Administrative Agency Health

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

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

FDA Rejects Hospira’s EPO Biosimilar Application

After the FDA approved the first U.S. biosimilar, Sandoz’s Zarxio (filgrastim-sndz), earlier this year, many predicted that the floodgates would open for biosimilar products. That has not been the case. No other U.S....more

OIG Issues Advisory Opinion Permitting Free Hospital Shuttle Service between Health Care System Facilities

The Office of the Inspector General (OIG) recently issued a favorable advisory opinion (Advisory Opinion) to an integrated health care system (System) regarding a proposed arrangement whereby the System would provide a free...more

Are Attorneys Entitled to “HIPAA Rate”?

Over the past year, numerous lawsuits and complaints to the HHS Office for Civil Rights (“OCR”) have been filed by plaintiffs’ attorneys over a seemingly obscure HIPAA issue – the rate that health care providers and their...more

Limited Modifications in Final ACO Fraud and Abuse Waivers Most Notably Include Cut of Gainsharing CMP Waiver

Nearly four years after publishing their joint interim final rule with comment period, effective November 2, 2011 (IFC), the OIG and CMS (Agencies) have finalized the waivers of various fraud and abuse laws in the context of...more

OIG Issues Advisory Opinion on Free Transportation

The Office of Inspector General (“OIG”) posted its most recent advisory opinion addressing a transportation program on October 21. This opinion analyzed a plan for a free van shuttle service provided by an integrated health...more

Developments in Long-Term Care Q2 2015

The following summary highlights key federal court developments and administrative decisions involving skilled nursing facility survey and related issues during the second quarter of 2015....more

FDA Stays Final Guidance on INDs for Foods and Dietary Supplement Studies

On October 30, 2015, the U.S. Food and Drug Administration announced that it was staying portions of its controversial Final Guidance relating to the types of studies that require compliance with Investigational New Drug...more

Challenges to Medicare's Outlier Payment Rules - the Secretary Largely Prevails

As we reported in an earlier Payment Matters article, the United States Court of Appeals for the District of Columbia Circuit handed hospitals a partial victory on May 19, 2015, in their challenge to Medicare outlier payments...more

Can We Still Be Friends? FDA and Pacira to Settle Lawsuit Relating to Off-Label Promotion?

Taking a page (or lyric) from Todd Rundgren’s 1978 song, “Can We Still Be Friends,” it looks like the government, namely, the Food and Drug Administration and Department of Justice, and Pacira Pharmaceuticals, are looking to...more

The Bad Debt Moratorium Requires a Flexible Approach to Evaluating "Reasonable Collection Efforts"

On September 10, 2015, District Judge Randolph D. Moss of the U.S. District Court for the District of Columbia issued an opinion in Mountain States Health Alliance v. Burwell (Mountain States) involving Section 310 of the...more

Standard of Review in Discipline Matter

Professional Conduct Committee of the Saskatchewan College of Paramedics v. Bodnarchuk, 2015 SKCA 81, reinstating a decision of the College Discipline Committee. A paramedic was disciplined by a Discipline Committee of...more

You Can Check Out Anytime You Want, But You Can Never Leave: FDA Import Detentions and Recommendations to Minimize Delays

In The Eagles’ song, “Hotel California,” Don Henley sings, “You can check out anytime you want, but you can never leave.” Life science companies can try to import all they want, but that doesn’t mean the products will make it...more

Four Key Takeaways on the Expansion of the Medicare Appeals Settlement Conference Project

On October 15, 2015, the Office of Medicare Hearings and Appeals (“OMHA”) conducted a teleconference to address Phase II of the Settlement Conference Facilitation (“SCF”) Pilot, effective October 1, 2015. SCF, launched in...more

Overreaching or Underreaching? Comments on the CMS Proposed Rule on Arbitration Agreement in Long Term Care Facilities

During the 90-day public comment period on the Center for Medicare & Medicaid Services (CMS) proposed rule entitled “Reform of Requirements for Long-Term Care Facilities” which closed October 14, 2015, CMS received nearly...more

District Court in D.C. Vacates HHS’ Interpretive Rule Regarding Orphan Drug Exclusion from 340B Discount Pricing

In what amounts to a victory for the pharmaceutical industry, on October 14, 2015, the U.S. District Court for the District of Columbia vacated the interpretive rule issued by the U.S. Department of Health and Human Services...more

OIG Hospital Compliance Audits: Is Your Number Up? Are You Ready?

In its Work Plan for Fiscal Year 2012, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) announced it would begin reviews of Medicare payments to hospitals to determine compliance...more

Board of Physician Reporting Requirements of Physician Privilege and Employment Changes

Attached is an annotated version of a letter I sent to the Board of Physicians (Board) regarding its proposed new regulations on mandatory hospital (and other healthcare facilities) reporting of any changes in privileges and...more

Uncertainty Continues for Two-Midnight Rule's Payment Reduction

In Shands Jacksonville v. Burwell [PDF], No. CV 14-1477, 2015 WL 5579653, (D.D.C. Sept. 21, 2015), the United States District Court for the District of Columbia gave the Secretary of the Department of Health and Human...more

3,378 Results
View per page
Page: of 136

Follow Administrative Agency 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.
*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.