Barriers to Access

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Getting an FDA‑approved GLP‑1 can be hard even when it’s clinically appropriate. The main obstacles are coverage rules, out‑of‑pocket cost, utilization management, pharmacy distribution, and information safety—all of which are specific pain points for GLP‑1 drugs.

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Barriers to Access

Coverage & eligibility

  • Commercial insurance: Many plans still exclude anti‑obesity medications or restrict coverage to narrow formularies. Approvals usually require BMI and comorbidity criteria, documentation of prior lifestyle interventions, and periodic re‑authorization.
  • Medicare Part D: GLP‑1s are generally covered for diabetes indications. Most plans still exclude weight‑loss use by statute; coverage may vary when products have other FDA‑approved indications (e.g., cardiovascular risk‑reduction).
  • Medicaid: Coverage is state‑specific, often with strict prior‑authorization rules; some states exclude weight‑loss indications entirely.
  • Step therapy & quantity limits: Many payers require trying older agents first and cap monthly quantities or dose escalations, slowing titration.

Cost & affordability

  • Cash prices are often unaffordable when coverage is excluded. Even with coverage, coinsurance and deductibles can be high. Manufacturer savings cards usually don’t apply to Medicare/Medicaid and may be limited by copay accumulator policies.

Utilization management (paperwork friction)

  • Prior authorization (PA): Payers commonly require baseline weight/BMI, ICD‑10 codes, comorbidities, prior therapies, and a titration plan. Renewals may demand proof of minimum % weight loss within 3–6 months or therapy is stopped.
  • Appeals: Initial denials are common; appeals need detailed clinical rationale, chart notes, and sometimes peer‑to‑peer review.

Pharmacy & logistics

  • Restricted distribution/specialty pharmacy: Plans may require a particular specialty pharmacy, causing delays when local stock is limited.
  • Cold‑chain & device handling: Temperature‑controlled shipping, pen‑device training, and needle supplies can be barriers—especially without reliable refrigeration.
  • Strength availability: Specific pen strengths may be out of stock locally, complicating safe dose escalation.

Telehealth‑specific hurdles

  • Some platforms are out of network, charge separate membership fees, or don’t complete PAs—leaving patients to navigate approvals alone. Delays can occur when the dispensing pharmacy isn’t disclosed or when shipping is the only option.

Information & safety

  • Counterfeits and non‑equivalent compounded products are aggressively marketed online. Confusion between FDA‑approved GLP‑1s and “compounded semaglutide/tirzepatide” can lead to unsafe purchases and dosing errors.

Equity considerations

  • Language access, broadband, transportation, and provider availability all affect the ability to obtain, store (cold‑chain), and safely use GLP‑1s—disproportionately impacting rural and under‑resourced communities.

What helps

  • Ask your clinician to include diagnosis, comorbidities, prior therapies, and a titration plan in the initial PA.
  • Request copies of denial letters and pursue appeals; many are approved on reconsideration with additional evidence.
  • Explore patient‑assistance or foundation support where eligible.
  • Use a state‑licensed U.S. pharmacy and avoid “too good to be true” offers to reduce safety risks

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Frequently Asked Questions

Timeline: The Treat & Reduce Obesity Act (TROA)

Fake products can contain the wrong ingredient or the wrong amount of drug, be contaminated by poor manufacturing practices, and come with vague or misleading labels that make safe dosing impossible. Multi‑use vials that require you to self‑measure doses are especially risky and have led to overdoses and hospitalizations. If anything about the product, packaging, or seller feels off, do not inject it—contact a licensed pharmacist or your prescriber right away and report the incident to FDA MedWatch.

Fake products can contain the wrong ingredient or the wrong amount of drug, be contaminated by poor manufacturing practices, and come with vague or misleading labels that make safe dosing impossible. Multi‑use vials that require you to self‑measure doses are especially risky and have led to overdoses and hospitalizations. If anything about the product, packaging, or seller feels off, do not inject it—contact a licensed pharmacist or your prescriber right away and report the incident to FDA MedWatch

Fake products can contain the wrong ingredient or the wrong amount of drug, be contaminated by poor manufacturing practices, and come with vague or misleading labels that make safe dosing impossible. Multi‑use vials that require you to self‑measure doses are especially risky and have led to overdoses and hospitalizations. If anything about the product, packaging, or seller feels off, do not inject it—contact a licensed pharmacist or your prescriber right away and report the incident to FDA MedWatch

Fake products can contain the wrong ingredient or the wrong amount of drug, be contaminated by poor manufacturing practices, and come with vague or misleading labels that make safe dosing impossible. Multi‑use vials that require you to self‑measure doses are especially risky and have led to overdoses and hospitalizations. If anything about the product, packaging, or seller feels off, do not inject it—contact a licensed pharmacist or your prescriber right away and report the incident to FDA MedWatch

Goal:

Expand Medicare to cover FDA-approved anti-obesity medications and allow more providers (NPs, PAs, RDNs, etc.) to deliver intensive behavioral therapy (IBT).

2013 (113th Congress):

First introduced — H.R. 2415 / S. 1184

2015 (114th):

Reintroduced — H.R. 2404 / S. 1509

2017 (115th):

Reintroduced — H.R. 1953 / S. 830

2019 (116th):

Reintroduced — H.R. 1530 / S. 595

2021 (117th):

Reintroduced — H.R. 1577 / S. 596

2023 (118th):

Reintroduced — H.R. 4818

2025 (119th, current):

Reintroduced — S. 1973 (June 5) and H.R. 4231 (June 27), with bipartisan support

Impact if passed:

Medicare patients could finally access GLP-1s and other obesity drugs through Part D.

Broader provider base could deliver behavioral therapy for weight management.

What This Means Now

Limits on Compounded GLP-1s

Compounded GLP‑1s may only be prepared under narrow conditions (e.g., a specific medical need not met by an approved product).

Unverified Imports Pose Risks

Bulk API from unverified foreign suppliers can be detained at the border; products labeled “research use only/not for human use” are not appropriate for patients.

Salt Forms Not Equivalent

Using salt forms (e.g., semaglutide sodium/acetate) is not equivalent to approved drugs and should not be used for compounding.