Category: Compliance
Louisiana Supreme Court Strikes Down Expansive Interpretation of State Medicaid Fraud Statute
In a decision that has important ramifications for the life sciences industry, on January 28, 2013, in Caldwell ex rel State of Louisiana v. Janssen Pharmaceutical, Inc., (No. 2012-C-2447, No. 2012-C-2466), the Supreme Court of Louisiana, by a 4–3 vote, reversed a $330 million trial court award against Janssen Pharmaceutica, Inc., and entered final judgment in Janssen’s favor. Under the theory of liability that had been pursued by Louisiana at trial, virtually any public statement about any product that might be subject to Medicaid reimbursement could be subject to civil penalties totaling hundreds of millions of dollars—on a state-by-state basis—even if the statement was not made as part of a claim for reimbursement and there was no proof that the providers who wrote prescriptions for it did so for any reason other than a medical determination the product was the more … Read More »
CMS Issues Sunshine Act FAQs
CMS recently issued an FAQ clarifying one of the most puzzling questions regarding implementation of the Sunshine Act reporting requirements: whether manufacturers must report transfers of value (“TOVs”) to non-physician employees of teaching hospitals. CMS’s answer is that “[n]on-physician employees of a teaching hospital and non-physician employees of a physician-owned practice or other physician-owned entity are not covered recipients for the purposes of [the Sunshine Act regulations]. Accordingly, payments or other transfers of value made to these non-physician employees generally do not need to be reported.” However, CMS added, the TOV would be reportable if the employer requested that the manufacturer make the TOV to the employee, or if the manufacturer designated that the TOV was made on behalf of the employer. In addition, CMS added that if the manufacturer makes a TOV to a non-physician employee, requiring, instructing or directing that it be passed on … Read More »
French Sunshine Act Implemented…Awaiting Guidance
As pharmaceutical and device manufacturers and others are scrambling to finalize interpretations and implementation of the U.S. Physician Payment Sunshine Act, the French government added to the activity by releasing similar transparency regulations. On May 22, 2013, the French Ministry of Health published Decree No. 2013-414, implementing the French Sunshine law, which was enacted on December 29, 2011 and is known as the Bertrand law, after the French Minister of Health, Xavier Bertrand. The compliance date was set for June 1, 2013, and reporting is retroactive to January 1, 2012, giving companies a mere 10 days to interpret the regulations and compile and report data. It is expected that a Circular (i.e., guidance document) interpreting the Decree will be released soon.
The French Sunshine law requires reporting by companies that produce, market, or provide services associated with products listed in a particular … Read More »
Privately Held Medical Device and Drug Companies Face Unique Sunshine Act Challenges
As widely reported, the Centers for Medicare and Medicaid Services (“CMS”) recently issued regulations implementing the Sunshine Act provisions of the Affordable Care Act. These regulations require medical device and pharmaceutical companies to submit annual reports to CMS describing all payments and “transfers of value” to physicians and teaching hospitals. Companies must begin to collect data on August 1, 2013, and the first annual report will be due on March 31, 2014. CMS will post the reports on a public website.
Less discussed is the additional reporting duty imposed on privately held drug and device companies. Privately held companies must also report information about each shareholder/owner who is either a physician or who has a physician as an immediate family member. The new regulation defines “immediate family member” broadly to include spouse, parent, child, sibling, stepparent, stepchild, stepsibiling, grandparent, grandchild, and … Read More »
Proposed New Requirements on FDA Acceptance of Data from Clinical Studies for Medical Devices
On February 25, 2013, the FDA proposed new regulations to amend its current requirements on the acceptance of clinical data for medical devices. Specifically, the FDA is proposing to amend its acceptance criteria for data from clinical studies outside of the United States used as support for an investigational device exemption (IDE) application, a premarket notification (510k) submission, a premarket approval (PMA) application, a product development protocol (PDP), or a humanitarian device exemption (HDE) application, by requiring that such studies be conducted in accordance with good clinical practice (GCP) standards. In addition, the proposed rule seeks to amend the 510(k), HDE, and IDE requirements for FDA acceptance of data from clinical studies conducted inside the United States to parallel existing FDA requirements for PMA applications. Should these proposed requirements ultimately become final, medical device manufacturers will need to ensure that their clinical … Read More »
CMS’s Final “Sunshine” Rule: Implications for Research
On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) released its long-awaited final rule (Final Rule) implementing Section 6002 of the Patient Protection and Affordable Care Act (ACA), commonly known as the “Physician Payment Sunshine Act” (Sunshine Act or Act).[1] The Sunshine Act was included in ACA to enhance disclosure and transparency of financial arrangements among physicians, teaching hospitals, and manufacturers of certain products (federally reimbursable drugs and biologicals as well as covered medical devices and medical supplies), and thereby reduce the risk of inappropriate financial incentives interfering with medical judgment and patient care. The Final Rule details requirements for processing and reporting payments by pharmaceutical, device, biological, and medical supply “applicable manufacturers”[2] to physicians and teaching hospitals that are “covered recipients.”[3] The Final Rule also sets forth requirements for reports of ownership and investment interests held … Read More »
HIPAA/HITECH Omnibus Final Rule: Implications for Research
The Department of Health and Human Services’ HIPAA/HITECH Omnibus Final Rule (Final Rule) includes a number of provisions that will alleviate certain restrictions and administrative burdens in human subjects research and help streamline the documentation associated with research. Here are the significant changes:
Compound Authorizations
The current HIPAA Privacy Rule generally prohibits “compound authorizations,” which are authorizations for use and disclosure of protected health information (PHI) that are combined with any other legal permission. An exception to this general prohibition permits combining an authorization for use and disclosure of protected health information in a research study with any other written permission for the same study, including an informed consent to participate in the research. However, until March 26, 2013, the effective date of the Final Rule, even the same study exception is unavailable if one of the authorizations or permissions conditions treatment, … Read More »
HHS Releases HIPAA Omnibus Final Rule
On January 17, 2013, the Department of Health and Human Services (HHS) publicly released the long-awaited HIPAA Omnibus Final Rule (Final Rule). The Final Rule (1) implements many provisions of the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act), expanding the privacy and security standards directly governing covered entities and business associates; (2) modifies the interim final rule for Breach Notification for Unsecured Protected Health Information (Breach Notification Rule); (3) modifies the HIPAA Privacy Rule to strengthen the privacy protections for genetic information by implementing section 105 of Title I of the Genetic Information Nondiscrimination Act of 2008 (GINA); and (4) makes certain other modifications to the HIPAA Privacy, Security and Enforcement Rules to improve their workability. Notably, the Final Rule does not address the anticipated accounting of disclosures requirements, which was the subject of … Read More »
Long-Awaited HIPAA and HITECH Final Rule Released
A final omnibus rule has been released by the Department of Health and Human Services. The final rule makes changes to the Health Insurance Portability and Accountability Act (HIPAA) regulations related to privacy and security. The final rule, in its entirety, can be found here.
Check back soon for a response from our life sciences team.
Follow continued coverage from our Government & Regulatory Affairs colleagues here.
Massachusetts Refines Its Sunshine Law; Final Federal Sunshine Regulations Moving Ahead
The relationship between health care providers and drug and device manufacturers has been a focus of lawmakers at both the federal and state level. While we continue to await final federal regulations implementing the Physician Payment Sunshine Act (federal Sunshine Act), which generally requires disclosure of financial arrangements among physicians, teaching hospitals, and drug and device manufacturers,[1] Massachusetts has refined its requirements governing relationships between physicians and drug and device manufacturers. Amendments to the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct regulations[2] (the Massachusetts Regulations) broaden the scope of permissible meals and refreshments that may be provided by manufacturers to health care practitioners and clarify issues related to preemption of the Massachusetts Regulations by the federal Sunshine Act. The Massachusetts changes and impending release of final federal regulations underscore the continuing need for drug and device manufacturers to … Read More »