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Hospital and its Clinic Agree to $34 Million Settlement to False Claims Act Allegation that Compensation to Oncologists Violated the Stark Law
May 24, 2017 | Blog | By Laurence Freedman
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").
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Health Care Weekly Preview from ML Strategies - Week of May 22, 2017
May 23, 2017 | Blog
Our ML Strategies colleagues have published a preview for another big week in health care. The American Health Care Act (AHCA) continues to be a big story as the Senate works on its version. This week we watch for updates on these items and how they might impact AHCA discussions.
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CMS Urged To Reverse Obama-Era Biosimilar Reimbursement Policy
May 22, 2017 | Blog | By Theresa Carnegie, Ryan Cuthbertson
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 when CMS initially released the guidance. CMS implemented the controversial guidance as a final rule in October 2016.
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CMS Releases the Proposed Part D DIR Reporting Requirements for 2016
May 18, 2017 | Blog | By Tara E. Dwyer
Yesterday, CMS released the Proposed Part D DIR (Direct and Indirect Remuneration) Reporting Requirements for 2016 and postponed the 2016 DIR Reporting deadline.
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Memorial Hermann’s Use of Patient Name in Press Release Leads to $2.4 Million HIPAA Settlement
May 18, 2017 | Blog
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 system in southeast Texas.
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ML Strategies Publishes Weekly Preview for the Week of May 15, 2017
May 17, 2017 | Blog | By Samantha Kingsbury
Our ML Strategies colleagues, Eli Greenspan, Katie Weider, and Rodney Whitlock, have published a new edition of the Health Care Weekly Preview. This edition covers upcoming hearings in the House, including one before the House Ways & Means Committee regarding expiring Medicare programs, as well as changes to Medicare’s payment system.
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FDA User Fee Legislation Moves Forward in Senate with Multiple Policy Riders On-Board
May 16, 2017 | Blog | By Joanne Hawana
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.
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Ransomware Attack – Quick Facts
May 13, 2017 | Blog | By Dianne Bourque, Cynthia Larose
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 “Wanna Decryption” or “WannaCry” works like any other ransomware: once it is inadvertently installed, it locks up the organization’s data until ransom is paid.
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The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 2
May 12, 2017 | Blog | By Benjamin Zegarelli
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 might end up a few years from now.
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MIECHV: A Minibus Rider
May 10, 2017 | Blog
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 handful of policy provisions tied together in one piece of legislation.
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More Bipartisan Bills Hope to Catch a Ride on the UFA Reauthorization Legislation
May 3, 2017 | Blog | By Joanne Hawana
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.
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Insiders Say New MACRA Rule Likely as Providers Look to Sec. Price to Ease Burden
May 2, 2017 | Blog
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 in The Hill.
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Join us for our Upcoming Webinar: Patient Assistance Programs & Government Enforcement: What You Need to Know
April 27, 2017 | Blog | By Lauren Moldawer
Patient assistance programs have been a staple within the health care industry for over a decade. These programs, operated by 503(c)(3) charities, may receive funding from pharmaceutical manufacturers or other providers to offer assistance to low-income patients in affording their medications, co-payments, deductibles, premiums, or other related services.
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Supreme Court Hears Oral Argument in Amgen v. Sandoz
April 27, 2017 | Blog
Regular readers of our blog know that we’ve been following developments related to biosimilar products for some time (see our past coverage here). On April 26, 2017, the U.S. Supreme Court heard oral argument in its first case involving the Biologics Price Competition and Innovation Act (“BPCIA”), Amgen v. Sandoz.
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GAO Report: Medicare Reimbursement Policies Impede Telehealth Adoption
April 26, 2017 | Blog | By Carrie Roll
RAlthough 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.
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California Advances PBM Licensing and “Transparency” Law
April 25, 2017 | Blog | By Theresa Carnegie, Tara E. Dwyer
Last week, the California Assembly Committee on Business and Professions voted in favor of Assembly Bill 315.
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A Spring Cheat Sheet to Congressional Health Care Policy
April 24, 2017 | Blog
ML Strategies has provided a Spring Cheat Sheet previewing the coming months in health care policy in the 115th Congress. The Cheat Sheet addresses attempts to amend the American Health Care Act, funding for the federal government, the heath insurance marketplace, FDA user fee acts, and the health care minibus.
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Health Care Weekly Preview from ML Strategies - Week of April 24, 2017
April 24, 2017 | Blog
Today, our colleagues at ML Strategies provided another installment of their Health Care Weekly Preview. The preview highlights upcoming activity in the House and Senate and other hot topics on the Hill.
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Mintz Matrix Updated with New State Data Breach Notification Laws
April 20, 2017 | Blog
Earlier this week, the Mintz Levin privacy team updated the “Mintz Matrix,” a summary of the U.S. state data breach notification laws, with updates from New Mexico, Tennessee, and Virginia. As the privacy team reports, with New Mexico enacting a data breach notification law, only Alabama and South Dakota remain the only states without data breach notification laws.
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Massachusetts Budget Process Continues with Impact on Health Care
April 20, 2017 | Blog
Next week, the Massachusetts House will continue the budget process and debate over 1000 amendments that members filed to the House Ways and Means Committee’s proposed $40.3 billion FY2018 budget.
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