Effective Date:
a) This policy will apply to all services performed on or after the above revision date which will become the new effective date.
b) For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.
Determinations of medical necessity are based upon published criteria. In the absence of published criteria, a determination about whether a medication, treatment or test is experimental or investigational will be based on published medical literature. QCA Health Plan policies are reviewed, and approved by the Medical Advisory Committee.
· Provides for the diagnosis or treatment of the enrollee’s covered medical condition;
· Is consistent with and necessary for the diagnosis, treatment or avoidance of the enrollee’s illness, injury or medical condition (e.g. evidence must show that the service or intervention will make a difference in outcome for the enrollee; if there is no evidence that a service or intervention will improve (or prevent worsening of) an enrollee’s condition, then, by definition, the service or intervention is not medically necessary);
· Is appropriate with regard to standards of good and generally accepted medical practice, as reflected by scientific and peer-reviewed medical literature or credible specialty society guidelines that have met the IOM (Institute of Medicine) and American Medical Association (AMA) standards to avoid conflicts of interest;
· Is not primarily for the convenience of the enrollee, his or her family, his or her physician, or other provider; and
Is the most cost-effective level of service or supply that is appropriate for the enrollee’s condition;
“Experimental or Investigational procedures” shall include therapies or surgeries that are not generally accepted, as reflected by national scientific and peer-reviewed medical literature. Any procedure or treatment which has no outcome advantage over alternative treatments but which is substantially more expensive may also be considered investigational while studies are in progress to determine if there are any subpopulations of the affected group in which there may be treatment advantages. Any therapy subject to government agency approval must have received final approval before it can be considered other than experimental or investigational.
In order to provide consistent, quality care to members, QCA Health Plan utilizes established decision-making criteria when reviewing requests for determination of benefit coverage. The following resources may be utilized:
The federal office which regulates HMOs, the Office of Prepaid Health Care (OPHC) uses the term experimental to define any treatment, procedure, facility, equipment, drug, drug usage, or device or supply that:
QCA Health Plan will not cover procedures or services, including transplants that, in our sole judgment, are experimental or investigative in nature; nor will we pay for equipment or supplies related to experimental procedures.
A Hayes rating of “A” or “B” implies an acceptable role for the issue in question. A Hayes rating of less than “B” requires review by the Medical Director.
Requests from prescribing providers for services which have an existing coverage policy or contract description may be reviewed by the nurse. Requests for which the clinical information is insufficient for the nurse to make a determination will be forwarded to the Medical Director for review.
Requests from prescribing providers for benefit coverage for procedures, treatments, or therapies for which there is not an established criteria, guideline, or policy which may be experimental or investigational in nature requires review by the Medical Director.
The Medical Director will need the following information in order to complete review of these requests:
Drugs:
1. Finalized FDA approval of the requested medication for the proposed use. If there is no FDA approval, then at least two (2) of the drug
Compendia indicate it is appropriate for the proposed use. It is the responsibility of the requesting physician to provide the compendia documentation.
2. Review of existing Hayes criteria
3. Review of the literature: At least two peer reviewed articles for which the manufacturer was not the sponsor and/or employees of the manufacturer were not major authors. It is the responsibility of the requesting physician to provide the literature to support his/her claim.
4. Review of current NCCN recommendation of 1 or 2A.
5. Review of existing coverage policies of other major carriers.
Devices:
1. Finalized FDA approval of the results of the use of the device. (FDA approval for marketing the device will not be considered as meaningful for approval of the request.)
2. Review of existing Hayes criteria.
3. Review of the literature: There should be at least two peer reviewed
articles for which the manufacturer was not the sponsor and/or
employees of the manufacturer were not major authors. It is the responsibility of the requesting physician to provide the literature to support his/her claim.
4. Review of existing coverage policies of other major carriers.
Surgical Procedures:
1. Review of existing Hayes criteria.
2. Review of the literature: At least two (2) peer reviewed articles reflecting studies done in centers other than the one in which the procedure was developed, and/or the originator of the procedure is not an author. It is the responsibility of the requesting physician to provide the literature to support his/her claim.
3. Review of existing coverage policies of other major carriers.
1. Skinner D. Defining Medical Necessity under the Patient Protection and Affordable Care Act. Public Administration Review, Volume 73, Supplement 1, 1 September 2013, pp. S49-S59(11)
2. Rosenbaum S, Kamoie B, et al. Medical Necessity in Private Health Plans, Implications for Behavioral Health Care. US Dept. of Health and Human Services Special Report, Jan. 2003.
3. Center for Health Policy Stanford University. State-by State Compendium of Medical Necessity Regulation, Survey of State Managed Care Regulators. Nov. 2001.
4. IHI Triple Aim Initiative. http://www.ihi.org/engage/initiatives/TripleAim/Pages/default.aspx
5. American Medical Association. Ethical considerations in the development of clinical practice guidelines H-410.953 https://searchpf.ama-assn.org/SearchML/searchDetails.action?uri=%2FAMADoc%2FHOD.xml-0-3636.xml
6. Institute of Medicine. Clinical Practice Guidelines We Can Trust. The National Academies Press, Washington, DC 2011 http://nap.edu/13058
7. Choudry NK, Stelfox HT and Detsky AS. Relationships between Authors of Clinical Practice Guidelines and the Pharmaceutical Industry. JAMA. 2002; 207(5):612-617
8. Jefferson AA and Pearson SD. Conflict of Interest in Seminal Hepatitis C Virus and Cholesterol Management Guidelines. JAMA Intern Med. 2017; 177(3):352-357.
9. Brand DA, Newcomer LN, Freiburger A and Tian H. Cardiologists’ Practice Compared With Practice Guidelines: Use of Beta-Blockade After Acute Myocardial Infarction. JACC. 1995; 26(6):1432-6.
10. Eaglstein WH. Evidence-Based Medicine, the Research-Practice Gap, and Biases in Medical and Surgical Decision Making in Dermatology. Arch Dermatol. 2010; 146(10):1161-1164.
11. Hunt LM, Kreiner M and Brody H. The Changing Face of Chronic Illness Management in Primary Care: A Qualitative Study of Underlying Influences and Unintended Outcomes. Ann Fam Med. 2012; 10(5):452-460.
12. Mendelson D and Carino TV. Evidence-Based Medicine in the United States—De Riguer or Dream Deferred? Health Affairs. 2005; 24(1):133-136.
13. Sox, Harold C. Conflict of interest in Practice Guideline Panels. JAMA. 2017; 317(17):1739-1740.
14. Tringale KR et al. Types and Distribution of Payments from Industry to Physicians in 2015. JAMA. 2017; 317(17):1774-1784.
15. Morris ZS, Wooding S and Grant J. The answer is 17 years, what is the question: understanding time lags in translational research. J R Soc Med 2011; 104:510-520.
1. Effective 07/01/2017: Added background, references, and clarification in medical necessity definition regarding conflicts of interest and interventions that will not make a difference in outcomes for enrollees.