Reimbursement Billing and Coding Guide

Transcription

1 Reimbursement Billing and Coding Guide Please see Indication and Important Safety Information on page 2 and 3

2 This billing guide is intended to provide healthcare providers with an overview of coding, coverage, and reimbursement information related to Somatuline Depot that they can use, with other sources of information, to determine for themselves the appropriate claims to file for Somatuline Depot-related services. Although this billing guide provides information that should facilitate the claims process, all coding and reimbursement information is for reference purposes only. Ipsen does not guarantee payment. The healthcare reimbursement environment is constantly evolving to keep pace with scientific advances and financial constraints. Information specific to coverage policies and payment levels is subject to change and should be verified for each patient prior to treatment. You should contact your payers for information or guidance on any revisions or additional requirements. While every effort is made to provide helpful information, Ipsen makes no representations about the eligibility or guarantee of coverage or reimbursement for any particular claim. Ipsen cannot guarantee success in obtaining third-party insurance reimbursement. Thirdparty coverage and payment for medical products and services is complex and affected by numerous factors. It is always a provider s responsibility to determine and submit the appropriate codes, charges and modifiers for services that are rendered. Providers should contact third-party payers for specific information on their coding, coverage, and payment policies. All coding and claims used by a provider in seeking reimbursement must be accurate, complete and adequately documented in the applicable patient record. All services must be medically appropriate.

3 Indication for Somatuline Depot Somatuline Depot (lanreotide) Injection is a somatostatin analog indicated for: Acromegaly Long-term treatment of patients with acromegaly who had an inadequate response to orcannot be treated with surgery and/or radiotherapy. Gastroenteropancreatic neuroendocrine tumors (GEP-NETs) Treatment of adult patients with unresectable, well- or moderately differentiated, locally advanced or metastatic GEP-NETs to improve progression-free survival. Important Safety Information Contraindications Somatuline Depot is contraindicated in patients with hypersensitivity. Warnings and Precautions Somatuline Depot may reduce gallbladder motility and lead to gallstone formation. Periodic monitoring maybe needed. Patients may experience hypoglycemia or hyperglycemia. Glucose level monitoring is recommended and antidiabetic treatment adjusted accordingly. Slight decreases in thyroid function have been seen in acromegalic patients during treatment, though clinical hypothyroidism is rare (<1%). Somatuline Depot may decrease heart rate. In cardiac studies with acromegalic patients, the most common cardiac adverse reactions were sinus bradycardia, bradycardia, and hypertension. In patient streated for GEP-NETs, the incidence of heart rate < 60 bpm was 23% with Somatuline vs 16% with placebo. Incidence of heart rate < 50 bpm or bradycardia was 1% in each group. Dose adjustment of coadministered drugs that decrease heart rate may be necessary. Somatuline Depot may decrease bioavailability of cyclosporine. Cyclosporine dose may need to beadjusted. Please see next page for additional Important Safety Information

4 Important Safety Information - continued Adverse Reactions In acromegaly, the most common adverse reactions (incidence > 5%) in clinical trials were diarrhea (37%), cholelithiasis (20%), abdominal pain (19%), nausea (11%), injection-site reactions (9%), constipation (8%), flatulence (7%), headache (7%), arthralgia (7%), vomiting (7%), and loose stools (6%). In the GEP-NETs clinical trial, the most common adverse reactions (incidence >10% and more common than placebo) in patients treated with Somatuline Depot vs placebo were abdominal pain (34% vs 24%), musculoskeletal pain (19% vs 13%), vomiting (19% vs 9%), headache (16% vs 11%), injection site reaction (15% vs 7%), hyperglycemia (14% vs 5%), hypertension (14% vs 5%), and cholelithiasis (14% vs 7%). Use in Special Populations In the treatment of acromegaly, for patients with moderate and severe renal impairment or moderate and severe hepatic impairment, initial dose is 60 mg every 4 weeks. You may report suspected adverse reactions to FDA at FDA-1088 or to Ipsen Biopharmaceuticals, Inc. at Please see next page for additional Important Safety Information 3

5 Reimbursement Coding When completing the CMS-1500 claim form, the UB-04 claim form, or submitting a prior authorization request for Somatuline Depot, include accurate descriptions of the patient s diagnosis, route or mode of administration, and the drug. Healthcare Common Procedure Coding System (HCPCS) Level II Code A permanent HCPCS code has been assigned to report use of Somatuline Depot. Somatuline Depot HCPCS Code Description J1930 Injection, lanreotide, 1 mg National Drug Codes (NDCs) Drug products are identified and reported using a unique, three-segment number, called the National Drug Code (NDC), which is a universal product identifier. The NDC is used primarily for pharmacy claims, but it may be required also when billing for physician-administered drugs to ensure crosswalk accuracy. When providers are required to include an NDC on an insurance claim, it typically must be in the 11-digit format. Single-dose Sterile Prefilled Syringe NDC 120 mg* mg mg *GEP-NET: dosing is 120 mg once every four weeks. Acromegaly: starting dose is 90 mg once every four weeks. For patients with moderate or sever renal or hepatic impairment, initial does is 60 mg once every four weeks. Current Procedural Terminology (CPT) Drug Administration Codes The following CPT1 code may be appropriate to report Somatuline Depot administration services. Evaluation and Management (E&M) codes for office visit services in addition to injection may be appropriate. Most payers require documentation of a separate and identifiable procedure. CPT Code Description Therapeutic, prophylactic, or diagnosis injection; subcutaneous or intramuscular Please consult the patient s specific plan or Ipsen CARES for information on other CPT codes that may be applicable and appropriate for billing the administration of Somatuline Depot Diagnosis Codes All claim forms should include an accurate and appropriately documented diagnosis code. Physicians should select the code that most closely and appropriately represents the diagnosis of the patient. The codes below are provided as examples. Physicians should select codes that most accurately reflect a patient s condition and corresponding utilization of Somatuline Depot. Some payers may not allow for a level one office visit and an injection code to be billed for the same date of service, and only for other levels when an appropriate modifier is billed. Diagnosis Codes for Acromegaly ICD-9-CM Code ICD-9 Description ICD-10-CM Code ICD-10 Description Acromegaly and gigantism, overproduction of growth hormone E22.0 Acromegaly and pituitary gigantism 4

6 Diagnosis Codes for GEP-NETs 1 Note: This list is not exhaustive ICD-9 CM Code ICD-9 Description ICD-10 CM Code ICD-10 Description Malignant carcinoid tumors of the small intestine C7A.019 Malignant carcinoid tumor of the small intestine, unspecified portion Malignant carcinoid tumor of the duodenum C7A.010 Malignant carcinoid tumor of the duodenum Malignant carcinoid tumor of the jejunum C7A.011 Malignant carcinoid tumor of the jejunum Malignant carcinoid tumor of the ileum C7A.012 Malignant carcinoid tumor of the ileum Malignant carcinoid tumors of the appendix, large intestine, and rectum Malignant carcinoid tumor of the large intestine, unspecified portion C7A.012 C7A.029 Omitted from ICD-10 Malignant carcinoid tumor of the large intestine, unspecified portion Malignant carcinoid tumor of the appendix C7A.020 Malignant carcinoid tumor of the appendix Malignant carcinoid tumor of the cecum C7A.012 C7A Malignant carcinoid tumor of the transverse colon C7A.023 Malignant carcinoid tumor of the transverse colon Malignant carcinoid tumor of the descending colon C7A.024 Malignant carcinoid tumor of the descending colon Malignant carcinoid tumor of the sigmoid colon C7A.025 Malignant carcinoid tumor of the sigmoid colon Malignant carcinoid tumor of the rectum C7A.026 Malignant carcinoid tumor of the rectum Malignant carcinoid tumor of the stomach C7A.092 Malignant carcinoid tumor of the stomach Malignant carcinoid tumor of foregut, not otherwise specified Malignant carcinoid tumor of mid-gut, not otherwise specified Malignant carcinoid tumor of hindgut, not otherwise specified C7A.094 C7A.095 C7A.096 Malignant carcinoid tumor of the foregut NOS Malignant carcinoid tumor of the mid-gut NOS Malignant carcinoid tumor of the hindgut NOS Benign carcinoid tumor of the appendix D3A.020 Benign carcinoid tumor of the appendix Benign carcinoid tumor of the cecum D3A.021 Benign carcinoid tumor of the cecum Benign carcinoid tumor of the ascending colon D3A.022 Benign carcinoid tumor of the ascending colon Benign carcinoid tumor of the transverse colon D3A.023 Benign carcinoid tumor of the transverse colon Benign carcinoid tumor of the descending colon D3A.024 Benign carcinoid tumor of the descending colon Benign carcinoid tumor of the sigmoid colon D3A.025 Benign carcinoid tumor of the sigmoid colon Benign carcinoid tumor of the rectum D3A.026 Benign carcinoid tumor of the rectum Benign carcinoid tumor of the stomach D3A.092 Benign carcinoid tumor of the stomach Benign carcinoid tumor of foregut, not otherwise specified Benign carcinoid tumor of mid-gut, not otherwise specified Benign carcinoid tumor of hindgut, not otherwise specified D3A.094 D3A.095 D3A Secondary Neuroendocrine tumors Omitted from ICD-10 Benign carcinoid tumor of the foregut NOS Benign carcinoid tumor of the midgut NOS Benign carcinoid tumor of the hindgut NOS Islets of Langerhans D13.7 Benign neoplasm of endocrine pancreas Ampulla of Vater (If insurance requires a code from the neuroendocrine section, consult with insurance on which unspecified code should be utilized) C24.1 Malignant neoplasm of ampulla of Vater 1 Per CPT coding guidelines, patients with any associated multiple endocrine neoplasia syndrome diagnosis will have codes coded first and neuroendocrine diagnosis coded second. 5

7 Payer Coverage Contacting the payer directly is the best way to determine how the physician may obtain reimbursement for Somatuline Depot. This may be done as part of an insurance benefit verification effort. Benefit verification provides the physician with important reimbursement information, such as benefit structure and coverage, and is typically performed prior to treatment. To ensure accuracy, benefit verifications should be conducted on a patient-specific basis. Contact Ipsen Cares or your Ipsen Field Reimbursement Manager for more information regarding coding coverage and reimbursement, including local medical policies. Medicare Medicare may cover Somatuline Depot (lanreotide injection) under Part B when provided and administered by a healthcare provider and under Part D when dispensed in an outpatient setting. When covered as a Part B benefit, claims for Somatuline Depot are billed to Medicare Administrative Contractors (MACs). Local Medicare Administrative Contractors (MACs) manage Medicare Part A/B Benefits. MACs may make specific coverage decisions for Somatuline Depot through Local Coverage Decisions (LCDs) and may issue other coverage instructions through articles and bulletins. The absence of a published coverage policy does not mean that there is no coverage for Somatuline Depot. The Part D drug benefit provides beneficiaries with coverage for outpatient prescription drugs. The Part D benefit is administered by private health plans such as stand-alone prescription drug plans (PDPs) or Medicare Advantage prescription drug (MA-PD) plans. The standard benefit design for Medicare Part D coverage includes an annual deductible and three tiers for the patient. Medicaid Most state Medicaid programs cover and reimburse Somatuline Depot. Medicaid coverage and payment for Somatuline Depot varies from state to state. Providers should check with the state program or may contact the Somatuline Depot Reimbursement Information and Patient Assistance Program for more specific coverage information. Private Payers Private payers vary in the payment methods they use to reimburse the sites of service where Somatuline Depot is administered. Private payers may require that physicians obtain Somatuline Depot through a specialty pharmacy. Specialty pharmacies may bill the payer through the medical or pharmacy benefit, depending on the payer s requirements. IPSEN CARES can provide information to patients and healthcare professionals relating to Medicare coverage and policies for Somatuline Depot at:

8 IPSEN CARES program can provide information to patients and healthcare professionals relating to payer-specific policies and can address other questions at:

9 Access to Somatuline Depot Sample CMS-1500 Claim Form Physician Office Administration. Box 19 List drug, strength, dosage and route of administration Box 21 Input the appropriate ICD-9 CM Code Box 24 A In the shaded area list the N4 qualifier, the 11 digit drug NDC#, the unit of measurement qualifier and dosage. Box 24D Indicate HCPCS and CPT codes Example: N MG90.00 (Note: some payers may request the NDC number be listed in box 19) In the non-shaded area, list the date of service. 8

10 Sample CMS-1450 (UB-04) Claim Form Hospital Outpatient Administration Box 42 Revenue Code: Enter the appropriate numeric code to identify specific accommodations and/or ancillary service in ascending numeric order by date of service if applicable. For the drug, most often revenue code 0636, drugs requiring detailed coding will be used. Use revenue code 0250, general pharmacy for payors who do not recognize the 0636 revenue code. For the administration, list the revenue code for the cost center where services were performed (e.g., 0510, clinic, 500, outpatient services, etc.) Box 45 Service Date: Enter the date on which the service was performed using MMDDYY format. Box 46 Service Units: Enter the total number of units of service as appropriate. Box 43 Box 44 Revenue Description: Enter the narrative description of the related room and board and/or ancillary categories shown in field 42. For payors that require a detailed drug description a drug description can be inputted. The N4 indicator is listed first, followed by the 11 digit NDC number, next a code describing the unit of measurement qualifier is listed and followed by the unit quantity. CPT/HCPCS Code: Enter the appropriate CPT/HCPCS code. For Somatuline Depot use J1930, Injection, lanreotide, 1 mg. For the administration use the CPT code representing the administration route, such as 96372, therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular. Box 67 Enter the complete ICD-9CM diagnosis code that describes the principal diagnosis or the chief reason for performing a service. 9

11 IPSEN CARES Ipsen is fully dedicated to helping patients and ensuring that they are able to access the medications that are critical to managing their conditions. To embody this commitment, Ipsen is proud to present IPSEN Coverage, Access, Reimbursement and Education Support (CARES) Program. PHONE OR FAX: Fax: HOURS Monday through Friday, 8:00am to 8:00pm, ET WEBSITE: resources Reimbursement Assistance Benefits Verification determine patient s coverage, coverage requirements and copayment/coinsurance amount. Prior Authorization identify and communicate the specific information required by a payer to submit a prior authorization or exceptions request. Appeals Support provide information on the payer specific process required to submit a level I or a level II appeal as well as provide guidance as needed through the process. Financial Support Copayment Assistance offer copayment assistance to eligible patients. This could be referring to Somatuline Depot Commercial Co-Pay Program or referring to an independent non-profit organization. Patient Assistance Program (PAP) determine patient s eligibility for free product. Product Distribution Specialty Distributor Network provide contact information to various distributors that can supply Somatuline Depot directly to your facility. Specialty Pharmacy Network determine which in-network pharmacy is best for a patient per insurance requirements and triage referrals. Follow-up phone calls are placed 24 hours after referral is triaged to confirm receipt and shipment date. Patient Support 360 Communication engage in consistent, proactive communication with patients and providers on access to Somatuline Depot. 10

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13 Frequently Asked Questions Q: How is Somatuline Depot reimbursed by payers? A: Q: How does Medicare pay for Somatuline Depot? A: Q: What can be done to verify Somatuline Depot is covered by patient s insurance and prior to administration? A: The reimbursement methods used by payers are not the same and may have variability between plans even within the same insurance company. Each payer may have a unique contract or payment policy in place with the healthcare facility. Similarly, patients will have a unique choice of benefits with different levels of coverage for Somatuline Depot. When Somatuline Depot is covered through the medical benefit, the claim will be subject to medical benefits reimbursement, deductible, copays. When Somatuline Depot is covered through the pharmacy benefit, the reimbursement is processed by the specialty pharmacy delivering Somatuline Depot. Most payers will have deductible, copay and coinsurance requirements that must be met by patients. Patients receiving Somatuline Depot in a physician s office setting with the drug injected by a healthcare professional will likely be covered under Medicare Part B (medical benefit). If the patient has supplemental insurance covering coinsurance and deductibles, the coinsurance and deductible left after Medicare payment can then be billed to the supplemental insurance. IPSEN CARES has trained specialists available to answer questions related to Medicare reimbursement and to help patients navigate different Medicare plan options for coverage. Payers vary in benefit design for patients enrolled in insurance coverage. Ipsen strongly recommends that healthcare professionals and patients utilize IPSEN CARES to help navigate the coverage and reimbursement process with payers, as well as answering any coding and billing specific questions. IPSEN CARES is available to provide this information and service to healthcare professionals and patients at

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15 Prescribing Information FULL PRESCRIBING INFORMATION 14

16 2014 Ipsen Biopharmaceuticals, Inc. January DEP00394