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Claim Payment Policy

Title:Equipment, Supplies, and Pharmaceuticals for the Treatment of Diabetes

Policy #:05.00.05f


Application of Claim Payment Policy is determined by benefits and contracts. Benefits may vary based on product line, group or contract. Medical necessity determination applies only if the benefit exists and no contract exclusions are applicable. Individual member benefits must be verified.

In products where members are able to self-refer to providers for care and services, members are advised to use participating providers in order to receive the highest level of benefits.When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

For more information on how Claim Payment Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.


Intent
The intent of this policy is to communicate the Company's coverage and reimbursement positions for equipment, supplies, and pharmaceuticals for the treatment of diabetes.

The provision of benefits for equipment, supplies, and pharmaceuticals for the treatment of diabetes is in accordance with the individual's benefit contract and varies by product and group. Therefore, individual member benefits must be verified. Some services may be subject to state mandates, medical necessity criteria, coverage limits, precertification or preapproval, or existing contractual exclusions.

For information on policies related to this topic, refer to the Cross References section in this policy.
Description
As used in this policy, diabetes refers to any of the following diagnoses:
  • Diabetes mellitus, juvenile type
  • Diabetes mellitus, type I
  • Diabetes mellitus, type II
  • Insulin-dependent diabetes mellitus (IDDM)
  • Non–insulin-dependent diabetes mellitus (NIDDM)
  • Gestational diabetes (insulin- or non–insulin-dependent)
  • Maternal diabetes mellitus
  • Abnormal maternal glucose tolerance
  • Neonatal diabetes mellitus
  • Secondary diabetes mellitus
EQUIPMENT AND SUPPLIES FOR THE TREATMENT OF DIABETES

Equipment and supplies for the treatment of diabetes are tools that assist an individual with diabetes in managing his/her disease. Examples of these items include, but are not limited to, the following:
  • Blood glucose monitors (also referred to as glucometers, blood glucose meters, or glucose meters)
  • Interstitial continuous glucose monitoring systems (CGMS)
  • Insulin pumps and associated supplies (eg, infusion sets)
    • The term insulin pump, as used in this policy, refers only to a US Food and Drug Administration (FDA)-approved, externally implanted (ie, subcutaneously implanted) insulin pump.
  • Injection aides (eg, air-jet insulin injectors)
  • Alcohol swabs
  • Lancing devices (eg, lancets, automatic lancing devices, laser skin perforators)
  • Blood and urine test strips (eg, glucose, ketone)
  • Insulin pens, needles, and syringes for the administration of injectable diabetic medications
PHARMACEUTICALS FOR THE TREATMENT OF DIABETES

Pharmaceuticals for the treatment of diabetes include both injectable and oral medications that have been approved by the FDA. These pharmaceuticals, which are used by an individual with diabetes for the purpose of attaining and maintaining his/her blood glucose within a medically acceptable range, include the following:
  • Injectable and inhaled pharmaceuticals, examples of which include the following:
    • Insulin, depending on the insulin-type, is an inhaled or injectable prescription or injectable nonprescription (over-the-counter [OTC]) FDA-approved biologic that is administered for the prevention or treatment of hyperglycemia (high blood glucose) associated with diabetes. This insulin is a replacement for or a supplement to an individual's own insulin, which is normally produced by the pancreas.
      • When insulin does not require a prescription, a physician directs its dosage and administration.
    • Glucagon, an injectable prescription biologic, is administered for the treatment of hypoglycemia (low blood glucose) associated with diabetes. This glucagon is a replacement for or a supplement to an individual's own glucagon, which is normally produced by the pancreas.
  • Oral medications, examples of which include the following:
    • Alpha-glucosidase inhibitors, biguanides, meglitinides, sulfonylurea drugs, and thiazolidinediones are orally administered prescription medications that are designed to maintain blood glucose levels within normal limits via various mechanisms.
Glucose tablets and gels are orally administered nonprescription (OTC) treatments for acute episodes of hypoglycemia associated with diabetes.
  • Although glucose tablets and gels are not prescription medications, a physician may direct their dosage and administration.
Policy
The Company covers and considers for reimbursement equipment, supplies, and pharmaceuticals that have been approved by the US Food and Drug Administration (FDA) for the treatment of diabetes when all of the following criteria are met:
  • The items are considered medically necessary for the treatment of diabetes.
  • The individual's physician prescribes the items for the treatment of diabetes.
  • An eligible provider supplies the items.
  • The group member contract identifies the items as a benefit for the individual.

The Company covers glucose tablets and gels, which are nonprescription (over-the-counter [OTC]) orally administered treatments for acute episodes of hypoglycemia associated with diabetes, in products that include benefits for such items.

When diabetes equipment, supplies, and pharmaceuticals are covered, the codes in Attachment B to this policy are eligible for reimbursement consideration as a treatment for diabetes when they are reported with a diagnosis code listed in Attachment A that corresponds to the individual's diabetic condition. However:
  • In addition to this policy, the Company has medical policies on topics related to the diagnosis and treatment of diabetes; a list of these policies is provided in the Cross References section of this policy. The medical necessity requirements and limitations listed in those policies apply.
  • Equipment, supplies, and pharmaceuticals for the treatment of diabetes that are not FDA-approved, or have been determined to be either not medically necessary or experimental/investigational, are not covered and are, therefore, not eligible for reimbursement consideration.
PRODUCT-SPECIFIC INFORMATION

COMPANY COMMERCIAL (NON-MEDICARE) PRODUCTS

Pennsylvania (PA) and New Jersey (NJ) Products
PA and NJ mandate benefits for the coverage of equipment, supplies, and pharmaceuticals for the treatment of diabetes.
  • Individual member benefits must be verified as the application of the benefit may vary between the medical and outpatient prescription benefit.
Delaware (DE) Products
DE mandates benefits for the coverage of equipment, supplies, and pharmaceuticals for the treatment of diabetes when the product includes an outpatient prescription benefit. However, in the presence of an outpatient prescription benefit, nonprescription medications and treatments (eg, glucose tablets and gels), with the exception of nonprescription insulin, are noncovered.

When an individual who is enrolled in a DE product does not have an outpatient prescription benefit with the Company:
  • Prescription and nonprescription (including insulin) pharmaceuticals for the treatment of diabetes are not covered.
  • Diabetic equipment and supplies are covered and eligible for reimbursement consideration under the applicable medical benefit.
MEDICARE ADVANTAGE PRODUCTS

Equipment and Supplies
FDA-approved equipment and supplies for the treatment of diabetes (eg, insulin pumps and associated supplies, blood glucose meters, test strips, lancets) for individuals enrolled in Medicare Advantage products are covered under the medical benefit, with the following exceptions:
  • Medical supplies associated with the injection of insulin (eg, syringes, alcohol swabs, gauze) are covered under the applicable Medicare Part D prescription drug benefit.
    • Individuals enrolled in Medicare Advantage products that do not include Medicare Part D prescription drug coverage do not have benefits for medical supplies associated with the injection of insulin for the treatment of diabetes. In such cases, these supplies are noncovered.
Pharmaceuticals
FDA-approved insulins administered by FDA-approved insulin pumps are covered under the medical benefit when supplied by an eligible durable medical equipment (DME) provider.
  • All other FDA-approved pharmaceuticals (eg, insulins, prescription oral medications) for the treatment of diabetes for individuals enrolled in Medicare Advantage products are covered under the applicable Medicare Part D prescription drug benefit.
    • Individuals enrolled in Medicare Advantage products that do not include Medicare Part D prescription drug coverage do not have benefits for insulins and prescription oral medications for the treatment of diabetes. In such cases, these medications are noncovered.

Under an applicable Medicare Part D prescription drug benefit, nonprescription medications and treatments (eg, glucose tablets and gels), with the exception of FDA-approved nonprescription insulin, are noncovered.


REQUIRED DOCUMENTATION

EQUIPMENT AND SUPPLIES FOR THE TREATMENT OF DIABETES

The Company may conduct reviews and audits of services to our members regardless of the participation status of the provider. Medical record documentation must reflect the medical necessity of the care and services provided. These medical records may include, but are not limited to: records from the health care professional's office, hospital, nursing home, home health agencies, therapies, and test reports.

An order for each item billed must be signed and dated by the health care professional who is treating the member and kept on file by the supplier. Medical record documentation must include a shipment confirmation or member's receipt of supplies and equipment. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

PHARMACEUTICALS FOR THE TREATMENT OF DIABETES

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the health care professional's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
Guidelines
This policy applies to equipment, supplies, and pharmaceuticals for the treatment of diabetes in general. When there is a Company policy addressing a specific item listed in this policy, refer to the applicable policy. The information in the specific policy takes precedence over this general policy.

Certain diabetes equipment and supplies (eg, blood glucose meters, test strips, lancets) that are included in a medical benefit may be obtained through a pharmacy. For additional information, contact Member Services or Provider Services.


BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, equipment, supplies, and pharmaceuticals for the treatment of diabetes are covered under the medical and/or outpatient pharmaceutical benefits of the Company's products.

Injectable drugs may be available under more than one benefit category; therefore, individual benefits must be verified. All applicable deductibles, coinsurance, and copayments are the member's responsibility, and the cost to members may vary based on where and how the drug is obtained.

MEDICARE

This policy is consistent with Medicare's coverage determination for these items and services. The Company's payment methodology may differ from Medicare.
MANDATES

This policy is consistent with applicable state mandates. The laws of the state where the group benefit contract is issued determine the mandated coverage.

References
Centers for Medicare & Medicaid Services (CMS). Coverage Issues Manual. Part 45 -- Chapter 3: Supplies -- drugs. §45-3: Insulin syringe. [CMS Web site]. December 1994. Available at: http://www.cms.hhs.gov/manuals/downloads/Pub06_PART_45.pdf. Accessed October 29, 2009.

Centers for Medicare & Medicaid Services (CMS). Coverage Issues Manual. Part 60 -- Chapter 11: Durable medical equipment. §60-11: Home blood glucose monitors. [CMS Web site]. November 2002. Available at: http://www.cms.hhs.gov/manuals/downloads/Pub06_PART_60.pdf. Accessed October 29, 2009.

Centers for Medicare & Medicaid Services (CMS). Coverage Issues Manual. Part 60 -- Chapter 11: Durable medical equipment. §60-14: Infusion pumps. [CMS Web site]. 01/01/02. Available at: http://www.cms.hhs.gov/manuals/downloads/Pub06_PART_60.pdf. Accessed October 29, 2009.

Centers for Medicare & Medicaid Services (CMS). Medicare National Coverage Determinations Manual. Chapter 1, Part 1. §40.2: Home blood glucose monitors. [CMS Web site]. 06/19/06. Available at: http://www.cms.hhs.gov/manuals/downloads/ncd103c1_Part1.pdf. Accessed October 29, 2009.

Centers for Medicare & Medicaid Services (CMS). Medicare National Coverage Determinations Manual. Chapter 1, Part 1. §40.4: Insulin syringe. [CMS Web site]. 10/03/03. Available at: http://www.cms.hhs.gov/manuals/downloads/d103c1_Part1.pdf. Accessed October 29, 2009.

Centers for Medicare & Medicaid Services (CMS). Medicare National Coverage Determinations Manual. Chapter 1, Part 3. §190.20: Blood glucose testing. [CMS Web site]. 01/01/05. Available at: http://www.cms.hhs.gov/manuals/downloads/ncd103c1_Part3.pdf. Accessed October 29, 2009.

Centers for Medicare & Medicaid Services (CMS). Medicare National Coverage Determinations Manual. Chapter 1, Part 4. §280.14: Infusion pumps. [CMS Web site]. 12/17/04. Available at: http://www.cms.hhs.gov/manuals/downloads/ncd103c1_Part4.pdf. Accessed October 29, 2009.

Centers for Medicare & Medicaid Services (CMS). Your Medicare benefits. [Medicare.gov Web site]. August 2008. Available at: http://www.medicare.gov/Publications/Pubs/pdf/10116.pdf. Accessed October 29, 2009.

Centers for Medicare & Medicaid Services (CMS). Your Medicare coverage. Diabetes - Insulin and syringes, diabetic services, and diabetic supplies. [Medicare.gov Web site]. 05/08/09. Available at: http://www.medicare.gov/Coverage/Search/Results.asp?State=PA%7CPennsylvania&Coverage=83%7CDiabetes+-+Insulin+and+Syringes&Coverage=18%7CDiabetic+Services&Coverage=17%7CDiabetic+Supplies&submitState=View+Results+%3E. Accessed October 29, 2009.

Company Benefit Contracts.

National Heritage Insurance Corporation (NHIC). Local Coverage Determination (LCD). L5044: External infusion pumps. [NHIC Web site]. Original: 10/01/93. (Revised: 01/01/09). Available at: http://www.medicarenhic.com/dme/medical_review/mr_lcds/mr_lcd_current/L5044_2009-01-01_PA_2009-01.pdf. Accessed October 29, 2009.

National Heritage Insurance Corporation (NHIC). Local Coverage Determination (LCD). L11530: Glucose monitors. [NHIC Web site]. Original: 10/01/93. (Revised: 10/01/08). Available at: http://www.medicarenhic.com/dme/medical_review/mr_lcds/mr_lcd_current/L11530_2008-10-01_PA_2008-10.pdf. Accessed October 29, 2009.

New Jersey (NJ) Permanent Statutes. Title 17:48-6n. Coverage for diabetes treatment by individual, group hospital service corporation. [NJ Legislature Web site]. 01/05/96. Available at: http://www.njleg.state.nj.us/. Accessed October 29, 2009.

New Jersey (NJ) Permanent Statutes. Title 17:48A-7l. Coverage for diabetes treatment by individual, group medical service corporation. [NJ Legislature Web site]. 01/05/96. Available at: http://www.njleg.state.nj.us/. Accessed October 29, 2009.

New Jersey (NJ) Permanent Statutes. Title 17:48E-35.11. Coverage for diabetes treatment by individual group health service corporation. [NJ Legislature Web site]. 01/05/96. Available at: http://www.njleg.state.nj.us/. Accessed October 29, 2009.

New Jersey (NJ) Permanent Statutes. Title 17B:26-2.1l. Coverage for diabetes treatment by individual health insurance policy. [NJ Legislature Web site]. 01/05/96. Available at: http://www.njleg.state.nj.us/. Accessed October 29, 2009.

New Jersey (NJ) Permanent Statutes. Title 17B:27-46.1m. Coverage for diabetes treatment by group health insurance policy. [NJ Legislature Web site]. 01/05/96. Available at: http://www.njleg.state.nj.us/. Accessed October 29, 2009.

New Jersey (NJ) Permanent Statutes. Title 26:2J-4.11. Coverage for diabetes treatment by HMO contracts. [NJ Legislature Web site]. 01/05/96. Available at: http://www.njleg.state.nj.us/. Accessed October 29, 2009.

Pennsylvania (PA) General Assembly. PA Insurance Company Law of 1921. Act 98 of 1998. H656;§633: Reimbursement for diabetic supplies; signed October 16, 1998. [PA General Assembly Web site]. Available at: http://www.legis.state.pa.us/CFDOCS/Legis/PN/Public/btCheck.cfm?txtType=PDF&sessYr=1997&sessInd=0&billBody=H&billTyp=B&billNbr=0656&pn=2505. Accessed October 29, 2009.

Pennsylvania (PA) Act 98 of 1998. Eff 02/12/1999.

State of Delaware. Delaware code. Title 18 Insurance code. Chapter 33: Health insurance contracts. §3344: Insurance coverage for diabetes. [Delaware Code Web site]. 06/30/2000. Available at: http://delcode.delaware.gov/title18/c033/index.shtml. Accessed October 29, 2009.

State of Delaware. Delaware code. Title 18 Insurance code. Chapter 35: Group and blanket health insurance. Subchapter III: Provisions applicable to group and blanket health insurance. §3560: Insurance coverage for diabetes. [Delaware Code Web site]. 06/30/2000. Available at: http://delcode.delaware.gov/title18/c035/sc03/index.shtml. Accessed October 29, 2009.
Coding Table

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

Code SystemCode Number(s) and Narrative(s)
CPTN/A
ICD ProcedureN/A
ICD DiagnosisRefer to Attachment A for a list of International Classification of Diseases, 9th Revision (ICD-9) codes representing diabetes.
HCPCS Level IIRefer to Attachment B for a list of Healthcare Common Procedure Coding System (HCPCS) codes that represent equipment, supplies, and pharmaceuticals for the treatment of diabetes.
Revenue CodesN/A
Cross References
Version Effective Date: 01/09/2010

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The Policy Bulletins on this web site were developed to assist AmeriHealth and its subsidiaries ("AmeriHealth") in administering the provisions of the respective benefit programs, and do not constitute a contract. If you are an AmeriHealth member, please refer to your specific benefit program for the terms, conditions, limitations and exclusions of your coverage. AmeriHealth does not provide health care services, medical advice or treatment, or guarantee the outcome or results of any medical services/treatments. The facility and professional providers are responsible for providing medical advice and treatment. Facility and professional providers are independent contractors and are not employees or agents of AmeriHealth. If you have a specific medical condition, please consult with your doctor. AmeriHealth reserves the right at any time to change or update its Policy Bulletins. ©2012 AmeriHealth, Inc. All Rights Reserved.  Current Procedural Terminology ©2012 American Medical Association. All Rights Reserved.
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