Medical Research and Patient Access Challenges
Coverage and Access Parity by Federal Payers
Patients regularly face difficulty with access to medical foods due to the fact they occupy a unique place within the healthcare system. Despite healthcare providers recommending (or requiring) the use of medical foods as safe and effective part of a treatment regimen, prescription drug plans regularly refuse to cover them, leaving patients to incur the financial burden by paying out-of-pocket. In addition to presenting a tremendous burden for affected individuals and families, this situation often leads to nonadherence and increased healthcare costs when a patient’s health suffers as a result of noncompliance.
To address this troubling dynamic, Congress recently passed the FY 2017 National Defense Authorization Act requiring TRICARE (military healthcare) coverage of medical foods (Sec. 714). While this is certainly a step in the right direction, other federal payers, such as the Veterans Health System and Medicare do not have the same protections. This means many patients still experience barriers through federal programs and private insurance. Patient access needs to be mandated and clarified through all forms of coverage moving forward.
Food and Drug Admiration Can Provide Clarity
In May of 2016, FDA released industry guidance entitled, Frequently Asked Questions About Medical Foods; Second Edition [81 FR 29866]. This document included two sequential clauses:
- FAQ 15, which states that a medical food must be used under physician supervision and explains that medical foods are only available at the direction and ongoing supervision of a physician and as a physician-determined course of medical care.
- FAQ 16, which goes on to state that a medical food may not carry the symbol “Rx only” to indicate that the product may not be dispensed without a prescription.
Interpretation of these FAQs has created confusion and barriers to patient access. Following the release of the FAQ document, some pharmacies interpreted the Rx only prohibition to mean that medicals foods are only available over-the-counter. This will result in inappropriate access to medical foods by patients who are not under physician supervision for the use of medical foods as required by 21 U.S.C. § 360ee(b)(3). Moreover, the lack of clarity has caused some health plans to drop coverage of medical foods citing a belief that they are non-Rx and therefore not essential for medical care. This action places extreme burden patients as they must pay out-of-pocket for a physician-directed treatment option.
Limitations in patient access and eligibility for government reimbursement:
- Currently, only an FDA “approved” drug qualifies for full government insurance reimbursement in Medicare/Medicaid and Tricare, and the only other federal reimbursement mechanism, the Healthcare Common Procedure Coding System (HCPCS), reimburses companies at a rate so low (based upon caloric content) it does not cover the company’s cost of production.
- Insurance programs that treat medical foods as simple over-the-counter products or nutritional supplements thus limiting patient reimbursement for physician-directed therapy.
Legislative and Policy Recommendations
Improve FDA’s consideration of medical foods as an important therapy for patients’ suffering from chronic conditions or diseases:
- Medical food research should be done under IRB oversight as it always has been, but not require an IND filing in order to substantiate the use of these products.
- Medical foods should be recognized as approved products following efficacy and safety based standards that are appropriate for the category. This will require an Act of Congress to give FDA authority to review and approved medical foods for specific intended uses.
Increase patient access:
- It is recommended that Medicare Part D be revised either through legislation or a rules revision, allowing for reimbursement of physician-ordered and medically necessary medical foods and that Medicaid and Tricare coverage include enteral nutrition so that patients do not have burdensome out-of-pocket costs which seriously limit patient access to these necessary products.
Improve research and development pathways at FDA for medical foods/nutrition:
- Withdraw IND filing requirements for medical foods which requires companies to follow a drug-development pathway as this hampers research and costs near $1 billion in research development of new products further increasing healthcare costs to the nation.
Collaboration with Medical Foods Industry and Medical Societies on “best practice” guidelines:
- Work with industry and medical societies to determine best practice guideline for appropriate scientific research and review of products within the medical foods category.
2016 NMFC Legislative Agenda
- Providing the National Institutes of Health with at least $34.5 billion in FY 2017 (a $2.4 billion increase) and supporting NIDDK’s new Office of Nutrition Research as outlined in the Committee Report accompanying the Senate’s FY 2017 Labor-HHS-Education Appropriations Bill.
- Encouraging an active dialogue between FDA and the stakeholder community regarding a distinct regulatory framework for medical foods as recommended in the Committee Report accompanying the Senate’s FY 2017 Agriculture-FDA Appropriations Bill.
Medical Foods.—The Committee urges the FDA to be more active in engaging external stakeholders on best practice standards for medical foods that are based upon the Generally Recognized as Safe [GRAS] status. The Committee requests the FDA work with external stakeholders in forming a framework for a distinct regulatory pathway for medical foods that does not encumber its progress towards approval for patient use.
- Encouraging the adoption of legislative language (sec. 704) of the Senate’s version of the National Defense Authorization Act that requires coverage of medical foods for the treatment of many rare and chronic conditions through TRICARE as the House and Senate negotiate a final measure.