Savannah Wiseman (US)

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OIG publishes Medicaid Fraud Control Units Fiscal Year 2018 Annual Report

On March 25, 2019, the Office of Inspector General (OIG) published its Medicaid Fraud Control Units Fiscal Year 2018 Annual Report. Forty-nine states and the District of Columbia have a Medicaid Fraud Control Unit (MFCU) which is responsible for investigating and prosecuting Medicaid provider fraud and patient neglect and abuse. The report notes that it … Continue reading

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

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

Anthem to pay US$115M to settle lawsuit relating to 2015 data breach

Anthem Inc. has agreed to a US$115 million settlement to resolve a class action lawsuit relating to a 2015 cyberattack that compromised data on 79 million individuals. Anthem has denied any wrongdoing. In February of 2015, Anthem reported that hackers stole personally identifiable information from millions of current and former customers, including names, addresses, social … Continue reading

Bipartisan effort to provide greater transparency into federally-negotiated settlement agreements

This week, U.S. Senators Elizabeth Warren (D-MA) and James Lankford (R-OK) reintroduced a bill designed to provide the public with more information about settlement agreements between federal agencies and companies and individuals. The bill, called the Truth in Settlements Act, was first introduced in 2014. In September 2015, it was unanimously passed by the Senate … Continue reading

Vote on MacArthur Amendment delayed; Trump Administration will continue to pay subsidies to insurers for low-income individuals; CMS issues three new payment rules for FY 2018 proposing increased payments to skilled-nursing facilities, inpatient rehabilitation facilities, and hospice care

Vote on MacArthur Amendment delayed: Last week, the House delayed voting on a revised bill to repeal and replace the 2010 Affordable Care Act, thwarting White House plans to hold a vote before President Donald Trump’s 100th day in office. The revised American Health Care Act (AHCA) would include the amendment drafted by Representative Tom … Continue reading

CMS issues new Self-Referral Disclosure Protocol (SRDP)

CMS recently finalized a new Self-Referral Disclosure Protocol (SRDP) that includes forms for healthcare providers to use to disclose actual and potential violations of the federal physician self-referral statute (the “Stark Law”). Use of the new forms is mandatory starting June 1, 2017, but CMS encourages healthcare providers to start using the new forms immediately. … Continue reading

Six legal and regulatory risks facing specialty pharmacies

“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

Ninth circuit upholds conviction for physician for re-using single use devices

Last week, the Ninth Circuit affirmed a physician’s conviction for conspiracy to distribute an adulterated device with intent to defraud or mislead in violation of Section 331(k) of the federal Food, Drug and Cosmetic Act (FDCA). The physician – who dubbed his own practice “The McDonald’s of Urology” because of the high volume of patients … Continue reading

FDA issues Data Integrity Guidance under CGMP

Increasing concerns about data integrity in the pharmaceutical industry have prompted the U.S. Food and Drug Administration (“FDA”) to release Draft Guidance addressing the issue as it relates to current good manufacturing practices (cGMP) for pharmaceutical companies. The Draft Guidance – titled Data Integrity and Compliance with CGMP, Guidance for Industry – is framed a … Continue reading

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

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

FDA issues accredited third-party certification rule

On November 13, 2015, the US Food and Drug Administration (FDA) issued a final rule establishing a voluntary program for the accreditation of third-party certification bodies to conduct food safety audits and to certify that foreign food facilities and the food they produce comply with FDA food safety requirements. According to the FDA, foreign entities … Continue reading

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

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

Third Circuit extends Actavis to non-cash reverse payments

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

OIG releases FY 2015 work plan mid-year update

This week, the OIG published its Mid-Year Update to its 2015 Work Plan, which we previously summarized. The Mid-Year Update adds several new monitoring activities to the existing Work Plan, summarized below. review of financial interests reported under the Sunshine Act: The OIG plans to review the number and nature of financial interests that were reported … Continue reading

Medigap plans can pass on in-network discounts to policyholders

The OIG released an advisory opinion April 29th stating that a Medigap plan would not face administrative sanctions for discounting up to 100% of policyholders’ inpatient deductibles at network hospitals for which it otherwise would be liable and then passing on a part of those savings to policyholders in the form of premium credits. Under the proposed … Continue reading

Broad interpretation of France’s Sunshine Act continues global trend toward transparency

Beyond the United States’ Physician Payments Sunshine Act reporting requirements, international pharmaceutical and device companies must account for a growing number of transparency requirements related to their interactions with healthcare professionals. For example, in France, the Bertrand Act requires transparency related to: (1) the agreements between companies and healthcare professionals (HCPs) and (2) any benefits, … Continue reading

Right to Appeal for Secondary Payer Determinations

Last week, CMS issued a final rule giving liability insurance, no-fault insurance, and workers’ compensation the right to appeal reimbursement demands from Medicare. The final rule implements appeal rights created under the Strengthening Medicare and Repaying Taxpayers Act of 2012 (“SMART Act”). Section 1862(b)(2) of the Social Security Act prohibits Medicare from paying for medical … Continue reading

Food safety newsletter – February 2015

The monthly newsletter will provide a quick overview of legal issues affecting food safety, including the enactment of new statutes and regulations and significant case law developments, in the US and abroad. In this issue: FDA Commissioner Margaret Hamburg, M.D. to step down Obama earmarks $1.6 billion for food-safety efforts in 2016 budget US District … Continue reading

February FDA warning letter update

It is FDA’s practice to issue Warning Letters in order to provide individuals and companies an opportunity to take voluntary and prompt corrective action before it initiates an enforcement action. The agency’s position is that it issues Warning Letters only for violations of regulatory significance. Significant violations are those violations that may lead to enforcement … Continue reading

CMS Extends Temporary Ban of Certain Providers in Six States

Last Friday, CMS announced a six month extension of a temporary moratorium preventing new ambulance suppliers and home health agencies in six states from enrolling in Medicare, Medicaid, and the Children’s Health Insurance Program (CHIP). The moratorium impacts providers in the metropolitan areas of Chicago, Miami, Detroit, Dallas, Houston, and Philadelphia. Federal regulations established under … Continue reading
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