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Read need-to-know updates, commentary, and analysis on Administrative Agency issues written by leading professionals.

Massachusetts Outlook: The Remainder of the 2017-2018 Legislative Session

With the end of the 2017-2018 legislative cycle fast approaching, Beacon Hill’s agenda for the coming months has begun to take shape. All major policymaking will need to be concluded by the end of formal sessions on July 31,...more

South Carolina Insurance Department Amends Privacy Regulations

by Weiner Brodsky Kider PC on

The South Carolina Department of Insurance recently amended its Privacy of Consumer Financial and Health Information provisions (Regulation 69-58) to eliminate the annual privacy notice requirements for financial institutions...more

Guidance on Guidance: DOJ Limits Use of Agency Guidance Documents in Civil Enforcement Cases

by McDermott Will & Emery on

In a two-page memorandum, the US Department of Justice (DOJ) announced a broad policy statement prohibiting the use of agency guidance documents as the basis for proving legal violations in civil enforcement actions,...more

FDA Issues Draft Guidance for Obtaining Qualified Infectious Disease Product Designation Under the GAIN Act

The U.S. Food and Drug Administration (FDA) recently issued draft guidance on obtaining "Qualified Infectious Disease Product" (QIDP) designation for antibacterial and antifungal drug candidates intended to treat serious or...more

The New Option in Town: Applying for the Low Volume Appeals Settlement

by Baker Ober Health Law on

In November 2017, the Department of Health and Human Services (HHS) announced new settlement options for providers and suppliers stuck in the backlog of the Medicare appeals process. One of the new options available is the...more

White House Releases Fiscal Year 2019 Budget (Plus an Infrastructure Proposal)

Fiscal Year 2019 Budget - The White House has unveiled President Trump’s budget proposal for Fiscal Year 2019, entitled Efficient, Effective, Accountable: An American Budget. The Administration has worked for...more

CMS Low-Volume Appeals Initiative

by Benesch on

On February 5, 2018, the Centers for Medicare and Medicaid Services (“CMS”) began accepting Expressions of Interest (“EOI(s)”) from Medicare fee-for-service providers to participate in a new Low-Volume Appeals Initiative...more

FDA Issues New Compounding Guidance

In January 2018, the U.S. Food & Drug Administration (FDA) published two guidance documents on Compounded Drug Products That Are Essentially Copies Of Approved Drug Products under Section 503A and Section 503B of the Federal...more

Healthcare Employers Rejoice? Recent Shift In NLRB Decisions Impacts The Industry

by Fisher Phillips on

A new Republican majority took hold over the National Labor Relations Board (NLRB) at the end of 2017, leading to several significant labor decisions. Because the NLRB’s decisions and actions impact all industries, healthcare...more

Nursing Facility Discounts Approved in OIG Advisory Opinion 17-08

by Baker Ober Health Law on

The OIG created an opening for nursing facility discounts to private payors when it approved a startup company's proposal to create a network of nursing facilities willing to offer discounts on the daily rates charged to...more

Rx IP Update - January 2018

by Smart & Biggar on

Apotex granted damages from contract research organization for delayed FDA approval of two products - Appeal of summary dismissal under PMNOC Regulations: dismissal order stayed...more

A Client's Guide to FDA Recalls

Product recalls are critical events for firms that produce food and medical products. The lives and health of patients and consumers can be at stake. Companies risk enforcement action by the Food and Drug Administration...more

FDA proposes rule to codify existing guidance on supervisory review of CDRH decisions

by Hogan Lovells on

On January 17, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a proposed rule to update the framework for requesting internal agency supervisory review of certain decisions related to devices regulated...more

New HHS Division to Focus on Health Care Workers' Religious or Moral Objections to Providing Certain Care

by FordHarrison on

The U.S. Department of Health and Human Services (HHS) has announced the formation of the Conscience and Religious Freedom Division of the HHS Office for Civil Rights (OCR). The new division will review complaints from...more

DOJ Memorandum Supports Government Dismissal of Qui Tam False Claims Act Cases

by Morgan Lewis on

In a recent memorandum, the US Department of Justice provided guidance to its attorneys on when they should seek dismissal of False Claims Act cases filed by relators. This appears to be the first directive advising DOJ...more

FDA Issues Draft Guidance on Requirements for Public Warnings for Recalled Products

by Hogan Lovells on

FDA recently released a draft guidance clarifying the regulatory requirements for public warnings in the event of a recall under the agency’s recall guideline at 21 CFR Part 7. ...more

CMS Announces Low Volume Appeal Settlement Option for Providers Mired in ALJ Backlog

by Arnall Golden Gregory LLP on

On January 9, 2018, the Centers for Medicare and Medicaid Services (CMS) announced details on the new low volume appeal settlement option, which is the latest alternative available to Medicare Part A and Part B providers and...more

Emergency Regulation Concerning Live-In Cases Lives On

by Hodgson Russ LLP on

Yesterday, the Industrial Board of Appeals dismissed a challenge brought by the Chinese Staff and Workers Association and other worker advocacy groups (collectively, the “Petitioner”) against the Commissioner of the New York...more

Six Things to Know on CMS's Guidance Addressing the Low Volume Medicare Appeal Settlement

by Polsinelli on

The Centers for Medicare and Medicaid Services (“CMS”) recently issued guidance that starting Feb. 5, 2018, CMS will begin the process for the Low Volume Appeal (“LVA”) settlement option that CMS had announced on Nov. 3....more

New SAMHSA Rule: Permissible Part 2 Substance Abuse Disclosures to Subcontractors

by Baker Ober Health Law on

On January 3, 2018, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a final rule to revise 42 CFR Part 2, the federal regulations governing confidentiality of certain substance abuse patients'...more

Medicare 340B Drug Payment Policy Survives Legal Challenge; Hospitals Say, It's Not Over

by Baker Ober Health Law on

A federal court has handed CMS an initial legal victory enabling drastic cuts in Medicare Part B payment to take effect for separately payable drugs and biologicals purchased by hospitals under the 340B Drug Discount Program...more

Court Upholds Procedural Validity of HHS's Outlier Reconciliation Instructions

by Baker Ober Health Law on

On December 26, 2017, the United States Court of Appeals for the District of Columbia Circuit upheld the procedural validity of 2010 manual instructions setting out the criteria by which Medicare outlier payments might be...more

Post-market medical devices, cybersecurity, and the U.S. FDA’s growing concerns

by Hogan Lovells on

From insulin pumps and pacemakers to defibrillators, medical devices increasingly rely on wireless and internet connectivity for efficient operations. Unfortunately, these interconnections also leave devices vulnerable to an...more

Four-Term Governor Jerry Brown: One Last Budget

This week, California Governor Jerry Brown, beginning the final year of his unprecedented four terms as governor, unveiled his 16th and last state budget proposal, which projects a $6.1 billion surplus, mostly a result of...more

FDA Proposes to Delay Off-Label “Intended Use” Rule

by Reed Smith on

Perhaps you have heard that elections have consequences. That is true not only for high-profile issues that hog the headlines on CNN and Fox News, but it is also true for drug and device litigation regulation. Such drug and...more

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