The past couple of weeks have involved a flurry of healthcare-related developments, including on the Medicaid drug pricing front. On February 9, 2018, President Trump signed into law the Bipartisan Budget Act of 2018, which revises the rebate formula for line extensions applicable to certain drugs in the Medicaid program. Then later that same day, the Council of Economic Advisors issued a report titled “Reforming Biopharmaceutical Pricing at Home and Abroad,” which among other things,… More
Category Archives: Waivers
On March 21 and 22, two of this blog’s authors will be presenting on two Medicaid topics at the American Health Lawyer’s Association (AHLA) annual Medicare and Medicaid conference in Baltimore, Maryland.
On December 15, 2017, CMS Director Brian Neale informed State Medicaid Directors of CMS’ intent to phase out funding for Designated State Health Programs (DSHP) in Section 1115 waivers. CMS will no longer approve waiver requests under Section 1115 for DSHP funding, and will not renew portions of existing waivers that provide DSHP funding.
On November 17th, Arizona’s state Medicaid agency (the Arizona Health Care Cost Containment System, or AHCCCS) sent a letter to CMS proposing policies that it believes will build on past successes and “leverage conservative principles.”
In the letter, AHCCS seeks input from CMS on ideas to “modernize” the prescription drug benefits offered under the state’s Medicaid plan.
(Also, notably, though not the topic of this blog post,… More
On November 6, 2017 the Centers for Medicare & Medicaid Services (CMS) issued an information bulletin on changes and improvements to the existing Section 1115 waiver process. Under Section 1115(a) of the Social Security Act, the Secretary of Health and Human Services is permitted to waive compliance with any of the requirements of section 1902 of the Act (which generally sets forth the requirements for state Medicaid programs in order to receive Federal financial assistance) in order to pilot or test projects which,… More
On September 8, 2017, following the mandated 30-day public comment period, the Baker Administration concluded its review of the pending MassHealth Section 1115 Demonstration Amendment Request. The submitted waiver request can be viewed online here. Once received at CMS, the agency will have to time to review the proposal, and must also solicit additional public feedback, prior to finalizing any waiver.
On July 21, 2017, the Massachusetts Executive Office of Health and Human Services (“EOHHS”) announced its intent to submit a request to amend its existing MassHealth Section 1115 Demonstration to the Centers for Medicare and Medicaid Services (“CMS”). If approved (by both the State legislature, and CMS), it would be the most sweeping change to any state’s Medicaid pharmacy benefit to date. We previously previewed some of the changes EOHHS was considering under the new flexibility granted to states under the Price/Verma administration on this blog.… More
Another state is stepping up to bat following Secretary Price’s and CMS Administrator Verma’s letter to state governors promising enhanced flexibility for their Medicaid programs. Wisconsin has recently unveiled its plan to submit a new Section 1115 waiver application to CMS by May 26, 2017. In short, the Wisconsin waiver seeks to infuse the state’s Medicaid program with features from the commercial sector, and it does this by borrowing some elements from the Healthy Indiana Plan (HIP 2.0) and Kentucky waivers,… More
Price and Verma to State Governors: Just Come and Ask Us for Flexibility – What Providers & Drug Manufacturers Could Expect
The last several weeks have been nothing short of enthralling, like an episode of House of Cards. After seven years of campaigning on the repeal of the Affordable Care Act (ACA), Republicans were ultimately unable to create consensus for their highly anticipated repeal-and-replace legislation known as the American Health Care Act (AHCA). But as the drama on the Hill comes to an end (at least until tax reform is picked up),… More
One of the most pressing issues before the 115th Congress and newly inaugurated President Trump will be to determine how the Medicaid expansion population will fit into a broader reform package for the Medicaid program as a whole. Many state governors in expansion states have expressed concern that the long-standing Republican proposal of block-granting Medicaid will leave them exposed to unsustainable financial pressures.
President Trump’s nominee for HHS Secretary,… More
Medicaid Directors: Trump Administration Should Formally Include States in Development of Medicaid Regulations
Over the course of the last several blog posts, we’ve discussed how the Medicaid program could potentially be transformed under the incoming Trump Administration. We also described the central role that state-led demonstration waivers would play in defining the parameters of this transformation. Now, the association for State Medicaid directors is weighing in on precisely this issue. The National Association of State Medicaid Directors (NAMD)recently published a document laying out the group’s priorities for the Medicaid program in the first 100 days of the incoming Trump Administration. … More
Currently, nearly 10 million Americans are dually-eligible for both Medicare and Medicaid. These “dual eligibles” are low-income seniors and individuals with disabilities who are separately eligible for and receive coverage under both the Medicare and Medicaid programs. In general, Medicare acts as the primary payer for dual-eligibles, while Medicaid provides “wrap-around” coverage for these individuals, helping with some out-of-pocket costs (such as premiums, copayments and deductibles) and offering coverage for services not otherwise covered by Medicare (vision,… More
As we noted here last month, Medicaid is a 1960s-era health insurance plan operating in a 21st century world. As Medicare and commercial payers have started taking steps to move away from payment by volume to paying for value, it’s important to recognize that the same innovation needs to occur in Medicaid. In fact, one could argue that this innovation is even more critical in Medicaid.
Why? … More
The nomination of Seema Verma by President-Elect Trump for the position of CMS Administrator sends a clear signal that the Trump Administration considers Medicaid one of its top healthcare reform priorities. Seema Verma is the the “architect” of the Healthy Indiana Plan 2.0” waiver (HIP 2.0), a consumer-driven Medicaid expansion demonstration approved by the Obama Administration under a Section 1115 waiver. Most recently, Verma was also involved in designing Kentucky’s proposed “Kentucky HEALTH” (“HEALTH”) Section 1115 waiver,… More
Last week, we wrote about the importance of the Medicaid program, especially given its size as, by far, the largest health insurance plan in the United States. We noted that Medicaid covers 71 million people (this number increased dramatically after the Affordable Care Act was enacted in 2010). We said that “Medicaid is important for all of us” – whether you are a program beneficiary, a taxpayer who helps pay for it,… More
Dear readers: this post is going to be a bit different from our regular posts, in that we are going to try to refrain from getting too far in the weeds, and avoid too much legalese. Why? Because the results of the November election will likely have major implications not only for the Medicaid program itself, but for the millions of individuals it serves. We are fortunate to have a platform here and it is our hope that,… More
On November 4, 2016, the Centers for Medicare & Medicaid Services (“CMS”) sent word to the Massachusetts Executive Office of Health and Human Services (EOHHS, referred to here as “MassHealth”) that it approved a major amendment to Massachusetts’ section 1115 demonstration project through June 30, 2017. At the same time, CMS also approved an extension of this same demonstration through June 30, 2022. Approval of Massachusetts’ waiver amendment comes after nearly a year of negotiations and may ultimately result in the transition of the vast majority of MassHealth enrollees into newly-formed Accountable Care Organizations (“ACOs”) operating under one three models,… More
We frequently read about state Medicaid programs receiving or being granted “waivers” by CMS, but what does that mean exactly? What is a “waiver”? What is the history of Medicaid waivers? How does the process work? We hope to answer these questions in this blog post.
The Legal Standard
A “waiver” refers to authority that the Secretary of Health and Human Services possesses under section 1115 of the Social Security Act:
“(a) In the case of any experimental,… More