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Injunction Enjoining Enforcement of HHS Attestation Rule Affirmed

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...

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

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

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?

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

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

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

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?

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

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

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

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

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

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

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

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

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

Prosecutors Strike Gold in Retailers’ Dumpsters with Hazardous Waste Enforcement Action

Retailers should implement hazardous waste management plans, even for simple consumer goods, as California, New York and other states launch aggressive enforcement campaigns. In recent years, California prosecutors...more

New FDA Guidance Opens the Door for Electronic Consent Forms That Come with Significant Advantages and Raise Privacy and Secure...

On March 9, 2015, the U.S. Food and Drug Administration (FDA) published a draft guidance that allows for the use of electronic informed consent (eIC) in human clinical trials. eICs have the potential to...more

Going Paperless: FDA Releases Draft Guidelines to Digitize Clinical Trials

The FDA released draft guidelines (“Guidelines”) on Monday, March 9, 2015 establishing recommendations on the use of e-media and processes to obtain informed consent for clinical investigations (trials) of medical products...more

Supreme Court Holds State Regulatory Board Not Immune From Antitrust Laws

On February 25, 2015, the U.S. Supreme Court determined that the North Carolina State Board of Dental Examiners (“Dental Board”) is not shielded from federal antitrust law under the doctrine of state-action antitrust...more

Blog: Vermont AG Announces Another Disclosure Law Enforcement Action

the Vermont Office of the Attorney General (“VT AG”) previously published several enforcement actions taken against manufacturers of pharmaceutical, biological and medical devices for failing to comply with the state’s...more

Blog: Congress Eyes Pharmaceutical Company Settlement Agreements as Source for Additional FDA & NIH Funding

Senator Elizabeth Warren (D-MA) recently introduced legislation that, if passed, would require certain pharmaceutical companies that enter into settlement agreements with the Department of Justice or other governmental...more

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