Tag Archives: Regulatory Enforcement

OCR Announces Settlement and Corrective Action Plan with Pharmacy Stemming from Alleged Violations

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

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

French Sunshine Act’s Scope Expands with Recent French Supreme Administrative Court Decision

Reed Smith’s Global Regulatory Enforcement Law Blog features a post on a recent decision by the French Supreme Administrative Court (Conseil d’Etat) that expands the scope of the French Sunshine Act. “French Supreme Administrative Court Decision Significantly Broadens the Scope of the French Sunshine Act,” written by Reed Smith attorneys Daniel Kadar and Caroline Gouraud, … Continue Reading

The SEC and the Pharmaceutical Industry – Recent Commentary by the SEC’s Enforcement Director Identifies Areas of SEC Focus Applicable to the Industry

Andrew Ceresney, enforcement director of the U.S. Securities and Exchange Commission (SEC), recently gave a presentation at CBI's Annual Pharmaceutical Compliance Congress in which he highlighted three current areas of SEC focus most relevant to the pharmaceutical industry: the Foreign Corrupt Practices Act, corporate disclosures relating to interactions with the Food and Drug Administration, and financial internal controls.… Continue Reading

Recent Regulatory Actions on Advertisement Disclosures

An article in Compliance Week discusses recent actions by the Federal Trade Commission (FTC) and Food and Drug Administration concerning advertisement disclosures. The FTC launched Operation Full Disclosure in fall 2014, which involved sending warning letters to more than 60 companies across "a wide range of industries" for failing to properly disclose information in their advertisements. These letters serve as a reminder to all companies, even those that did not receive letters, to review their disclosures in order to minimize the likelihood of a violation in the future.… Continue Reading

Insurance Coverage Considerations for Alleged Mislabeling of Herbal and Dietary Supplements

In the wake of the New York Attorney General's recent enforcement actions against four major retailers who allegedly sold herbal supplements that did not contain labeled ingredients or contained ingredients not explicitly identified on the labels, companies throughout the supply chain should consider examining their insurance policies to see whether or not they are sufficiently covered in the event of an investigation, enforcement action and/or litigation. Types of insurance policies that may provide coverage for affected companies are commercial general liability (CGL), directors and officers liability (D&O), errors and omissions liability (E&O), and product recall.… Continue Reading

OCR Settlement Reflects Continued Emphasis on HIPAA Security Rule Safeguards

The U.S. Department of Health and Human Services, Office for Civil Rights (OCR) recently announced a $150,000 settlement of potential violations of the HIPAA Security Rule by Anchorage Community Mental Health Services (ACMHS). These potential violations were caused by a malware breach of ACMHS's information technology resources. OCR's subsequent investigation of the breach found that ACMHS's preventative security measures prior to the breach were insufficient, and the settlement includes a Resolution Agreement with a corrective action plan for ACMHS to improve its security measures.… Continue Reading

Recent OCR Enforcement Activities Cause Serious Case of Déjà Vu: Theft of Unencrypted Laptops Leads to Two Separate HIPAA Settlements

Two separate instances of unencrypted laptop theft from different health care providers have resulted in two settlements for potential violations of the HIPAA Privacy and Security Rules. These alleged violations were uncovered following investigations by the Department of Health and Human Services, Office for Civil Rights (OCR). In the first instance, involving Concentra Health Services, OCR found that Concentra had previously recognized its need for increased encryption on its technological devices but had failed to fully address this issue before the breach. In the second instance, involving QCA Health Plan, Inc. of Arkansas, OCR found that QCA had failed to comply with multiple requirements set forth by the HIPAA Security Rule. Both instances resulted in settlements comprised of financial payments to OCR as well as agreement to Corrective Action Plans that will allow for continued oversight by OCR in regards to HIPAA compliance.… Continue Reading

County Governments Not Immune From HIPAA Enforcement: OCR Announces $215,000 Settlement with Skagit County, Washington

This post was written by Brad Rostolsky, Nan Bonifant, and Jen Pike On March 7, 2014, the HHS Office for Civil Rights (“OCR”) announced its first settlement and corrective action plan with a county government. Skagit County in northwest Washington State has agreed to pay $215,000 to settle potential violations of the HIPAA Privacy, Security … Continue Reading

Don’t Forget: FDA Frequents Facebook

FDA's Office of Prescription Drug Promotion has warned a Swiss drug company about failing to include risk information and omitting material facts regarding its products. What makes these particular violations noteworthy is that they occurred on the company's Facebook page. FDA became aware of the company's Facebook promotion through its own monitoring and surveillance program.… Continue Reading

EU Research Group Condemns EU Regulation for Restricting Growth in Life Sciences Sector; NHS Advocates Selling Confidential Patient Data For Secondary Purposes

Reed Smith’s Global Regulatory Enforcement Law blog features two posts of interest to those in the life sciences industry, both written by Reed Smith partner Cynthia O’Donoghue. “EU Research Group Condemns EU Regulation for Restricting Growth in Life Sciences Sector” discusses the opposition of a lobbying group, led by the Wellcome Trust, to amendments to … Continue Reading

Final Rule Gives Patients a New Right under HIPAA to Access Completed Test Reports Directly from Labs

On February 6, 2014, the U.S. Department of Health & Human Services' (HHS) Centers for Medicare & Medicaid Services, Centers for Disease Control and Prevention, and Office for Civil Rights jointly published a final rule amending the HIPAA Privacy Rule and the Clinical Laboratory Improvement Amendments of 1988 regulations to provide patients with direct access to laboratory test reports. HHS believes that patients should have the right to access these test reports in order to gain vital information, allowing them to better manage their health and take action to prevent and control disease. The amendments to both regulations become effective April 7, 2014, and HIPAA-covered laboratories must comply by October 6, 2014.… Continue Reading

China Issues New Regulations Prohibiting Commercial Bribery in the Health Care Industry

This post was written by John Tan, Amy Yang, and Crystal Xu. In late December, China’s National Health and Family Planning Commission (NHFPC), the successor organization to the Ministry of Health, issued two sets of anti-corruption regulations for the health care industry: the 2013 Regulations on the Establishment of a Commercial Bribery Blacklist for the … Continue Reading

China’s Life Sciences Regulatory Crackdown: September 10 Update

The regulatory enforcement environment in China remains tense, as both the Chinese government and media bring new actions and allegations against life sciences manufacturers in both the pharmaceutical and device sectors. We are seeing: Increased attention to medical device sector Enforcement actions spreading to smaller cities Continued pressure on pharmaceutical sector Reports of misconduct by … Continue Reading

China: Life Sciences Regulatory Crackdown Spreads to Medical Device Sector

On August 15, 2013, the local Beijing office of the Ministry of Health (MOH) of the People's Republic of China announced (Chinese link) that it has started a three-month review of the use of high-value medical consumables and large-scale medical equipment in Beijing. In its announcement, the Beijing MOH noted that prior inspections of hospitals had found continuing problems with the misuse and overuse of medical devices to increase profits. The investigation is intended to strengthen hospitals' management of the use of medical devices and to regulate the use of high value medical consumables.… Continue Reading

Affordable Care Act and the Post-Election Implications for Radiology

As the dust settles from Tuesday's election, pundits and prognosticators are predicting the future of the world based on highly charged and deeply polarized perspectives. Those predictions are sweeping in scope and many we have seen tend toward dire scenarios - even for the diagnostic imaging industry. The more prudent course is to step back for a moment and assess the situation in a more pragmatic and dispassionate way. With this in mind, we wanted to take this opportunity to describe what we expect to see as health reform efforts continue.… Continue Reading

Increased Scrutiny for the 510(k) Process

On November 14, 2011, the Senate Health, Education, Labor and Pensions Committee held a hearing called "Medical Devices: Protecting Patients and Promoting Innovation." The hearing focused on the continued viability of a medical device clearance process that clears for market medical devices that are "substantially equivalent" devices to previously cleared devices (also known as the "510(k) process," in reference to the statutory provision governing this process). Class III medical devices not cleared through this process must undergo the more rigorous and time-consuming Premarket Approval process. Among the issues considered were whether the 510(k) process sufficiently evaluated the safety of devices when clinical data is not necessarily always considered or part of the submission; whether high-risk medical devices should always be considered for the 510(k) process; the user fees for medical device applications; strengthening post-approval monitoring requirements; and the resources and needs for the FDA and the Center of Devices and Radiological Health (CDRH) in reviewing, clearing and approving medical devices.… Continue Reading

Notes on the National Summit on Health Care Fraud

Last week, in my capacity as president of the American Health Lawyers Association, I attended the first National Summit on Health Care Fraud, a joint undertaking by the U.S. Department of Health and Human Services and the U.S. Department of Justice. The conference brought together private sector leaders, law enforcement personnel, and health care experts as part of the Obama Administration's coordinated effort to fight health care fraud. This was the first national gathering on health care fraud between law enforcement and the private and public sectors.… Continue Reading

HHS Rule Implements HITECH Act Changes to HIPAA Enforcement

On Friday, October 30, 2009, the U.S. Department of Health and Human Services ("HHS") published an interim final rule and request for comments that implements certain HIPAA enforcement changes made pursuant to the HITECH Act. Consistent with the provisions of the HITECH Act, the new rule amends the HIPAA enforcement regulations applicable to violations of each of HIPAA's Administrative Simplification Rules (i.e., Privacy Rule, Security Rule, Transactions and Code Sets Rules, Standard Unique Identifier for Employers (EIN Rule), and the Standard Unique identifier for Health Care Providers (NPI Rule)) by instituting the below categories of violations and tiered penalty scheme to HIPAA violations that occur on or after February 18, 2009.… Continue Reading

FDA Commissioner Announces Aggressive New Enforcement Policy

After just passing her eighth week as FDA Commissioner, Dr. Margaret Hamburg announced on August 6, 2009, six new enforcement procedures to a group of industry representatives, attorneys, consumers, and others attending a speech sponsored by the Food and Drug Law Institute in Washington, D.C. "The FDA must be vigilant, the FDA must be strategic, the FDA must be quick, and the FDA must be visible," according to Commissioner Hamburg. She stated that vigilance means regular inspections and follow-up to ensure problems are resolved; identifying and resolving problems early; a "greater emphasis on significant risk and violations;" rapidly responding to egregious violations or violations that jeopardize public health; and using "meaningful penalties to send a strong message" to discourage future offenses. The Commissioner also said that the agency must be visible publicize its enforcement actions (and the rationale for those actions) widely and effectively. Commissioner Hamburg described six new policy changes to meet these goals.… Continue Reading

Hospital Agrees to Pay $700,000 To Texas AG For Allegedly Orchestrating an Insurer Boycott of Competitor

In a time of economic crisis, when hospitals, like most other businesses, are struggling to operate within a constrained budget, Memorial Hermann Healthcare System ("Memorial Hermann") agreed Jan. 26, 2009 to pay $700,000 to settle claims of the Texas Attorney General alleging that Memorial Hermann orchestrated an agreement among health plans not to do business with a new competitor, Town and County Hospital ("Town and Country"). According to the complaint, Memorial Hermann, which owns and operates acute care hospitals furnishing inpatient care, is the largest hospital system in the Houston area. Town and County, a physician-owned hospital, opened in November 2005. Before opening, Town and County approached insurers to enter into contracts to be included in those insurers' hospital networks. Memorial Hermann allegedly took steps to discourage insurers from entering into contracts with Town and Country, including sending notification of an intent to terminate its contract with one insurer as to all Memorial Hermann facilities, and subsequently renegotiating a contract with the insurer for substantially higher rates.… Continue Reading
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