Health Consumer Protection

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Part I - TCPA: Regulatory - Calls By or on Behalf of the Federal Government

A number of organizations filed comments and/or reply comments regarding the National Consumer Law Center (“NCLC”)’s Petition for Reconsideration of the Broadnet Declaratory Ruling, which asks that the FCC reconsider its...more

California Clamps Down On Surprise Out-Of-Network Bills

On September 23, 2016, Governor Brown signed AB 72, California’s surprise out-of-network law. The bill protects patients who seek care at an in-network facility from balance billing by individual health care providers who are...more

California Targets Surprise Medical Bills, Follows on the Heels of New York and Florida

Governor Brown approved a new law last Friday that limits patient exposure to so-called surprise medical bills. AB 72 caps the cost-sharing obligations of patients who unexpectedly receive care from non-contracted providers...more

FDA Issues Draft Guidance on Risk Evaluation and Mitigation Strategy (REMS) Determinations

On September 21, 2016, the US Food and Drug Administration (FDA) issued Draft Guidance for Industry: FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary, which is intended to clarify how the FDA...more

FTC Wins Key Appellate Victory in FTC v. Penn State Hershey Medical Center

The Federal Trade Commission (FTC) won a decisive victory today in its efforts to slow the record pace of health care provider consolidation, when the U.S. Court of Appeals for the Third Circuit reversed a District Court's...more

Consumer Fraud Allegations For A Prescription Medical Device Do Not Pass The Test

When we think of prescription medical devices, we usually think of the sorts of devices that are implanted during surgery and tend to end up in litigation—artificial joints, pacemakers, surgical meshes, and bone cements, to...more

Ugly details emerge on how Big Pharma fueled painkiller scourge

New information has surfaced about Big Pharma’s relentless campaign to sell the public on prescription, opioid painkillers-powerful, addictive drugs whose wide availability and abuse now has become a killer scourge that...more

Can Antitrust Prevent Excessive Drug Price Increases?

The antitrust agencies are often asked to intervene in markets where pricing appears to be excessive to help protect consumers and stabilize markets. In the drug arena, healthcare providers, consumers and politicians have...more

Health Update - September 2016

The Election’s Impact on Healthcare: Preparing for Potential Scenarios - Editor’s Note: Election 2016 will have a major impact on federal and state healthcare policy. To be prepared for all the possibilities, it’s...more

Taking Measure of HIPAA Enforcement

Last month, the U.S. Department of Health and Human Services, Office for Civil Rights (OCR) announced the largest settlement to date for alleged violations of the Health Insurance Portability and Accountability Act (HIPAA)....more

FDA Mandates Black Box Warnings For Opioids And Benzodiazepines

The Food and Drug Administration (FDA) recently decided to require so-called “black box warnings” on nearly 400 products, warning of the risks of combining certain opioid medications and central nervous system depressants...more

FDA Extends Deadline for Removal of NDC and NHRIC Numbers from Device Labeling and Packaging

On August 30, 2016, the US Food and Drug Administration (FDA) published final guidance in which the agency announced it does not intend to enforce its prohibition against the inclusion of National Health Related Item Code...more

California Joins New York and Florida, Passes Out-Of-Network Legislation

Last month the California legislature passed AB-72, which amends the Health & Safety Code to address reimbursement for out of network (OON) providers who provide services at in-network facilities, such as hospitals and...more

First Circuit Reinstates Consumer Action Previously Dismissed on FDCA Preemption Grounds

In 2014, Ronda Kaufman brought a proposed nationwide class action against drug store giant CVS alleging that the labeling of its Vitamin E supplements misled consumers about heart health benefits. Kaufman's complaint, among...more

LabMD Seeks To Stay FTC Decision Related To Evidence Of Consumer Harm Pending Appeal

LabMD—a medical testing lab that, the Federal Trade Commission (“FTC”) alleged, exposed consumer personal information through a peer-to-peer (“P2P”) file-sharing network—is now seeking a stay pending its appeal of the FTC’s...more

September Privacy and Security Updates

Although National Cyber Security Month isn’t until October, September has brought plenty of privacy and security updates that health care companies need to be aware of. In this post, we review guidance from the Office for...more

Don’t Ignore Ransomware Vulnerabilities; You Could Be Violating FTC Act

Last week, the Federal Trade Commission convened a ransomware workshop to discuss the rising epidemic of attacks against U.S. businesses and individuals. In a ransomware attack, a malicious actor tricks a user into...more

FDA to Host Public Hearing on Manufacturer Communications Regarding Unapproved Uses of Medical Products

On November 9 and 10, 2016, the Food and Drug Administration (FDA) is hosting a public hearing on “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.” The hearing is intended to...more

Congressional Health Policy Hearings, Markups Resume After Summer Break

Congress has returned from recess, and health care policy continues to be on the agenda. The following health-related hearings and markups were held this week: ..The House Ways and Means Committee approved H.R. 5942, a...more

California puts curbs on surprise medical bills

Surprise! California lawmakers waited until the very end of their legislative session before joining an increasing number of states in protecting patients from unexpected out-of-network medical charges. As many as 70 percent...more

Government Charges Sixteen In $175 Million Pharmacy Fraud

On September 1, 2016, the United States Attorney’s Office for the Southern District of Florida filed a five-count information, variously charging sixteen individuals, including three physicians, in connection with a scheme to...more

Better Healthcare Newsletter from Patrick Malone - September 2016

The cancer quandary: improving outcomes as costs explode: It long has been the dreaded C diagnosis: Cancer. For many Americans, the memory persists of a dreadful, deadly disease. But medical science has changed that,...more

Sixth Circuit Denies Seal of Approval for Unjustified Filings Under Seal

Litigants and third parties subpoenaed to produce information in litigation who believe that information that they deem confidential will not ever become part of the public record so long as a discovery protective order is in...more

ONC Releases Enhanced Regulatory Requirements to Improve Transparency for Health Information Technology Products

The Office of the National Coordinator for Health Information Technology (“ONC”) has operationalized regulatory requirements to improve transparency in health information technology (“health IT”). The regulations, which were...more

FDA Announces Dates for Long-Awaited Public Hearing on Its Regulation of Off-Label Communications

Times, They Are A-Changin’ - On Wednesday, FDA announced that it will hold a two-day public hearing on November 9th and 10th to obtain input from a broad cross-section of the health care industry, including...more

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