As noted in our recent post, OIG’s recent Special Fraud Alert on Physician-Owned Entities is the strongest statement to date that investing in or doing business with a physician-owned distributor, or POD, is a significant Antikickback law risk, not only for the POD and its physician-investors but for the hospitals and ASCs that purchase from… Continue Reading
Category Archives: Medical Devices
Subscribe to Medical Devices RSS FeedOIG: PODs “inherently suspect” under anti-kickback statute; Hospitals and ASCs warned of AKS risks to them if they purchase from PODs
In its strongest statement so far on the subject, the HHS Office of Inspector General (OIG) today released a Special Fraud Alert which concludes that physician-owned entities that distribute the implantable medical devices ordered by the physician-owners for their own patients (PODs) are “inherently suspect under the [Federal Health Care Programs] anti-kickback statute” (AKS). OIG… Continue Reading
Sunshine Regulations to Unmask PODs’ Financial Relationships
The final Sunshine regulations, published in the Federal Register on February 8, require applicable manufacturers (“AMs”) and applicable GPOs (“AGPOs”) to submit reports on physician ownership and investment interests. Notably, the regulations require physician-owned distributors of covered products (including implantable medical devices) (“PODs”) to collect and report information on their financial relationships with their physician… Continue Reading
Review of issues for 2013
The following is a summary of some of the key issues Congress and the Administration will be debating in 2013. Please contact us with any questions. We are happy to provide further analysis as well as insight into other areas of interest. Agriculture: Tom Vilsack is expected to stay on as Secretary of Agriculture…. Continue Reading
IRS Publishes Final Regulations re Medical Device Excise Tax
In the December 7, 2012 Federal Register, the IRS issued the final regulations under the medical device excise tax, accompanied by interim guidance that deals with a number of time-sensitive issues including the determination of the taxable sales price and relief from the penalties associated with deposit with the IRS of the correct tax amount. … Continue Reading
The Court of Justice of the European Union Rules that the Intended Medical Purpose is an Inherent Part of the Concept of Medical Device in the EU
On 22 November 2012, the Court of Justice of the European Union rendered a judgment interpreting what constitutes a medical device in the European Union (“EU”)[1]. The Court was asked to respond to the question whether a device intended to investigate a physiological process constitutes a medical device governed by the Medical Devices Directive[2] if,… Continue Reading
Publication of new Ordinances concerning the prior approval of the French authorities for the advertising of certain high risk medical devices in France
On 19 December 2011, the Act on the reinforcement of the safety of medicinal and healthcare products was adopted in France[1]. This Act imposes new obligations on manufacturers concerning the advertising of medical devices. As a result of this Act and the related implementing Decrees No 2012-743 and No 2012-744 of 9 May 2012, the advertising… Continue Reading
Reining in FDA’s “Expansive Language” and “Doubly Grandiose” Interpretations of Chemical Action
When the Food and Drug Administration (“FDA” or the “agency”) issued two draft guidances regarding the definition of “chemical action” and how it would relate to product designations under the FDC Act in June 2011, we argued in an FDLI Update article that the agency’s interpretation of the statute and guidances could “provide FDA with… Continue Reading
European Commission Proposes Overhaul of European Medical Devices Regulation
On 26 September, the European Commission published two draft Regulations (here and here) intended to replace the current Medical Devices Directive, the Active Implantable Medical Devices Directive, as well as the In Vitro Diagnostic Medical Devices Directive. The draft Regulations will now be discussed in the European Parliament and in the Council. The European Commission expects the proposals… Continue Reading
Senate Commerce Committee’s Probe of Fortune 500 Corporate Cybersecurity is Unprecedented; Responses Requested Oct. 19
Each of the 500 largest businesses in America has been asked by the Senate Commerce Committee to describe how it deals with cybersecurity, demonstrating that government’s focus on cybersecurity is not going away despite stalled legislative efforts. On 19 September, Senator Jay Rockefeller (D-WV) sent an unprecedented letter to the chief executives of the 500 largest companies… Continue Reading
FTC Speaks Out On Mobile App Advertising and Privacy
With the ever increasing use of mobile apps designed to do everything from shopping, to online banking, to managing medical conditions, the Federal Trade Commission (FTC) recently issued guidance for the marketing of mobile apps. The guidance is intended to help companies entering the mobile app business to comply with the agency’s truth-in-advertising standard and basic… Continue Reading
The Australian pharmaceutical industry association introduces self-regulation requirement to disclose payments to healthcare professionals and consumer organisations
On 5 July 2012, Medicines Australia, the pharmaceutical industry association in Australia, announced the adoption of its new Code of Conduct. Although the Code is not legally binding, it reflects a growing tendency, partly legislative in nature and partly through industry self-regulation, to promote transparency in relationships between the pharmaceutical industry and healthcare professionals and… Continue Reading
Money! Money! Money!
CMS released three proposed rules addressing Medicare payment changes for calendar year (CY) 2013 for physicians, hospital outpatient departments and ambulatory surgical centers and home health agencies on Friday, July 6, 2012. The proposed rules will be published in the Federal Register on July 30, 2012, and comments for all three proposed rules are due… Continue Reading
Supreme Court Issues Long-Awaited Health Reform Decision: Upholds Entire Law, but Imposes Certain Restrictions on Medicaid Expansion
In the most closely-watched decision of its 2012 term, Chief Justice Roberts delivered the opinion for a majority of a divided Supreme Court today upholding the individual mandate in the Affordable Care Act (ACA). The vote was 5-to-4. While the Court also upheld the Medicaid expansion, it narrowly read the federal government’s power to terminate… Continue Reading
Congress Clarifies the Custom Device Exemption, But Questions Remain
Congress has passed The Food and Drug Administration Safety and Innovation Act (FDASIA) reauthorizing existing FDA user fee programs and extending these programs to generic drugs and biosimilars, which is now headed to the President’s desk to be signed into law. In addition to authorizing user fee programs that are expected to cover 60% of the agency’s 2013‒2017… Continue Reading
Is Inherent Reasonableness Coming Back to CMS?
Six and a half years after CMS promulgated regulations for the use of “inherent reasonableness” authority to alter a payment rate, CMS is considering applying this little used authority to Medicare payment levels for non-mail order diabetic testing supplies. In 2011, a competitive bidding process for the mail order equivalent of such supplies resulted in an… Continue Reading
New Federal Health Reform Funding Announced
Two sets of new grants of federal funding under the health reform law have been announced over the past week. First, CMS’s Center for Medicare and Medicaid Innovation (CMMI) announced the second and final group of Health Care Innovation Awards on June 15, 2012. These 81 awards were granted to innovative projects designed to deliver… Continue Reading
PCORI Releases Preliminary Draft Methodology Report
The Patient Centered Outcomes Research Institute (PCORI) released its Preliminary Draft Methodology Report, entitled “Our Questions, Our Decisions: Standards for Patient-centered Outcomes Research” on June 4, 2012. Among other things, the report sets forth 60 standards to guide the process of patient-centered outcomes research. This initial list of standards, set forth in Appendix A of… Continue Reading
FDA’s Unsolicited Requests Docket is Closed – 35 Commenters address various issues, including First Amendment
As discussed in our earlier post, FDA solicited comments in a Federal Register notice on its “Draft Guidance for Industry: Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Devices.” See 76 Fed. Reg. 82303 (December 30, 2011). As of March 29, 2012, the docket is technically closed. The docket features 35 comments submitted by biopharmaceutical companies, trade organizations, and… Continue Reading
States take action to address POD proliferation
As federal regulatory or enforcement activity concerning physician-owned distributors (PODs) awaits a study by OIG (expected later this year), states are beginning to recognize the serious potential for patient and program harms that PODs involve and to take action on their own. The New Hampshire legislature’s recent actions in the area of physician-owned distributorship (POD)… Continue Reading
U.S. tax reform: elements of reform already being developed by Congress
U.S. businesses and foreign multinationals with U.S. tax obligations should be on alert that the elements of a major U.S. tax reform legislative package are already in development within the U.S. Congress, the Obama Administration, and in interest groups and think tanks in Washington. The make-up of this tax reform package – to be debated… Continue Reading
Comparative Effectiveness Research Institute Announces $96 Million in Grant Funding
The Patient-Centered Outcomes Research Institute (PCORI) released research funding announcements on May 22, 2012 for $96 million in grant funding to support clinical comparative effectiveness research (CER). These PCORI funding announcements (PFAs) will support four of the five areas of focus outlined in PCORI’s National Priorities for Research and Research Agenda, including: Assessing different prevention,… Continue Reading
Advisory Panel on Hospital Outpatient Payment Meeting Dates Set
The Centers for Medicare & Medicaid Services (CMS) issued a Federal Register notice on May 25, 2012 announcing that the second semi-annual meeting of the Advisory Panel on Hospital Outpatient Payment (Panel) will take place on the following dates: Monday, August 27, 2012, 1 p.m. to 5 p.m. EDT Tuesday, August 28, 2012, 9 a.m…. Continue Reading
Despite the Fixings and Garnish Atop FDA’s Proposed Risk Classification Scheme, the Obesity Device Industry Appears to Have Been Served a Potentially More Restrictive Diet
FDA recenlty held a general issues advisory panel meeting to present a proposed risk classification scheme designed to allow the agency to stratify medical devices intended to treat obesity into varying risk levels. Each risk level would be tied to a specific efficacy endpoint, with higher endpoints required for higher risk devices and lower efficacy… Continue Reading