QUESTIONS & ANSWERS


Questions


  1. What are Medical Foods?
  2. Are there other Medical Foods available?
  3. How are Medical Foods validated?
  4. Do Medical Foods go through clinical trials?
  5. Are Medical Foods safe?
  6. Do Medical Foods interact with synthetic drugs?
  7. How do they work differently than synthetic drugs?
  8. How are they regulated and/or approved by the FDA?
  9. What diseases or symptoms do they treat?
  10. How long have these products been available?
  11. Are Medical Foods bound by the same laws as "traditional" drugs regarding medical claims?
  12. Do Medical Foods reduce the therapeutic dose of traditional medications? Why?
  13. What evidence is there?
  14. Can I carry both Convenience Packs and Medical Foods?
  15. Can a physician prescribe more than one product to a singular patient?
  16. What does reduced dosage refer to? Frequency or milligram dosage?
  17. Can a physician prescribe a Medical Food alone?
  18. Why should a doctor prescribe a Convenience Pack (co-pack) rather than a Medical Food?
  19. What comprises a Convenience Pack?
  20. Who is not a candidate for Medical Foods?
  21. Are there generic equivalents to either Medical Foods or Convenience Packs?
  22. Is dispensing legal and accepted? What states do not allow dispensing?
  23. What is the dispensing process?
  24. Why should a physician office dispense?
  25. Why would a patient prefer dispensing?
  26. How much office time is necessary for a typical dispense?
  27. Can any physician dispense?
  28. What is the licensing process to allow an office to dispense?
  29. How long does it take to get a dispensing license?
  30. How is the HMA dispensing program different from other dispensing companies, e.g., RX Solutions, etc.?
  31. Do other companies have the same products and programs as HMA?
  32. How much time transpires between the doctor's agreement to participate and the first dispense?
  33. Can a physician write a prescription to be filled at the pharmacy?


Answers


  1. What are Medical Foods?

  2. Medical Foods are FDA regulated products that meet the distinctive nutritional requirements and/or metabolic deficiencies of a particular disease state. The featured Medical Foods utilize Targeted Cellular Technology to deliver specific doses of amino acids, the precursors to some neurotransmitters.


  3. Are there other Medical Foods available?

  4. There are numerous Medical Foods marketed by other companies, but most companies only make a singular product for a specific disease state. The following is a partial list of other Medical Foods made by other companies: Nepro (Abbott), Tolerex (Novartis), Deplin (Pamlabs), Fosteum (Primus), Cerofolin (Pan American Labs), and Limbrel (Amgen).


  5. How are Medical Foods validated?

  6. Validation is supported by extensive peer reviewed literature subsequent to completion of double blind placebo controlled trials, crossover clinical studies and physiological endpoint studies.


  7. Do Medical Foods go through clinical trials?

  8. Yes
    Physiological? yes
    Peer review or pooled data? yes
    Double blind? yes
    Clinical trials? yes


  9. Are Medical Foods safe?

  10. Yes. All ingredients in Medical Foods are GRAS (generally recognized as safe) listed by the FDA.


  11. Do Medical Foods interact with synthetic drugs?

  12. Not in an adverse way. They facilitate the applicable dose titration to a therapeutic regime that has been shown to allow a reduced drug dosage of approximately 50% - 90%, while maintaining efficacy and decreasing the side profile over a period of time.


  13. How do they work differently than synthetic drugs?

  14. They address each patient's underlying metabolic requirements, while managing the scientific nutritional requirements associated with the particular disease state. Synthetic drugs treat the symptoms of the disease state e.g., pain, etc.


  15. How are they regulated and/or approved by the FDA?

  16. They are in a special category called "Medical Foods", which addresses the dietary management of certain disease states. The FDA conducts on-site inspections of production facilities, reviews all labeling, and performs an analysis of all ingredients and substantiates all claims. They further require that all ingredients in Medical Foods are GRAS (generally recognized as safe) listed.


  17. What diseases or symptoms do they treat?

  18. Pain and inflammation related to joint disorders
    Pulmonary hypertension and asthma
    Fatigue and cognitive disorders
    Metabolic syndrome & obesity
    Sleep disorders due to anxiety
    Pain and Inflammation
    Mild Hypertension
    Viral Infections
    Sleep disorders due to depression


  19. How long have these products been available?

  20. The company has been in existence for over 10 years. The products have been available to physicians for 8 years.No, they do not require pre-approval from the FDA for marketing, unlike pharmaceutical drug products, but disease claims for Medical Foods must be supported by sound scientific evidence, including clinical investigations to substantiate claims of successful nutritional management of a disease.


  21. Are Medical Foods bound by the same laws as "traditional" drugs regarding medical claims?

  22. No, they do not require pre-approval from the FDA for marketing, unlike pharmaceutical drug products, but disease claims for Medical Foods must be supported by sound scientific evidence, including clinical investigations to substantiate claims of successful nutritional management of a disease.


  23. Do Medical Foods reduce the therapeutic dose of traditional medications? Why?

  24. Yes. Because these Medical Foods increase the production of neurotransmitters whose depletion levels are directly related to the disease state. When these levels are improved, the cellular health and metabolic requirements are restored and the lowest therapeutic level of a synthetic drug can be effective if needed at all


  25. What evidence is there?

  26. Clinical studies, product monographs, and clinical trials


  27. Can I carry both Convenience Packs and Medical Foods?

  28. Yes


  29. Can a physician prescribe more than one product to a singular patient?

  30. Yes


  31. What does reduced dosage refer to? Frequency or milligram dosage?

  32. Both depending on the medication and treatment. In some medications, it reduces the milligram dosage (e.g., sleep medication and anxiety and depression medication. For pain medication it reduces the frequency of the standard dosage. e.g., Vicodin 5 may be taken twice daily instead of 4 times daily (or once every 4-6 hours.)


  33. Can a physician prescribe a Medical Food alone?

  34. Yes


  35. Why should a doctor prescribe a Convenience Pack (co-pack) rather than a Medical Food?

  36. For the convenience of pairing 2 products. This provides 2 therapies to the patient and allows the patient to receive a Medical Food and a generic drug that each have an indication for the treatment of a specific disease.


  37. What comprises a Convenience Pack?

  38. A generic drug and an appropriate Medical Food address the patient's underlying metabolic requirement associated with a particular disease state. Two products; one generic drug and one Medical Food in addition to product inserts for both medications. Each convenience pack and Medical Food have NDC codes.


  39. Who is not a candidate for Medical Foods?

  40. Patients that are taking MAO inhibitors are not candidates for Apptrim.


  41. Are there generic equivalents to either Medical Foods or Convenience Packs?

  42. There are no generic equivalents to these Medical Foods and Convenience Packs because of the patented technology.


  43. Is dispensing legal and accepted? What states do not allow dispensing?

  44. Yes dispensing is legal and accepted in most states.

    A few specific states have restrictions various on physicians. Some examples are as follows: New York allows only a 72 hours dispense by a physician. New Jersey allows only a 72 hour dispense and the physician cannot charge more than the original invoice cost of the medication. Washington does not allow for physician dispensing to Workers' Compensation patients. Wyoming does not allow for physician dispensing if a pharmacy is within 10 miles. Texas does not allow for physician dispensing if a pharmacy is within 10 miles. Louisiana does not allow for physician dispensing of any class 2 and/or 3 drugs. Ohio does not reimburse physicians who dispense medications to Workers Compensation patients.

    While most remaining states are considered viable, not all states have been vetted at this time, but will be evaluated on a case-by-case basis.


  45. What is the dispensing process?

  46. The physician checks the item to be dispensed on a pre-printed prescription form. A member of the office staff scans the product into the PDX system (inventory management system). It prints out the necessary labels and instructions. Both product and instructions are given to the patient. A patient will then sign for the drug, much like a pharmacy.


  47. Why should a physician office dispense?

  48. To increase patient compliance.
    To decrease pharmacy error rates
    To add to the patient's convenience
    To improve and enhance the practice revenue


  49. Why would a patient prefer dispensing?

  50. Convenience


  51. How much office time is necessary for a typical dispense?

  52. 1-3 minutes


  53. Can any physician dispense?

  54. Dispensing may be done by an MD, Physician's Assistant or Registered Nurse Practitioner (laws vary from state to state).


  55. What is the licensing process to allow an office to dispense?

  56. Acquisition of an NPDS number (non pharmacy dispensing site number).


  57. How long does it take to get a dispensing license?

  58. The contracts department facilitates the process of applying on behalf of the physician. The process takes a few days.


  59. How is the HMA dispensing program different from other dispensing companies, e.g., RX Solutions, etc.?

  60. These Medical Foods and convenience packs are branded and therefore have a substantially higher AWP (average wholesale price), which is billed to the insurance company. Other dispensing companies offer only generic drugs and their reimbursement profiles with Medicare Part D and private insurance carriers are relatively small; between $4 - $10 per dispense is allocated to the physician. This program offers the physician a revenue stream of approximately $40 -$60 per Medical Food or convenience pack (depending on the item).


  61. Do other companies have the same products and programs as HMA?

  62. No


  63. How much time transpires between the doctor's agreement to participate and the first dispense?

  64. Approximately 4 weeks in most cases. This process entails the processing of the physician's contracts, the application for the NPDS number, the submission and/or registration for the pharmacy contracts (with various insurance companies and PBM's), the initial installation of the PDX system (inventory management system) and the delivery of the product inventory.


  65. Can a physician write a prescription to be filled at the pharmacy?

  66. Only for any generic or branded drug, but not for the Convenience Pack or Medical Food.