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MEDICAL FOODS AND NUTRICEUTICALS: A NATIONAL CARE DILEMMA Medical Foods Expert Workgroup of the Committee’s Subcommittee on Follow-up and Treatment Susan.

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Presentation on theme: "MEDICAL FOODS AND NUTRICEUTICALS: A NATIONAL CARE DILEMMA Medical Foods Expert Workgroup of the Committee’s Subcommittee on Follow-up and Treatment Susan."— Presentation transcript:

1 MEDICAL FOODS AND NUTRICEUTICALS: A NATIONAL CARE DILEMMA Medical Foods Expert Workgroup of the Committee’s Subcommittee on Follow-up and Treatment Susan A. Berry, MD

2 Why did we do this?

3 FDA Definition: Medical Food "a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation."

4 What are the treatments?  Medical foods  Specially compounded formulas that supply a substantial portion of nutrition for the treatment of inborn errors of metabolism  “Nutriceuticals”  Pharmacologic doses of cofactors or vitamins  Amino acids provided to give substrate or prevent specific amino acid deficiency  Other vitamin-like drugs that may provide benefit, e.g. carnitine  MCT oil  Both classes of agents require physician supervision  Both are required therapies for treatment of inborn errors of metabolism Also at issue: Specially manufactured low protein foods

5 What is the problem?  Medical foods (etc) are NOT drugs, they are materials of nutritional value  Medical foods are substantially more expensive than traditional foods  Everyone needs food, yet traditional foods are harmful to persons with inborn errors of metabolism  They are not optional, they ARE the treatment  Because they are foods, they are EXCLUDED from coverage by many insurers  Costs may be prohibitive; coverage is at best variable Affected persons cannot survive without them but cannot afford to buy them

6 What are (some of) the barriers?  Each insurer has its own practices  Private insurers  Public practices vary state to state  Each policy, even with the same company, may have differing coverage  Each state has different rules / laws covering provision of medical foods (see for list of laws)http://www.ncsl.org/programs/health/lawsfoodsformula.htm  Even when laws exist they don’t cover all insurance carriers  Even when laws/guidelines exist they are subject to interpretation by insurers and the states

7 How I got started on this: Minnesota (pretty average) 2007 Minnesota Statutes 62A.26  COVERAGE FOR PHENYLKETONURIA TREATMENT.  Subd. 2. Required coverage. Every policy, plan, certificate, or contract referred to in subdivision 1 issued or renewed after August 1, 1985, must provide coverage for special dietary treatment for phenylketonuria when recommended by a physician. History: 1985 c 49 s 41; 1Sp1985 c 9 art 2 s 1; 1992 c 564 art 1 s 54  For MN: note law is specific to PKU

8 Nutraceutical prescriptions: denied…  Reviewed denials of health insurance claims for reimbursement of metabolic medications in my MN clinic (01/01/04-08/05/05)  78 pharmacotherapeutic agents initially denied  All denials appealed by metabolic center  19 additional re-appeals submitted by metabolic center Total appeals/re-appeals: 97 Final outcomes: 50 requests for coverage had appeals ultimately approved 11 requests for coverage had appeals ultimately denied 17 requests for coverage had unknown final outcome

9 Medical food prescriptions: also denied! Medical Food Denials (01/01/04-08/05/05)  Most requests handled by dietician, reviewed only if denied on initial submission  17 appeals by metabolic center after initial denial  4 required re-appeals by metabolic center Final outcome:  9 ultimately approved  2 denied  6 unknown status

10 Lessons Learned?  Many nutraceuticals and medical foods ultimately covered by insurance BUT many paid only after repeated appeals  Responses not uniform, each takes its own strategy with varying success  In the meantime…  Some went without treatments  Some changed private insurer or obtained Medicaid  Some found charity groups who graciously paid for a month of formula or medicine while we continued to appeal  Each year the process starts over (coverage granted for 12 month time periods) Is there another way?

11 Medical Foods Expert Workgroup  Workgroup of the Follow-up and Treatment Subcommittee  Ensure that families of children with inborn errors of metabolism have coverage for medically necessary treatments INCLUDING medical foods

12 Medical Foods Expert Workgroup  Susan A. Berry, Workgroup Chair  Coleen Boyle, Committee Member  James J. Figge, Consultant  Carol Greene  Jennifer N. Kraszewski  Jill Levy-Fisch  Mary Kay Kenny  Michele Lloyd-Puryear  Rani H. Singh  Jill F. Shuger  Regional Collaborative investigators for survey implementation  Region 2 NYMAC: Katharine B. Harris  Region 3 Southeast: Rani H. Singh  Region 4: Cynthia A. Cameron

13 Defining the scope of the problem  Find out what families are experiencing  Examine mandates and regulations governing public and private coverage

14 Defining the scope of the problem  Find out what families are experiencing  A family survey regarding coverage for medical foods, nutriceuticals, and feeding supplies  Examine mandates and regulations governing public and private coverage

15 Medical Foods Survey Information sought  Demographics: age, disorder, state  Type of coverage  Financial burdens incurred  Success (or not) in coverage for  Medical foods (formulas)  Low protein foods  Nutriceuticals  Feeding supplies (G-tubes, equipment, etc.)  Room for free text comments

16 Survey Work Plan  Phase 1 – Initial survey development  Workgroup met by phone/  Cognitive testing with two parent focus groups  Phase 2 – Pilot testing  Qualitative testing to determine response patterns  Done in 3 Regions small sample children and young adults  Tests also feasibility (IRB, procedures)  Phase 3 – Full survey implementation

17 Phase 2 - Accomplishments  Region 2 NYMAC – 8 surveys submitted  Region 3 Southeast – 15 surveys submitted  Region 4 – 21 surveys submitted Surveys analyzed for utility of format and questions

18 Phase 2 – pilot testing  Issues and Solutions:  “Type of insurance” – distinguish between State subsidized private insurance vs. unsubsidized private insurance  Re-format – condense, collapse and reorganize to simplify recording of responses and distinction between Medical Foods and Dietary Supplements  Provide for genetic center staff review of completed surveys to verify patient information  Re-pilot in a small sample from two geographic areas

19 What next?  Assess issues encountered in survey use, revise for full implementation  Present Roundtable at APHL  Phase 3: Full implementation of survey  Goal: Spring 2009  200 surveys per Region Use the information derived to  Develop manuscript  Identify potential actions

20 Phase 3 – Survey Implementation Region 2 NYMAC Collaborative (expressed interest)  AI duPont Children's Hospital  Albany Medical Center  Children's Hospital of Pittsburgh  Mount Sinai Medical Center  SUNY at Stony Brook  University of Maryland  University of Virginia  University of Rochester  Westchester Medical Center Region 3 Southeast Collaborative (centers confirmed)  Emory University  Tulane University  University of Florida  University of South Carolina  University of Tennessee Region 4 Great Lakes Collaborative (centers confirmed)  University of Cincinnati  University of Minnesota

21 Defining the scope of the problem  Find out what families are experiencing  A family survey regarding coverage for medical foods, nutriceuticals, and feeding supplies  Examine mandates and regulations governing public and private coverage

22 Meeting on Reimbursement Issues for Medical Foods Meeting on Reimbursement Issues for Medical Foods June 2, 2008  Purpose:  examine barriers to reimbursement  develop recommendations for Advisory Committee actions  Invitees:  Medical Foods Workgroup  Representatives: Private insurance Industry U.S. Dept of Labor/IRS (employer-based health plans) CMS – State and Federal

23 Medicaid Possible Actions to Impact Financing of Medical Foods: Medicaid  Federal: broaden Federal statute to cover medical foods  State: Develop a model state policy for medical food

24 Private Insurers Possible Actions to Impact Financing of Medical Foods Private Insurers  Develop a model state insurance law to minimize variation from state to state  Work with AMA Editorial Board to develop reimbursement codes (CPT) that facilitate billing  Work with insurers to recognize and reimburse for appropriate CPT codes  Work with insurers to improve knowledge-base of staff re: medical foods issues

25 Other Possible Actions to Impact Financing of Medical Foods Other  Explore options to influence employer-based health plans including federal mandate under ERISA (exempt from state statutes – 60% of those with private insurance)  Seek advice from FDA about updating the definition of medical foods

26 Defining the scope of the problem  Find out what families are experiencing  A family survey regarding coverage for medical foods, nutriceuticals, and feeding supplies  Examine mandates and regulations governing public and private coverage  Workgroup meeting June 2008  Document mandates and regulations in place in each state


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