Back in December 2021, the state of Oregon released a draft Medicaid waiver proposal that caught the attention of many stakeholders. In the draft proposal, Oregon stated that it was considering asking CMS for approval to a) adopt a commercial-style closed drug formulary and b) exclude from Medicaid coverage certain drugs approved via the accelerated approval pathway “with limited or inadequate evidence of clinical efficacy.” Oregon proposed to “use its own rigorous review process to determine coverage of new drugs and to prioritize patient access to clinically proven,… More
Category Archives: Medicaid News
Before jumping into the latest litigation over Medicaid waivers, Medicaid and the Law would like to introduce its readers to Adam Schilt. Adam is a healthcare associate in the Washington, DC office and will be a regular contributor to the blog. In a past role, he’s written pieces of legislation that have been enacted into the Medicaid statute and continues to be very passionate about the subject,… More
This week’s news that Justice Stephen Breyer would step down from the Supreme Court at the conclusion of the Court’s term definitely caught our attention here at the Medicaid and the Law Blog. Our view is that Justice Breyer – who, for whatever reason, did not get a significant amount of attention from the mainstream media – had a monumental influence on the American health care system,… More
New State Health Official Letter Extends Post-PHE Processing Timelines, Implements Redetermination Requirement
We’ve previously discussed the numerous flexibilities CMS offered state Medicaid programs to respond to local outbreaks and address health concerns associated with the COVID-19 public health emergency (PHE).
Back in March 2020 (which feels like ages ago, right?) my colleague Tom discussed the enhanced 6.2% Federal Medical Assistance Percentage (FMAP) funding—authorized by the Families First Coronavirus Response Act (FFCRA) and amended by the CARES Act—including the continuous-enrollment requirement for beneficiaries who had been enrolled in Medicaid on or after March 18,… More
Due to the COVID-19 pandemic, most people have spent considerably more time at home over the past year. For many, this meant long hours of Netflix binging, crossword puzzles, and the occasional zoom happy hour. But for some of the most vulnerable Americans, stay at home orders and social distancing have caused significant interruptions in access to health care services, including preventative doctor visits, medication management and nutritional services.… More
On April 22, 2021 the Tennessee Justice Center and the National Health Law Program, representing thirteen (13) aggrieved Medicaid beneficiaries in the state of Tennessee, filed suit in the U.S. District Court for the District of Columbia against the U.S. Department of Health and Human Services (HHS) seeking to block the implementation of the TennCare III “modified block grant” 1115 waiver approved in the waning days of the Trump Administration.… More
Readers of our blog know that Haider, Alex and I have a longstanding interest in the intersection of health care law and immigration law. That’s important for our blog, especially because of the needs of the immigrant community to be able to access critical healthcare services through the Medicaid program. Over the past couple of years, we’ve written extensively about a regulation published by the Department of Homeland Security (DHS) in 2019 that’s known as the “public charge” rule. … More
Here at the Medicaid and the Law Blog, we’ve spent the past couple of days going through the American Rescue Plan Act, legislation introduced in the U.S. House of Representatives last Friday that is the latest attempt by Congress to respond to the COVID-19 pandemic. There are several provisions of the legislation that would revise and expand the Medicaid program, and we thought it would be of interest to highlight them here. … More
While CMS has been relatively quiet as of late from a public-facing perspective as it waits for new political leadership to arrive (including newly announced CMS Administrator, Chiquita Brooks-LaSure), a recent review by your Editors at www.MedicandandtheLaw.com of CMS’ website indicates a fast-paced effort to roll back a number of Trump-era Medicaid policies, particularly around waiver flexibilities. As I recently mentioned,… More
On Friday, February 12, the Centers for Medicare and Medicaid Services (CMS) took a first step to ending Medicaid work requirements. Acting CMS Administration Elizabeth Richter sent letters to Medicaid Directors in states which had previously received 1115 waiver approvals to implement so-called “community engagement” requirements, explaining CMS now does not believe that requiring employment as a condition for Medicaid coverage promotes the program’s objectives and intends to commence a process of determining whether to withdraw the waiver approvals. … More
BREAKING: CMS Withdraws Letter of Agreements to States Establishing Additional Procedures for Waiver Withdrawals
This just in – as previously discussed, on January 4, 2021 CMS Administrator Seema Verma sent a letter (available here) to State Medicaid Directors requesting they sign a Letter of Agreement “as soon as possible” establishing new procedural rights for any future waiver withdrawals by CMS.
Acting CMS Administrator Elizabeth Richter on Friday February 12th sent a letter to states that had signed the Letter of Agreement (including Tennessee) advising them that CMS is now retracting these additional procedures,… More
A few years ago, we told you about the “ongoing saga” surrounding the ability of a Medicaid beneficiary or a provider of health care services to a Medicaid beneficiary to challenge a state Medicaid agency’s putative violation of a requirement of the Medicaid program. For example, section 1902(a)(8) of the Social Security Act says that a state Medicaid agency must provide Medicaid benefits “with reasonable promptness to all eligible individuals.” Well,… More
On December 4, 2020, the Supreme Court agreed to hear arguments to decide the legality of the Department of Health and Human Services’ (HHS’s) authorization for states to incorporate work requirements into their Medicaid programs. The consolidated cases, Azar v. Gresham and Arkansas v. Gresham, challenge the legality of work requirements in two states’ Medicaid programs—Arkansas and New Hampshire. On January 19,… More
Before discussing the new Medicaid guidance on social determinants of health, Medicaid and the Law would like to formally introduce its readers to Regina DeSantis, a new Law Clerk in the Washington, DC office who will become a regular contributor to the blog.
The social determinants of health (SDOH) describe the range of environmental, social, and economic factors that can impact health outcomes. According to the Centers for Disease Control and Prevention (CDC),… More
Right before the new year, we told you about some of the Medicaid-related provisions of the COVID relief package that was recently signed into law by President Trump. One provision of that law that we thought merited a separate article was a new requirement that state Medicaid plans cover the routine patient costs of items and services furnished in connection with the participation by a Medicaid beneficiary in a routine clinical trial. … More
A quick, timely update for our reader. As reported in our previous posts on the recently approved Tennessee waiver, in likely anticipation of the Biden Administration withdrawing the newly approved, but controversial waiver, on January 4, 2021 CMS Administrator Seema Verma sent a letter (available here) to State Medicaid Directors requesting they sign a Letter of Agreement “as soon as possible”… More
If you have not already read it, you can read our main summary of the Tennessee waiver approval HERE.
Now that we have had the chance to read and meditate on the historic Medicaid waiver approved on Friday January 8th, giving Tennessee permission from the Federal government to fundamentally alter Medicaid’s traditional “matching” financing structure for the 1.5 million Tennesseans who rely on the program for healthcare services,… More
For our discussion of the new “closed formulary” flexibility approved in Tennessee, you can read our follow-up post here.
On Friday January 8th, in the final days of the Trump Administration, CMS announced approval of a first-in-the-nation waiver that would permit Tennessee to transition from Medicaid’s longstanding, open-ended financing model to a modified “block grant” model – a financing system under which the Federal government has agreed to commit a discrete amount of dollars to the state,… More
Today we want to address a topic that many state Medicaid agencies will no doubt be thinking about in the coming months, as the COVID-caused pandemic continues to threaten state finances and Congress has somewhat tied states’ hands in responding to increased Medicaid expenditures by prohibiting coverage disenrollments. (Although as my colleague Ross Margulies has pointed out here, CMS has recently given states some additional flexibilities in this regard).… More
Earlier this year, my colleague Ross Margulies and I told you about a new proposed rule issued by CMS that makes several changes to the Medicaid prescription drug rebate program, or the MDRP. Recently, CMS finalized the rule and we thought we’d take this opportunity to tell you about it. On balance, we think that the rule succeeds in CMS’s stated goals of increasing access to innovative health care therapies to Medicaid beneficiaries as well as clarifying some longstanding questions about the operation of the MDRP.… More
Earlier today, the Medicaid and CHIP Payment and Access Commission (MACPAC) released its annual MACStats: Medicaid and CHIP Data Book for 2020. This document contains a wealth of information about the Medicaid and CHIP programs and it is the primary source of information about these two important public health insurance programs. You can access MACStats here.
This is the first MACStats to derive information from the Transformed Medicaid Statistical Information System (T-MSIS). … More
On November 9, 2020, the Centers for Medicare and Medicaid Services (“CMS”) announced it finalized the Medicaid and Children’s Health Insurance Program (“CHIP”) Managed Care final rule (“2020 final rule”). According to CMS, the 2020 final rule advances CMS’s efforts to streamline the Medicaid and CHIP managed care regulatory framework and “reflects a broader strategy to relieve regulatory burdens; support state flexibility and local leadership; and promote transparency, flexibility, and innovation in the delivery of care.”
Back in March, Tom gave you, our readers, an overview of the Administration’s and Congress’ initial response to the COVID-19 pandemic, including the inclusion in the second Congressional package (the Families First Coronavirus Response Act) of a substantial “bump” to each state Medicaid program’s federal medical assistance percentage (FMAP) during the period of the current national emergency to the extent they abide by certain minimum standards.… More
On September 24, 2020 the U.S. Food and Drug Administration took two major steps to implement its Safe Importation Action Plan, including publishing a new Final Rule allowing the importation of certain prescription drugs from Canada, and a Final Guidance describing procedures to allow manufacturers to obtain National Drug Codes (NDC) for FDA-approved drugs originally intended to be marketed in a foreign country ( referred to as “multi-market approved products” or “MMA products”).… More
We’ve written before about the 340B program, which allows some health service providers that treat low-income patients to purchase outpatient prescription drugs at deeply discounted prices. It’s related (at least tangentially) to our blog because of the link between the 340B program and the manner in which the Medicaid program pays for outpatient drugs; essentially, the price that a 340B covered entity pays for a drug is the price that Medicaid would pay for the drug when it’s dispensed to a Medicaid patient: at least 23.1% off of the manufacturer’s price of the drug.… More
Last month, we described the announcement by the Department of Health and Human Services (HHS) announcing the allocation to Medicaid providers under the Coronavirus Aid, Relief, and Economic Security (CARES) Act. In the past couple of days, HHS has updated its policies regarding the Medicaid allocation (including the allocation to safety net providers) and we thought now would be a good time to highlight those updated policies.
By way of background,… More
My colleague Ross Margulies has already told our readers about a provision of the new proposed Medicaid regulation governing how the program pays for outpatient prescription drugs under the Medicaid Drug Rebate Program, or MDRP. Today, we turn our attention to another provision of that proposed rule, and that is CMS’s attempts to permit pharmaceutical manufacturers, states, and commercial payers to enter into value based payment arrangements for covered outpatient drugs. … More
As many of our astute readers are aware, on June 17, 2020 CMS released a long-awaited Medicaid proposed rule addressing a number of far-ranging issued involving Medicaid coverage and payment for prescription drugs, including new regulations to encourage the development value-based purchasing arrangements between states and manufacturers. Over the next several days we will be posting our thoughts on a number of these key policy proposals, including CMS’… More
Well, we’ve been waiting for awhile and now it’s been made public: the Department of Health and Human Services (HHS) announced on June 9 that it was releasing $25 billion in funding from the Coronavirus Aid, Relief and Economic Security (CARES) Act to high Medicaid providers and to safety net hospitals. President Trump signed the CARES Act into law on March 27; the CARES law and a subsequent law appropriated $175 billion to a Provider Relief Fund to address the needs of healthcare providers that had increased expenses or lost revenues due to COVID-19. … More
Since the COVID-19 pandemic began to seriously affect the United States in March, Congress has passed four major pieces of legislation to address the public health crisis. CMS has also jumped into action and has issued a series of waivers designed to ensure that the American health care system can function without bureaucratic obstacles preventing the appropriate delivery of care. Today, we want to highlight some of the major Medicaid provisions of those four pieces of legislation;… More
We haven’t posted on the blog in a while due to the rapid increase in our workload due to the coronavirus pandemic. We’re preparing a longer post that will go through everything that’s happened in Medicaid legislatively and administratively in the past six weeks that will be up soon, but wanted to flag an important development in today’s post.
On March 27, President Trump signed the Coronavirus Aid,… More
As my colleague Tom Barker wrote last week, the second emergency COVID-19 supplemental bill (officially referred to as the Families First Coronavirus Response Act), signed by the President on March 18, 2020, included a new section 6008 increasing each state Medicaid program’s federal medical assistance percentage (FMAP) by 6.2% during the period of the current national emergency to the extent they abide by certain minimum standards.… More
The global pandemic caused by the novel corona virus has certainly shaken up our normal way of life and will do so for the foreseeable future. Times like this reinforce the importance of public health insurance programs like Medicare and Medicaid. Our post today addresses many of the ways that CMS and Congress are bolstering the Medicaid program to respond to the unique challenges posed by the pandemic. We’ve updated this post to reflect the fact that,… More
We are still reviewing the just-released draft waiver from Oklahoma, but wanted to share with our readers in the meantime. As we’ve discussed here previously, we expected Oklahoma to be the first-mover after release of the Trump Administration’s Health Adult Opportunity guidance in January.
The Centers for Medicare & Medicaid Services (CMS) suffered a big loss in court last week. The United States Court of Appeals for the D.C. Circuit upheld a lower court ruling that blocked CMS from implementing one of the hallmarks of the Trump Administration’s efforts to restructure the Medicaid program. We first wrote about the agency’s attempts to require some Medicaid recipients to participate in community engagement activities back in 2018. … More
On January 30, 2020, the Centers for Medicare & Medicaid Services (CMS) issued its long awaited and highly anticipated State Medicaid Director Letter (SMD Letter) announcing the “Healthy Adult Opportunity” (HAO) initiative that will allow states to carry out demonstrations to implement either an aggregate or per-capita cap financing model for certain Medicaid populations. We’ve previously previewed and highlighted some of the key expectations for this long-awaited guidance.… More
UPDATED: It’s out! The much anticipated guidance, entitled the “Healthy Adult Opportunity” (HAO), from CMS introducing ways to revamp Medicaid financing has been out for nearly a week and we have had some time to review the guidance in more detail. We’ve update our questions below with answers based on our review of the guidance document.
Our friends at MACPAC have released the December 2019 edition of MACStats: the Medicaid and CHIP data book. MACStats has data and statistics on virtually any aspect of Medicaid and CHIP that you’d care to learn about. You can find the link to the document here.
We’ve written previously about the the 2014 final regulation issued by the Obama administration making significant updates to the requirements for the qualities of settings eligible for reimbursement for Medicaid home-and-community-based services (HCBS) provided under sections 1915(c), 1915(i) and 1915(k) of the Medicaid statute. With the deadline for full compliance nearing (HCBS providers must comply with the new requirements by March 17, 2022,… More
Earlier this year, we wrote about a lawsuit involving the 340B drug pricing program. We sometimes write about the 340B program because it is integrally linked to the Medicaid prescription drug rebate program. So today, we wanted to call attention to a proposed regulation issued by the Massachusetts Medicaid program (which is called “MassHealth”) that shows that link clearly.
Section 1927 of the Social Security Act requires pharmaceutical manufacturers to provide a rebate to state Medicaid plans if they want to have their drugs covered by Medicaid. … More
On November 19, 2019, CMS announced key results from the 2019 HHS Agency Financial Report, which generally provides fiscal and high-level performance data for HHS for the reporting period of October 1, 2018 through September 30, 2019. While CMS leads off its press release with the good news — payment error rates in the Medicare fee-for-service program are at their lowest level since FY 2010 —… More
We’ve posted previously the long-standing rumor (substantiated by several folks within the Administration) that CMS is working on a guidance document to states to receive their Medicaid funding through a block grant. In June, the Office of Management and Budget (OMB) received a guidance document entitled, “State Medicaid Director Letter: Medicaid Value and Accountability Demonstration Opportunity.” This document was widely reported by press as the block grant guidance document. … More
Earlier this week, CMS released for publication a proposed rule that would add some degree of transparency and oversight to the somewhat opaque world of Medicaid financing. It’s a topic that’s fascinated us here at the Medicaid and the Law Blog for some time and we’ve written about it on a couple of occasions. Over the years, Congress and CMS (and even before there was a CMS,… More
On September 17, 2019, Tennessee released its proposal to block grant most of the funding the state’s Medicaid program (TennCare) receives from the Federal government. If approved by CMS, the amendment to the state’s longstanding 1115 waiver program would make Tennessee the first state in the nation to move to a true “block grant” format for Medicaid funding. A draft of the proposed waiver is available on the state’s website —… More
Last Fall, we wrote about a proposed regulation issued by the Department of Homeland Security that involved one of our favorite topics: the intersection of immigration and health care law. My colleague Christian Springer and I have been following this proposed regulation very closely, and last week, it was issued in final form. Because it has generated enormous press attention and because it has significant implications for the Medicaid program,… More
On July 25, 2019 the Senate Finance Committee voted to advance their long-awaited drug pricing package to the Senate floor (we anticipate a Floor vote sometime this Fall). The Prescription Drug Pricing Reduction Act (PDPRA) of 2019, as the package is called, proposes numerous drug pricing reforms across Federal healthcare programs (including Part B and Part D), but for today’s blog post we will focus on some of the many Medicaid provisions included in the final mark-up.… More
Last week, CMS issued a proposed rule as part of a broader Administration-wide initiative to reduce regulatory and administrative burdens. The proposed rule would absolve states from many of the requirements of a final regulation issued by CMS in 2015 that requires states, before reducing or restructuring payments in their Medicaid programs, to conduct a review (called an access monitoring review plan, or AMRP) of the effect of the proposed rate reductions or restructuring on access to services. … More
On June 19, the House of Representatives passed the funding bill for the Department of Health and Human Services for fiscal year 2020. CMS is funded in this annual legislation and this funding bill is often a vehicle for Congress to express its support or displeasure for some of CMS’s activities during the year.
This year’s bill is no different. Section 239 of the legislation (H.R.… More
On June 4, 2019, the House of Representatives’ Committee on Energy and Commerce, Subcommittee on Health, held a hearing entitled “Investing in America’s Health Care.” Among other topics covered at the hearing was the future of the Medicaid disproportionate share hospital payment system, a topic that we have written about in the past. Unless Congress acts, Medicaid DSH payments will be cut by $4 billion on October 1,… More
We have talked previously on this blog about ongoing efforts by the Administration to reform drug pricing, including efforts to dramatically revamp the way in which health plans and their PBMs (including Medicaid MCOs) negotiate drug discounts. At the state level, PBMs have been under fire in recent years, with several State Medicaid agencies alleging a lack of transparency in contracts with the states.… More
New Executive Order Could Restrict Medicaid Coverage for Non-U.S. Citizens Seeking Immigration Benefits
We have written in the past about the link between Medicaid and immigration. Last October, we described a proposed rule issued by the Department of Homeland Security that would strengthen the “public charge” grounds for inadmissibility to the United States. If this proposed rule is finalized, many non-U.S. citizens seeking immigration benefits (such as a visa, adjustment in status or naturalization) could see those benefits denied if they utilized public benefits such as Medicaid.… More
One of the things that gets drummed into your head working with Medicaid is this: Medicaid is a payer of last resort. Medicaid can only pay for a health care service when there is no other payer available. If a Medicaid beneficiary has virtually any other source of health insurance coverage, that coverage pays first.
This requirement is set forth in the basic rules of the Medicaid program;… More
The Department of Health and Human Service’s Office of Inspector General (OIG) has issued a couple of reports lately on Medicaid coverage of prescription drugs and we thought we’d highlight them here.
The first report suggests that the Medicaid program could save hundreds of millions of dollars a year by re-determining the calculation of average manufacturer price (AMP) for some authorized generic products. … More
CMS Updates “Settings that Isolate” Guidance for HCBS Waivers, Providing Relief to Farmstead and Lifesharing Communities
On March 22, 2019, CMS published a long-awaited letter to State Medicaid Directors and a new guidance document regarding the Home and Community-Based Services (HCBS) waiver program. The letter revises previous guidance that CMS had provided to states on “Settings that have the effect of isolating individuals receiving HCBS from the broader community” for purposes of receiving Federal funding for services provided under a HCBS waiver. … More
On January 31, 2019 the HHS Office of Inspector General (OIIG) issued a proposed rule that will be published in the Federal Register on February 6. The proposed rule has the potential to fundamentally re-structure the prescription drug marketplace in the United States by dramatically altering the economics of pharmaceutical pricing. Although much of the attention surrounding the rule has been focused on its effect on the Medicare Part D prescription drug program,… More
It was just earlier this week that we were writing about a flurry of solicitations released by the the Massachusetts Executive Office of Health and Human Services (EOHHS) seeking bids from manufacturers of select, generally high-priced outpatient drugs for supplemental rebates in MassHealth’s fee-for-service and managed care programs. At that time, we noted that this exercise was likely foreshadowing the release of Governor Baker’s budget proposal.… More
A recent news article suggests that Trump Administration officials are considering allowing states to receive their Medicaid funding through a block grant. The article did not specify how CMS would accomplish such a goal without a statutory change. Details are supposedly being developed, but until we see those details, it’s hard to know exactly what the agency is considering.
My colleagues and I at the Medicaid and the Law Blog thought it might be helpful to provide some background on the concept of block grants in Medicaid,… More
In an interesting (intriguing even?) turn of events, in late December 2018 the Massachusetts Executive Office of Health and Human Services (EOHHS) announced through its public bidding site that it was seeking bids from manufacturers of select, generally high-priced outpatient drugs for supplemental rebates in MassHealth’s fee-for-service and managed care programs. While the state has before used the public bidding process successfully to negotiate supplemental rebates for the state’s Medicaid program (for example,… More
On December 13, 2018, the Medicaid and CHIP Payment and Access Commission (MACPAC) held its December 2018 public meeting.
Dr. Paul Jeffrey, the Director of Pharmacy for MassHealth, spoke on MassHealth’s drug pricing approach, in particular with respect to a drug pipeline he described as “alarming” in terms of cost but “sensational” in terms of potential impact. Although Dr. Jeffrey suggested that implementing a closed formulary would require waiver authority (which CMS denied Massachusetts last year),… More
Despite Mylan’ $465 million settlement with the Department of Justice for overcharging Medicaid millions of dollars for its product EpiPen, Congress is not ready to let bygones be bygones. In a display of bipartisanship, Sen. Grassley (R-IA) and Sen. Wyden (D-OR) unveiled a bill (section-by-section summary) entitled “The Right Rebate Act” (RRA) on December 4, 2018 and explicitly cited the EpiPen experience as the chief motivating factor for its creation. … More
Court Case Involving Massachusetts Health Care Law Shows Relationship Between Medicare Payments and Medicaid
In 2006, former Massachusetts Governor Mitt Romney signed Chapter 58 of the Massachusetts Acts of 2006 into law. Chapter 58 was designed to ensure that all Massachusetts residents would have access to some form of health insurance, and it accomplished this through reforms to the individual insurance market; subsidies to purchase health insurance; and an expansion of the Massachusetts Medicaid program, known as “MassHealth.” Many observers have suggested that the enactment of Chapter 58 in Massachusetts paved the way for enactment of the Affordable Care Act at the federal level four years later (although Governor Romney strenuously denied this during his campaign for President in 2012).… More
Despite all of the drama surrounding the 2018 midterm elections, one thing was clear: Medicaid had a big night on November 6, 2018.
In particular, the electorate in the Red states of Nebraska, Idaho, and Utah voted to expand Medicaid (i.e. extend Medicaid coverage to low-income able-bodied adults). Although the Montana electorate rejected a ballot measure that would have permanently funded the Medicaid expansion in that state beyond 2019,… More
In a wide-ranging speech on CMS’s efforts to lower Medicaid drug costs, Administrator Seema Verma announced yesterday that CMS has approved Michigan’s proposed state plan amendment to utilize value-based payment arrangements with drug manufacturers. With CMS’s blessing, Michigan can now enter contracts with pharmaceutical companies in which manufacturers provide the state supplemental rebates when their drugs fail to meet specified treatment benchmarks.
Michigan is the second state that has received CMS’s approval to pursue value-based purchasing agreements.… More
On November 13, 2018 CMS (as mandated by Congress in the 21st Century cures Act) issued a State Medicaid Director Letter providing states with guidance on both: (1) existing authority for states to provide support for adults with serious mental illness (SMI) and/or children with a serious emotional disturbance (SED); and (2) a new demonstration opportunity to permit states to offer care for certain individuals with serious mental illness residing in Institutions for Mental Disease (IMDs).… More
We have written recently about the interrelationship between the Medicaid program and U.S. immigration law. Our post generated a lot of interest and now there’s a new development to report.
On October 10, 2018, the Department of Homeland Security (DHS) published a proposed regulation in the Federal Register that, if finalized, may have an effect on individuals seeking admission to the United States,… More
In prepared remarks delivered by Administrator Seema Verma on September 27, 2018 at the 2018 Medicaid Managed Care Summit, the Administrator previewed the release of an impending guidance document on a new/updated “work requirement” demonstration. As noted in the prepared remarks:
Additionally, in January, we released a groundbreaking new demonstration opportunity in response to state requests to test work and community engagement incentives among able-bodied adult beneficiaries.… More
The United States Supreme Court will have the opportunity to hear an important case out of Fifth Circuit Court of Appeals affecting how states pay community health centers for Medicaid beneficiaries enrolled in a managed care plan. Community health centers represent the largest primary health care safety net for the nation’s poorest urban and rural communities.
This is a brief post about a CMS proposed rule that sort of slipped under the radar last week. But it has the potential to raise some eyebrows because it is clearly designed to make it harder for labor unions to collect dues from some home health care workers who are paid directly by Medicaid.
Section 1902(a)(32) of the Social Security Act prohibits reassignment of Medicaid funds, and only allows Medicaid funds to be paid directly to individuals performing health care services,… More
It has not been a good week for states that want to try innovative Medicaid waivers. First, CMS shot down Massachusetts’ attempt to re-structure the 25-year old Medicaid prescription drug rebate program to achieve additional savings on the cost of prescription drugs. And then on Friday, the United States District Court for the District of Columbia effectively blocked Kentucky’s attempt to impose “community engagement” requirements on some Medicaid recipients. … More
If recent history provides us with any guideposts on how the current Administration will review and approve (or not approve) State waiver requests, today’s news may come as a bit of a surprise. In the wake of recent approvals of never-before-seen waivers — including the imposition of new work requirements in Kentucky, Indiana , and Arkansas — today we learned that CMS has said no to lifetime limits on Medicaid benefits in the state of Kansas.… More
In the midst of a busy day on Capitol Hill yesterday, President Trump signed a long-anticipated Executive Order (EO) entitled, “Reducing Poverty in America by Promoting Opportunity and Economic Mobility.” Notably, the EO directs various Federal agencies (including the Department of Health and Human Services) to review existing guidelines on publish assistance programs to ensure they are in line with the President’s outlined “Principles of Economic Mobility.”… More
Last summer we wrote about an interesting court case involving payments to disproportionate share hospitals (DSH) under the Medicaid program. It’s one of the hottest issues in Medicaid right now; seven courts have invalidated the CMS policy that is at issue. The most recent decision came last week, in the US Court of Appeals for the First Circuit, involving a challenge brought by New Hampshire hospitals.… More
On March 23, CMS finalized updates to the Medicaid National Drug Rebate Agreement (NDRA) for the first time in 27 years to incorporate legislative and regulatory changes that have occurred since the Agreement was first published. As my colleague previously wrote, CMS proposed changes to the NDRA in November 2016—most, though not all, of the proposed changes were finalized.
On March 26,… More
Our readers may remember our discussion of the ongoing saga surrounding enforcement of the entitlement to Medicaid. We have covered it several times before (here and here) on this blog. Aside from discussing the topic because it allows us to flex our legal muscle with italicized case names, we also believe it’s critical for our readers to understand how Medicaid entitlement has evolved over time. … More
My colleague Tom Barker and (my former boss) Professor Sara Rosenbaum just finished a series of back-to-back sessions on enforcing the Medicaid entitlement – the sessions were entertaining and engaging for all involved. We have written about this topic previously – notably here and here. Tom and Sara’s excellent slide deck can be viewed here:
During the opening session of AHLA yesterday, we had the opportunity to hear remarks for Calder Lynch, current Counselor to CMS Administrator Seema Verma and potential replacement pick for outgoing CMCS Director. Lynch reiterated the three pronged approach the current administration is taking to Medicaid (as previously outlined by administrator Verma):
- Program Integrity
According to Lynch,… More
Good morning from snowy Baltimore! Myself, along with my colleagues Tom Barker, Sean Ahern, and Erik Schulwolf are excited to be here here at AHLA’s Institute on Medicare and Medicaid Payment Issuers. Over the next few days we plan on blogging about our insight, key sessions, and other fun tidbits and developments as we take in all of the great information at this annual gathering of the health bar.… More
We’re certain that no one has forgotten about the January CMS policy announced by the current administration that supports states seeking to adopt work and community engagement requirements as part of their Medicaid programs through section 1115 waivers. We certainly have not. We previously covered this topic in-depth following CMS’ policy announcement and the approval of Kentucky’s 1115 waiver containing a work requirement.… More
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
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
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
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
There is little doubt now that Republicans have set their sights on Medicaid as part of their effort to repeal the Affordable Care Act (ACA). On February 24, 2017, a House Republican Discussion Draft Bill (Draft Bill) dated February 10, 2017, was leaked to the press. The Draft Bill repeals major provisions of the ACA and includes some replacement proposals as well. However, one of the Draft Bill’s prominent focus areas is Medicaid. … More
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
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
Although outpatient prescription drugs are not a mandatory benefit under the Medicaid program, all 50 states do provide at least some coverage for prescription drugs. Manufacturers that want their drugs covered under Medicaid must agree to pay rebates to the Medicaid program (for brand name drugs, rebates must equal at least 23.1% of the average manufacturers price of the drug); must agree to participate in the 340B program; and must agree to provide federal supply schedule pricing to federal government agencies.… 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 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
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
- The Washington Post is out with a short analysis on the Indiana deal with CMS to expand Medicaid in the state using some new methods (HSAs, kick-out penalties.)
- In a longer, more thoughtful piece the NY Times yesterday took a step back and opined on how what was once supposed to be a relatively simple change (expanding Medicaid to 138% of the federal poverty level) has now become something of a “many-headed”…
Sometimes news is so interesting you need a night to ponder on it. Yesterday’s announcement that Indiana reached an agreement with CMS to expand its Medicaid program to the ACA-levels (138% of the Federal Poverty Level) was a big surprise and carries with it some very real, long-term implications. The Indiana model creates two new Medicaid pools: Health Indiana Plan (HIP) Basic and HIP Plus. HIP basic will be made only available to individuals making less than the federal poverty level and includes coverage of all essential health benefits,… More
[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