On 2 June, the European Commission (Commission) published a roadmap (Roadmap) that will pave the way for the Commission’s communication on the EU pharmaceutical strategy, which is now due in the last quarter of 2020. The Roadmap should be read together with the Commission’s proposal for a recovery of the EU’s economy (Next Generation EU), … Continue Reading
On Wednesday, November 20, a three-judge panel of the U.S. Court of Appeals for the Eleventh Circuit heard oral argument in the closely watched False Claims Act (FCA) case of United States ex rel. Ruckh v. Salus Rehabilitation, Inc. The case involves questions regarding how to interpret and apply the FCA’s materiality standard set forth … Continue Reading
As 2019 comes to an end, the United States Food & Drug Administration’s (“FDA” or the “Agency”) Center for Veterinary Medicine has published a new draft Guidance for Industry #256, “Compounding Animal Drugs from Bulk Drug Substances” (the “Draft Guidance”). The Draft Guidance addresses FDA’s regulatory approach to compounding animal drugs from bulk drug substances. … Continue Reading
Reed Smith will be hosting an upcoming webinar, “12 Months in Health Care Law: A Roller Coaster Journey”, on Tuesday, October 15, 2019 at 12:00 PM ET. The webinar will deliver an informative and entertaining review of many of the key regulatory developments and court rulings in health care law over the past 12 months. … Continue Reading
As part of our FDA series, Reed Smith will be hosting the upcoming webinar, “FDA inspections of health care facilities: How to keep calm and carry on when FDA walks through your door” on Thursday, October 10, 2019 at 12:00 PM ET. The webinar, presented by partner Rachael Pontikes and associate Emily Hussey, will provide … Continue Reading
Reed Smith will be hosting an upcoming CLE webinar, “Best Practices for managing privacy risks in vendor engagements – diligence, contracting, and oversight under the California law” on Wednesday, September 11, 2019 at 2:00 PM ET. This program will offer a review on how organizations can approach third-party information sharing under the CCPA. Furthermore, as … Continue Reading
Reed Smith will be hosting an upcoming CLE webinar, “Physician Compensation Issues in the World of Evolving Value-Based Payment Programs” on Wednesday, August 28, 2019 at 12:00 PM ET. This program will provide an overview of the most prevalent value-based reimbursement programs in the market today. This overview will be followed by a discussion of … Continue Reading
The Advanced Medical Technology Association (AdvaMed) – the national industry association of medical technology manufacturers – recently issued an updated Code of Ethics on Interactions with Health Care Professionals (HCPs) (the AdvaMed Code or Code). Last revised in 2009, AdvaMed’s updated Code will go into effect January 1, 2020. The Code speaks to the evolving … Continue Reading
The Office of Inspector General (OIG) recently gave the green-light on a medical device manufacturer’s proposed warranty program, wherein the company would provide a refund to the hospital at which a patient underwent joint replacement surgery using the company’s knee or hip implant and related products, if the patient was readmitted within 90 days because … Continue Reading
The Office of Inspector General (OIG) of the Department of Health Human Services (HHS) is seeking input on Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Anti-Kickback Statute and Beneficiary Inducements CMP. The OIG describes this request for information (RFI) as part of HHS’s endeavor “to transform the health … Continue Reading
Last month, New Jersey joined several other states in adopting a new regulation limiting payments and gifts that can be made by pharmaceutical manufacturers to health care providers. The regulation caps include a maximum of $10,000 per calendar year for a prescriber’s bona fide services, and $15 per meal. Additional information about this new regulation … Continue Reading
As covered in “Court Overturns $350 Million Judgment in FCA Case: Materiality, Scienter, and Causation Standards Preclude Liability by “’Zaps, Traps, and Zingers’”, Andy Bernasconi discusses a recent case, in which the Middle District of Florida issued a blistering opinion vacating a $350 million judgment in a False Claims Act (FCA) case and granting the … Continue Reading
The Reed Smith Life Sciences Health Industry Group will be hosting an upcoming CLE webinar “12 Months in Health Care Law: A Roller Coaster Journey” on October 25, 2016 at 12:00 p.m. ET. Please join Reed Smith Partner Elizabeth Carder-Thompson as she presents her annual informative and entertaining review of many of the key regulatory … Continue Reading
By Jennifer Pike and Brad Rostolsky on Posted in Privacy & HIPAA
In a joint effort by the Federal Trade Commission (FTC), Office for Civil Rights (OCR), HHS Office of National Coordinator for Health Information Technology (ONC), and Food and Drug Administration (FDA), a new web-based tool has been released that is designed to help developers of mobile health apps understand the multitude of federal laws and … Continue Reading
A False Claims Act (“FCA”) retaliation claim, 31 U.S.C. 3730(h), filed January 26, 2016 in federal district court in Oregon, provides a perfect example of the type of challenging cases confronting health care employers today. Pediatrician Robert Dannenhoffer, MD, the former CEO of a joint venture between a hospital and physicians’ group, alleges that he … Continue Reading
As previously discussed here and over on Health Industry Washington Watch here, this past Thursday, CMS and OMB issued the final, 600+ page Medicaid Rebate Program Final Rule. The pre-Federal Register version of the final rule may be accessed here. While we are still processing what this will mean for drug manufacturers and other health … Continue Reading
The 2013 changes to HIPAA’s privacy and security regulations in combination with the government’s bolstered approach to compliance and enforcement reinforces the need for health care providers to remain focused on preparing for the inevitable likelihood that privacy or security issues will occur. With the number of significant data breaches expected to rise, it is … Continue Reading
More than three years after the Cancer Care Group, P.C. (“CCG”) notified the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) of a breach of unsecured electronic protected health information (“ePHI”), the radiation oncology private practice settled and implemented a corrective action plan (“CAP”) with OCR for $750,000. This settlement … Continue Reading
Cybersecurity issues are nothing new to those operating in the health care industry. But while these issues have most commonly been faced by hospitals and health care providers, medical device companies must now take note. As reported recently in the news, medical devices have increasingly become the targets for cybersecurity breaches, given the information contained … Continue Reading
On August 28, 2015, the Health Services Resources Administration (“HRSA”) published its 340B Drug Pricing Program Omnibus Guidance Notice in the Federal Register. Although many aspects of the Notice reiterate previous HRSA guidance, several elements will generate significant debate among program stakeholders regarding the scope of the 340B program. In addition, the Notice presages a … Continue Reading
The HITECH Act—including the HITECH Final Rule’s provisions about HIPAA, data privacy, security, and breach notification—is an issue we have covered in detail previously. According to a June 17, 2015 press release, the former CFO of the Shelby Regional Medical Center in Texas has pleaded guilty to making a false statement in “representing that the … Continue Reading
The HHS Office for Civil Rights recently announced a settlement and corrective action plan with Cornell Prescription Pharmacy (CPP), a small for-profit, single location, compounding pharmacy located in Denver, CO. CPP has agreed to pay $125,000 and enter into a corrective action plan to settle potential violations of the HIPAA Privacy Rule. This outcome is indicative of OCR's unwillingness to demonstrate wide variance in its enforcement response based on the size of an affected covered entity or the number of patients involved in a potential HIPAA violation.… Continue Reading
3D printing is providing physicians with a steady flow of new options for medical treatment. Reports are constantly emerging about novel, life-saving procedures made possible through 3D printing. As one might imagine, however, 3D printing a medical device for use in humans carries particular challenges not present with 3D printing in other contexts.… Continue Reading
The bipartisan leadership of the House Energy and Commerce Committee has released their 2015 version of the 21st Century Cures Act, which is intended to bolster medical discovery, treatment development and delivery of treatment to patients. The nearly 200-page legislation is the product of a year-long collaboration between lawmakers and stakeholders.… Continue Reading
