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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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New State Substitution Laws, and a Busy Spring for Biosimilars

April 19, 2017 | Blog | By Joanne Hawana

We recently updated our chart that tracks state biosimilar substitution laws to include new laws in Iowa and Montana. These new laws bring the total number of states with biosimilar substitution laws to 27, plus Puerto Rico.
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The Health Care Minibus

April 19, 2017 | Blog

Welcome to Spring Break! That time of the year where college kids head to a beach somewhere, families pack up for some tourist trap to spend lots of money, and Congress gets out of DC and goes back home.  This is also a time to consider where we are and where we are heading in terms of health care policy.
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Five Trends in False Claims Act Enforcement: Take Two

April 17, 2017 | Blog | By Theresa Carnegie

In July 2015, we posted about the N.Y. Attorney General’s False Claims Act (FCA) settlements with Trinity HomeCare and its related entities, and how the case provided insight into the future of FCA enforcement.  We identified five key trends based on the settlements.
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Congressional Leaders Seek Input in UFA Reauthorization Draft Bill by April 28, 2017

April 17, 2017 | Blog | By Joanne Hawana

On April 14, 2017, leaders from the Senate HELP Committee and the House Energy & Commerce Committee released the first discussion draft of the 2017 FDA user fee reauthorization bill. As we’ve been reporting (see here and here for our past coverage), these two committees have held numerous public hearings since the beginning of March to learn more about FDA’s “big 4” user fee programs.
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Gone Phishin’: Hack Leads to HIPAA Settlement

April 13, 2017 | Blog

Earlier this week, the HHS Office for Civil Rights (“OCR”) announced a $400,000 settlement with Metro Community Provider Network (“MCPN”) related to a 2012 HIPAA breach caused by a phishing scam. The phishing scam, carried out by accessing MCPN employees’ email accounts, gave a hacker access to the electronic protected health information (“ePHI”) of 3,200 individuals.
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The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 1

April 13, 2017 | Blog | By Benjamin Zegarelli

As 2017 began, FDA appeared poised to implement significant changes to the rules governing off-label communications related to drugs, biologics, and medical devices.
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Medicaid Reform Beyond the AHCA

April 7, 2017 | Blog

As 2017 began, the FDA appeared poised to implement significant changes to the rules governing off-label communications related to drugs, biologics, and medical devices.
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Anti-Steering Lawsuit Against Carolinas Healthcare Survives Preliminary Motion for Judgment on the Pleadings

April 5, 2017 | Blog | By Dionne Lomax

On March 30, 2017, in a closely watched case, a federal district court denied the Motion for Judgment on the Pleadings filed by Carolinas Healthcare against a Complaint filed by the DOJ Antitrust Division and the State of North Carolina. The Complaint alleged that Carolinas Healthcare insisted on contract provisions with payors that limited or prohibited steering to lower-cost providers.
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OCR Identifies Continuing HIPAA Enforcement Issues, Areas of Future Guidance and Regulations

April 4, 2017 | Blog

Last week the Health Care Compliance Association hosted its annual "Compliance Institute."  Iliana Peters, HHS Office for Civil Rights' Senior Advisor for HIPAA Compliance and Enforcement, provided a thorough update of HIPAA enforcement trends as well as a road map to OCR's current and future endeavors.
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ML Strategies Publishes Weekly Preview for the Week of April 3, 2017

April 3, 2017 | Blog | By Ryan Cuthbertson

ML Strategies has published the first installment of a new weekly preview, designed to give you quick overview of health happenings in the coming week. The preview highlights upcoming activity in the House and Senate and other hot topics on the Hill.
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