Archives: Health Care

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Health care workers and private employees could be affected by new CMS interim final rule and OSHA final rule

On November 5, 2021, the Centers for Medicare and Medicaid Services (CMS) published an interim final rule that requires vaccinations for certain health care workers. The rule is limited to only those entities who are surveyed by CMS and have Conditions of Participation, Conditions for Coverage, or Requirements for Participation in the Medicare and Medicaid … Continue Reading

About That Brand Memo . . .

Issued in January 2018, the so-called Brand Memo reminded Department of Justice (DOJ) attorneys that “[g]uidance documents cannot create binding requirements that do not already exist by statute or regulation.” It also instructed DOJ attorneys that they “may not use noncompliance with guidance documents as a basis for proving violations of applicable law in affirmative … Continue Reading

FDA Announces Its Plan for Encouraging Reliance on Newer Predicate Devices and Medical Device Performance Criteria

On November 26, 2018, the Food & Drug Administration (FDA) announced its intent “to modernize the FDA’s 510(k) clearance pathway”1 by encouraging manufacturers to rely on newer (that is, 10 years old or less) medical devices as predicate devices in 510(k) notifications, and providing an alternative 510(k) pathway that allows manufacturers to rely on objective … Continue Reading

FDA to implement OIG suggestions on IoT cybersecurity

The Office of the Inspector General (OIG) published a report in September 2018 after a review of the Food and Drug Administration’s (FDA) policies, procedures, and guidance relating to cybersecurity reviews of networked medical1 devices. In its findings, covered in our recent client alert, the OIG determined that while the FDA has started to include … Continue Reading

OIG Gives Stamp of Approval for Innovative Warranty Program

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

OIG Issues RFI Regarding Federal Anti-kickback Statute and Beneficiary Inducement CMP

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

A Complete Victory for Multi-Office Team as the U.S. Department of Justice Dismisses Billion-Dollar False Claims Act Case

On November 8, 2017, following many years of investigation, the U.S. Department of Justice dismissed a billion-dollar False Claims Act (FCA) case against our long-standing client HCR ManorCare, the industry leader in post-acute rehabilitation care. The DOJ alleged that HCR ManorCare delivered unnecessary therapy to patients covered under Medicare Part A in its skilled nursing … Continue Reading

FDA Finalizes Policy for Sharing Patient-Specific Data from Medical Devices

FDA recently released guidance (“Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients Upon Request”) finalizing its policy on medical device manufacturers sharing patient-specific information from devices with patients at the patients’ request. In response to the more active roles patients are playing in their health care, and increased frequency with which patients are seeking … Continue Reading

New Regulations Reshape Transparency-Related Obligations in France, Could Impact Life Sciences Companies

In France, transparency requirements are regulated by two main sets of laws: “The French Anti-Gift Law” regulates the provision of gifts, discounts and other incentives to health care providers by life sciences companies, while “the French Sunshine Act” imposes disclosure obligations on companies relating to benefits granted to, and agreements concluded with, health care providers. … Continue Reading

U.S. Supreme Court Decision Upholds Implied Certification Theory of False Claims Act Liability, Articulates New Limits

Last month, Lindsey provided readers of the Drug and Device Law blog with an overview of United Health Services, Inc. v. U.S. ex rel. Escobar, a False Claims Act (FCA) case that was bringing the implied certification theory of FCA liability before the U.S. Supreme Court for review. The FCA imposes liability on anyone who knowingly … Continue Reading

Medicaid Rebate Program Final Rule Issued….Finally!

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

Stark Law Regulations: More Flexible in 2016

Recently, the Centers for Medicare & Medicaid Services (CMS) released final regulations under the physician self-referral law known as the Stark Law. We previously discussed the topic here, on our Health Industry Washington Watch blog here and in a  American Health Lawyers Association Weekly article  “CMS Publishes Final Stark Law Regulations” written by Karl Thallner and Nicole … Continue Reading

Final Stark Law Regulations Published by CMS

As previously discussed here and on our Health Industry Washington Watch blog here the Centers for Medicare & Medicaid Services (CMS) has released final regulations under the physician self-referral law known as the Stark Law. The provisions of the final rule are effective on January 1, 2016, except for certain changes on calculating ownership percentages for … Continue Reading

Proposed Budget Deal Would Add Medicaid Inflation Rebates for Generic Drugs

As noted in our recent Health Industry Washington Watch blog post, outgoing House Speaker John Boehner and the Obama Administration have reached agreement on a two-year, $80 billion budget/debt-ceiling deal that includes Medicare and Medicaid “offsets” to finance other spending.  For manufacturers of generic pharmaceuticals marketed under abbreviated new drug applications, Section 602 of the proposed … 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

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

House Easily Passes 21st Century Cures Legislation, Includes Significant FDA Reforms

On July 10, 2015, the U.S. House of Representatives passed with an overwhelming majority (344-77), the 21st Century Cures bill (H.R. 6), a high-profile bipartisan bill intended to speed up and improve the process for approving innovative drugs and medical devices, and to address other issues, including those regarding clinical trial design, research funding, and … Continue Reading

Texas Hospital CFO Pleads Guilty To Making A HITECH Act False Statement

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

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

21st Century Cures Markup Underway; Offsets Released

Today the House Energy and Commerce Committee is marking up H.R. 6, the 21st Century Cures Act, a high-profile, bipartisan bill that seeks to accelerate the pace of medical cures in the United States through a variety of reforms addressing drug and device development and approval, clinical trial design, research funding, interoperability of health technology, … Continue Reading

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

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

Bipartisan Energy & Commerce Committee Leaders Release Updated 21st Century Cures Draft

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
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