It has been some time since we provided a detailed update on the status of FDA’s user fee legislation making its way through Congress, so that’s what is on tap for today. The House passed the lengthy FDA Reauthorization Act (FDARA) on July 13, 2017 as H.R. 2430, and House members have now left Washington, D.C. for the traditional August recess.

Although the previous self-imposed congressional deadline of completing work on FDARA by the end of July has passed, FDA Commissioner Scott Gottlieb informed agency employees via email on July 24th that he would not be sending out any lay-off notices to user fee-funded staff “unless and until September 30 passes without reauthorization.” The publicizing of this policy decision by the Commissioner may have been intended to signal to the Senate that the sky is not falling (yet), but that they need to get to work.  Continue Reading August 2017 Is Here – Will FDARA Get Done Soon?

Today, our colleagues at ML Strategies released their first look at what the results of Tuesday’s election mean for health care.  The client alert addresses both the lame duck session and what to expect in 2017 and beyond.  Key issues areas include the future of the Affordable Care Act, MACRA, drug pricing, and FDA User Fee Act reauthorization.

In the coming days, ML Strategies will be sharing further insight into what the election means for health care and what to expect from the new administration and Congress.

We spend a lot of time covering prescription drug costs on this blog (and here), and even convened a Pharmacy Industry Summit earlier this year focusing on the various pressures that are contributing to higher drug prices. Although Congress has not been sitting on the sidelines of the drug pricing debate – having conducted three separate committee investigations, which included subpoenas of top executives and the most well-known of them, Martin Shkreli, getting booted from the committee room for refusing to answer any questions – Members of Congress are finally beginning to roll out legislation with the end goal of increasing prescription drug competition and decreasing the costs of drugs. Continue Reading Congress Proposes Legislative “Fixes” to Drug Industry Rules Believed to Be Contributing to High Costs

As Congress is back to Washington for its next work period, ML Strategies has published an Advisory outlining health care issues on the radar for the upcoming weeks.  Highlights include: legislative initiatives on opioid abuse, mental health access, chronic care and a group of innovation bills; the FDA Commissioner nomination; and Medicare Advantage (MA) lobbying efforts.

ML Strategies reminds us that the current Congressional environment – with a possible diversion of resources to a FY 2017 budget, and the impact of Justice Scalia’s death and election year politics – will impact all legislative considerations, including health care initiatives.

Continue Reading Opioids, FDA and Medicare Advantage Spending on the List for Congress

Last week, pharmacy benefit manager (PBM) and independent pharmacy representatives provided testimony to the House Judiciary Subcommittee on Regulatory Reform, Commercial and Antitrust Law in a congressional hearing examining the state of competition in the pharmacy and PBM marketplace.  You can watch the hearing and read the filed testimony here. This was the third in a series of congressional hearings examining competition in healthcare markets. While the focus was on PBMs and pharmacies, some panelists and committee members recognized that a full discussion of certain issues, like drug pricing, needs to involve other players in the prescription drug supply chain.

The witness panel included 2 PBM industry representatives, an independent pharmacy owner, and an antitrust attorney who represents the interests of independent pharmacies:

  • Amy Bricker, Vice President of Retail Contracting & Strategy, Express Scripts
  • Natalie A. Pons, Senior Vice President and Assistant General Counsel, CVS Health
  • Bradley J. Arthur, Owner, Black Rock Pharmacy
  • David A. Balto, Law Offices of David Balto

Each panelist gave testimony aligned with his or her role in the debate and voiced well entrenched opinions regarding the role PBMs play in the health care industry. Ms. Bricker and Ms. Pons each focused on their PBM’s ability to use scale to keep prescription drug costs down for patients and their clients, and stressed that they rely on independent pharmacies to participate in their networks. Mr. Arthur focused on the scale of the PBMs compared to his independent pharmacy, while Mr. Balto pointed to market trends, like rising profit margins, to claim that the entire PBM marketplace is broken and needs regulation to require more transparency. Continue Reading Congressional Hearing Examines Competition in the PBM Industry

On July 7th, the House introduced much anticipated bipartisan telehealth legislation. The Medicare Telehealth Parity Act of 2015, introduced by Representative Mike Thompson (D-CA) and co-sponsored by Representatives Gregg Harper (R-MS), Diane Black (R-TN), and Peter Welch (D-VT), would gradually increase the scope of telehealth services covered by Medicare and addresses many of the current limitations in Medicare’s coverage of services provided to patients remotely.

Over a four-year implementation period, the bill, if enacted, would incrementally expand coverage for telehealth services by easing current limitations on coverage.  Specifically, the bill would:

  • Expand the provider types whose services are covered to include certain allied health professions, including physical and occupational therapists and audiologists;
  • Expand the types of services that are covered to include services like audiology and outpatient therapy services;
  • Relax the “originating site” requirements for certain services;
  • Expand the geographic locations in which telehealth services are covered; and
  • Establish coverage for remote patient monitoring for certain chronic conditions.

Notably, the bipartisan measure would, two years after enactment, permit reimbursement under Medicare for certain services provided in a beneficiary’s home, regardless of rural or urban designation.  The bill is similar to the Medicare Telehealth Parity Act of 2014, also introduced by Representative Thompson, and is one of a growing number of legislative efforts to expand the use of telehealth in federal healthcare programs.  Working groups are being initiated in both chambers of Congress, with introductions of additional measures likely in the coming months. Continue Reading Telehealth Roundup: Federal Bill Seeks to Expand Medicare Use of Telehealth; Delaware and Connecticut Update Telemedicine Laws

The spring of 2015 is shaping up to be a busy time in the field of food and nutrition. Issues relating to food labeling, food safety, dietary guidelines, dietary supplements, child nutrition, and nutrition education in medical schools are being examined by the FDA, Congress, the Obama administration, and some states. For an in-depth discussion of what is being considered by the agency, the houses of Congress, and the President, please click here for ML Strategies’ recent Update on Food Labeling, Food Safety, & Nutrition.

This week Mintz Levin also welcomed Joanne S. Hawana to its Health Law practice. Ms. Hawana represents clients in the  food, drug, and biotechnology industries on issues ranging from prescription drug advertising to state licensing requirements for wholesale distribution and is well-positioned to work with clients on issues that may arise as a result of the matters currently being considered by the FDA, Congress, and President Obama.

ML Strategies has posted its weekly Health Care Update.  This publication provides timely information on implementation of the Affordable Care Act (ACA), Congressional initiatives affecting the health care industry, and federal and state health regulatory developments.

Among other newsworthy items, this edition of the Health Care Update summarizes reactions to the news that hackers breached Healthcare.gov’s security and uploaded malware to the website earlier this summer, provides details about the Department of Health and Human Services’ efforts to make the second enrollment period for the ACA’s health insurance exchanges run smoothly, and notes that the Federation of State Medical Boards finalized its model legislation to allow states to enter interstate medical licensure compacts.

Click here to read this week’s full Health Care Update.

ML Strategies has posted its weekly Health Care Update.  This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments.

Last week, Congress took rare bipartisan action to hear from stakeholders on how to leverage and support new technologies, including telehealth, to improve quality, increase access, and lower system costs.  Following significant action from the Federation of State Medical Boards to develop a model policy on appropriate use of telemedicine, the Energy and Commerce Committee requested comments from stakeholders by mid June on what lawmakers can do to support companies and providers utilizing new technologies.

Also, the Solvaldi firestorm continues, this time as plans and policymakers consider what role public health programs like Medicaid should play in financing new therapies that are more expensive than the standard of treatment today.  While Solvaldi is at the center of attention now, stakeholders are certainly looking ahead at the possible implications for a host of new therapies that are expected to hit the market over the next several years.

Click here to read this week’s Health Care Update.

ML Strategies has posted its weekly Health Care Update.  This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments.

Top news this week is the continued scrutiny of drug pricing.  Between Congress, payors, and physician groups, the biopharmaceutical industry is facing significant headwinds and will be tasked with changing the value proposition (or at least articulating it differently) in order to withstand the pressure from stakeholders on cost and comparative effectiveness.

In keeping with the cost theme, the CBO released new estimates showing that the Affordable Care Act would be less costly and cover more people than previous reports.  We believe the major debate after open enrollment is now shifting to cost containment, which will be the context for many legislative and regulatory debates to come in 2014 and going forward.

Click here to read this week’s Update.