Health Administrative Agency

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.
News & Analysis as of

Latest OCR Enforcement Action: Underbed Storage is Not Appropriate for PHI

Recent enforcement actions by the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) have highlighted that, not surprisingly, Covered Entities should not leave medical records in a...more

Historic Moment: Husband Reports Wife’s HIPAA Violation Triggering Six Figure Penalty Against Employer

For the second time in history, the Office for Civil Rights (“OCR”) has imposed a civil monetary penalty (“CMP”) against a covered entity for violations of the Health Insurance and Portability Act (“HIPAA”). Lincare, Inc., a...more

HHS Psychiatric Hospital Reimbursement Methodology Upheld

On December 29, 2015 the U.S. Court of Appeals for the District of Columbia rejected a challenge to a psychiatric hospital's pre-PPS Medicare reimbursement. Washington Regional Medicorp v. Burwell, No. 1:13-cv-00622 (D.C....more

New Ruling Challenges FTC Authority to Regulate Cybersecurity Based on “Possible Consumer Harm”

A Nov. 13, 2015 ruling supports the argument that various companies and lawyers have been making for years: the Federal Trade Commission is exceeding its authority in prosecuting cybersecurity breaches under Section 5 of the...more

FDA Classifies Transvaginal Pelvic Mesh As “High Risk” Medical Device

The U.S. Food and Drug Administration issued two final orders on Monday, January 4, 2016 to strengthen the data requirements for transvaginal surgical mesh devices that repair pelvic organ prolapse (POP). First, the agency...more

CMS Changes to Cost Report and Appeal Rules Are Now in Effect

As part of the Outpatient Prospective Payment System (OPPS) final rule published in the Federal Register on November 13, 2015, CMS made noteworthy changes to the Medicare cost report and appeal rules. See 80 Fed. Reg. 70298...more

WEBINAR: Protecting Your Patients, Workforce and Visitors from Workplace Violence and Active Shooters

The Ober|Kaler Health Care General Counsel Institute presented this webinar on key considerations for health care facilities in protecting patients, workers and visitors from workplace violence and active shooter situations....more

A Return to Evanston: FTC Revisits Old Ground in Yet Another Hospital Merger Challenge

Last week, the Federal Trade Commission (“FTC” or “Commission”) authorized staff to file an administrative complaint and to seek in federal court a temporary restraining order and a preliminary injunction to block the...more

Notice of Plan-Imposed Statute of Limitations for Filing Suit Must Be Included in Adverse Benefit Determination Letters

In Mirza v. Insurance Administrator of America, 800 F.3d 129 (3rd Cir. 2015), the court held that adverse benefit determination letters must include any plan-imposed time limits for seeking judicial review to be enforceable....more

FDA Medical Device Approval Rate Hits 15 Year High

According to a Food and Drug Administration 2015 performance report, the FDA’s approval rate for high-risk medical devices jumped to 98 percent for medical devices submitted within the most recent fiscal year. This was a 12...more

Food and Drug Newsletter - December 2015

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Spectranetics Announces FDA Approval for Turbo-Power™ Laser Atherectomy Catheter Device

According to a recent press release, Colorado Springs-based Spectranetics announced that it has received FDA 510(k) clearance for its Turbo-Power™ Laser Atherectomy Catheter, a peripheral atherectomy product used to treat...more

FDA Plans Workshop to Address Cybersecurity in Medical Devices

Two months after finalizing its first guidance on cybersecurity, the FDA has announced a public workshop entitled “Moving Forward: Collaborative Approaches to Medical Device Cybersecurity” to continue to address a growing...more

Tell Me, Tell Me, Where I’m Going: Recent FDA Presentation Offers a Crystal Ball Into Medical Device Inspectional Priorities and...

In this Bulletin, we highlight some of these findings, which provide a glimpse into FDA’s priority concerns and should help companies proactively and properly plan for their next inspections. To paraphrase from the rock band...more

"Key Takeaways: Fifth Annual Pharmaceutical and Medical Device Seminar"

On November 17, 2015, a group of Skadden attorneys and corporate counsel joined representatives from more than 20 life sciences companies to discuss U.S. enforcement issues companies throughout the industry face. The key...more

Company Prevails in Challenge to FTC Data Security Complaint

A recent decision by the Federal Trade Commission (FTC) Chief Administrative Law Judge (ALJ) dismissed the FTC’s complaint against LabMD, Inc. (LabMD) asserting the company’s alleged failure to protect consumer data in two...more

Stakeholders Say Biosimilars Names Should Be Meaningful and Memorable

FDA has received comments from more than 170 groups on its proposal for naming biosimilars. Biosimilar makers, insurers and pharmacies largely oppose distinct nonproprietary names (also known as proper names) for...more

The Food and Drug Administration Announces a Stay Related to IND Guidance

On October 30, 2015, the Food and Drug Administration (FDA) announced in the Federal Register a stay of certain portions of a September 2013 final guidance for clinical investigators, sponsors and institutional review boards...more

FDA data underscores why patients need to ask tough questions about care

The epidemic of overtreatment is hardly new, and it often stems from physicians’ tendency to order excessive tests. But now Uncle Sam is getting ready to step in even more, prompted in part by disturbing data that detailed...more

OMB Releases Fall 2015 Regulatory Agenda

Earlier today, the White House Office of Management and Budget released its semi-annual Unified Regulatory Agenda and Regulatory Plan for Fall 2015, covering 59 Federal departments, agencies, and commissions. Entries are...more

The baby boomer gamblers: Running out of money

As the first of the baby boomers have reached retirement age, the greatest financial threat to the American middle class is silently waiting for them. Most are unprepared for what actuaries call “longevity risk.” The real...more

Bills Introduced to Streamline FDA Review of Medical Devices

U.S. Senators Cory Gardner (R-CO) and Joe Donnelly (D-IN) recently introduced the Rare Device Innovation Act and the FDA Regulatory Efficiency Act.  The bills, if passed, would streamline the U.S. Food and Drug Administration...more

FTC Theory of Unrealized Consumer Injury Rejected in LabMD Data Security Case

In what could be a major setback for the Federal Trade Commission (FTC) in the data security arena, an Administrative Law Judge (ALJ) has ruled that an unfairness claim brought by the FTC under Section 5 of the FTC Act...more

Court Upholds HHA Face-to-Face Narrative Requirement

The Medicare statute requires that home health agency (HHA) patients must be homebound and in need of skilled nursing or therapy services in order to receive Medicare HHA services. 42 U.S.C. § 1395f(a)(2)(C). Historically,...more

AGG Helps Hospice Weather the Perfect Storm of Aggressive Medicare Payment Denials and Administrative Appeal Backlog

Medicare’s implementation of post-payment review through private contractors who are overly aggressive in denying payments, combined with a severe backlog of cases in queue for hearing before an Administrative Law Judge...more

3,393 Results
|
View per page
Page: of 136

Follow Health Updates on:

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

Already signed up? Log in here

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.
×