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: Medicaid
Since August, 2017, a new class of transformative therapies referred to as cell therapies or gene therapies have been approved by the US Food and Drug Administration (FDA). These new cell and gene therapies are typically administered once, as opposed to repeatedly over the course of the patient’s lifetime.
Payers, providers, and manufacturers have been considering how existing payment systems – particularly Medicare and Medicaid – can recognize the value of these new treatments. … More
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
The MassHealth program is embarking on a dramatic shift away from fee-for-service Medicaid to a reimbursement model that relies more on value and quality. The Baker Administration hopes to accomplish this through enrolling some MassHealth enrollees into accountable care organizations, or ACOs,… More
We have written in the past about enforcing the entitlement to Medicaid through the federal court system. In light of a recent opinion by the United States Court of Appeals for the 8th Circuit, it seems that this judicial saga continues.
The federal Medicaid statute imposes roughly 80 requirements on a state Medicaid plan. For example, a state Medicaid plan must make medical assistance available “with reasonable promptness.” Social Security Act § 1902(a)(8). … More
Back in July, my colleague Tom Barker told you about a CMS proposal to institute a fundamental reimbursement methodological change for 340B drugs used in the hospital outpatient setting. We have noted before the link between the Medicaid prescription drug rebate program and the 340B program. As a refresher, in order to have its outpatient drugs covered by Medicaid, the manufacturer must agree to three separate requirements. First,… 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.
An appeal recently filed in the United States Court of Appeals for the First Circuit could give further clarity regarding the CMS’s ability to discount Medicaid DSH payments for hospitals that received funds from Medicare and private insurers.
DSH Uncompensated Care Costs and the FAQ Policies
The Medicaid Act requires state Medicaid programs to increase payments to hospitals that treat a disproportionate share of Medicaid and uninsured patients. … More
CMS Proposes Fundamental Reimbursement Methodological Change for 340B Drugs Used in Hospital Outpatient Setting
We have noted before the link between the Medicaid prescription drug rebate program and the 340B program. As a refresher, in order to have its outpatient drugs covered by Medicaid, the manufacturer must agree to three separate requirements. First, the manufacturer must agree to provide a rebate to Medicaid equal to the greater of 23.1% of the average manufacturer price (AMP) of the drug, or AMP minus the best price of the drug. … More
Since the beginning of this year’s legislative session, Governor Baker has expressed concern over the growth in enrollment in MassHealth, the state’s Medicaid program. A look at the numbers explains why. Prior to the enactment of the Affordable Care Act’s Medicaid expansion in 2014, there were 1.3 million people enrolled in MassHealth. By April of this year, that number had increased by 28.4%, to nearly 1.7 million state residents.… More
Partner Tom Barker joined POLITICO’s Pro Health Care Briefing: Medicaid as a Driver of Care Innovation in the States on Tuesday to discuss how states are reshaping Medicaid to deliver more value to patients and taxpayers. Watch a video from the live event here:
Partner Tom Barker will speak at POLITICO’s Pro Health Care Briefing: Medicaid as a Driver of Care Innovation in the States on Tuesday, June 13, 2017. This event brings together experts and leading voices from around the country to discuss how states are reshaping Medicaid to deliver more value to patients and taxpayers, no matter the future of the Affordable Care Act.
Additional featured speakers include Trish Riley,… 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
On March 22, 2017, the Massachusetts Secretary of the Executive Office of Health and Human Services (EOHHS) sent a letter to CMS Administrator Seema Verma taking her and HHS Secretary Tom Price up on their offer to grant states more flexibility under the Medicaid program. In her letter, Secretary Sudders pointed to four aspects of the Medicaid program from which Massachusetts would like “immediate relief” and greater flexibility:
- Flexibility in benefit design;…
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
Recent reports say that Mayo Clinic will give preference to privately insured patients over Medicaid and other publicly-funded patients under a new policy, which the Minnesota Department of Human Services is currently investigating. MPR News spoke to partner Tom Barker about the implications of the new Mayo Clinic policy under federal law. Click here to read the full article. More
It’s official—the 115th Congress has set its sights on overhauling the Medicaid program. We predicted as much (here and here) shortly after the November 2016 presidential elections, but now we have some insight into exactly what those proposed changes to Medicaid will be.
On January 30, 2017, President Trump signed an executive order (“EO”) that has generated considerable confusion in the administrative law space, and has produced at least one lawsuit thus far. The EO requires that for every new regulation issued by an executive agency, two regulations must be identified for elimination (“repeal”). This requirement is coupled with another provision that imposes an immediate cap on net costs imposed by new regulations (“offsets”). … 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
On January 20, 2017, President Donald Trump signed an Executive Order (EO) entitled “Minimizing the Economic Burden of the Patient Protection and Affordable Care Act Pending Repeal” to signal a clear message that “repeal and replace” of the Affordable Care Act (ACA) is a priority for the new administration. On the same day, the White House Chief of Staff, Reince Priebus, issued a memorandum to executive agencies ordering an immediate “regulatory freeze” and directing the Departments to send no regulation to the Federal Register “until a department or agency head appointed or designated by the President .… 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
As we continue our coverage of the potentially seismic changes to the Medicaid Program under a Trump Administration, we’d like to take a momentary detour into the weeds—it’s inevitable in Medicaid after all—and touch on a recent development that may be of interest to some of our readers.
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
In light of the growing cost (and demand for) specialty pharmaceutical products, and the corresponding stress this growth has had on state Medicaid coffers, CMS is now actively encouraging states Medicaid programs to engage in value based purchasing (VBP) arrangements with manufacturers. On Thursday July 14, CMS released guidance documents to state Medicaid agencies and manufacturers regarding participation in these VBP arrangements.
As states consider creative ways to finance high cost drug spend,… More
Here is another video from my recent guest lecture at George Mason University. Discussing the evolution of U.S. healthcare delivery and financing was particularly challenging because of the many ongoing and approaching changes, such as the Medicare Part B Drug Payment Model, the implementation of MACRA, the launch of CMMI’s Oncology Care Model, and the steady expansion of value-based arrangements in the private market.
The Office of Inspector General (OIG) recently issued a report titled “State Efforts to Exclude 340B Drugs from Medicaid Managed Care Rebates.” In its report, OIG wanted to study the different methods that states were using to prevent illegal “duplicate discounts” that occur as a result of the interaction between the Medicaid drug rebate program and the 340B drug-discount program. OIG revealed that the systems a majority of states have for preventing duplicate discounts are actually quite vulnerable,… More
On January 21, 2016, the Centers for Medicare & Medicaid Services (CMS) published a long-awaited final rule entitled “Medicaid Program: Covered Outpatient Drugs.” CMS actually proposed this rule in February, 2012, so it’s taken almost four years for the agency to finalize the many policies on which they sought comment – almost all of which flow from the enactment of the federal health care reform law that was enacted in 2010,… More
As states and the federal government alike grapple with Medicaid in the 21st century, we at www.medicaidandthelaw.com believe it is helpful to take a step back and view the program in a historical perspective. This slide deck was created by Tom as part of a presentation to key government officials considering various Medicaid reforms. More
On July 30, the country marks the 50th anniversary of the enactment of the Medicare and Medicaid programs. Fifty years ago, President Lyndon Johnson signed the two programs into law.
I am very proud to say that I have been involved in health care law and policy for more than one-half of the lifetime of these important social programs. My first job out of college – right after the 15th anniversary of Medicare and Medicaid –… More
On May 26, 2015 the Centers for Medicare & Medicaid Services (CMS) released its long-awaited proposed rule designed to modernize the Medicaid managed care regulations (last updated in 2002) to reflect changes in the use and growth of the managed care program and to align the program more closely with other existing healthcare programs, including Medicare/Medicare Advantage and qualified health plans offered by Exchanges.
As of FY 2011,… More
If the Office of Management and Budget’s website is to be believed, CMS will release the long-awaited Medicaid managed care rule in the coming weeks (our conversations with senior CMS officials indicated a similar timeline.) The federal regulations governing Medicaid managed care have not been updated since 2002 and much has changed in the program since then, most notably managed care enrollment numbers: between 2002 and 2015 the percentage of managed care enrollees has grown from roughly 50% to nearly 80%. … More
On March 31, the United States Supreme Court concluded, in a long-awaited decision, that the alleged failure of a state Medicaid plan to comply with the provisions of the federal Medicaid Act is not enforceable in the federal courts by alleging that the state plan has been adopted in violation of the Constitution’s Supremacy Clause. Armstrong v. Exceptional Child Center. The decision, while relatively narrow, (more on that in a bit) does seem to largely foreclose federal judicial enforcement of the requirements of the Medicaid statute against the states.… More
On March 9, 2015 the Office of Inspector General (OIG) for the Department of Health and Human Services announced the publication of a new report documenting the OIG’s audit of “personal care services” provided in New York State between 2007 and 2011 (this Report followed on the heels of a 2009 Report focused on personal care services in New York City which resulted in a $70 million dollar settlement with the Federal government in 2011). … More
Could the same “state’s rights” argument that struck down the Medicaid expansion, save the subsidies?
To completely ignore the Supreme Court’s oral arguments last week in King v. Burwell would be a disservice to you, our readers. Even though this is a Medicaid blog, in a post-ACA world is it increasingly difficult to separate out the individual pieces of our insurance system. The ACA (at least in how it was designed) was intended to create a continuum of coverage: Medicaid for the lowest income Americans,… More
The big news out of Ohio today is the announcement by the State Medicaid Director John McCarthy that, at the end of week, 61,000 Ohioans are set to lose their Medicaid coverage for failure to verify household income. According to McCarthy, the federal government requires states to verify income each year to ensure that Medicaid recipients still qualify for coverage.
So what do the Federal rules and regulations say about Medicaid income verification?… 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
Yesterday I had the opportunity to speak at the Pharmaceutical Strategic Patient Access and Support Conference in Charlotte about how access and patient support executives should position their programs for individuals otherwise Medicaid-eligible living in non-expansion states. Here is the presentation, for your enjoyment.
Note: for a fairly up-to-date analysis of where states stand on the Medicaid expansion, check out this nice break down by the Advisory Board.
As we previously discussed, the agreement between Indiana and CMS last week to expand Medicaid in that state has big implications for the Medicaid program. First, Indiana’s agreement with CMS has seemed to trigger a handful of other Red States that now appear ready to rethink agreements with CMS. … More
As if eligibility for public health insurance programs in the United States weren’t confusing enough, the issues become even more complicated when the applicant isn’t a U.S. citizen. This presentation (created by Editor Tom for a class he teaches at George Washington University), with a few case studies, walks through some of the pathways to coverage and even points out a few surprising results!
[Updated at 1:12 p.m.]
Hello dear readers. For those of you just joining us, this is a very new blog and we are still exploring different content options. Today we are going to try out a new feature, “What’s New in Medicaid Today.” We can’t promise yet that you will see this daily, but if you do find it helpful, comment, and you may just convince us to make this a regular routine.… More
The Supreme Court of the United States heard oral arguments this morning in Armstrong v. Exceptional Child Center, Inc., an appeal from a decision from the United States Court of Appeals for the Ninth Circuit that tees up a major question of federalism in the Medicaid program: can a Medicaid provider (or beneficiary) use the Supremacy Clause of the U.S. Constitution to enforce a provision of the Medicaid statute against a state where the Congress chose not to create enforceable rights under that statute.… More
The Affordable Care Act extends and simplifies Medicaid eligibility beginning January 1, 2014, by replacing Medicaid’s previous multiple categorical groupings and limitations with one simplified overarching rule: all individuals aged <65 years with incomes less than 138 percent of the federal poverty level ($15,415 for an individual or $26,344 for a family of 3 in 2012) who meet citizenship/lawful US status and state residency requirements are entitled to Medicaid benefits.… More
Enforcing Medicaid’s Entitlement Still Uncertain in the Wake of the Supreme Court’s Douglas Decision
The Medicaid statute begins with seven words: “A state plan for medical assistance must,” and the statute then proceeds to list 83 requirements that a state Medicaid plan is required to meet.1 Absent from the statute, however, is any remedy for Medicaid beneficiaries or providers who are harmed by a state’s failure to satisfy any one of those requirements. An aggrieved party can always petition the Centers for Medicare &… More