Carol Poindexter (US)

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OIG proposes to eliminate safe harbor protection for drug manufacturer rebates to PBMs; proposes two new safe harbors

By Carol Poindexter (US) and Savannah Wiseman (US) on February 5, 2019 Posted in Regulatory

On January 31, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a proposed new rule that, if finalized, would eliminate existing protection under the Anti-Kickback Statute (AKS) “discount” safe harbor (42 C.F.R. 1001.952(h)) for drug manufacturers’ rebates to plan sponsors or pharmacy benefit managers (PBMs) acting under contract with plan … Continue reading

Rumors of sea change in DOJ policy potentially confirmed by two recent memos

By Sarah Cummings (US) and Carol Poindexter (US) on January 31, 2018 Posted in Enforcement

Rumors of a significant shift in U.S. Department of Justice (DOJ) policy were confirmed last week when a privileged and confidential internal DOJ memo was leaked to the press. The memo outlines seven factors government attorneys should use for evaluating whether the government should seek dismissal of qui tam actions filed under the federal False Claims … Continue reading

OIG rescinds advisory opinion to charity

By Carol Poindexter (US) on November 30, 2017 Posted in Enforcement

For the first time, the OIG has rescinded an advisory opinion issued to a charity. According to the OIG, the advisory opinion – issued in 2006 and modified in 2015 – was revoked because the charity “failed to comply with certain factual certifications” about independence from donors, potentially steering Medicare beneficiaries toward certain prescription drugs. … Continue reading

Six legal and regulatory risks facing specialty pharmacies

By Carol Poindexter (US) and Savannah Wiseman (US) on March 9, 2017 Posted in Regulatory

“Specialty drugs” are a fast growing sector of the pharmaceutical industry and are predicated to represent 50 percent of drug expenditures in the United States by 2020.[1] Specialty drugs are typically dispensed by specialty pharmacies. Although there is no agreed-upon industry definition of “specialty pharmacy,” generally, these pharmacies focus on dispensing and distributing high cost … Continue reading

Fourth circuit declines to rule on the appropriateness of statistical sampling in FCA cases

By Carol Poindexter (US) and Megan Engel (US) on February 15, 2017 Posted in Enforcement

As expected after oral arguments, the Fourth Circuit Court of Appeals declined to decide whether parties may use statistical sampling to prove False Claims Act liability in United States ex rel. Michaels v. Agape Senior Community, Inc., Nos. 15-2145 and 15-2147, by finding that the issue was fact-driven and thus not appropriate for interlocutory review. … Continue reading

FDA finalizes guidance on medical device safety

By Carol Poindexter (US), Chaula Mehta (US) and Krishna Kavi (US) on December 19, 2016 Posted in FDA & Food Safety

The Food and Drug Administration (“FDA”) released its final guidance on medical device safety on December 14, 2016, titled “Public Notification of Emerging Postmarket Medical Device Signals (Emerging Signals).” The final guidance comes almost a year after FDA issued a similar draft guidance on the topic. As with the draft guidance, industry remains concerned about … Continue reading

FCA civil penalties to increase substantially under proposed rule

By Carol Poindexter (US), Michael Koon (US) and Megan Engel (US) on May 5, 2016 Posted in Enforcement

Earlier this week, the Railroad Retirement Board (RRB) became the first federal agency to promulgate an interim final rule implementing provisions of the Bipartisan Budget Act of 2015 intended to index civil penalties assessed under certain statutes to inflation. The RRB’s proposed final rule would double civil penalties assessed under the False Claims Act (FCA). … Continue reading

Company exec can face $18M in restitution for ignoring attorney warnings

By Carol Poindexter (US), Jim Wiehl (US) and Savannah Wiseman (US) on March 21, 2016 Posted in Enforcement

On March 3rd, the Ninth Circuit ruled that the president of Commerce Planet, Inc. could be held personally liable for violations of the Federal Trade Commission Act (FTC Act) after he ignored warnings from his in-house counsel that the company’s disclosures about the monthly fees for an online auction kit were inadequate under the FTC Act. … Continue reading

CMS issues anticipated Medicare overpayments final rule; relaxes initial proposals

By Thomas Dowdell (US), Carol Poindexter (US), Mark Faccenda (US) and Blake Walsh (US) on February 12, 2016 Posted in Regulatory

On February 11, 2016, CMS issued a final rule clarifying the requirement of § 1128J(d) of the Social Security Act (created by § 6402(d) of the Affordable Care Act) that health care providers must report and return overpayments within 60 days of the date when they have identified the overpayment or the date any applicable … Continue reading

FDA builds on postmarket cybersecurity measures for medical devices

By Carol Poindexter (US) and Krishna Kavi (US) on January 26, 2016 Posted in FDA & Food Safety, Regulatory

On January 15, 2016, the U.S. Food and Drug Administration (“FDA”) released draft guidance entitled, “Postmarket Management of Cybersecurity in Medical Devices,” outlining recommendations to medical device manufacturers for managing postmarket cybersecurity vulnerabilities for marketed medical devices. The FDA stresses that an effective cybersecurity risk management program should address potential cybersecurity risks throughout the product’s … Continue reading

FDA advocates for new regulatory framework for in vitro clinical tests at November 17 Hearing before the Committee on Energy and Commerce

By Carol Poindexter (US) and Blake Walsh (US) on November 19, 2015 Posted in FDA & Food Safety

On November 17, 2015, the Committee on Energy and Commerce, Subcommittee on Health, held a hearing focusing on draft proposed legislation supporting a new regulatory framework for in vitro clinical tests that would comprise a new category under the Federal Food, Drug, and Cosmetic Act. Jeffrey Shuren, M.D., J.D., Director, Center for Devices and Radiological … Continue reading

OIG changes requirements for Patient Assistance Programs, modifies favorable Advisory Opinions

By Carol Poindexter (US) and Elizabeth Han (US) on November 9, 2015 Posted in Regulatory

The Office of Inspector General has revised two Advisory Opinions in light of changes made by two charities in response to new fraud protection guidance from the OIG. As we previously discussed, in 2014 the OIG issued a Supplemental Bulletin (“the Bulletin”) providing guidance to independent charities that operate patient assistance programs (“PAPs”) to ensure … Continue reading

OIG releases FY 2016 work plan

By Carol Poindexter (US), Megan Engel (US) and Erin Close (US) on November 3, 2015 Posted in Regulatory

On November 2, 2015, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published its Work Plan for fiscal year (FY) 2016. The OIG announced that in the upcoming year, it will continue to investigate various Medicare and Medicaid claims made by nearly every type of provider group. Below is a … Continue reading

Tuomey settles for $72.4 million, will be sold and under CIA

By Carol Poindexter (US) on October 19, 2015 Posted in Enforcement

Facing a $237 million verdict for alleged illegal compensation arrangements with doctors, Tuomey Healthcare System has agreed to settle with the government for $72.4 million. According to the government’s press release, Tuomey will be sold to Palmetto Health, a multi-hospital healthcare system, as part of the settlement. Tuomey must also retain an independent review organization … Continue reading

Fourth circuit agrees to review appeal of FCA sampling case

By Michael Koon (US), Carol Poindexter (US) and Megan Engel (US) on October 1, 2015 Posted in Enforcement

On Tuesday, the Fourth Circuit Court of Appeals agreed to hear an appeal of a False Claims Act (FCA) case that raises the question of whether statistical sampling and data extrapolation can be used to prove liability without other claim-by-claim proof. The case also presents the question of whether the government has absolute, unreviewable veto … Continue reading

OIG approves free 30-day supply of drugs for patients experiencing coverage delay

By Carol Poindexter (US) and Savannah Wiseman (US) on August 17, 2015 Posted in Regulatory

The OIG released an advisory opinion stating that it would not impose administrative sanctions against two drug manufacturers or their affiliated pharmacy for offering a free 30-day supply of an antineoplastic drug to patients who experience a delay in the insurance approval process. Although the advisory opinion addresses the provision of a limited free supply … Continue reading

NY Federal Judge shields Amarin Pharma Inc. from FDA’s chill on its First Amendment rights

By Carol Poindexter (US) and Lidia Niecko-Najjum (US) on August 10, 2015 Posted in FDA & Food Safety

On August 7, New York Federal Judge Paul A. Engelmayer granted Amarin Pharma Inc. (Amarin) a preliminary injunction “to ensure its ability to engage in truthful and non-misleading speech free from the threat of a misbranding action” by the Food and Drug Administration (FDA). Amarin had brought a First Amendment challenge to FDA regulations that … Continue reading

Judge sides with government on FCA 60-day overpayment rule

By Carol Poindexter (US) and Megan Engel (US) on August 6, 2015 Posted in Enforcement

In the first decision interpreting the 60-day overpayment rule of the False Claims Act (”FCA”), Judge Edgardo Ramos of the Southern District of New York held that an overpayment has been “identified” for purposes of starting the 60-day overpayment refund clock when “a provider has been put on notice of a potential overpayment, rather than … Continue reading

Third Circuit extends Actavis to non-cash reverse payments

By Darryl Anderson (US), Carol Poindexter (US) and Savannah Wiseman (US) on July 9, 2015 Posted in Enforcement

On June 26, the Third Circuit ruled that so-called “reverse payment” settlement agreements of patent infringement litigation between branded and generic pharmaceutical companies can face antitrust scrutiny under the Supreme Court’s decision in FTC v. Actavis, even when the “payment” at issue is an agreement by the branded company not to market an authorized generic … Continue reading

Feds unveil sweeping Medicare fraud “takedown”

By Carol Poindexter (US) and Benjamin Wallfisch (US) on June 19, 2015 Posted in Enforcement

On June 18, Federal officials announced criminal enforcement actions against 243 individuals across the country. The nationwide arrests mark the largest criminal health care fraud takedown in history and came as a result of Medicare Fraud Strike Force investigations. The Attorney General, HHS Secretary, and FBI Director announced the charges, which allege various health care … Continue reading

FDA attempts to derail First Amendment challenge

By Carol Poindexter (US) and Savannah Wiseman (US) on June 10, 2015 Posted in FDA & Food Safety

In May, Amarin Pharma Inc. filed a lawsuit over its First Amendment right to distribute information about unapproved uses of its fish oil prescription, Vascepa. On June 8, in response to Amarin’s free speech challenge, the U.S. Food and Drug Administration (FDA) appears to be trying to derail that suit by releasing a letter to … Continue reading

OIG approves charitable cost-sharing subsidies to financially-qualified patients

By Carol Poindexter (US) and Zach Smith (US) on June 9, 2015 Posted in Regulatory

In an Advisory Opinion posted on June 4, 2015, the Office of Inspector General for the Department of Health and Human Services advised that a proposed arrangement involving financial assistance to individuals with chronic diseases would not constitute grounds for sanctions under either the provisions prohibiting inducements to beneficiaries or the Anti-Kickback statute. Advisory Opinion … Continue reading

OIG okays manufacturer’s subsidies to Medicare subjects in a study benefiting commercial product

By Carol Poindexter (US) and Lidia Niecko-Najjum (US) on June 5, 2015 Posted in Regulatory

In its recently published Advisory Opinion 15-07, the OIG approved a medical device manufacturer’s (Manufacturer’s) subsidies to Medicare patients in a clinical trial (Study) designed to test the effectiveness of a procedure using the Manufacturer’s specific commercial product. The OIG’s most recent opinion is significant because it pertains to a product-specific clinical trial sponsored by … Continue reading

FDA limits use of antibiotics in food-producing animals

By Carol Poindexter (US) and Sarah Cummings (US) on June 3, 2015 Posted in FDA & Food Safety

By December 2016, it will be illegal to use certain antibiotics in food-producing animals’ feed or water unless (1) the animal producer obtains authorization from a licensed veterinarian and (2) the drug is used only for prevention, control, or treatment of a specifically identified disease. The U.S. Food and Drug Administration (“FDA”) announced the new … Continue reading