South Country utilizes CMS or DHS coverage criteria, evidence-based standards of care (i.e. InterQual Solution), and South Country Medical policy as medical necessity criteria when reviewing medical necessity for benefit coverage for authorization decisions.
Coverage criteria for Medicare plans:
South Country follows the below CMS coverage guidelines and rules:
- National coverage determinations (NCDs) and/or local coverage determinations and/or articles (LCDs/LCAs)
- Other CMS guidance including, the Medicare Benefit Policy Manuals, Medicare Claims Processing Manuals and MLN Matters publications.
When coverage criteria are not fully established in the above CMS guidelines or applicable Medicare statute, a decision for medical necessity would be based on standard of care for that service/item using South Country’s “general medical necessity” policy.
Coverage criteria for Medicaid plans:
South Country follows the below coverage guidelines:
- Department of Human Services (MHCP) coverage manuals
- InterQual, or other nationally recognized guidelines
- South Country internal medical policies
South Country internal coverage policies:
General Medical Necessity Criteria
Purpose
The General Medical Necessity Criteria may be used by the South Country Health Alliance (SCHA) Medical Director, or designated physician reviewer, when there are no item-specific nor service-specific DHS (in the case of Medicaid only requests), CMS (in the case of Medicare or dual eligible requests), InterQual, nor SCHA Medical Coverage Policy criteria applicable to a given prior authorization or claim appeal request. The SCHA Medical Director and Utilization Management Medical Coverage Policy Committee may develop item-specific or service-specific criteria that may be used for prior authorization or claim appeal request determination.
Definitions
Medical Necessity – Medicaid
"Medically necessary" or "medical necessity" means a health service that is consistent with the recipient's diagnosis or condition AND:
A) is recognized as the prevailing standard or current practice by the provider's peer group; and
B) is rendered in response to a life-threatening condition or pain; or to treat an injury, illness, or infection; or to treat a condition that could result in physical or mental disability; or to care for the mother and child through the maternity period; or to achieve a level of physical or mental function consistent with prevailing community standards for diagnosis or condition; or
C) is a preventive health service under Minnesota Rule part 0355 Subpart 2.
Medical Necessity - Medicare
South Country will make Medicare medical necessity determinations based on all the following:
A) Coverage and benefit criteria as specified at 42 CFR § 422.101(b) and (c). South Country will apply coverage criteria established in applicable Medicare statutes, regulations, NCDs or LCDs. If such coverage criteria are not fully established, South Country will only apply internal coverage criteria if it is created and made publicly accessible as required in 42 CFR § 422.101(b)(6).
B) Whether the provision of items or services is reasonable and necessary under section 1862(a)(1) of the Act.
C) The enrollee's medical history (for example, diagnoses, conditions, functional status), physician recommendations, and clinical notes.
D) Where appropriate, involvement of the organization's medical director as required at 42 CFR 422.562(a)(4).
Experimental or Investigative [from DHS Contract]
Experimental or Investigative Service means a drug, device, medical treatment, diagnostic procedure, technology, or procedure for which reliable evidence does not permit conclusions concerning its safety, effectiveness, or effect on health outcomes. [Minnesota Rules, Parts 4685.0100, subpart 6a and 4685.0700, subpart 4, item F]
Standards
All criteria must be met for the service to be considered medically necessary.
- The services are prescribed by a licensed health care practitioner practicing within the scope of his/her license in the context of his/her treatment of the individual; AND
- The services are safe, effective, and recognized as the prevailing standard or current practice by the provider’s peer group; AND
- The services are not experimental or investigational (see Minnesota Administrative Rules, Part 9505.5005, Subpart 9); AND
- The services are not considered cosmetic. Reference from the DHS Provider manual, “Medicaid or MinnesotaCare does not cover surgery primarily for cosmetic purposes”. Reference from the 2021 DHS contracts: “Cosmetic procedures or treatment are not covered, except that the following services are not considered cosmetic and therefore must be covered: services necessary as the result of injury, illness or disease, or for the treatment or repair of birth anomalies.” AND
- The services are individualized, specific, and consistent with the individual’s signs, symptoms, history, diagnosis or condition; AND
- The health service rendered (consistent with current DHS contracts) is:
- in response to a life-threatening condition or pain; or
- to treat an injury, illness or infection; or
- to treat a condition that could result in physical or mental disability; or
- to care for the mother and unborn child through the maternity period; or
- to achieve a level of physical or mental function consistent with prevailing community standards for diagnosis or condition; or
- a preventive health service defined under Minnesota Rules, Part 0355 Subpart 2.; AND
- The health service must be determined by prevailing community standards or customary practice and usage to be appropriate and effective for the medical needs of the of the patient and represent an effective and appropriate use of program funds; AND
- The services are not primarily for the convenience of the individual, practitioner, caregiver, family, or another party; AND
- The services are not predominantly domiciliary or custodial; AND
- No exclusionary criteria apply to the situation.
Procedure
During the Utilization Management authorization process, the clinical reviewer staff will review established authorization criteria, as defined in “Purpose” above, for possible approval of the medical service as medically necessary. In the circumstance where there are no item-specific or service-specific criteria applicable for authorization of services, or these specific criteria are not met, the authorization request will be sent for secondary medical review by the Medical Director, or designated physician reviewer, for determination based on medical necessity. This secondary review process may include consideration of any relevant, specific clinical factors that may uniquely apply to the request, as well as the medical necessity principles noted above, and other sources, including, but not necessarily limited to, peer reviewed medical literature, UpToDate, Professional Practice Guidelines, clinical judgement, and standards of medical care, but at no time will South Country utilize coverage criteria that does not meet the requirements stated above.
Coverage Criteria for Breast Cancer Screening
Purpose
There is more scientific evidence related to screening for breast cancer, the most common nonskin cancer and second deadliest cancer in women, than for any other cancer.
Breast Imaging may include ultrasound, film or digital mammography, tomosynthesis, breast MRI, scintimammography, molecular breast imaging, breast specific gamma imaging, PET mammography, thermography, or impedance mammography. Not all breast imaging is appropriate for breast cancer screening, rather are utilized in diagnostic assessment when indicated.
Many breast imaging techniques can be utilized to diagnosis members with various symptomatic or elevated risk clinical scenarios. The scope of this policy is focused on guidance for breast cancer screening in asymptomatic average risk individual. The National Cancer Institute posts a Breast Cancer Risk Assessment Tool online based on a statistical model known as the Gail Model that allows health professionals to estimate a woman’s risk of developing invasive breast cancer over the next 5 years and up to age 90 (lifetime risk).
Guideline:
In general, SCHA is adopting coverage of breast cancer screening following the Breast Screening Considerations and Recommendations (BSCR) algorithms in the NCCN Breast Cancer Screening Guidelines.
Women aged 40 years and over
Coverage/Limitations:
- Annual screening mammography
- Tomosynthesis is covered with any covered mammogram
Women aged less than 40 years
- Refer to NCCN Guidelines
- Tomosynthesis is covered with any covered mammogram
References
Last literature review: April 2024
NIH: National Cancer Institute
- Breast Cancer Risk Assessment Tool
https://bcrisktool.cancer.gov/
Professional Organization Guidelines:
- NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Breast Cancer Screening and Diagnosis Version 1.2024 — March 29, 2024
https://www.nccn.org/professionals/physician_gls/pdf/breast-screening.pdf
CMS National Coverage Determination (NCD) 220.4 Mammograms
This policy may be used to authorize services in a way less restrictive than CMS National Coverage Determination (NCD) 220.4, but shall not be used in any way more restrictive than CMS National Coverage Determination (NCD) 220.4.
Coverage Criteria for Medicare Part B Medical Pharmacy Drug Continuation Therapy Authorizations
Purpose
Authorization of retail pharmacy and Medicaid medical pharmacy drug authorization benefits are managed by the contracted pharmacy benefit manager, PerformRx. For dual eligible members, providers may request authorization for pharmaceuticals under the Medicare Part B medical benefit, referred to as medical pharmacy authorization. To facilitate efficient authorization by the utilization management team, authorization will be allowed for the continuation of Medicare medical pharmacy benefit if the request meets the general criteria outlined in this policy.
FDA approved criteria for each prescription drug are summarized on each drug’s published prescribing information, referred to as the drug label or package insert. Information on the Package insert is consistently formatted with any black box warning, recent major changes, indications and usage, dosage and administration, dosage forms and strengths, contraindications, warning and precautions, adverse reactions, and drug interactions. Additionally, full prescribing information also includes use in specific populations, drug abuse and dependence, overdosage, description, clinical pharmacology, nonclinical toxicology, clinical studies, how supplied/stored and handled, and patient counseling information. The drug label information is available for many drugs on the FDA website: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm (select drug, then select package insert)
Definitions
Continuation of Therapy is defined as having used the medication in the past.
Coverage criteria:
Authorization request is for continuation of therapy authorization and all of the following criteria are met:
- Diagnosis meets covered uses criteria as listed on FDA approved Indication and Usage
- Dosage and Administration consistent with prescribing information
- Age restriction criteria met
- Coverage Duration up to one year
- Cost for authorization request does not exceed the threshold of $10,000/month
Not Covered/Exclusions:
- Required medical information not provided upon request to satisfy indication criteria
- Off-label usage
- Drug is contraindicated for member conditions
- Exclusion criteria as listed under contraindications on the drug label
- Quantity and duration that exceeds plan benefit limit
- Known prescriber restrictions not met for certain classes of drugs
Referral to PharmD and/or Medical Director:
- Utilization management team will refer authorization to the PharmD and/or medical director for determination if:
- initial authorization of the medical pharmacy benefit if there is not an available CMS NCD nor LCD or if coverage criteria are not met by available CMS NCD nor
- the coverage criteria of this policy are not known to be met
- exceeds the cost threshold
- referencing pharmacy compendium is required
References
Last literature review: April 2024
U.S. Food & Drug Administration