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Health Care Enforcement Review and 2017 Outlook: Major Case Developments

January 5, 2017 | Blog | By Ryan Cuthbertson

Today, my colleagues Laurence Freedman, Samantha Kingsbury, and Karen Lovitch released the latest in our ongoing series reviewing health care enforcement activities in 2016 and their impacts looking forward to 2017.
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Join Mintz and ML Strategies as We Kick-Off Our 21st Century Cures Act Webinar Series

January 4, 2017 | Blog | By Lauren Moldawer

Next Tuesday, January 12th, Mintz and ML Strategies will host the first installment of our three-part series focusing on the 21st Century Cures Act (“Cures Act”).  The Cures Act represents significant legislation that will have overarching implications on medical research, product development, and drug and biologic manufacturing.
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Health Care Enforcement Review and 2017 Outlook: FDA's Wide-Ranging Activities

January 4, 2017 | Blog | By Joanne Hawana , Benjamin Zegarelli

Over the past year, clear trends have emerged in FDA’s enforcement activities. Enforcement arising from alleged violations of the Federal Food, Drug, and Cosmetic Act (FFDCA) can take many forms, including FDA advisory actions such as warning letters, adverse inspectional observations that can lead to specific administrative action.
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Health Care Enforcement Review and 2017 Outlook: Yates Memo in Action

January 3, 2017 | Blog | By Eoin Beirne

Happy New Year! As we kick off 2017, our Health Care Enforcement Defense team brings you its annual review of key government policies, regulations, and enforcement actions in 2016, and the impact these trends are expected to have on enforcement in the year ahead.
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Join Us on January 12th for the Fifth Installment in Our EU General Data Protection Regulation Webinar Series

January 3, 2017 | Blog | By Samantha Kingsbury

On January 12th at 1:00pm EST, my colleague Susan Foster, PhD will present a webinar on Transferring Data from the EU.
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OIG Report Offers Glimpse into CMS Progress Towards MACRA Implementation

December 28, 2016 | Blog

Last week, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services released a report analyzing CMS' readiness to implement major parts of the Medicare Access and CHIP Reauthorization Act  of 2015 (MACRA).
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Cures Act Affirms Drug Companies’ Ability to Discuss Certain Information with Payors

December 22, 2016 | Blog | By Joanne Hawana

Since congressional enactment and presidential signing of the Cures Act into law earlier this month, we have been blogging on discrete regulatory and clinical areas affected by its provisions.
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21st Century Cures Act – Med Tech Impact Webinar January 18

December 21, 2016 | Blog

As you have seen in our recent coverage, the 21st Century Cures Act is a major legislative undertaking, and it will have a great impact the medical device industry. Join my Mintz Levin and ML Strategies colleagues Tom Crane, Bethany Hills, and Rodney Whitlock on January 18th for a MassMEDIC webinar, “Impact of the Cures Act on the Medical Device Industry.”
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21st Century Cures Act Requires FDA to Expand the Role of Real World Evidence

December 19, 2016 | Blog | By Benjamin Zegarelli

As we noted in our December 9th post, the 21st Century Cures Act (the “Cures Act”) requires FDA to develop a framework and guidance for evaluating real world evidence (“RWE”) in the context of drug regulation to support approvals of new indications for previously approved drugs, and to support or fulfill post-approval study requirements.
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The Medicare Part B Demo May be Dead, but Drug Pricing Concerns Still Linger

December 16, 2016 | Blog | By Lauren Moldawer

The Centers for Medicare & Medicaid Services (CMS) has withdrawn its controversial rule implementing the Medicare Part B payment demonstration. The agency stated that after consideration of the comments, it will not move forward with the demo.
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President Obama Signs 21st Century Cures Act; Creates Accelerated Approval Pathway for Regenerative Medicine

December 15, 2016 | Blog | By Joanne Hawana

On Tuesday, President Obama signed the 21st Century Cures Act (the "Act”) into law. The Act is a massive piece of legislation that has implications for many different aspects of the interconnected medical research, product development, and health care delivery enterprises.
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At Long Last, OIG Issues Final Rule for Beneficiary Inducement Safe Harbors

December 12, 2016 | Blog | By Carrie Roll

More than two years since issuing the proposed rule, the HHS Office of the Inspector General (OIG) issued the long-awaited and highly anticipated final rule (the Final Rule) that provides amendments to the Anti-Kickback Statute (AKS) regulatory safe harbors and adds protections for certain payment practices and business arrangements under the beneficiary inducement provisions of the Civil Monetary Penalty Law (CMP).
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Senate Passes 21st Century Cures Act, but Can It Cure an Ailing FDA?

December 9, 2016 | Blog

On Wednesday, the U.S. Senate overwhelmingly passed the 21st Century Cures Act (the “Act”) by a vote of 94 to 5.  Spearheaded by Michigan Representative Frank Upton, the bill now heads to President Obama who has promised to sign it. The Act is ambitious, and will impact a wide swath of the U.S. health care system.
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In the Wake of the Election, What’s Next for State Drug Pricing Initiatives?

December 8, 2016 | Blog | By Carrie Roll

A Trump victory was not the only surprise on election night. California’s drug pricing initiative, which would have required state agencies to negotiate drug prices at least as low as those paid by the U.S. Department of Veterans Affairs, was defeated by a wide margin (46% to 54%).
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Forty-Five Days and Counting for Current HHS Leadership: Implications for Rulemaking

December 7, 2016 | Blog

Before we all turn our full attention to the nominations of Representative Tom Price as Secretary of Health and Human Services, and policy consultant Seema Verma to lead CMS, we need to remember that there are still approximately 45 days remaining in the current administration.
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OCR Provides Additional Clarification on Phishing Scam

December 2, 2016 | Blog

As we reported earlier this week, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights described a phishing campaign that is attempting to convince recipients of their inclusion in OCR's Phase 2 audit program.
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OCR Warns of Phishing Campaign Disguised as Official OCR Communication

November 29, 2016 | Blog

The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) published an alert on Monday describing a phishing campaign disguised as an email from OCR. The email is being circulated on mock HHS letterhead under the signature of OCR's Director Jocelyn Samuels and is being sent to HIPAA covered entities and their business associates.
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The Future of the Medicare Part B Payment Demo under a Republican-held Congress

November 29, 2016 | Blog | By Theresa Carnegie, Lauren Moldawer

There has been much controversy over the Medicare Part B payment demonstration proposed by the Center for Medicare and Medicaid Innovation (CMMI) in March 2016.
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Making the Sausage: Medicaid Block Grants in the 115th Congress

November 28, 2016 | Blog | By Bridgette Keller

Republicans have been talking about remodeling the Medicaid program through block grants or per capita caps for years. Both block grants and per capita caps are designed to limit federal spending by providing a state with a set amount of federal money to fund its Medicaid program.
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The Fate of the Children’s Health Insurance Program Under the 115th Congress

November 22, 2016 | Blog | By Cassandra Paolillo

The Children’s Health Insurance Program (“CHIP”), created in 1997, helps states provide health care coverage to low-income children up to age 19 whose families fall above the Medicaid eligibility threshold but are unable to afford private insurance.
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