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Hospital and Fixed Indemnity Policies; Excepted Benefits; Supplemental Coverage under Recently Proposed Treasury Regulations; and...

We reported in a recent post on proposed regulations dealing with, among other things, the treatment of hospital indemnity or other fixed indemnity insurance products in the group market. This post takes a closer look at the...more

HHS Wins Summary Judgment Against Hospitals Disputing CMS’s Treatment of Part C Days as Days “Entitled to Part A” for Purposes of...

On August 17, 2016 the United States District Court for the District of Columbia granted summary judgment in favor of HHS in a dispute over whether Part C days can be treated as “days entitled to benefits under Part A” for...more

Massachusetts Determination of Need Regulation Overhaul

The Massachusetts Department of Public Health (DPH) Determination of Need (DoN) Program has unveiled proposed regulations that constitute an ambitious and, perhaps, long overdue overhaul of the DoN Program regulations....more

D.C. District Court Invalidates CMS’s “Protest” Requirement

On August 19, 2016, the United States District Court for the District of Columbia granted a group of hospitals’ motion for summary judgment against HHS in a challenge of the Provider Reimbursement Review Board’s (PRRB) denial...more

HRSA Proposes Administrative Process to Resolve Disputes Between 340B Program Covered Entities and Drug Manufacturers

Taking a step toward completing a requirement imposed by the Affordable Care Act, the federal government has proposed regulations that would create an administrative dispute resolution (“ADR”) process to resolve disputes...more

HRSA Releases Proposed Rule Governing the Administrative Dispute Resolution Process for 340B-Related Claims

On August 12, 2016, the Health Resources and Services Administration (“HRSA”) released a notice of proposed rulemaking (the “Proposed Rule”) to formally regulate the administrative dispute resolution (“ADR”) process for...more

FDA Issues Draft Guidance on "Deciding When to Submit a 510(k) for a Change to an Existing Medical Device"

On August 8, 2016, the U.S. Food and Drug Administration (FDA) issued draft guidance on the important topic of deciding when to submit a new 510(k) premarket notification application (510(k)) for a change to an existing...more

HHS Proposes Administrative Dispute Resolution Process for 340B-Related Claims

On August 12, 2016, the US Department of Health and Human Services (HHS) Health Resources and Services Administration issued a notice of proposed rulemaking that establishes an administrative dispute resolution process for...more

A Favorable, New Climate for Challenging Medicare Appeals

Over the past decade, health care providers seeking to challenge Medicare claim denials have faced increasing delays in reaching what many consider the most important step in the Medicare appeals process - a hearing before an...more

CMS Re-proposes Ban on Per-Click Fees for Space and Equipment Leases under Stark

In the CY 2017 Medicare Physician Fee Schedule (CY 2017 MPFS), the Centers for Medicare & Medicaid Services (CMS) issued proposed updates to the physician self-referral law (Stark law). The primary Stark law update focused on...more

CMS Audit Practices: How false can you get?

Caring Hearts Personal Home Care Services provided physical therapy and skilled nursing services to homebound Medicare patients. During an audit, CMS determined that Caring Hearts provided services to patients who didn’t...more

DEA Rejects Petitions to Reclassify Marijuana, but Opens the Door to Expanded Marijuana Research Efforts

In a long-awaited decision released this morning, the United States Drug Enforcement Administration announced that it has denied two petitions to reschedule marijuana under the Controlled Substances Act (the “CSA”). The DEA...more

DEA Declines to Change Stance on Marijuana but Opens Door to Federally Sanctioned Marijuana Research

On August 11, 2016, the Drug Enforcement Administration (DEA) formally declined to change its position on the medical or recreational use of marijuana, denying two petitions urging the federal government to change marijuana’s...more

Under the Dome: Inside the Maine State House

Under the Dome: Inside the Maine State House provides a high-level overview of recent activity at the Maine State House. Maine’s Health Exchange Co-op Sues Federal Government & Files for Rate Increase - Community...more

CMS Still Finding Its Way Through Significant Medicare Appeals Backlog – Proposes New Rule in an Effort to Catch Up

In the proposed rule, CMS focuses on taking administrative actions to alleviate the backlog, including introducing the concept of precedential decisions, delegating certain administrative law judge tasks to “attorney...more

FDA Accepts Merck’s Lantus Biosimilar for Review

We recently posted that Merck had announced “promising” results from Phase III studies evaluating MK-1293, an investigational follow-on biologic insulin glargine candidate for the treatment of people with type 1 and type 2...more

Alert: FTC Commissioners Find LabMD's Failure to Implement Data Security Practices "Unfair"

On July 29, 2016, the Federal Trade Commission (FTC or Commission) announced its long-awaited decision in its LabMD enforcement action. The Commissioners reversed the decision of an Administrative Law Judge (ALJ) and held...more

Federal Trade Commission Holds Medical Laboratory Liable for Allegedly Unfair Data Security Practices

On July 29, the Federal Trade Commission (“FTC” or “Commission”) issued a unanimous Opinion and Final Order reversing the FTC Administrative Law Judge (“ALJ”) Initial Opinion issued November 13, 2015, which had dismissed the...more

FDA Isn't Moving to Regulate Devices that Track Fitness Regimes!

At long last, the Food and Drug Administration issued its Nonbinding Recommendations and Guidance regarding "General Wellness: Policy for Low Risk Devices," announcing it will not regulate "low-risk general wellness...more

FDA Issues Draft Guidance on Use of "Real-World Evidence" in Medical Device Decision-Making

The U.S. Food and Drug Administration (FDA) issued on July 27, 2016, a draft guidance document addressing how it may use data and evidence collected outside of the traditional clinical trial context to support medical device...more

USPTO Launches Patents 4 Patients

To support the National Cancer Moonshot initiative, the USPTO has launched the Patents 4 Patients program, also known as the Cancer Immunotherapy Pilot Program. Under this program, applicants can obtain expedited examination...more

Commission Holds FTC Unfairness Claim Does Not Require “Probable” or Tangible Injury in LabMD Data Security Case

The Federal Trade Commission unanimously (3-0) ruled on July 29, 2016 that LabMD’s data security practices were “unfair” under Section 5 of the FTC Act, reversing a decision of its Administrative Law Judge (ALJ). As we...more

LabMD Opinion Reverses ALJ Decision; Articulates Standard for “Substantial Injury” Under the Unfairness Prong of the FTC Act for...

In a widely anticipated move, the Federal Trade Commission (FTC) has overruled a decision by its own Administrative Law Judge (ALJ) that had dismissed a case against a medical testing laboratory accused of unreasonable data...more

Companies That Collect Sensitive Consumer Data Should Note the FTC’s LabMD Ruling

The FTC has been a leader in enforcing cybersecurity issues in recent years, and just last week it issued a highly-anticipated decision on its authority to regulate cybersecurity as a form of unfair consumer practice under...more

Breaking News: FTC Vacates ALJ’s Ruling and Finds LabMD Liable for Unfair Data Security Practices

In a ruling issued this morning, the Federal Trade Commission found that LabMD, the defunct Atlanta-based cancer detection lab, failed to protect patient information and is liable for unfair data security practices. The...more

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