shutterstock_282978377Although 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. That is the core finding of a report issued by the Government Accountability Office (GAO) this month on telehealth and remote patient monitoring use for Medicare beneficiaries.

The GAO report was issued as part of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), which included a provision for the GAO to study telehealth and remote patient monitoring. In compiling the report, the GAO interviewed representatives of nine provider, patient, and payor associations who provided feedback on, among other things, barriers to providing telehealth services to Medicare beneficiaries. Continue Reading GAO Report: Medicare Reimbursement Policies Impede Telehealth Adoption

shutterstock_428983732Last week, the California Assembly Committee on Business and Professions voted in favor of Assembly Bill 315.  AB 315 seeks to amend the California Business and Professions Code: (a) to require PBMs to obtain licensure from the Board of Pharmacy, (b) to state that PBMs have fiduciary duties to their “purchaser” clients (i.e., health plans), and (c) to require PBMs to disclose to their purchaser clients data regarding drug costs, rebates, and fees earned. The favorable vote moves the bill to the Committee on Appropriations.

California is not the only state that is considering adopting a PBM “transparency” law.  New York’s Governor Cuomo released a proposal that seeks to require PBMs to both register with the State and obtain a license (from the Department of Financial Services) as well as disclose financial incentives or benefits for promoting the use of certain drugs and financial arrangements that affect customers.  The Governor would also like to impose price controls on pharmaceutical manufacturers.  New York has a long history of regulating PBMs through a handful  of systems because the services that PBMs offer often result in a PBM needing to hold a specific non-PBM license and to adopt a specific corporate structure.  In addition, Senator Wyden (D-Ore.) introduced the C-THRU Act to the Senate Finance Committee in March.  The C-THRU Act seeks to make PBM rebate data publicly available, require the Secretary of HHS to adopt a minimum percentage of drug rebates that a PBM would need to pass through to certain of its health plan clients, and amend the definition of “negotiated prices” under the Medicare Part D Program.  Continue Reading California Advances PBM Licensing and “Transparency” Law

shutterstock_350936345Today, our colleagues at ML Strategies provided another installment of their Health Care Weekly PreviewThe preview highlights upcoming activity in the House and Senate and other hot topics on the Hill.  Highlights this week include the potential of a government shutdown, uncertainty around cost-sharing reductions for the 2018 plan year, and scheduled mark-ups by the Senate HELP Committee. 

For an outlook on health care policy in the coming months in Congress, ML Strategies provided their insight in our prior post.

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.  The full Cheat Sheet is available here.  Stay tuned for upcoming coverage of the health care policy actions (and inactions) in Washington, D.C.

Boston_StateHouseNext 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. The Committee’s budget includes some notable departures from Governor Baker’s proposed budget, including changes to budget items impacting the health care industry. In an Alert released earlier this week, my ML Strategies colleagues Julie CoxSteven BaddourDan ConnellyCaitlin BeresinMax Fathy and Haejin Hwang describe some of the variances in health care and public health spending proposals. Continue Reading Massachusetts Budget Process Continues with Impact on Health Care

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.  Their full blog post on the updates is available here.

In addition to complying with HIPAA, health care organizations must remain aware of the separate state notification obligations and other privacy and security laws when responding to data breaches.  These states laws are often broader than HIPAA and apply may apply to personally identifiable information that is not protected health information.

Our quick disclaimer: The Mintz Matrix is for informational purposes only and does not constitute legal advice or opinions regarding any specific facts relating to specific data breach incidents. You should seek the advice of experienced legal counsel (e.g., the Mintz Levin privacy team) when reviewing options and obligations in responding to a particular data security breach.

MedicalTechnologies_Tubes2We 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. The latest version of our chart can be found here. As with the laws we’ve seen before, both the Iowa and Montana biosimilar amendments mirror the state’s existing generic drug substitution laws. More specifically, they amend state pharmacy laws to allow, and in some situations require, the substitution of interchangeable biosimilars. Continue Reading New State Substitution Laws, and a Busy Spring for Biosimilars

shutterstock_573245464Welcome 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.  We will continue to hear of potential policies aiming to unify Republicans on health care reform, but until we see substantive policy changes that get members to change their votes from the American Health Care Act, this is all talk.  However, there is a health care minibus coming.  The “minibus” refers to a handful of policy provisions tied together in one piece of legislation.  This minibus will carry a number of provisions into law.  How many riders will be onboard the minibus remains to be seen. Continue Reading The Health Care Minibus

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 – for prescription drugs, medical devices, generic drugs, and biosimilars.  Continue Reading Congressional Leaders Seek Input in UFA Reauthorization Draft Bill by April 28, 2017

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:

  1. The FCA cases were based on qui tams and pursued by the State Attorney General after federal government declination.
  2. The FCA cases were based on a narrow, single state or regional arrangement, as opposed to allegations of a national scheme or program.
  3. One of the FCA cases was based on conduct about which Trinity had previously been warned.
  4. The FCA cases were based on government billings for specialty drugs.
  5. All parties to the arrangement were named as defendants in the qui tams.

Trinity was already under investigation by the N.Y. Attorney General’s office for its billing of hemophilia drugs (the basis of the first 2015 settlement) when a second qui tam alleged that Trinity submitted false claims in connection with a specialty drug used to treat premature infants at risk for lung disease.  That second qui tam led to the second settlement and now, almost 20 months later, has led to a new Complaint. Continue Reading Five Trends in False Claims Act Enforcement: Take Two