Bulletin 2024-03 — Step Therapy Protocols and Standardized Medication Prior Authorization Forms
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Bulletin 2024-03 governs Massachusetts carriers' obligations for step therapy protocols, required exception processes, timelines for determinations, continuity of coverage, and standardized prior authorization forms for medications; it applies to commercial health insurers and HMOs offering insured products in Massachusetts.
The Division approves amended Massachusetts standard prior authorization forms for medications, hepatitis C medications, and chemotherapy/supportive care, replacing prior Bulletins 2016-08, 2017-04, and 2022-07.
Carriers must provide a clear, readily accessible, and convenient process for insureds and prescribers to request exceptions to step therapy protocols and grant exceptions when statutory criteria are met.
Timelines for exception determinations: carriers must decide within 3 business days (or 24 hours if delay would pose significant risk) after receipt of all necessary information; failure to respond in time results in deemed grant.
Carriers must maintain a continuity of coverage policy, including providing a 30-day fill of an FDA-approved pharmacy benefit drug the insured is stable on during exception review, without applying greater cost-sharing.
Carriers must submit implementation plans to the Division by February 15, 2024, describing steps and timelines to implement the Bulletin.
Coverage and Exception Criteria
inv-01: Exception approval criteria
An exception to a step therapy protocol must be granted when ANY ONE of the following statutory conditions is met:
Documentation supporting the applicable ground must be provided on the Massachusetts Standard Prior Authorization Form (Exceptions to Step Therapy section).
inv-02: Timelines
Decision timelines once 'all necessary information' is received:
Business days exclude Saturdays, Sundays, and holidays. The applicable standard prior authorization form, as amended by Bulletin 2024-03, will be deemed to constitute 'all necessary information' when completed and submitted.
inv-03: Continuity of coverage
During exception review, carriers must ensure uninterrupted access:
Carrier shall not apply greater deductible, coinsurance, copayments, or out-of-pocket limits than would otherwise apply to drugs covered by the plan.
inv-04: Hepatitis C information collection
Information required to assess medical necessity for Hepatitis C treatment (collected on the form):
Form prompts Zepatier-specific check for absence of genotype 1a with a baseline NS5A polymorphism and includes expedited/urgent request checkbox. Week 8 HCV RNA is requested for continuation requests.
inv-05: Chemotherapy and supportive care information collection
Information required to assess medical necessity for chemotherapy and supportive care agents:
Attach required documents: labs, imaging, chemotherapy orders, pathology, and progress notes; capture billing method (Buy-and-Bill vs Pharmacy) and J-code/CPT fields for professionally administered medications (include billing provider NPI/TIN and place of treatment details).
The standard prior authorization form is the Division-approved Massachusetts Hepatitis C medication PA form; some plans might not accept this form for Medicare or Medicaid requests. Providers should confirm plan-specific submission requirements for Medicare and Medicaid members before relying on the form for those populations.
Billing, Diagnosis and Code Fields
| J-code | Field requested for professionally administered medications (enter appropriate J-code) |
| CPT | Field requested for number of visits / procedure codes for professionally administered medications |
| B18.2 | Hepatitis C (chronic) |
What Providers Must Do and Required Documentation
Use the Division‑approved standard PA forms
Carriers must accept the Division-approved Massachusetts Standard Prior Authorization Forms for: (1) Medication Prior Authorization Requests; (2) Hepatitis C Medication Prior Authorization Requests; and (3) Chemotherapy and Supportive Care Prior Authorization Requests. Carriers may not require other paper forms for these services and must make the approved standard forms available to contracted providers.
Include required patient, prescriber, drug, staging, labs, and billing fields
Complete the applicable Massachusetts Standard Prior Authorization Form sections to include patient and prescriber details, the requested drug and duration, clinical indication and staging fields (e.g., HCV genotype and fibrosis stage), relevant labs, and billing fields for professionally administered medications (CPT and J‑code fields).
- Patient identifiers (name, DOB, member ID)
- Prescribing clinician name, specialty, NPI, contact/fax
- Requested medication and planned duration; Type of therapy (initial/continuation)
- HCV-specific: genotype, fibrosis stage and assessment method, baseline HCV RNA and GFR
- Professionally administered meds: CPT, # of visits, J‑code, # of units
Grounds that require granting a step therapy exception
You may request a step therapy exception; the carrier must grant an exception if any one statutory ground is met — contraindication/likely harm, expected ineffectiveness based on clinical characteristics, prior trial and discontinuation for lack of efficacy or adverse event, or patient stability where switching would likely cause harm.
Document exception rationale in the Exceptions section
Document the basis for the exception in the form’s Exceptions to Step Therapy section — including contraindications or likely harm, reasons the alternative is expected to be ineffective, details of prior trials (drug name, dates/duration, adverse reaction or inadequate response), or evidence the member is stable on the requested drug.
- For prior trials: drug name, dates/duration, indicate adverse reaction or inadequate response, and brief description
- For contraindication or expected ineffectiveness: clinical rationale and supporting details
- For stability: description of stability and specific likely harms from switching
Complete and submit the Massachusetts Standard PA Form (include Exceptions section)
Complete and submit the applicable Massachusetts Standard Prior Authorization Form (as amended by Bulletin 2024‑03), including Section F (Exceptions to Step Therapy) or the Hepatitis C/Chemotherapy form Exceptions section when applicable.
Attach required clinical documents and provide billing/provider/place details
Attach supporting clinical documentation with the PA form: progress notes, chemotherapy orders, labs, pathology, imaging results, and include billing provider and treatment place identifiers (billing provider NPI/TIN and place of treatment NPI/TIN) for professionally administered medications.
- Progress notes, chemo orders, labs, pathology, imaging results
- Ordering/servicing/billing provider NPI and TIN; place of treatment NPI/TIN and address
- Billing fields: Billing Provider name and NPI, CPT/J‑code and units or # of visits
Deemed grant if carrier misses statutory timelines
If the carrier does not issue a determination within the statutory timelines after receipt of all necessary information (the completed standard PA form constitutes all necessary information), the exception request is deemed granted.
- Standard form completion and submission constitutes receipt of 'all necessary information'
- Carrier must decide within 3 business days (or 24 hours if delay poses significant risk); failure to respond results in deemed grant
Include plan‑specific supporting documentation to avoid denial risk
Consult the health plan’s coverage policies, member benefits, and medical necessity guidelines when completing the form and include any supporting clinical documentation required by plan‑specific criteria; missing required supporting data may risk denial.
- Refer to plan‑specific criteria for details on required information
- Attach any additional data relevant to medical necessity as requested by the plan
Initial Therapy Requirements
inv-22: Initial Hepatitis C therapy
Initial Hepatitis C treatment requests should document the following information:
For Zepatier, confirm absence of genotype 1a with a baseline NS5A polymorphism per the form; include expedited review checkbox if clinically urgent.
Continuation and Renewal Requirements
inv-23: Continuation/Renewal for Hepatitis C
Continuation/renewal requests must document on-treatment labs and clinical response:
Form explicitly asks: 'If renewal, has the patient shown improvement in related condition while on therapy? Yes/No/N/A' and requests Week 8 HCV RNA for continuation requests.
Step Therapy Documentation and Exceptions
| Requirement | What to document on the standard PA form |
|---|---|
| Prior trial(s) of the alternative required under the step therapy protocol | |
| Provide drug name(s), dates/duration of use, and indicate whether the member experienced an adverse reaction or inadequate response; briefly describe the adverse reaction or inadequate response | |
| Contraindication to the alternative drug | |
| Describe details of the contraindication, anticipated adverse reaction, or physical/mental harm that would result from the alternative drug | |
| Member stability on the requested drug | |
| Explain how the member is stable on the requested therapy and why switching would likely cause harm | |
| Expected ineffectiveness of the alternative drug | |
| Describe clinical characteristics of the member and known characteristics of the alternative drug regimen that support expected ineffectiveness |
| Supporting detail | Form fields / required information |
|---|---|
| Document contraindication | |
| Yes/No checkbox and free-text description of contraindication or likely adverse reaction/physical or mental harm | |
| Document expected ineffectiveness | |
| Yes/No checkbox and brief description of known clinical characteristics of the member and the alternative drug regimen | |
| Prior trial details | |
| For each prior trial provide drug name, dates/duration of use, indicate adverse reaction or inadequate response, and brief description of the event or inadequate response | |
| Member stability on requested drug | |
| Yes/No checkbox and narrative describing stability and why switching would likely cause harm | |
| Attachments to support documentation | |
| Providers may attach progress notes, labs, pathology, imaging, chemo orders or other relevant data to substantiate the exception request |
Site of Service Requirements
Specify site of service for chemotherapy/supportive care
Indicate the site of service on chemotherapy/supportive care PA requests (Outpatient Hospital, Home Infusion, Other) and include site‑specific provider/place fields and attachments as requested on the form.
Key Definitions
Background and Form Purpose
The Hepatitis C prior authorization form collects clinical elements needed to assess regimen selection and duration, including HCV genotype, stage of hepatic fibrosis, baseline and on-treatment HCV RNA values and dates, transplant and HIV coinfection status, and renal function (GFR). These data support application of plan-specific medical necessity criteria and any drug-specific checks (for example, confirming absence of certain NS5A polymorphisms when required).
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