Public Comment: Allow Medicare to cover anti-obesity medications (AOMs) and strengthen patient protection “guardrails” through better oversight of Medicare Advantage Part D (MAPD) plans.

No Patient Left Behind (NPLB) wrote to the Centers for Medicare and Medicaid services (CMS) urging the agency to allow Medicare to cover anti-obesity medications (AOMs) and to strengthen patient protection “guardrails” through better oversight of Medicare Advantage Part D (MAPD) plans.

1. Coverage of anti-obesity medications

We support CMS’ proposal to permit Medicare and Medicaid coverage of medications for the treatment of obesity and urge that CMS ensure prescribed treatments authorized by health plans are available to beneficiaries in Contract Year 2026 at low or no out-of-pocket costs.

Reducing obesity will prevent several scientifically linked comorbidities, improve beneficiary quality of life, and result in significant reductions in acute care spending.

  • Research published in the Journal of the American Medical Association (JAMA) found that for seniors, a 5% weight loss reduced their health care spending by $1,262. A 25% weight loss saved this group $5,442 in annual medical expenses. Savings also were significant for the under-65 insured population, where a weight loss of 5% reduced health care spending by $670 on average. For adults with weight loss of 25%, the savings were an average of $2,849.

  • Research from the USC Shaeffer Center found that the societal benefits of Medicare coverage of weight loss therapies alone — with no additional impacts on private insurance coverage — would generate almost $1 trillion in value over the next 10 years.

It also is important to note that while GLP-1s are making a difference for many Americans – there is so much more research that’s needed before AOMs benefit all who need them. We are in the first chapter of this innovation story, with many exciting improvements yet to come.

We urge CMS to avoid policies that may stifle new R&D in small molecule AOMs. CMS’s concurrent proposal to have the government, not the market, set the price of small molecule anti-obesity medications prior to 13 years after FDA approval fails to take into account what continued AOM innovation will do for the world’s health, productivity, and wealth. So much more research needs to be done to:

  • improve obesity treatment efficacy;

  • reduce potential side effects;

  • improve duration of treatment so that just one shot or one pill is needed every few

  • months;

  • learn how to use AOMs to reduce other harmful and costly diseases;

  • allow greater competition that drives market prices down;

  • ensure new drugs are easily genericized once their patents expire.

CMS should use its regulatory authority carefully to ensure proper coverage of prescribed treatments at low or no out of pocket costs without stifling future innovation. Current CMS price controls on novel medicines prior to 13 years after FDA approval threaten the ability to fund continued progress in AOM small molecule R&D.

2. Enhancing Medicare Advantage and Medicare Part D patient protections

We share CMS’ concern that MAPD plans use prior authorization and other harmful restrictions to create unnecessary friction for patients. This friction impedes access to prescribed treatments. Research from KFF finds that virtually all MAPD beneficiaries are required to obtain prior authorization for some services, that the number of prior authorization requests physicians

seek on behalf of beneficiaries is increasing, and yet so is the percentage of requests that health plans deny.

We encourage CMS to implement its proposed “guardrails” to better protect Medicare beneficiaries who in general are the nation’s sickest population, as well as the most vulnerable to insurance scams and fraud. In particular,

  • Strengthening prior authorization and utilization management guardrails

    • CMS should make every effort to ensure that health plans do not create unnecessary administrative burdens that prevent beneficiaries from getting timely access to physician prescribed treatments.

    • One way to reduce unnecessary friction would be for CMS to require MAPD plans to charge low or no cost-sharing for prior-authorized treatments the health plan ultimately confirms as medically necessary.

  • MA and Part D medical loss ratio (MLR) reporting

    • CMS should take steps to better understand how health plans may use their vertically integrated sister organizations to circumvent MLR as well as plan-by-plan margin test requirements and reporting.

    • In particular, requiring plans and their pharmacy benefit managers (PBMs) to pass on market savings and net price discounts to beneficiaries at the pharmacy counter and when determining their cost-sharing requirements will also assist in ensuring proper MLR reporting.

  • Formulary inclusion of low-cost treatments

    • CMS should require that MAPD plans place government price set treatments on the lowest tier formulary with low or no copays for the patient. This would ensure that beneficiaries see meaningful out-of-pocket savings from the Inflation Reduction Act’s drug price setting provisions. Imposing an arbitrary price control on a novel medicine prior to 13 years after FDA approval effectively makes it a “generic” medicine to the purchaser and the patient, regardless of whether its patents have expired.

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