A bipartisan congressional effort is underway to convince CMS to reverse its biosimilar reimbursement policy implemented under the Obama administration. We discussed the current reimbursement policy in a March 2016 blog post when CMS initially released the guidance.  CMS implemented the controversial guidance as a final rule in October 2016.

The current policy requires all biosimilars that are related to a reference product to be given a shared Healthcare Common Procedure Coding System (HCPCS) code. For Medicare Part B, reimbursement is then calculated based on the average sales price (ASP) of all of the biosimilars with that HCPCS code plus 6% of their reference product’s ASP. Continue Reading CMS Urged To Reverse Obama-Era Biosimilar Reimbursement Policy

shutterstock_573245464In a recent post we noted that the Maternal, Infant, Early Childhood, Home Visiting (MIECHV) program is one of the many potential riders on the health care minibus. In contrast to an omnibus bill, 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 and when the minibus leaves the station remain to be seen.

In this post we provide additional details on the structure, funding, and evaluation of the MIECHV program. Future posts will review additional details of other potential riders on the minibus. Continue Reading MIECHV: A Minibus Rider

HealthLaw_stethoscope2The 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.

By way of background, MACRA consolidates a number of existing reporting programs into a two-track system under which eligible clinicians will receive incentive reimbursement payments through either the Merit-Based Incentive Payment Systems (MIPS) or through certain alternative payment models (APMs). Under MIPS, eligible clinicians can receive incentive payment (or penalties) based on their reporting of various measures. (For a detailed discussion of MACRA and these reporting requirements, see our prior post.) Alternatively, clinicians can be reimbursed under the second track if they participate in an “Advanced APM,” which include certain accountable care organizations (ACOs) and patient-centered medical homes. Continue Reading Insiders Say New MACRA Rule Likely as Providers Look to Sec. Price to Ease Burden

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.

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

While we continue to monitor Congressional efforts to repeal and replace the ACA, we are also monitoring CMS’s efforts to implement the administration’s Medicaid program goals without Congressional action.  The future of the Medicaid program depends not only on the final outcome of a repeal and replace bill, but also on the Secretary Price’s and CMS Administrator Verma’s strategy and vision for the program. In two recent Letters to Governors from Secretary Price and Administrator Verma, we see how some legislative provisions from the AHCA that are still the subject of debate could be implemented despite the lack of legislative action. Continue Reading Medicaid Reform Beyond the AHCA

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.

Spoiler alert: the confirmation processes for Dr. Scott Gottlieb (FDA) and Judge Neil Gorsuch (Supreme Court) will get a lot of attention this week.

See HERE for this week’s preview and be sure to stay tuned in the coming weeks.

6350-Pharma-Summit-blog-buttonMintz Levin and ML Strategies will be hosting the 2nd Annual Pharmacy Industry Summit on April 5th and 6th! The Summit will bring together stakeholders and thought leaders from across the industry to discuss legal and policy challenges facing manufacturers, PBMs, payors, pharmacies, and providers.

With a new administration and state legislatures taking aim at the pharmacy industry, manufacturers, PBMs, payors, and pharmacies face a number of unknowns and questions:

  • What is the fate of FDA User Fees?
  • Will Senator Wyden’s Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act gain traction?
  • What are state legislatures proposing to address drug pricing?
  • Will the Republicans take another shot at the Affordable Care Act?
  • What is President Trump’s “new system” for competition in the drug industry referenced in his March 7th tweet?
  • What’s new in value-based contracting and what does the future hold for innovative contracting arrangements?

With sessions focusing on the Affordable Care Act developments, drug pricing, state law developments, value-based contracting, and the FDA impact on the supply chain, among others, we plan to discuss these and many other issues impacting the pharmacy industry.

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

This week, in their “Future of the Affordable Care Act” series on our Employment Matters blog, my colleagues Alden Bianchi and Edward Lenz provided an analysis of the major provisions of the American Health Care Act (“AHCA”).

Introduced on March 6, 2017, the AHCA is the first concrete legislative proposal detailing the initial provisions designed to repeal and replace the Affordable Care Act.  As Alden and Ed discuss, the bill currently is the subject of widespread media scrutiny and intense criticism.  The bill is not final and will likely face numerous changes, including the last minute proposals changes of the past 48 hours.  The March 6th version offers an outline of Republican priorities in the regulation of health and health care financing, which include a strong bias in favor of market-based solutions and aversion to most (but not all) government intervention in the health care markets.

Check out their full analysis on The Future of the Affordable Care Act Week 7: The American Health Care Act, here. Continue Reading Future of the Affordable Care Act and the American Health Care Act