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.

Definitions:

“Medically Necessary” means: A covered service which meets all the following criteria:

·         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:

• Local coverage and benefit interpretation policies
• Member contracts
• MCG (formerly Milliman) Guidelines
• Hayes Criteria
• Coverage policies established by other major carriers
• CMS Coverage Policies
• Credible guidelines or protocols established by recognized authorities/professional organizations. (i.e.; American College of Cardiology, American College of Obstetrics and Gynecology, the Center for Disease Control, American Diabetes Association, American Heart Association, etc.)—assuming the Institute of Medicine (IOM) and American Medical Association (AMA) standards to avoid conflicts of interest are met
• FDA approvals and guidelines
• National Comprehensive Cancer Network guidelines
• Evidence-based literature review
• Manufacturer recommended uses and guidelines

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:

• Is not recognized as an accepted medical practice for other than research purposes; or
• Requires federal or other governmental agency approval for marketing to the general public; or
• Is not proven to be safe and/or effective.

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. 

CM 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. 

Prior authorization/medical necessity requests are not accepted from vendors because the information submitted by vendors is insufficient to accurately determine medical necessity. 

The concept of medical necessity is one that is widely debated and continually evolving—just as medical knowledge evolves. While an advocacy group for a particular condition may argue a particular test or treatment is always medically necessary, the available research may not support that perspective.  While widely accepted medical practices suggest an intervention is medically necessary, this may be more based on tradition than on scientific evidence. The Choosing Wisely Campaign is an excellent case in point (www.choosingwisely.org ), The ABIM Foundation is a national leader in advancing dialogue regarding wasteful or unnecessary medical tests, treatments, and procedures.

An example of a common medical practice that is not supported by medical research is the administration of Vitamin B12 shots for fatigue in patients without B12 deficiency.  While there may be a placebo response, this response is typically transient and no greater than giving an inert saline injection.  On the other hand, giving B12 when there is a known B12 deficiency or there is B12 wasting or malabsorption would be considered medically necessary—it depends on the diagnosis.

One of the most widely incorporated concepts in definitions of medical necessity is the idea of services that are consistent with generally accepted medical practices. Generally accepted medical practices are a moving target and they are often out of synch with what the research shows.  This research-practice gap is widely recognized with multiple studies estimating a 17 year lag for research findings to be widely adopted in clinical practice.  One of the major challenges contributing to this research-practice gap is the rapid pace of advancement of medical knowledge.  In 2016 alone, there were over 1.2 new million research papers indexed in PubMed (Medline).  That’s over 3,400 studies per day!  It’s impossible for clinicians to stay current with all the latest research findings without subscribing to a service that helps manage the exponentially growing information overload. 

Another strategy for managing medical information overload is to rely on practice guidelines developed by specialty societies after extensive review and discussion of the available research literature by committees comprised of experts in their fields.    Recognizing this as an opportunity to drive increased sales, pharmaceutical companies have taken advantage of the increasing reliance on practice guidelines to influence members of the committees drafting guidelines.  This pervasive practice has been noted in several countries as a strategy to drive increased pharmaceutical utilization. Some countries have passed legislation to prevent this type of undue influence on medical practices.  The USA has not passed legislation to prevent this but in 2011 the Institute of Medicine (IOM) published specific standards that should be followed by committees drafting guidelines in order to avoid undue conflicts of interest. The American Medical Association (AMA) also has a formal policy to avoid conflicts of interest in the development of medical guidelines.  Despite this, there are documented instances of current specialty society guidelines developed in violation of the IOM and AMA standards for avoiding conflicts of interest.   The credibility of these guidelines makes them of questionable value in determining medical necessity. 

Since the definition of medical necessity may vary widely depending on one’s perspective, it’s not surprising there is no standard, universally accepted definition of medical necessity.  In order to be relevant and widely applicable, a good definition of medical necessity must take into account the social and political context of the times and the perspectives of the affected stakeholders.  In the current era of value-based care, there is an increased emphasis on improving health outcomes while simultaneously reducing per capita costs.  In this value-based approach, the evidence of efficacy (improved outcomes in the numerator) is counterbalanced by the resources required to achieve the outcomes (in the denominator).  It’s not efficacy vs. costs, one vs. the other—it’s both.

Interventions (tests, medicines, therapies, procedures) that have no favorable impact on outcomes decrease value because they only add costs to the denominator without adding anything to the numerator. By definition, any intervention that doesn’t impact outcomes is not medically necessary. If interventions A and B have a comparable impact on outcomes but A costs ten times as much, then intervention B obviously provides better value. Going from the more abstract and conceptual to a real world application, if a brand drug is available and a generic version of the same medication is also available (at a fraction of the cost), the generic version clearly provides better value.  In this very practical scenario it’s easy to see the brand drug in not medically necessary.  When there are equally effective interventions, the more cost-effective interventions are preferred and the less cost-effective options cannot be considered medically necessary unless the more cost-effective interventions are contraindicated, have failed or have not been tolerated. 

Broadly defining medical necessity at a population health level and then applying that definition at an individual level is quite a balancing act.  It requires balancing what the continually evolving scientific research supports, what the provider prescribes, what credible guidelines recommend, what the patient wants, what advocacy groups demand, what direct to consumer ads from drug manufacturers promote and what legislators require to determine what is actually medically necessary for an enrollee.  This is not for the faint of heart!

Obviously, no definition of medical necessity will make everyone happy.  This will be an ongoing source of controversy and debate.  However, despite all the different perspectives, there seems to be unanimous support for the “triple aim” (improved health outcomes, lower per capita costs and improved patient experience) that has been promoted by the Institute for Healthcare Improvement since 2007.  With this as a shared goal, different stakeholders have the opportunity to collaborate to ensure patients get what they need in the most cost-effective manner.

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.

Addendum:

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.