Physician Open Payments June 30th Data Publication to Incorporate New Final Rule Changes

2024/06/27

The Physician Payments Sunshine Act (PPSA) took effect in 2013. It requires medical product manufacturers to disclose to the CMS payments or transfers of value made to physicians or teaching hospitals including meals, travel reimbursement, and consulting fees.1 Payments related to research are reported through a separate reporting system.2 The act also requires manufacturers and group purchasing organizations to disclose any physician’s ownership or financial interest in those companies.3 The Process Data about payments made to covered recipients is collected by reporting entities throughout the year. Data collected during the previous calendar year is submitted to CMS between February 1 and March 31 each year. Covered recipients may review and dispute the data from April 1 until May 15. Reporting entities resolve disputes and correct data from April 1 until May 30. The disclosed data is published by CMS in a publicly searchable database by June 30th each year.4 The search tool currently has data from January 2016 until December 31, 2022. The 2023 data will be published on June 30, 2024. Between 2016 and 2022, $68.42 billion dollars have been reported through Open Payments. Penalties Penalties for failure to comply with the act are broken down into two main categories: violation of the PPSA and knowing violation of the PPSA. The penalties as adjusted annually pursuant to 45 CFR §102. Currently, violations of the PPSA are subject to a civil money penalty of not less than $1,362, but not more than $13,625, for each payment or other transfer of value or ownership or investment interest not reported as required under the act. The total amount of civil monetary penalties imposed under this subsection is limited to $204,384.5 Knowing violations are currently penalized at not less than $13,625, but not more than $136,258, for each payment or other transfer of value or ownership or investment interest not reported. Read More

Supreme Court Just Made a Prosecutor’s Job More Difficult: The Impact of ‘Ruan’

2022/07/21

On June 27, the U.S. Supreme Court expanded the scope of the government’s burden of proof of a defendant’s mental state, or mens rea. The Supreme Court held that in a statute that provided an exception or exemption to prosecution, that is a clause stating “except as authorized,” the government must now prove beyond a reasonable doubt that a defendant knew that he did not fall within the scope of that exception. Although the case related to a federal criminal statute prohibiting the dispensing or distribution of controlled substances by a physician, the ruling can be applied to myriad criminal statutes that carve out exceptions or exemptions to prosecution. This article explains the Supreme Court’s decision and focuses on the ramifications as it pertains to other criminal statutes. It also raises questions regarding the reasonableness standards of the exclusionary rule under United States v. Leon, 468 U.S. 897 (1984). In Ruan v. United States, 597 U.S.        (2022), two physicians in two distinct cases were convicted of dispensing or distributing controlled substances by issuing opioid prescriptions in violation of 21 U.S.C. Section 841(a). Section 841 makes it a federal crime “except as authorized, … for any person knowingly or intentionally … to manufacture, distribute, or dispense … a controlled substance.” The Supreme Court consolidated the cases for purposes of the opinion. The defendants asserted that they were authorized to issue the prescriptions under 21 CFR Section 1306(a)(2021), which allows physicians to write prescriptions for controlled substances only “for a legitimate medical purpose … acting in the usual course of his professional practice.” They further asserted that even if they failed to comply with such standard, they believed they did. In other words, they asserted a good faith defense. The government in both trials argued that the prescriptions issued by the defendants did not comply with the standards set forth in 21 CFR Section 1306(a). Read More

Chambers USA Recognizes Pietragallo as a Leading Law Firm in Pennsylvania

2021/05/20

Pietragallo Gordon Alfano Bosick & Raspanti, LLP is pleased to be recognized by Chambers USA in its 2021 guide in the area of Litigation: White-Collar Crime & Government Investigations in Pennsylvania.  Chambers ranks leading law firms and attorneys across the U.S. based on the opinion of their clients and peers, and by the quality of their work. Chambers USA acknowledges that the team has experience “handling actions brought under the False Claims Act and tackling significant cross-border mandates.”  Clients and peers are quoted as saying, “Pietragallo Gordon has an excellent securities and white-collar practice” and as having “a good statewide footprint.” Additionally, the following partners are ranked: William Pietragallo— Litigation: General Commercial— Pennsylvania: Pittsburgh & Surrounds Marc S. Raspanti— Litigation: White Collar Crime & Government Investigations— Pennsylvania Read More

Postponed: Pietragallo Partner Chris Iacono to present at Cyberlaw Update 2020 in Pittsburgh

2020/04/27

The Pennsylvania Bar Institute will be holding it’s next Cyberlaw Update program on April 27, 2020 in Pittsburgh. During this program, attendees will discuss: experiences with new state and EU regulations on privacy, current security dangers and data breach responses, the impact of Artificial Intelligence (AI), cloud and other technologies in business, electronic communication and its impact on litigation and discovery, and ethical challenges with social media and the ever-changing social technology environment. Pietragallo Partner Chris A. Iacono is faculty of the program. He will co-present during a Cyber and Litigation segment titled, “Responding to Data Breaches: Legal Updates and Practical Counsel.” THIS EVENT HAS BEEN POSTPONED. PLEASE SUBSCRIBE TO OUR FIRM NEWSLETTER FOR ALERTS AND UPDATES.   Read More

One of many — a remembrance for Veterans Day by Paul K. Vey

November 11, 2019

As Veterans’ Day neared, Pietragallo attorney Paul K. Vey shared the following for all members of our Team: One of many — a remembrance for Veterans Day Roughly 78 years ago, a high school senior from Bellevue PA, just outside of Pittsburgh, learned that the United States had been attacked and was entering World War II. He wanted to join the war effort immediately but his parents insisted that he finish high school. He graduated from high school that spring and enlisted in the Army Air Corps, the predecessor of the United States Air Force. Although he wasn’t a great student, he desperately wanted to fly. He managed to show enough promise that he was sent to flight school in Lafayette Louisiana, where after a rigorous, but incredibly short training period, became the captain of a B-24 Liberator bomber at age 18, and responsible for a 10 man crew. The bomber group to which he was assigned was called upon to support the Italian campaign in Europe where he and his crew managed to stay airborne through almost 50 bombing raids. Just as he and his crew were about to be sent to England for rest and recuperation, his orders were changed and his bomber group was dispatched to India to support the Allied effort to drive the Japanese from Southeast Asia. It was now 1943. On what turned out to be his last mission, he and his crew were part of a three bomber mission to destroy a rail line in Burma, now known as Myanmar. The approach to the target was a low altitude approach to increase the likelihood of surprise. His aircraft was the first to the target. Almost immediately upon releasing his bomb load, the plane was struck by ground fire starting a fire in two engines and dramatically reducing the power from a third. Read More