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Kate Stewart is the Associate Editor of Health Law & Policy Matters and is an Associate in the firm’s Boston office. Kate’s practice involves a variety of regulatory and transactional matters for healthcare providers, including hospitals, physician groups, clinical laboratories, retail health clinics, and pharmacies.  Kate counsels health care clients on HIPAA compliance, telemedicine practice, licensure and scope of practice issues, clinical trial compliance, physician contracting and the federal Physician Payments Sunshine Act.

Earlier this week, our colleague Don Davis addressed the increasing amount of disability discrimination litigation against health care entities on the Employment Matters Blog. In the blog post, Don provides an overview of the Americans with Disabilities Act (“ADA), describes employment disability discrimination litigation and enforcement trends in the health care industry, and highlights the recent spike in accessibility-related litigation (including issues related to both facility accessibility and website accessibility).

The full post is available here.

In a recent Antitrust Alert, our colleagues Dionne Lomax, Bruce Sokler, Robert Kidwell, and Shawn Skolky discuss the allegations in the consolidated class actions, In re Blue Cross Blue Shield Antitrust Litig., the court’s analysis, and its market implications.  In this antitrust case against the Blue Cross Blue Shield Association and various individual Blue Plans, a federal court recently ruled that certain allegedly restrictive practices are properly analyzed under the Sherman Act’s per se standard, which deems certain types of agreements inherently unlawful. The court’s April 5 decision, which relied on two Supreme Court decisions from the 1960s and 1970s, runs contrary to a recent growing trend to apply the rule of reason to modern business relationships by analyzing the competitive impact of restrictions and weighing the procompetitive benefits against the potential anticompetitive effects.

 

Mintz Levin and ML Strategies will host the 3rd Annual Pharmacy & Pharmaceutical Industry Summit on May 8, 2018!  This year’s summit will take place in Boston and we are thrilled to announce that Massachusetts Governor Charlie Baker will be the keynote speaker.  The Summit brings together stakeholders and thought leaders to discuss current hot topics facing manufacturers, PBMs, payors, pharmacies, and other providers.  This year’s Summit will include sessions on:

  • The evolving drug supply chain – distruptor models and the Amazon effect
  • Addressing drug pricing and supply chain economics – government investigations and ERISA litigation
  • The uncertain state of the 340B program
  • Government enforcement targeting financial relationships
  • Combatting the opioid crisis

For additional information on the Summit, including the full agenda and registration information, please visit our event website.

Our colleagues at ML Strategies have provided their Health Care Weekly Preview for the week of July 24, 2017.  This week’s preview focuses on the Better Care Reconciliation Act and Senate parliamentary rules.  The preview also addresses Wednesday’s House Energy & Commerce Health Subcommittee’s hearing on Special Needs Plans, FDA User Fee Reauthorizations, and the health care minibus.

Stay tuned for additional updates from ML Strategies!

Our colleagues at ML Strategies have provided a Health Care Weekly Preview.  This week’s preview describes the ongoing wrangling in the Senate over health care reform as well as highlighting the upcoming need to address FDA User Fees and the health care minibus

Stay tuned for additional updates and analysis from ML Strategies.

Children in United States receive their health insurance from multiple sources: the Children’s Health Insurance Program (CHIP), Medicaid, employer-sponsored insurance, or a qualified health plan on the Marketplace. This creates a fragmented system of coverage for children and families, particularly for low- and moderate-income families, who often have children and parents enrolled in across separate coverage sources.

With CHIP funding scheduled to expire on September 30, 2017, the future of children’s coverage will be up for debate again. Proposals have called for an extension of CHIP funding. However, as Katie Weider and Rodney Whitlock of ML Strategies discuss in their latest Health Affairs blog, it is time for us to stop talking about CHIP, and instead start talking about integrating the myriad of children’s coverage sources.  That blog is available here.

 

Last week, in a case being watched locally and nationally, the Massachusetts Supreme Judicial Court (“SJC”) ruled that local government approval is not required for the operation of a private needle exchange program and that the Town of Barnstable cannot bar such a program from operating.  The ruling confirms that private needle exchange programs — an important tool in combating the spread of HIV and hepatitis C associated with injection drug use — can continue in Massachusetts as the Commonwealth copes with an ongoing opioid epidemic.   My Mintz Levin colleagues, Andrew DeVoogd and Tiffany Knapp, and I drafted an amici curiae brief in the case in support of the plaintiff’s position on behalf of approximately thirty public health organizations, healthcare providers, and payors.  Continue Reading Private Needle Exchange Programs Do Not Require Local Approval: Massachusetts Supreme Judicial Court Weighs In

As we gear up for a busy week in Washington, D.C., our colleagues at ML Strategies have provided a Health Care Weekly Preview.  This week’s preview describes upcoming hearing on safety net health programs and prescription drug costs along with the progress of the American Health Care Act.  Stay tuned for additional updates and analysis from ML Strategies.

In addition to yesterday’s post on the June session of Congress, our colleagues at ML Strategies have provided another weekly preview of Congressional activity for the week of June 5, 2017.   The preview includes the upcoming schedule of the House and Senate, along with the looming issues of the American Health Care Act, the health care minibus, and tax reform.  Stayed tuned for more upcoming previews and blog posts from the ML Strategies team!

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”) related to CCDH’s failure to enter into a business associate agreement with a paper medical records storage vendor.  The cost of that missing agreement?  $31,000.  Then, on April 24, OCR announced a settlement with CardioNet, a remote monitoring company for cardiac arrhythmias, related to CardioNet’s failure to implement compliant HIPAA policies and procedures and failure to conduct a sufficient risk assessment.  The price of those failures?  $2.5 million! Continue Reading Two HIPAA Mistakes Lead to Fines from OCR