RISE summarizes recent regulatory-related headlines.
Bipartisan bill would ensure fair Medicare coverage consideration for new drugs
A new bipartisan bill would require the Centers for Medicare & Medicaid Services (CMS) to consider covering new, innovative treatments when enough data is collected on the drug’s effectiveness. The ‘‘Access to Innovative Treatments Act of 2022,” introduced by Rep. Nannette Diaz Barragan (D-Calif.) and Rep. John Joyce, M.D. (R-Penn.), would create a review process within CMS to ensure that as new treatments become available, the agency would consider each drug and its effectiveness individually to determine whether it should be covered by Medicare, instead of applying a broad or outdated decision to an entire class of drugs.
The proposed legislation comes in the wake of CMS’ decision in April to limit coverage of the cost of the Alzheimer’s drug Aduhelm and other medicines in its class to patients enrolled in qualifying clinical trials. This decision restricts coverage to the only known class of drugs that is reasonably likely to affect the course of the disease to randomized controlled trials approved by CMS, and severely limits access to this entire class of drugs. As a result, less than one percent of Medicare beneficiaries can access currently available treatments, according to Barragan.
Currently, there is no mandatory review process for CMS National Coverage Determinations. This means that if a new drug in this class is produced, even if the FDA approves it and deems it effective, it will be subject to the same coverage restrictions, she said.
“Before its decision on Alzheimer’s disease, CMS had historically covered most FDA-approved drugs for their on-label use, and the agency had never denied coverage of an entire class of drugs based on the safety and efficacy profile of one FDA-approved drug,” said Sue Peschin, president and CEO of the Alliance for Aging Research, one of several Alzheimer’s disease patient organizations that has endorsed the legislation. “That is for two good reasons. First, the scientific expertise lies within FDA, and respectfully, not within CMS. Second, each FDA-approved drug has a unique molecular structure, different mechanism of action, and different side effect profile, making it wholly inappropriate for CMS to issue class-wide coverage determinations. The Access to Innovative Treatments Act would help fix some of the problems CMS created by departing from its past practice.”
The Access to Innovative Treatments Act creates a fair and transparent process to ensure that CMS reconsiders Medicare coverage decisions for drugs and therapies when enough data is collected on an individual drug’s effectiveness by mandating:
- CMS must open reconsideration of applications within 30 days of notification that a drug under CMS’ coverage with evidence development (CED) program is effective and complete reconsideration with 90 days of this notification
- CMS may not implement limited coverage policies for an entire class of drugs
Open enrollment on the fast track: 5.5M have signed up for coverage on ACA marketplace
Since the start of the 2023 Marketplace Open Enrollment Period (OEP) on November 1, nearly 5.5 million people have selected a plan on the Affordable Care Act (ACA) marketplace, an 18 percent increase from this time last year. The figures represent activity through the fifth week of open enrollment for the 33 marketplaces using HealthCare.gov and the fourth week for the state-based marketplaces in 17 states and the District of Columbia.
The Department of Health and Human Services (HHS) announced in a second national snapshot about open enrollment activity that total plan selections include 1.2 million people (22 percent of the total enrollments) who are new to the marketplaces for 2023 and 4.3 million people (78 percent of total) who have active 2022 coverage and returned to their respective marketplaces to renew or select a new plan for 2023. Last year at this time, 4.6 million had signed up for coverage.
“We are off to a strong start - and we will not rest until we can connect everyone possible to health care coverage this enrollment season,” said HHS Secretary Xavier Becerra in the announcement. “The Biden-Harris Administration has taken historic action to expand access to health care and ensure everyone can have the peace of mind that comes with being insured. With four out of five people eligible for coverage at $10 or less, do not miss your opportunity to sign up for high-quality, affordable health care. We urge everyone to visit HealthCare.gov and find the coverage that meets your needs.”
This year, due to the Inflation Reduction Act, more people will continue to qualify for help purchasing quality health coverage with expanded financial assistance. Four of our five HealthCare.gov enrollees will be able to find a plan for $10 or less after tax credits. HHS also said that the marketplace is highly competitive this year. Ninety-two percent of HealthCare.gov enrollees will have access to options from three or more insurance companies when they shop for plans. New standardized plan options are also available in 2023 through HealthCare.gov, which offer the same deductibles and cost-sharing for certain benefits, and the same out-of-pocket limits as other standardized plans within the same health plan category, to help consumers compare and select plans. Most of these standardized plan options offer many services pre-deductible, including primary care, generic drugs, preferred brand drugs, urgent care, specialist visits, mental health and substance use outpatient office visits, as well as speech, occupational, and physical therapy.
KFF: More employers offer Medicare Advantage to retirees
Few employers offer retiree health benefits, and those that do are increasingly turning to Medicare Advantage plans to provide that coverage–a shift that has implications both for retirees and for federal spending, according to a new Kaiser Family Foundation (KFF) analysis.
Among the relatively small share of large firms (200 or more workers) that offer retiree health benefits to Medicare-age retirees, 50 percent provide these benefits through a Medicare Advantage plan in 2022, according to the analysis of data from the 2022 KFF Employer Health Benefits Survey. That’s up from 26 percent in 2017.
Under this approach, employers contract with a Medicare Advantage private insurer that provides all Medicare-covered benefits in addition to supplemental benefits, rather than other approaches, such as providing supplemental coverage that wraps around traditional Medicare.
Among the findings:
- Thirteen percent of large employers offer retiree health benefits to Medicare-age retirees in 2022.
- Among larger employers with 1,000 or more workers that offer retiree health benefits through a Medicare Advantage plan, the most common reason the employer elected this option was the lower cost.
- About 44 percent of large employers offering Medicare Advantage coverage to their retirees give them no choice but to receive their benefits through a Medicare Advantage plan, rather than give them a choice between Medicare Advantage and non-Medicare Advantage options.
The shift to Medicare Advantage has implications for retirees, KFF said. On the one hand, this approach may help retirees if it enables employers to maintain or even broaden retiree health benefits rather than scale back or even terminate coverage. On the other hand, it has the potential to restrict retirees’ access to doctors and hospitals for Medicare-covered services, depending on the plan’s provider network, and subject retirees to utilization management tools, such as prior authorization, that may limit access to Medicare-covered services. The rising number of large employers choosing Medicare Advantage for their Medicare-eligible retirees also has implications for federal spending because Medicare spends more per person for enrollees in Medicare Advantage plans (including in group plans) than for beneficiaries covered by traditional Medicare, KFF noted.
Urban Institute: 18M projected to lose Medicaid coverage when PHE expires
A new report by the Urban Institute examines what will happen to health coverage after the COVID-19 public health emergency (PHE) expires and states resume normal Medicaid eligibility determinations. Using the latest available administrative data on Medicaid enrollment, recent household survey data on health coverage, and the Urban Institute’s Health Insurance Policy Simulation Model, the nonprofit research organization estimated health coverage at the expiration of the PHE (when Medicaid enrollment will be at its peak) and after the major coverage transitions that will follow.
If the PHE expires in April 2023, 18 million people will lose Medicaid coverage in the following 14 months, according to the report. Of those, about 3.2 million children are estimated to transition from Medicaid to separate Children’s Health Insurance Programs, about 3.8 million people will become uninsured, about 9.5 million people will either newly enroll in employer-sponsored insurance after losing Medicaid or transition to employer-sponsored insurance as their only source of coverage after being enrolled in both employer-sponsored insurance and Medicaid sometime during the PHE, and more than 1 million people will enroll in the nongroup market, most of whom will be eligible for premium tax credits in the Affordable Care Act marketplace.
“Further extensions of the PHE are possible,” Urban Institute noted in the executive summary of the report. “If it is extended for an additional 90 days, we estimate that the number of people losing Medicaid will rise to nearly 19 million.”