Coverage policy: Primary coverage criteria

The Primary Coverage Criteria apply to all benefits a member may claim under a health plan or policy, no matter what types of health intervention may be involved or when or where the intervention is obtained. Health Intervention or Intervention means an item or service delivered or undertaken primarily to:

• Diagnose, detect, treat, palliate or alleviate a medical condition; or
• Maintain or restore functional ability of the mind or body.

Purpose and Effect of Primary Coverage Criteria

The Primary Coverage Criteria are designed to allow Plan benefits for only those health interventions that are proven as safe and effective treatment. Members will receive an Explanation of Benefits (EOB), and Providers will receive an Explanation of Payment (EOP) with claims processing remarks that indicate that a claim was not eligible for benefits since the Primary Coverage Criteria was not met.

Another goal of the Primary Coverage Criteria is to provide benefits only for the less invasive or less risky intervention when such intervention would safely and effectively treat the medical condition or to provide benefits for treatment in an outpatient, doctor's office or home-care setting when such treatment would be a safe and effective alternative to hospitalization. Examples of the types of health interventions that the Primary Coverage Criteria exclude from coverage include such things as the cost of a hospitalization for a minor cold or some other condition that could be treated outside the hospital or the cost of some investigational drug or treatment, such as herbal therapy or some forms of high-dose chemotherapy not shown to have any beneficial or curative effect on a particular cancerous condition.

Finally, the Primary Coverage Criteria require that if there are two or more effective alternative health interventions, the member's health plan or policy should limit its payment to the Allowable Charge for the most cost-effective intervention.

Regardless of anything else in a member's health plan or policy, and regardless of any other communications or materials received in connection with a member's health plan or policy, the member will not have coverage for any service, prescription drug, treatment, procedure, equipment, supplies or associated costs unless the Primary Coverage Criteria set forth are met. At the same time, just because the Primary Coverage Criteria are met does not necessarily mean the treatment or services will be covered under a member's health plan or policy. For example, a health intervention that meets the Primary Coverage Criteria will be excluded if the condition being treated is a Pre-Existing Condition excluded by the member's health plan or policy.

Elements of the Primary Coverage Criteria

To be covered, medical services, drugs, treatments, procedures, tests, equipment or supplies (interventions) must be recommended by the member's treating physician and meet all of the following requirements:

1. The intervention must be a health intervention intended to treat a medical condition. A health intervention is an item or service delivered or undertaken primarily to diagnose, detect, treat, palliate or alleviate a medical condition or to maintain or restore functional ability of the mind or body. A medical condition means a disease, illness, injury, pregnancy or a biological or psychological condition.
   
   
2. The intervention must be proven to be effective (as defined below) in treating, diagnosing, detecting or palliating a medical condition.
   
   
3. The intervention must be the most appropriate supply or level of service, considering potential benefits and harms to the patient. The following three examples illustrate application of this standard (but are not intended to limit the scope of the standard):
   
   
   1. An intervention is not appropriate, for purposes of the Primary Coverage Criteria, if it would expose the patient to more invasive procedures or greater risks when less invasive procedures or less risky interventions would be safe and effective to diagnose, detect, treat or palliate a medical condition;
      
      
   2. An intervention is not appropriate, under the Primary Coverage Criteria, if it involves hospitalization or other intensive treatment settings when the intervention could be administered safely and effectively in an outpatient or other less intensive setting, such as the home; and
      
      
   3. Maintenance Therapy is another example of this standard because under the Primary Coverage Criteria, chiropractor services or other physical therapy, speech or occupational therapy, are not considered appropriate for purposes of coverage if the frequency or duration of therapy reaches a point of maintenance where the patient remains at the same functional level and further therapy would not improve functional capacity or ambulation.
   
   
4. The Primary Coverage Criteria allows the member's health plan or policy to limit its coverage to payment of the Allowable Charge for the most cost-effective intervention . Cost-effective means a health intervention where the benefits and harms relative to the costs represent an economically efficient use of resources for patients with the medical condition being treated through the health intervention. For example, if the benefits and risks to the patient of two alternative interventions are comparably equal, a health intervention costing $1,000 will be more cost-effective than a health intervention costing $10,000. Cost-effective shall not necessarily mean the lowest price.
   

Primary Coverage Criteria Definitions

1. Effective Defined.
   1. An existing intervention (one that is commonly recognized as accepted or standard treatment or which has gained widespread, substantially unchallenged use and acceptance throughout the United States) will be deemed effective for purposes of the Primary Coverage Criteria if the intervention is found to achieve its intended purpose and to cure, alleviate or enable diagnosis or detection of a medical condition without exposing the patient to risks that outweigh the potential benefits. This determination will be based on consideration of the following factors, in descending order of priority and weight:
      
      
      1. Scientific evidence, as defined below (where available); or
         
         
      2. If scientific evidence is not available, expert opinion(s) (whether published or furnished by private letter or report) of an Independent Medical Reviewer(s) with education, training and experience in the relevant medical field or subject area; or
         
         
      3. If scientific evidence is not available, and if expert opinion is either unavailable for some reason or is substantially equally divided, professional standards, as defined and qualified below, may be consulted; or
         
         
      4. If neither scientific evidence, expert opinion nor professional standards show that an existing intervention will achieve its intended purpose to cure, alleviate or enable diagnosis or detection of a medical condition, then Health Advantage in its discretion may find that such existing intervention is not effective and on that basis fails to meet the Primary Coverage Criteria.
      
      
   2. A new intervention (one that is not commonly recognized as accepted or standard treatment or which has not gained widespread, substantially unchallenged use and acceptance throughout the United States) will be deemed effective for purposes of the Primary Coverage Criteria if there is scientific evidence (as defined below) showing that the intervention will achieve its intended purpose and will cure, alleviate or enable diagnosis or detection of a medical condition without exposing the patient to risks that outweigh the potential benefits.
      
      Scientific evidence is deemed to exist to show that a new intervention is not effective if the procedure is the subject of an ongoing phase I, II or III trial or is otherwise under study to determine its maximum tolerated dose, toxicity, safety, efficacy, or its efficacy as compared with a standard means of treatment or diagnosis. If there is a lack of scientific evidence regarding a new intervention, or if the available scientific evidence is in conflict or the subject of continuing debate, the new intervention shall be deemed not effective, and therefore not covered in accordance with the Primary Coverage Criteria, with one exception, if there is a new intervention for which clinical trials have not been conducted because the disease in issue is rare or new or affects only a remote population, then the intervention may be deemed effective if, but only if, it meets the definition of effective as defined above.
   
   
2. Scientific Evidence Defined. Scientific Evidence, for purposes of the Primary Coverage Criteria, shall mean only one or more of the following listed sources of relevant clinical information and evaluation:
   
   
   1. Results of randomized controlled clinical trials as published in the authoritative medical and scientific literature that directly demonstrate a statistically significant positive effect of an intervention on a medical condition. For purposes of this Definition A, authoritative medical and scientific literature shall be such publications as are recognized by Health Advantage, listed in its Coverage Policy or otherwise listed as authoritative medical and scientific literature on the Health Advantage website at www.HealthAdvantage-hmo.com.

   or

   2. Published reports of independent technology or pharmaceutical assessment organizations recognized as authoritative by Health Advantage. For purposes of this Definition B, an independent technology or pharmaceutical assessment organization shall be considered authoritative if it is recognized by Health Advantage, listed in its Coverage Policy, or otherwise listed as authoritative medical and scientific literature on the Health Advantage website at www.HealthAdvantage-hmo.com.
   
   
3. Professional Standards Defined. Professional standards, for purposes of applying the effectiveness standard of the Primary Coverage Criteria to an existing intervention, shall mean only the published clinical standards, published guidelines or published assessments of professional accreditation or certification organizations or of such accredited national professional associations as are recognized by the Health Advantage Medical Director as speaking authoritatively on behalf of the licensed medical professionals participating in or represented by the associations.
   
   Health Advantage shall have full discretion whether to accept or reject the statements of any professional association or professional accreditation or certification organization as professional standards for purposes of this Primary Coverage Criteria. No such statements shall be regarded as eligible to be classified as professional standards under the Primary Coverage Criteria unless such statements specifically address effectiveness of the intervention and conclude with substantial supporting evidence that the intervention is safe, its benefits outweigh potential risks to the patient, and it is more likely than not to achieve its intended purpose and to cure, alleviate or enable diagnosis, or detection of a medical condition.
   

Application and Appeal of Primary Coverage Criteria

1. The following rules apply to any application of the Primary Coverage Criteria. Health Advantage shall have full discretion in applying the Primary Coverage Criteria, and in interpreting any of its terms or phrases, or the manner in which it shall apply to a given intervention. No intervention shall be deemed to meet the Primary Coverage Criteria unless the intervention qualifies under all of the following rules:
   
   
   1. Illegality: An intervention does not meet the Primary Coverage Criteria if it is illegal to administer or receive it under federal laws or regulations or the law or regulations of the state where administered.
      
      
   2. FDA Position: An intervention does not meet the Primary Coverage Criteria if it involves any device or drug that requires approval of the U.S. Food and Drug Administration (FDA), and FDA approval for marketing of the drug or device for a particular medical condition has not been issued prior to the date of service. In addition, an intervention does not meet the Primary Coverage Criteria if the FDA or the U.S. Department of Health and Human Services or any agency or division thereof, through published reports or statements, or through official announcements or press releases issued by authorized spokespersons, have concluded that the intervention or a means or method of administering it is unsafe, unethical or contrary to federal laws or regulations. Neither FDA Pre-Market Approval nor FDA finding of substantial equivalency under 510(k) automatically guarantees coverage of a drug or device.
      
      
   3. Proper License: An intervention does not meet the Primary Coverage Criteria if the health-care professional or facility administering it does not hold the proper license, permit, accreditation or other regulatory approval required under applicable laws or regulations in order to administer the intervention.
      
      
   4. Plan Exclusions, Limitations or Eligibility Standards: Even if an intervention otherwise meets the Primary Coverage Criteria, it is not covered under the member's health plan or policy if the intervention is subject to a Plan exclusion or limitation, or if a member fails to meet eligibility requirements.
      
      
   5. Position Statements of Professional Organizations: Regardless of whether an intervention meets some of the other requirements of the Primary Coverage Criteria, the intervention shall not be covered if any national professional association, any accrediting or certification organization, any widely used medical compendium, or published guidelines of any national or international workgroup of scientific or medical experts have classified such intervention or its means or method of administration as experimental or investigational or as questionable or of unknown benefit. However, an intervention that fails to meet other requirements of the Primary Coverage Criteria shall not be covered, even if any of the foregoing organizations or groups classify the intervention as not experimental or not investigational, or conclude that it is beneficial or no longer subject to question. For purposes of this Definition E, national professional association or accrediting or certifying organization, or national or international workgroup of scientific or medical experts shall be such organizations or groups recognized by Health Advantage, listed in its Coverage Policy, or otherwise listed as authoritative medical and scientific literature on the Health Advantage website at www.HealthAdvantage-hmo.com.
      
      
   6. Coverage Policy: With respect to certain drugs, treatments, services, tests, equipment or supplies, Health Advantage has developed specific Coverage Policies, which have been put into writing, and are published on the website at www.HealthAdvantage-hmo.com. If Health Advantage has developed a specific Coverage Policy that applies to the drug, treatment, service, test, equipment or supply that a member received or seeks to have covered, the Coverage Policy shall be deemed to be determinative in evaluating whether such drug, treatment, service, test, equipment or supply meets the Primary Coverage Criteria; however, the absence of a specific Coverage Policy with respect to any particular drug, treatment, service, test, equipment or supply shall not be construed to mean that such drug, treatment, service, test, equipment or supply meets the Primary Coverage Criteria.
      
   
   
2. Members may appeal a determination by Health Advantage that an intervention does not meet the Primary Coverage Criteria to the Appeals Coordinator using the procedures for appeals outlined in the member's policy or certificate.
   
   

1. The Primary Coverage Criteria must be met.
   
2. The health intervention must conform to specific limitations stated in the member's health plan or policy.
   
3. The health intervention must not be specifically excluded under the terms of the member's health plan or policy.
   
4. At the time of the intervention, the member must meet eligibility standards.
   
5. The member must comply with the applicable provider network and cost-sharing arrangements.
   
6. The member must follow the required procedures for filing claims.