ET3) Model for EMS / ambulance suppliers to partner with other health care providers such as telehealth entities and urgent care centers in order to triage and treat Medicare beneficiaries more effectively.  In response to a recent inquiry, the ET3 Model Help Center clarified that at this time, CMS does not plan to issue fraud and abuse…
In November 2018, I had the honor and pleasure of speaking at the AHLA Fundamentals of Health Law program in Chicago. This is a conference that is designed for attorneys (and others) who are relatively new to health law. I spoke on the exciting topic of “Medicare Parts A and B.” As I prepared for this session, the first thought I had was that it was too hard a topic, even though I have been…
On January 31, 2019, the United States Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) announced a proposed rule, which would eliminate certain drug rebates and encourage direct discounts for federal beneficiaries.  Specifically, the rule would:…
This year marks the 15th anniversary of the completion of the Human Genome Project. In the decade and a half that has passed since, the genomic revolution has spurred an immeasurable level of excitement and support surrounding the promise of personalized medicine, setting high expectations for a new era of health care and rapidly transforming the field into a multi-billion dollar industry. While realizing that promise has turned out to be neither quick nor easy,…
On July 18, 2018, the federal Department of Health and Human Services (HHS) sent a proposed rule to the Office of Management and Budget (OMB) for review and clearance. While the substance of the proposed rule is not yet published (or leaked), the title of the rule itself is rather transparent: Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of a New Safe Harbor Protection (Proposed Rule).…
Providers and suppliers who have been assessed overpayments for Medicare services are entitled, by statute, to a stay of recoupment while the provider or supplier’s appeal is pending – but only at the first two levels of administrative appeal. If both appeals are unfavorable to the provider or supplier, the next step is an appeal to the Office of Medicare Hearings and Appeals, where the matter is heard by an Administrative Law Judge (ALJ).  During…
Two recent announcements reflect that the U.S. Government is taking aggressive steps to address opioid abuse by identifying and targeting the involvement of medical professionals in facilitating opioid abuse involving Federal health care program beneficiaries.  The U.S. Department of Justice announced on July 13, 2017 fraud charges involving 412 defendants in 41 federal districts across the country, including 115 doctors, nurses, and licensed professionals.  In what the DOJ asserted was the “largest ever health care…
Fresh off his noticeably smooth confirmation, the new Commissioner of Food and Drugs, Dr. Scott Gottlieb, appeared before Congress last Thursday and unveiled his strategic initiatives and priorities for the Trump Food and Drug Administration (“FDA”).  These run the gamut from improving regulatory science and policies to streamlining clinical trials to spurring innovation on behalf of patients.  Two initiatives, in particular, merit closer attention and discussion: combating opioid abuse and addressing drug price increases through…
On Jan. 12, 2017, the Office of Inspector General of the U.S. Department of Health and Human Services issued the third and final installment of its recent three-part rulemaking effort — a final rule updating its exclusion regulations, 82 Fed. Reg. 4100 (Jan. 12, 2017). This final rule follows two others that were published in December updating the OIG’s civil monetary penalty (CMP) regulations, 81 Fed. Reg. 88,334 (Dec. 7, 2016), and safe harbors under the anti-kickback statute and…
The Centers for Medicare and Medicaid Services (CMS) has demonstrated that it will not hesitate to use one of its most crippling administrative enforcement tools—the revocation of Medicare billing privileges—against one of its largest suppliers, as is evident in its case against Arriva Medical, LLC. Medicare billing privileges may be revoked for any one (or more) of several grounds laid out in the regulations at 42 C.F.R. § 424.535. In this case, CMS relied upon…