January/February 2022 Industry Updates
CMS Proposes Rule to Lower Costs for Medicare Part D Prescriptions
With the new year come new rule proposals from the Centers for Medicare & Medicaid Services (CMS), which recently proposed updates to the Medicare Advantage (MA) and Part D programs that could reduce out-of-pocket costs, as well as improve experiences for dually eligible enrollees and more.
“We are dedicated to ensuring older Americans and those with disabilities who are served by the Medicare program have access to quality, affordable health care, including prescription drugs and therapies,” said CMS Administrator Chiquita Brooks-LaSure.
The newly proposed rule is partially based on feedback from late 2018 on a policy that requires Part D plans to apply price concessions—the arrangement in which plans pay discounted rates to pharmacies that do not meet certain metrics. CMS noted these concessions lack public visibility and the pricing is not shared with the beneficiaries. After receiving comments, CMS proposes that come January 1, 2023, Part D plans be required to apply all price concessions received from network pharmacies at the point of sale. The goal is to increase transparency, as well as encourage market competition.
“In addition, CMS is proposing actions that reduce health disparities by ensuring that all MA special needs plans solicit information about an individual’s barriers to accessing care, through standardized questions in required health risk assessments on housing instability, food insecurity, and transportation,” said CMS in the press release.
In an effort to further protect those with Medicare, CMS proposed increased oversight of third-party marketing organizations that disseminate information on behalf of MA organizations and Part D sponsors, as well as requiring plans to communicate the availability of free translations services.
Other proposed updates under the new rule include:
- Limiting MA plans’ ability to expand or enter into new contracts if previous performance is poor
- Requiring MA and Part D plans to provide more extensive reports on how revenue is spent
Lastly, CMS is seeking to better understand access barriers to behavioral health care and is requesting feedback on challenges within provider networks and the potential impact of CMS policy changes. —Edan Stanley
Medicaid Enrollment Assistance, Utilization Rates Among Formerly Incarcerated People With SUD
The addition of Medicaid enrollment assistance to correctional facilities’ discharge plans was linked to a higher likelihood of individuals with substance use disorders (SUDs) using health care resources, new findings indicate.
“The transition from prison to community is characterized by elevated morbidity and mortality, particularly owing to drug overdose,” authors noted. “However, most formerly incarcerated adults with substance use disorders do not use any health care, including treatment for substance use disorders, during the initial months after incarceration.”
The retrospective cohort study was conducted with a sample of 16,307 adults with 18,265 eligible releases who had a history of substance use and were released from Wisconsin state prisons beginning April 2014 through December 2016. Prerelease Medicaid enrollment assistance was added to prison discharge plans in January 2015.
The sample included people between 19 and 64 years of age (mean 35.5) who were predominantly male (16,320 of 18,265 total eligible releases). About one-third of individuals were Black (6213 of 18,265 eligible releases).
Authors reviewed Medicaid-reimbursed health care utilization within 30 days of individuals being released from prison. They included both outpatient and inpatient care, as well as emergency department use.
After Medicaid enrollment assistance was implemented, in the month following release, individuals were 7.7% more likely to use outpatient care for substance use (95% CI, 6.4-8.9%; P < .001). This outpatient increase included a .7% higher likelihood for an opioid use disorder visit (95% CI, .
4-1%; P < .001), a 1% higher likelihood for any SUD visit (95% CI, .5-1.6%; P < .001), and a .4% higher likelihood for receiving medication to treat opioid use disorder, such as methadone, buprenorphine, or others (95% CI, .2-.6%; P < .001).
Authors also reported a .4% increase in the probability of inpatient stays (95% CI, .03-.7%;P = .03), but no significant change in emergency department utilization (.7% [95% CI, -.15-1.4%].
“Treatment of [substance use disorders] during this transition is associated with a reduced risk of relapse and overdose,” researchers noted.
“Currently, adults leaving correctional facilities face different Medicaid enrollment opportunities depending on the Medicaid expansion status of their state and the availability and type of enrollment assistance,” authors added. “The results of this cohort study suggest that prerelease Medicaid enrollment assistance was associated with increased use of outpatient health care after incarceration and highlights the value of making this assistance universally available within correctional
settings.” —Maria Asimopoulos
Medicaid Expansion in Louisiana Reduces Travel for Care Among Minority Groups
Louisiana’s Medicaid expansion decreased the distance between beneficiaries and service providers with the greatest effects being seen in general practice visits in nonmetropolitan areas and for Black patients, according to study findings.
“…the fact that the policy had a stronger effect on the Black population has important public health implications, given that members of racial and ethnic minority groups are consistently found to face longer travel times to obtain health care services,” stated authors of the study. “Medicaid expansion increased access, in particular, for these most vulnerable populations.”
For this study, in metropolitan areas, 51.2% of beneficiaries were Black and 34.2% were White and in nonmetropolitan areas, 45.1% of beneficiaries
were Black and 45.5% were White. Authors of the study noted that age distribution was similar in both areas and of the total nonmetropolitan sample, 58.8% of beneficiaries were women and in the metropolitan sample 58.9% were women.
Study authors compared mean distances traveled both pre- and post-expansion and results showed a decline for all service lines after the expansion. Due to expansion in nonmetropolitan areas, Black patients traveled 9.25 fewer miles for general practices and 2.93 fewer miles for primary care services, while White patients traveled 4.29 fewer miles for internal medicine services and 3.32 fewer miles for primary care services.
Results were significant in all service lines for Black enrollees in metropolitan areas and in 5 service lines for White enrollees, according to authors of the study. Other notable benefits stemming from the expansion include improvement in quality of life for Medicaid beneficiaries, as well as patients receiving appropriate screenings and follow-ups, and better health outcomes.
“We provide evidence for the fact that Medicaid expansion contributed to the amelioration of preexisting race and ethnicity-based inequalities that were contributing to higher barriers to obtain health care services for Black Medicaid beneficiaries,”
concluded authors. —Samantha Matthews
CMS Proposes Medicare Coverage of Therapy for Alzheimer Disease, but Only for Patients in Clinical Trials
The Centers for Medicare & Medicaid Services (CMS) shared a proposed National Coverage Determination (NCD) decision memorandum for which FDA-approved monoclonal antibodies that target amyloid for the treatment of Alzheimer disease (AD) would be covered by Medicare through a coverage with evidence development (CED) policy.
This stipulation means only patients enrolled in qualifying clinical trials would have access to the treatment and not those with early-stage disease or mild cognitive impairment.
“CMS has proposed an evidence-based coverage policy after experts reviewed all relevant publicly available evidence and feedback received from stakeholders,” said CMS Administrator Chiquita Brooks-LaSure. “Before finalizing this proposal, we will have more opportunities to hear from people with Medicare living with mild cognitive impairment due to [AD] or mild [AD] dementia, their family members and caregivers, as well as many other stakeholders, including patient advocacy groups, medical experts, states, payers, and industry professionals.”
CMS is requesting public comment for 30 days following the proposal and expects to make a final decision by April.
If the NCD is finalized, CMS will evaluate each clinical trial for the necessary inclusion criteria and all approved, eligible trials will be posted on the agency’s website. Participants with Medicare in the approved trials would be eligible for coverage of the drug, as well as related services and other routine costs—including PET scans if required via the trial protocol.
At present, aducanumab is the only monoclonal antibody FDA-approved for the treatment of amyloid beta and AD.
“This proposed [NCD] is the result of robust evidence analysis conducted through a thorough review process that found while there may be the potential for promise with this treatment, there is also the potential for harm to patients. This harm may range from headaches, dizziness, and falls, to other potentially serious complications such as brain bleeds,” said Dr Lee Fleisher, CMS chief medical officer and director of the Center for Clinical Standards and Quality. “We believe that any appropriate assessment of patient health outcomes must weigh both harm and benefit before arriving at a final decision.” —Edan Stanley
Comparing Cost-Effectiveness of 3 Treatment Regimens for Multiple Myeloma
Compared to 2 other combination treatments, lenalidomide plus dexamethasone was the most cost-effective therapy for patients with newly diagnosed, transplant-ineligible multiple myeloma, according to recent findings.
Researchers compared the cost-effectiveness of daratumumab and lenalidomide plus dexamethasone triple therapy (DRd); bortezomib and lenalidomide plus dexamethasone triple therapy (VRd); and lenalidomide plus dexamethasone (Rd).
“There have been cost-effectiveness analyses for daratumumab and bortezomib use in [relapsed/refractory multiple myeloma], but there are limited data regarding cost-effectiveness for daratumumab or bortezomib use in newly diagnosed multiple myeloma patients who are ineligible for stem cell transplantation,” authors wrote.
The study was conducted using progression-free survival data from the MAIA and SWOG S0777 phase 3 trials, as well as national data on costs, discounted by 3%. Cost-effectiveness was defined as “a willingness to pay of $150,000 per progression-free quality-adjusted life-year” (PFQALY).
Overall costs were $329,867, $385,434, and $626,900 for Rd, VRd, and DRd, respectively. DRd had the highest number of PFQALYs at 1.52, followed by 1.35 PFQALYs for VRd and 1.24 PFQALYs for Rd.
After analyzing costs in accordance with the willingness to pay threshold, researchers found that:
- VRd was not cost-effective compared with Rd standard therapy, with an incremental cost-effectiveness ratio (ICER) of $530,256 per PFQALY;
- DRd was not cost-effective compared with VRd (ICER=$1,396,318 per PFQALY); and
- DRd was also not cost-effective compared with Rd standard therapy (ICER=$1,060,832).
VRd would be cost-effective in 40% of cases if the willingness to pay threshold were increased to $550,000, probabilistic sensitivity analysis indicated. Researchers added that DRd would not be more cost-effective than VRd within any reasonable willingness to pay threshold (up to $800,000).
“Neither DRd nor VRd triple therapy were found to be cost-effective vs Rd,” authors concluded. “Further cost-effectiveness analyses that include overall survival data for daratumumab and bortezomib triple therapies are needed to demonstrate an ICER in QALYs.” —Maria Asimopoulos
Mandate Requires Coverage of At-Home COVID-19 Testing by Insurers, Group Health Plans
January 15, 2022 kicked off the start of over-the-counter (OTC), at-home COVID-19 tests being covered by insurance companies and group health plans, under the Biden-Harris Administration.
According to a Centers for Medicare & Medicaid Services (CMS) press release, most consumers will be able to buy a COVID-19 test either at a pharmacy, store, or online and it will be paid for up front or reimbursed by submitting a claim to their health care plan.
“Testing is critically important to help reduce the spread of COVID-19, as well as to quickly diagnose COVID-19 so that it can be effectively treated,” said CMS Administrator Chiquita Brooks-LaSure.
Covered individuals will be eligible for 8 free OTC, at-home tests per month. For individuals who need tests due to underlying medical conditions or if a health care provider orders or administers a test following a clinical assessment, there is no limit on the number of tests, according to CMS.
CMS noted in its press release that per this requirement, insurers are incentivized to cover these costs up front so an order from an individual’s health care provider will not be necessary in order to access the free tests.
Furthermore, other medical management requirements, deductibles, copayments or coinsurance, or prior authorization will not be required for these tests.
“When plans and insurers make tests available for upfront coverage through preferred pharmacies or retailers, they are still required to reimburse tests purchased by consumers outside of that network, at a rate of up to $12 per individual test (or the cost of the test, if less than $12),” stated CMS in the press release. “For example, if an individual has a plan that offers direct coverage through their preferred pharmacy, but that individual instead purchases tests through an online retailer, the plan is still required to reimburse them up to $12 per individual test.”
In addition, the US Department of Health and Human Services (HHS) has provided upward of 50 million tests at no cost to health clinics and centers across the country. HHS and the Federal Emergency Management Agency have also created more than 10,000 free community-based testing states nationwide in an effort to provide increased access to in-need and rural populations.—Samantha Matthews
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