Health Administrative Agency

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"2014-15 Supreme Court Highlights"

Approaching the midpoint of its 2014-15 term, the Supreme Court has added to its docket several cases with potentially wide-reaching implications for a range of important policy and business issues. The Court accepted for...more

Medical Device Update: FDA Releases General Wellness Products and Device Accessories Guidance Documents

Background - On January 20, 2015, the U.S. Food and Drug Administration (FDA or the Agency) announced the availability of two draft guidance documents in the Federal Register: “General Wellness: Policy for Low Risk...more

No Judicial Relief to the ALJ Waiting Game — Yet

In May 2014, the American Hospital Association filed suit against the United States Department of Health and Human Services seeking to compel Administrative Law Judges (ALJs) to comply with applicable statutory deadlines for...more

Williams Mullen and Local Counsel, Bryan Davis, Win Declaratory Action Against HSD in New Mexico!!

For those of you who follow my blog, you know that the single state agency in New Mexico, Human Services Department (HSD), accused 15 behavioral health care providers, which made up 87% of the mental health care in NM, of...more

FDA Proposes Electronic Distribution of Prescribing Information

Drug manufacturers may no longer be required to distribute prescribing information on paper—with limited exceptions—and instead may have to distribute that same information electronically. The FDA recently issued a proposed...more

Manatt on Health Reform: Weekly Highlights #4

This week, the IRS announces relief for some taxpayers who received excess advanced premium tax credits; Indiana and Arkansas make major announcements on Medicaid expansion and Iowa’s Governor announces a shift towards...more

Regulating a Healthy Lifestyle? FDA Distributes New Draft Guidance on “General Wellness Products”

On January 16, 2015, the Food and Drug Administration (FDA) promulgated a much - anticipated draft guidance concerning the classification and regulation of general wellness products. The draft guidance is the FDA’s latest...more

FDA Draft Guidances on General Wellness Products and Device Accessories Continue Risk-Based Approach to Health IT

On January 20, 2015, the United States Food and Drug Administration (FDA) issued two new draft guidance documents, announcing the agency’s plans not to regulate “general wellness products” (including certain software...more

FDA Clarifies Orphan Drug Exclusivity Policy Following Court Defeat

On the heels of a loss in federal court last fall, the FDA recently announced a clarification of its policy concerning orphan drug exclusivity. In short, despite a court ruling requiring the FDA to grant orphan drug...more

MedPAC Voices Concerns about Growing Volume, Burden of Medicare Quality Measures

In December 2014, CMS released a 329-page list of quality measures under consideration for the Medicare program. In a January 13, 2015 comment letter, MedPAC observes that volume of measures under consideration “reinforces...more

Texas Torches Telemedicine? Board Issues Emergency Rule

The Texas Medical Board issued an Emergency Rule with proposed changes to the practice standards and disciplinary guidelines for remote prescribing via telemedicine consults. The Emergency Rule states that the use of online...more

Electronic Distribution of Prescribing Information for Prescription Drugs & Biologicals

The FDA published a proposed rule on December 18, 2014 that would require electronic distribution of the prescribing information intended for health care professionals, which is currently distributed in paper form on or...more

CMS Guidance on Provider Timeframes for Responding to Additional Documentation Requests

CMS has updated the Medicare Program Integrity Manual to clarify that providers and suppliers have 45 days to produce documents in response to a pre-payment review Additional Documentation Request (ADR) issued by a Medicare...more

FDA One Step Closer to New Direct-To-Consumer Television Ad Requirements

Last February, the Food and Drug Administration (FDA) asked for public feedback on a proposed research study related to prescription drug television advertisements. In a notice published in the Federal Register on January 13,...more

NIH Announces New One-Grant-at-a-Time Policy

In a move designed to stretch budget dollars and spread the research wealth, the National Institute of General Medical Sciences (NIGMS) announced last week that starting next year, it will impose a one-grant-at-a-time policy...more

Patterson Companies Lead the Charge to Secure Dental Supply Chain

On January 14, 2015, Patterson Companies, LLC, announced that it is formalizing its efforts to shore up its supply chain integrity for its dental customers. The program will assure that dental products that Patterson Dental...more

FDA Proposes Additional Flexibility for Mobile Health Products

Draft Guidances Address General Wellness Products and Device Accessories - The U.S. Food and Drug Administration (FDA or “the Agency”) has announced two more key parameters of its regulatory approach to mobile health...more

Potentially Burdensome Reporting Obligations Ahead for Industry Interactions with APRNs in Connecticut

The Connecticut Department of Consumer Protection (Department) recently released its Expenditure Disclosure Form for manufacturers subject to section 75 of Public Act 14-217, which requires manufacturers of a covered drug,...more

Heads Up – The ACA Employer Mandate Is Now In Effect: Beware of Actions that Could Result in ACA Whistleblower Liability

Effective January 1, 2015, certain employers became subject to the employer mandate of the Patient Protection and Affordable Care Act (ACA), and thus subject to liability under the ACA Employer Shared Responsibility...more

IT Maintenance Crucial for HIPAA Compliance

The Department of Health and Human Services' (HHS) Office for Civil Rights (OCR) recently announced an agreement with a medical center to settle charges stemming from the center’s failure to prevent malware from infecting its...more

OIG Provides Leeway for Copay Assistance to Low-Income Patients

Earlier this week the OIG released an advisory opinion stating that a nonprofit organization’s proposed arrangement to provide copayment assistance to financially needy patients would not result in civil monetary penalties or...more

ODAC Committee Votes to License Sandoz’s Zarxio®

As noted in our previous client alert, FDA Accepts First Biosimilar Application Filed under Section 351(k) of the Public Health Service Act, Sandoz Inc. (“Sandoz”) filed the first biosimilar application under the Biologics...more

FDA Regulatory Update: Forecasting FDA Regulation of Laboratory Developed Tests (LDTs) in 2015

2015 is proving to be a landmark year for FDA’s regulation of laboratory developed tests. As we have previously discussed (see our blog here), the U.S. Food and Drug Administration (FDA) has been expressing its intention to...more

FDA Regulatory and Compliance Monthly Recap - December 2014

FDA replaces pregnancy labeling system with a new standard in a bid to provide more clarity - The regulator is discarding its decades-old system to explain the risks of prescription drugs to women who are pregnant or...more

DOL and Treasury Update 2014-2015 Regulatory Agendas for Employee Benefits

The principal regulators of U.S. employee benefits have recently published updates to their guidance plans for the coming months. The updated plans are reflected in the attached chart. ...more

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