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Health Law & Policy Matters

Health Care Attorneys | Mintz Levin Law Firm

ML Strategies Publishes Washington Outlook for 2016

Posted in Health Care Reform

Earlier today, my colleagues at ML Strategies published the Washington Outlook for 2016, offering their insights about what we might expect from Capitol Hill and the Administration in the coming year. The Outlook covers a wide range of issues and includes a preview of the US legislative agenda as well as a look at the Obama Administration’s regulatory plans.

Also, check out the Outlook’s Appendix for an election season cheat sheet, including the dates of the US state primaries and lists of the important Senate and House races to watch, as well as the 2016 House and Senate calendars.

With regard to health care, it is likely that the Administration’s signature health care law will continue to be at the forefront of its domestic agenda.  ML Strategies says that we should expect additional activity on targeted bipartisan reform efforts to modify the ACA.  Issues include:

  • The “30-hour work week” fix.
  • The Simplifying Technical Aspects Regarding Seasonality Act, or the “STARS Act,” which would exempt seasonal employees from the definition of “full time employee” of the ACA’s employer mandate.
  • The “Small Business Healthcare Relief Act,” which would allow for small businesses with fewer than 50 employees that do not offer health insurance coverage to establish a health reimbursement arrangement.
  • Efforts to address rising insurance prices in the exchanges, which could include efforts to modify insurance “rating,” or pricing rules.

Continue Reading

Employment Matters: “Wrap” Documents for Employee Health and Welfare Plans

Posted in Health Care Reform, Payors & PBMs

On Tuesday, our colleague, Patricia Moran, discussed the importance of employers using “wrap” documents for certain health and welfare plans on Mintz Levin’s Employment Matters Blog. Plans subject to ERISA must meet certain reporting and disclosure rules, such as distributing a Summary Plan Description (SPD) to participants. Some of these rules vary based on the plan type and/or number of participants, which can create confusion and leave employers out of compliance. To further complicate things, the Affordable Care Act’s increased attention to health and welfare benefits make audits and heightened scrutiny inevitable for employers. Wrap documents offer a way to bring employers back into compliance and ensure all required components of an ERISA SPD are satisfied. To read more about wrap documents and why they make sense, click here.

Health Care Enforcement Report: A Look Back at 2015 and a Forecast for 2016

Posted in Clinical Laboratories, Enforcement, Fraud & Abuse, Health Care Fraud Enforcement, Hospitals & Health Systems, Pharma & Medical Devices

My colleagues Hope Foster, Larry Freedman, and Bridget Rohde, members of Mintz Levin’s Health Care Enforcement Defense group, recently published a report surveying health care enforcement trends and developments in 2015 and forecasting what these developments herald for 2016.

2015 was a year of transition for the U.S. Department of Justice (“DOJ”), with the installation of a new Attorney General, Deputy Attorney General, and several other high-level officials. Nevertheless, based on the number of cases pursued by the agency and its partners — and despite the other important law enforcement challenges that confronted the government — health care fraud remained a top enforcement priority. Moreover, there were important policy developments that will impact health care fraud enforcement in the coming year.

Mintz Levin’s report covers several trends, policy developments, notable decisions, and significant pending cases, including the following: Continue Reading

A New Year’s Resolution: Avoid The Rising Tide of Defamation Claims In The Health Care Arena

Posted in Pharma & Medical Devices, Physicians

In college and graduate school, we all had professors that had “non-attribution/academic freedom” policies designed to foster open debate, critical thinking and robust discussion.  To state the obvious, we are a long way from those college days.  In the highly competitive health care arena where public views associated with products, services, research and technology can translate into millions of dollars gained or lost, the last several years have seen a rising number of defamation claims, particularly arising in the context of published clinical studies or product testing articles.

For example, this past year the Massachusetts federal district court in Saad v. American Diabetes Association, 2015 U.S. Dist. LEXIS 108977 (D. Mass. 2015) was faced with the issue of whether statements in a prominent research publication  expressing “concern” about the manipulation of scientific data were actionable. Continue Reading

Gun Control: HIPAA Final Rule Targets Background Checks and Mental Health Reporting

Posted in Health Care Reform, Privacy & Security/HIPAA/HITECH

President Obama has announced plans to tighten gun control regulations, including applying the background check requirement to dealers at gun shows and on websites.  Federal law already requires that those “engaged in the business” of selling guns must have a Federal Firearms License (FFL) and conduct background checks at the time of every purchase.  Some sellers assert they are not gun dealers but collectors or hobbyists who do not sell regularly and, therefore, are not “engaged in the business” of selling firearms and not required to have a FFL and conduct background checks.  The Obama administration has clarified that people who claim to be hobbyists may be engaged in the business if, for example, they operate an online gun store, frequently sell guns in their original packaging, or pass out business cards.  The Bureau of Alcohol, Tobacco and Firearms (“ATF”) issued Guidance to help individuals understand when a FFL is required.

Consistent with this initiative, the Office for Civil Rights (“OCR”) released a Final Rule modifying the Health Insurance Portability and Accountability Act (“HIPAA”) Privacy Rule to permit certain covered entities to disclose identifying information on persons subject to a “Federal mental health prohibitor “ to the National Instant Criminal Background Check System (“NICS”). Continue Reading

Massachusetts Uses Telemedicine Technology to Expand Access to Behavioral Health Services

Posted in Telemedicine

Recognizing the importance of telemedicine, a committee of the Massachusetts Health Policy Commission recently voted on a grant program that will award up to $500,000 each for two telemedicine pilots that target the behavioral health needs of children, homebound seniors, and people with substance use disorders.  The two grants will be awarded with monies from a 2016 budget provision that authorized a one-year, regional pilot program “to further the development and utilization of telemedicine in the commonwealth.”  The Commission expects to release a request for proposals in February and announce the awards in the spring.

Massachusetts joins other states in taking needed steps to expand the use of telemedicine.  Last year was an important year for the expansion of Medicaid and private insurance coverage of telemedicine services with many states passing laws to ensure that telemedicine visits would be covered and paid for similar to office based visits. We expect this to be one of many trends that continue into 2016, as telemedicine continues to grow, highlighted in our recent post “Telemedicine – 2015 Year in Review.”

The Managed Care Industry – 2015 Year in Review

Posted in Fraud & Abuse, Health Care Reform, Hospitals & Health Systems, Payors & PBMs, Physicians

As we start a new year, let’s take a look back at a few hot topics that emerged in the managed care industry in 2015 and will likely be drivers of developments in 2016.

Industry Consolidation – The Changing Landscape

2015 was a year of significant activity for MCOs large and small. In addition to proposed mergers among some of the largest payors, smaller MCOs are also consolidating with other MCOs, as well as service providers, in an attempt to leverage purchasing power and integrate care models. As we discussed in our Pharmacy Industry year in review, consolidation reshaped the traditional PBM industry paradigms with a move away from stand-alone PBMs to MCO and provider-affiliated PBMs.

Competition Scrutiny

Moving into 2016, we will learn whether the proposed consolidations will be approved and whether the trend will continue. The government will also generally continue to scrutinize health care competition, paying close attention to the proposed mergers among Aetna/Humana and Anthem/Cigna. In early 2015, our colleagues highlighted the FTC-DOJ workshop examining health care competition where the agencies’ worked together to identify and examine the potential competitive implications of strategies currently used by providers and payors seeking to reduce costs and improve quality.

We are also beginning to see competition scrutiny expand beyond the regulatory agencies. For example, the House Judiciary Subcommittee on Regulatory Reform, Commercial and Antitrust Law held hearings examining competition in the PBM industry, while the Central District of Illinois District Court permitted a small regional hospital’s antitrust challenge to its largest competitor’s exclusive dealing contracts with payors to move forward. Continue Reading

Rodney Whitlock Joins ML Strategies

Posted in biosimilars, Health Care Reform, Hospitals & Health Systems, Payors & PBMs, Pharma & Medical Devices, Pharmacies, Physicians
Rodney Whitlock

Rodney Whitlock

ML Strategies is pleased to welcome Rodney Whitlock as Vice President, Health Policy. Rodney joins our consulting team in Washington, DC, where he will work with clients in the health, pharmaceutical, and biotechnology industries. Leveraging his extensive experience as a health care policy advisor on Capitol Hill, Rodney will provide knowledgeable guidance to support his clients’ key business decisions and help them develop and implement effective strategies to promote their success.

Rodney has more than 20 years of experience working with the US Congress. Most recently, he served as Health Policy Director for Senator Chuck Grassley (R-IA) during the senator’s tenure as Finance Committee Chairman. In that role, Rodney led efforts to advance ambitious health care legislation. In 2015, he developed innovative legislation regarding both disability policy and rural hospitals. Rodney also shepherded the Medicare and Medicaid Extenders Act of 2010 into law, worked on the Children’s Health Insurance Program Reauthorization Act — passed twice by Congress and subsequently vetoed twice by President Bush — and served as lead Senate staffer for the Medicaid provisions of the Deficit Reduction Act of 2005 and the Tax Relief and Health Care Act of 2006. In 2009 and 2010, he was deeply engaged in health care reform legislation.

In addition, Rodney spent 10 years in the office of the late Congressman Charlie Norwood (R-GA), and worked closely with the congressman on legislation such as the Patients’ Bill of Rights Act, which passed the House in 1999 and 2001.

“We are thrilled that Rodney has chosen to join us,” said William “Mo” Cowan, Senior Vice President and Chief Operating Officer at ML Strategies. “During his time working with members of Congress — over the course of more than two decades — he had the ability to move the needle because he intimately understood the issues at hand and had the respect of the most senior policy makers.”

Rodney has taught for many years at George Washington University, in both the Department of Health Policy and the Graduate School of Political Management. He holds a PhD in Political Science from the University of Georgia, an MA from Appalachian State University, and a BA from Roanoke College.

» Download Rodney’s vCard

Biosimilars Webinars: A Five-Part Legal and Regulatory Issues Series

Posted in biosimilars, Food and Drug Administration (FDA), Health Care Reform, Hospitals & Health Systems, Payors & PBMs, Pharma & Medical Devices, Pharmacies, Physicians, Privacy & Security/HIPAA/HITECH, Reimbursement

Mintz Levin is running a series of webinars to educate our clients and friends on developments in the biosimilars space.  A cross-practice team of professionals from the IP, Health and Litigation sections are collaborating to present on Patent Prosecution, Health Regulatory, FDA, Patent Litigation, Transactional and Products Liability issues.  Anyone working in the biotechnology space, as well as pharmacy payors and health care providers who may be administering or dispensing biosimilars to their patients, will be interested in these presentations. The first webinar on January 7, 2016 will provide a legal and regulatory overview of the biosimilars industry and will feature Terri Shieh-Newton, PhD, and Joanne Hawana.

Subsequent presentations:

Part II:  FDA/Regulatory — January 28  |  3:00 pm ET

Part III: BPCIA Patent Litigation — February 25  |  3:00 pm ET

Part IV: Transactions and Patent Portfolios — March 17  |  3:00 pm ET

Part V:  Post-Market Legal and Regulatory Issues — April 7  |  3:00 pm ET

Additional Information about each of the five sessions is available here, as is a link to the registration page from which you may sign up for any or all of the seminars.




Upcoming Webinar and Report – Health Care Enforcement in 2016

Posted in Enforcement, Fraud & Abuse, Health Care Fraud Enforcement, State & Federal Audits, Investigations & Litigation

As 2015 comes to a close and you look ahead to the New Year, we hope that you will consider joining us for an informative webinar on health care enforcement trends for 2016. On Wednesday, January 13, 2016, my colleagues Hope Foster, Laurence Freedman, and Bridget Rohde will host “Health Care Enforcement in 2016: A Look Back on 2015 and Forecasting the Year Ahead.” The webinar will highlight key enforcement activities from 2015 and the trends we expect to see in 2016. Continue Reading