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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

Can a license issued by Health Canada for producing or dealing cannabis be assigned as security?

by Dentons on

The last year has been filled with sensational headlines relating to the spectacular growth and rise to prominence of Licensed Producers (as defined below) in response to the federal government's plan to legalize recreational...more

What’s Past is Prologue - NLRB Restores the Common Sense Meaning of Past Practice

In Raytheon Network Centric Systems, 365 NLRB No. 161 (December 15, 2017), the National Labor Relations Board (NLRB) jumped back into the quagmire of past practice, dynamic status quo, and impasse to create firmer ground for...more

Canada releases proposed amendments to Regulations governing patented medicines pricing

by Smart & Biggar on

On December 2, 2017 Canada’s Governor-in-Council published proposed Regulations Amending the Patented Medicines Regulations (“the proposed Regulations”). The 75-day consultation period ends February 15, 2018. The proposed...more

Recent Developments in Antitrust Scrutiny of Healthcare-Provider Transactions

by Holland & Knight LLP on

As the trend of acquisitions of physician practices and mergers of hospitals continues, so does antitrust scrutiny of these deals. There was activity this week in three different proposed transactions that caught the...more

FDA Launches New Webpage to Report Regulatory Misconduct

by Stinson Leonard Street on

Earlier this week, the FDA launched a new webpage to simplify the process of reporting violations of the law by medical device manufacturers and individuals marketing medical devices. Unlike the MedWatch system for reporting...more

Injunction Enjoining Enforcement of HHS Attestation Rule Affirmed

by Foley & Lardner LLP on

The Court of Appeals for the District of Columbia affirmed the District Court’s decision in Central United Life v. Burwell on July 1, 2016. This decision is very significant for those assessing the future strength of, and...more

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

by Arnall Golden Gregory LLP on

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

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

by Arnall Golden Gregory LLP on

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

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

by Arnall Golden Gregory LLP on

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

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

by Baker Donelson on

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

Massachusetts Proposes New Rules for Nursing Home Sales and Closures

by Arnall Golden Gregory LLP on

Massachusetts regulators recently announced new rules that, if adopted, will change the requirements for nursing home sales and closures in the state. The proposed new rules require nursing home owners intending to sell a...more

Beyond Ebola: Environmental Regulatory Issues Creating Business Risks for Health Care Providers

by Pepper Hamilton LLP on

Business and legal risks to health care companies reach far beyond scientific uncertainties in the prevention protocols for infectious diseases due to lack of clarity among regulators with public health...more

NLRB Affirms Its Previous Decision Requiring Employer to Continue Providing Annual Wage Increases Beyond Contract Expiration

by Seyfarth Shaw LLP on

We previously blogged about the NLRB’s relatively shocking September 2012 decision in Finley Hospital (359 NLRB No. 9), in which the Board held that an employer was required to continue providing wage increases after the...more

Blog: General Wellness Products: Will the FDA Regulate Your Medical App or Device?

by Cooley LLP on

In January 2015, the U.S. Food and Drug Administration (FDA) released its draft guidance on general wellness products, a reassuring indication that the FDA will focus its efforts on regulating higher risk products rather than...more

OIG Issues Compliance Guidance for Healthcare Governing Boards

Members of healthcare governing boards now have direction from the OIG as to what is expected of them as they oversee the regulatory compliance of their organizations. And the good news is that the board members don’t have to...more

Compliance Guidelines for Governing Boards: Some Further Thoughts and Comments

by Davis Wright Tremaine LLP on

On April 20, 2015, four organizations (including OIG, American Health Lawyers Association, the Association of Healthcare Internal Auditors and the Health Care Compliance Association) issued “Practical Guidance for Health Care...more

Spotlight on Responsibility and Accountability: OIG’s New Compliance Guidance for Health Care Governing Boards

by Epstein Becker & Green on

On April 20, 2015, the Office of the Inspector General of the U.S. Department of Health and Human Resources (“OIG”), in collaboration with the American Health Lawyers Association, the Association of Healthcare Internal...more

OIG Issues Compliance Oversight Guidance for Governing Boards of Health Care Organizations

by K&L Gates LLP on

On April 20, 2015, the Office of Inspector General (OIG), in collaboration with the Association of Healthcare Internal Auditors, the American Health Lawyers Association, and the Health Care Compliance Association, issued...more

OIG Issues Board Guidance on Compliance Oversight

by Davis Wright Tremaine LLP on

On April 20, 2015, the Inspector General of the Department of Health and Human Services (OIG), the American Health Lawyers Association (AHLA), the Association of Healthcare Internal Auditors (AHIA) and the Health Care...more

OIG Releases New Guidance Offering “Practical Tips” to Health Care Boards for Overseeing Compliance Program Functions

by Ropes & Gray LLP on

On April 20, 2015, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”), together with industry leaders, released a new educational resource to help governing boards of health care...more

OIG Provides Additional Compliance Guidance for Healthcare Governing Boards

by BakerHostetler on

On April 20, 2015, the HHS Office of Inspector General (HHS OIG), in collaboration with the American Health Lawyers Association (AHLA), the Association of Healthcare Internal Auditors (AHIA), and the Health Care Compliance...more

OIG Issues Practical Guidance for Health Care Governing Boards on Compliance Oversight

by Dorsey & Whitney LLP on

On April 20, 2015, the Office of the Inspector General of the United States Department of Health and Human Services (“OIG”), in collaboration with the Association of Healthcare Internal Auditors, the American Health Lawyers...more

5 Takeaways from the HHS OIG’s Guidance for Health Care Governing Boards

Tuesday, the HHS OIG, in collaboration with the Association of Healthcare Internal Auditors, the American Health Lawyers Association (AHLA), and the Health Care Compliance Association, released a guidance document entitled...more

Open Season on Provider-controlled Licensing Boards

by Baker Ober Health Law on

In a closely followed decision with significant consequences for state licensing boards and their members, the Supreme Court in North Carolina State Board of Dental Examiners v. Federal Trade Commission, 135 S. Ct. 1101...more

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