Archives: Regulatory Developments

Subscribe to Regulatory Developments RSS Feed

Proposed Rule Issued by CMS Modifies Requirements for LTC Facilities Participating in Medicare and Medicaid Programs

As previously discussed here on our Health Industry Washington Watch blog, CMS is publishing a notice extending by 30 days the comment period for its July 16, 2015 proposed rule entitled “Reform of Requirements for Long-Term Care Facilities.” The revisions of the “Proposed Rule” indicate an increased cost of $729 million in the first year … Continue Reading

Cure of Security Rule Violations Following Breach of EPHI Cannot Save Covered Entities from $750,000 Settlement; Non-Breach Related Security Complaint Leads to $218,000 HIPAA Settlement

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

First Amarin Pharm v. FDA, Now Pacira Pharm, Inc. v. FDA

The Southern District of New York certainly is becoming a hotbed for issues relating to the FDA’s ability to take enforcement action against manufacturers who promote their FDA-regulated products for uses outside the approved label indications.  The Amarin Pharm v. FDA litigation has garnered a good deal of attention, and after Amarin and the FDA … Continue Reading

Federal Departments and Agencies Release Proposed Rule to Modernize Regulations Under Common Rule

As discussed on our Health Industry Washington Watch blog here, on September 2, 2015, the Department of Health and Human Services (HHS),  along with fifteen other federal departments and agencies, released a proposed rule to modernize regulations governing human research subjects under the Common Rule. Currently the Common Rule applies to all research involving human … Continue Reading

FCC Sheds New Light on TCPA’s Exemption for Healthcare-Related Calls

As we have previously reported, the Federal Communications Commission (“FCC”) issued a Declaratory Ruling and Order (“Order”) on July 10, 2015, clarifying several sections of the Telephone Consumer Protection Act (“TCPA”) and its implementing regulations.  One important clarification addressed a petition filed by the American Association of Healthcare Administrative Management (“AAHAM”) in October 2014 regarding … Continue Reading

340B Drug Pricing Program Omnibus Guidance Notice Published by Health Services Resources Administration

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

First Opinion Issued on ACA “60-Day Overpayment Rule” in a FCA Case

In a case dating back several years, the first judicial opinion interpreting the Affordable Care Act’s “60-Day Overpayment Rule” in a False Claims Act case was recently issued by the Southern District of New York. In Kane v. Healthfirst, Inc., et al., the court found in favor of the DOJ, denying the defendant hospitals’ motion … Continue Reading

What Comes Next In Amarin Pharm v. FDA?

The Southern District of New York’s preliminary injunction in Amarin Pharm, Inc. v. FDA—prohibiting the FDA from taking action against Amarin over truthful, non-misleading “off-label” statements about its prescription drug Vascepa—understandably has been big news, analyzed here  and  elsewhere. Some are asking whether the FDA will pursue appellate review of the decision.  An indication about … Continue Reading

Amarin Obtains Preliminary Injunction Against FDA Regarding Off-Label and First Amendment Issues

In our prior posts about Amarin Pharma, Inc. v. FDA, we wondered what the Southern District of New York would make of Amarin’s request for an order prohibiting the FDA from taking enforcement actions against it over speech regarding “off-label” uses of its prescription drug, Vascepa.  Although Vascepa is regulated as a drug, equivalent products … Continue Reading

CMS Releases Proposed Stark Law Regulations

As previously discussed on our Health Industry Washington Watch blog, the Centers for Medicare & Medicaid Services (CMS) has proposed regulations “to reduce burden and to facilitate compliance” under the physician self-referral law known as the Stark Law. However, even with changes, the regulations will remain highly complex, with major implications for health care providers … Continue Reading

FCC Finally Issues Omnibus Ruling on TCPA Litigation and Compliance

Ambiguities in the Telephone Consumer Protection Act (TCPA) have been a recent topic of interest. This past week, the FCC finally released the long awaited TCPA Omnibus Declaratory Ruling and Order resolving 21 petitions on many issues associated with the enforcement and interpretation of the Act. As the authors note in yesterday’s Reed Smith Client Alert, … Continue Reading

Amarin Pharma v. FDA – More Briefs Filed Regarding Off-Label Promotion And The First Amendment

Our prior  posts  looked at the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit, which raises issues regarding the First Amendment and how it applies to speech by drug and device manufacturers regarding “off-label” uses.  We provided links to amicus briefs by the Pharmaceutical Research and Manufacturers of America and the Washington … Continue Reading

FDA Files Brief Regarding Off-Label Promotion In Amarin Pharma Lawsuit

As we mentioned in our prior post, the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit pending in the Southern District of New York raises interesting issues regarding the First Amendment and how it applies to speech by drug and device manufacturers regarding “off-label” uses.  As we noted, on June 8, 2015, … Continue Reading

FCC Ruling Clarifies Ambiguities in the TCPA

For years  industry groups have been petitioning the Federal Communications Commission (FCC) to clarify ambiguities in the Telephone Consumer Protection Act (TCPA), which make it difficult for businesses to comply and leave them vulnerable to litigation. Finally, on June 18, 2015, the FCC responded. As discussed in a Client Alert by Reed Smith attorneys Judith … Continue Reading

FDA Sued By Drug Manufacturer Over Constitutional Right To Discuss Off-Label Uses

The FDA has long sought to ban manufacturers from promoting off-label uses of approved drugs and medical devices.  In taking the position that manufacturers and their agents cannot promote off-label uses, the FDA suggests they are safeguarding the public from misbranded medical products and ensuring that manufacturers do not circumvent the drug- and device-approval processes. … Continue Reading

Texas Legislature Passes Two Bills Affecting Personal Injury And Wrongful Death Litigation

Two bills recently passed by the 84th Texas Legislature, HB 1692 and SB 735 have the potential to affect businesses at risk of personal injury and wrongful death litigation in Texas.  Intended to curb the practice of foreign plaintiffs filing claims in Texas courts for personal injuries occurring outside state borders, HB 1692 would change … Continue Reading

U.S. Supreme Court Ruling Addresses Wartime Tolling of Statute of Limitations Under False Claims Act

On May 26, the U.S. Supreme Court issued its ruling in Kellogg Brown & Root Services, Inc. v. United States ex rel Carter, No. 12-1497, __ S. Ct. __ (2015), in which a relator brought civil False Claims Act (FCA) claims against government contractors. The relator alleged that the contractors had made fraudulent payment claims … Continue Reading

The Continuing Evolution of the French Sunshine Act

Since the general disclosure rule for provider-manufacturer relationships in France was enacted into law on January 1, 2012, its compliance and enforcement have been a common point of discussion for health care professionals, pharmaceutical and medical device manufacturers, and government officials, among others. As Reed Smith partner Daniel Kadar points out in “The French Sunshine … Continue Reading

OIG Report: FDA Has Made Progress on Oversight/Inspections of Manufacturers of Generic Drugs

On May 5, the Office of Inspector General (OIG) issued a report entitled "FDA Has Made Progress on Oversight and Inspections of Manufacturers of Generic Drugs" in response to a Congressional request expressing concerns about the safety and quality of generic drugs produced by manufacturers outside the United States. The OIG report contains an analysis of FDA's inspections of generic drug manufacturers over the past several years, and provides several recommendations for the FDA going forward.… Continue Reading

3D Printing Medical Devices

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

FDA Releases Draft Guidance on Acceptance of Medical Device Clinical Data from Studies Conducted Abroad

The Food and Drug Administration (FDA) has issued a notice announcing the availability of a draft guidance document clarifying its acceptance of medical device clinical data from studies conducted in countries other than the United States. The document is intended to provide guidance regarding the 2012 Food and Drug Administration Safety and Innovation Act § 1123, amending Food, Drug & Cosmetic Act § 569B, which codified FDA's policy of accepting scientifically-valid clinical data obtained from non-U.S. clinical studies in support of premarket submissions for medical devices.… Continue Reading

FDA, CMS Form Interagency Task Force on LDT Quality Requirements

FDA and CMS have announced that they are establishing an interagency task force to reinforce their collaboration regarding the oversight of laboratory-developed tests (LDTs) - tests intended for clinical use and designed, manufactured, and used within a single lab. According to an FDA blog post, the goals of the FDA/CMS task force include identifying areas of similarity between the FDA quality system regulation and requirements under the Clinical Laboratory Improvement Amendments (CLIA); working together to clarify responsibilities for laboratories that fall under the purview of both agencies; and leveraging joint resources to avoid duplication and maximize efficiencies.… Continue Reading

CMS Discusses Medicare Implications of FDA Approval of First Biosimilar Product

CMS has issued an educational article on the FDA's approval of the first biosimilar product, and what implications this approval will have for Medicare coverage. CMS plans to ensure that Medicare beneficiaries will have access to this new product, as it does for other drugs that receive FDA approval. The CMS article addresses several questions that have arisen regarding biosimilars.… Continue Reading

Erroneous Country of Origin Determinations May Result in Significant FCA Penalties for Medical Device Companies

Country of origin labeling issues can be exceedingly complex, as we have noted before. Several manufacturers have recently paid multi-million dollar settlements for alleged misstatements about their products’ country of origin, under the Trade Agreements Act (TAA) and False Claims Act (FCA). As described by Reed Smith attorneys Larry Sher, Larry Block and Jeffrey Orenstein … Continue Reading