Mintz Levin - Health Law & Policy Matters

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Firm Profile: Mintz Levin
701 Pennsylvania Avenue, N.W.
Washington, DC 20004-2608, United States
Phone: 202-434-7324
Fax: 202-434-7400
Areas of Practice
  • Administrative Law
  • Commercial Law & Contracts
  • Health
  • Litigation
  • Mergers & Acquisitions
  • Securities Law
Locations
Other U.S. Locations
  • California
  • Connecticut
  • D.C.
  • Massachusetts
  • New York
Other Countries
  • Israel
  • United Kingdom
Number of Attorneys
400+ Attorneys

CBO Greenlights Telehealth Provisions in Senate’s CHRONIC Care Act

Last week, the Congressional Budget Office (CBO) concluded that a key piece of telehealth legislation, the CHRONIC Care Act of 2017, would not, overall, increase or decrease Medicare spending. This score is significant as it…more
 /  Elections & Politics, Health

Seven Takeaways from the ABA National Institute On Health Care Fraud

On May 17, 2017 the American Bar Association convened its 27th National Institute on Health Care Fraud. I have attended many of the past annual meetings, and always enjoy the presentations and the opportunity to network with…more
 /  Business Torts, Criminal Law, Government Contracting, Health

Hospital and its Clinic Agree to $34 Million Settlement to False Claims Act Allegation that Compensation to Oncologists Violated the Stark Law

Last week, the Department of Justice (DOJ) entered into a $34 million settlement with Mercy Hospital Springfield (“Hospital”) of Springfield, Missouri, and its affiliate Mercy Clinic (“Clinic”). The settlement resolves an…more
 /  Business Torts, Government Contracting, Health

CMS Urged To Reverse Obama-Era Biosimilar Reimbursement Policy

A bipartisan congressional effort is underway to convince CMS to reverse its biosimilar reimbursement policy implemented under the Obama administration. We discussed the current reimbursement policy in a March 2016 blog post…more
 /  Elections & Politics, Health, Science, Computers, & Technology

Health Care Weekly Preview from ML Strategies – May 2017

We are half way through May – are we having fun yet? There is a lot of activity this week in addition to ongoing talks in the Senate regarding their version of the American Health Care Act. The reauthorization of FDA User Fees…more
 /  Elections & Politics, Health, Insurance, Science, Computers, & Technology

Memorial Hermann’s Use of Patient Name in Press Release Leads to $2.4 Million HIPAA Settlement

The U.S. Department of Health and Human Services Office for Civil Rights (OCR) announced another large HIPAA-related settlement last week with Memorial Hermann Health System (Memorial Hermann), the largest not-for-profit health…more
 /  Health, Privacy, Science, Computers, & Technology

CMS Releases the Proposed Part D DIR Reporting Requirements for 2016

Yesterday, CMS released the Proposed Part D DIR (Direct and Indirect Remuneration) Reporting Requirements for 2016 and postponed the 2016 DIR Reporting deadline…more
 /  Health

FDA User Fee Legislation Moves Forward in Senate with Multiple Policy Riders On-Board

On May 11, 2017, the Senate Health, Education, Labor and Pension (HELP) Committee voted in support of the FDA Reauthorization Act of 2017, or FDARA, now formally moving through the legislative process as S. 934. The committee…more
 /  Elections & Politics, Health, Science, Computers, & Technology

Ransomware Attack – Quick Facts

By now, you may have heard about the global ransomware attacks affecting health care and other organizations throughout the world, in particular the United Kingdom, but also in the United States. The ransomware variant, called…more
 /  Criminal Law, Health, International Law & Trade, Privacy, Science, Computers, & Technology

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 2

In my last post, I introduced a series of posts that will explore FDA’s historical approach to off-label drug and device communications, how that position has evolved (or not) to the modern day, and predict where that policy…more
 /  Communications & Media Law, Consumer Protection, Health, Science, Computers, & Technology

MIECHV: A Minibus Rider

In a recent post we noted that the Maternal, Infant, Early Childhood, Home Visiting (MIECHV) program is one of the many potential riders on the health care minibus. In contrast to an omnibus bill, the “minibus” refers to a…more
 /  Elections & Politics, Health

More Bipartisan Bills Hope to Catch a Ride on the UFA Reauthorization Legislation

Just as the public comment period for the bicameral, bipartisan discussion draft of the “FDA Reauthorization Act of 2017” ended on Friday, what we have been calling the User Fee Games got even more interesting and engaging. As…more
 /  Elections & Politics, Health, Science, Computers, & Technology

Insiders Say New MACRA Rule Likely as Providers Look to Sec. Price to Ease Burden

The Trump administration is considering releasing a rule to ease the burden that small practices are facing in trying to comply with the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), according to a recent report…more
 /  Elections & Politics, Health

Two HIPAA Mistakes Lead to Fines from OCR

It was a busy April for the Office for Civil Rights (“OCR”) (see our prior post on a settlement from earlier in April). On April 20, OCR announced a Resolution Agreement with Center for Children’s Digestive Health, S.C. (“CCDH”)…more
 /  Health, Privacy, Science, Computers, & Technology

GAO Report: Medicare Reimbursement Policies Impede Telehealth Adoption

Although telehealth has the potential to improve or maintain quality of care for Medicare beneficiaries, payment and coverage restrictions create barriers that prevent providers from fully utilizing telehealth technologies. That…more
 /  Elections & Politics, Health, Science, Computers, & Technology
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