130 CMR 428.00 — Prosthetics Services

Commonwealth of Massachusetts MassHealth Provider Manual Series Subchapter Number and Title Table of Contents Page iv Prosthetics Manual Transmittal Letter PRT-32 Date 07/31/26

4. Program Regulations

130 CMR 428.000: Prosthetics Services

130 CMR 428.00 Prosthetics Services

428.401 Introduction .......................................................................................................... 4- 1

428.401: Introduction .......................................................................................................... 4- 1

428.402 Definitions ............................................................................................................. 4- 1

428.402: Definitions ............................................................................................................. 4- 1

428.403 Eligible Members .................................................................................................. 4- 2

428.403: Eligible Members .................................................................................................. 4- 2

428.404 Provider Eligibility ............................................................................................... 4- 3

428.404: Provider Eligibility ............................................................................................... 4- 3

428.405 Provider Responsibility .......................................................................................... 4- 4

428.405: Provider Responsibility .......................................................................................... 4- 4

428.406 Covered Services ................................................................................................... 4- 4

428.406: Covered Services ................................................................................................... 4- 4

428.407 Service Limitations ................................................................................................ 4- 4

428.407: Service Limitations ................................................................................................ 4- 4

428.408 Noncovered Services ............................................................................................. 4- 4

428.408: Noncovered Services ............................................................................................. 4- 4

428.409 Prescription Requirements ..................................................................................... 4- 5

428.409: Prescription Requirements ..................................................................................... 4- 5

428.410 Prosthetic Equipment Provided to Institutionalized Members .............................. 4- 5

428.410: Prosthetic Equipment Provided to Institutionalized Members .............................. 4- 5

428.411 Repairs of Prosthetic Equipment ........................................................................... 4- 5

428.411: Repairs of Prosthetic Equipment ........................................................................... 4- 5

428.412 Prior Authorization ................................................................................................ 4- 6

428.412: Prior Authorization ................................................................................................ 4- 6

428.413 Procedure for Requesting Prior Authorization....................................................... 4- 7

428.413: Procedure for Requesting Prior Authorization....................................................... 4- 7

428.414 Medicare Coverage ............................................................................................... 4- 7

428.414: Medicare Coverage ............................................................................................... 4- 7

428.415 Early and Periodic Screening, Diagnosis and Treatment (EPSDT) Services ...... 4- 7

428.415: Early and Periodic Screening, Diagnosis and Treatment (EPSDT) Services ...... 4- 7 (130 CMR 428.416 through 428.419 Reserved)

428.420 Payment for Prosthetic Services ............................................................................ 4- 8

428.420: Payment for Prosthetic Services ............................................................................ 4- 8

428.421 Individual Consideration ...................................................................................... 4- 8

428.421: Individual Consideration ...................................................................................... 4- 8

428.422 Adjusted Acquisition Cost .................................................................................... 4- 9

428.422: Adjusted Acquisition Cost .................................................................................... 4- 9

428.423 Recordkeeping Requirements .............................................................................. 4- 9

428.423: Recordkeeping Requirements .............................................................................. 4- 9

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428.401 Introduction

428.401: Introduction

130 CMR 428.000 states the requirements and procedures for the purchase and repair of prosthetic devices, customized equipment, and supplies under MassHealth. All providers of prosthetic services participating in MassHealth must comply with the regulations governing MassHealth, including, but not limited to, MassHealth regulations set forth in 130 CMR 428.000 and 130 CMR 450.000: Administrative and Billing Regulations.

428.402 Definitions

428.402: Definitions

The following terms used in 130 CMR 428.000 have the meanings given in 130 CMR 428.402 unless the context clearly requires a different meaning. The reimbursability of services defined in 130 CMR 428.000 is not determined by these definitions, but by application of regulations elsewhere in 130 CMR 428.000 and 130 CMR 450.000: Administrative and Billing Regulations.

Accessory Equipment. Equipment that is fabricated primarily and customarily to modify or enhance the usefulness or functional capability of another piece of prosthetic equipment and that is generally not useful in the absence of such prosthetic equipment.

Adjusted Acquisition Cost. Except where the manufacturer is the provider, the price paid by the provider to the manufacturer or any other supplier for prosthetic devices, customized equipment, or supplies, excluding all associated costs such as shipping, handling, and insurance costs in accordance with 130 CMR 428.422. Where the manufacturer is the provider, the adjusted acquisition cost is the actual cost of manufacturing such prosthetic devices, customized equipment, or supplies.

American Board for Certification in Orthotics, Prosthetics and Pedorthics, Inc. (ABC). The national certifying and accrediting body for the orthotic, prosthetic, and pedorthic professions.

Board of Certification/Accreditation, International (BOC). A credentialing entity for practitioners and suppliers of comprehensive orthotic and prosthetic care.

Certified Mastectomy Fitter (CMF). A health care professional with current certification through the ABC or BOC who is specifically educated and trained in the provision of breast prostheses and post-mastectomy services, including patient assessment, formulation of a treatment plan, implementation of the treatment plan and follow-up, and practice management.

Date of Service. The date the prosthesis is delivered and fitted to the MassHealth member. If the prosthetic service involves a series of fittings and adjustments, the date of service is the date on which the final adjustment is made. If the prosthetic service involves only the provision of a service (for example, a repair), then the date of service is the date on which the service was completed.

Discount. Any remuneration or reduction of payment of any kind, whether direct or indirect, received by the provider.

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Nursing Facility. A licensed facility that meets the provider-eligibility and certification requirements of 130 CMR 456.404: Requirements for Provider Participation: In-state or 130 CMR 456.405: Requirements for Provider Participation: Out-of-state and whose members meet the medical eligibility criteria under 130 CMR 456.409: Services Requirement for Medical Eligibility. Nursing facilities do not include facilities such as rest homes, state schools, and state hospitals.

Nursing Facility Visit. A visit by a provider to a nursing facility for the purpose of providing prosthetic services.

Prior Authorization (PA) Request. A request submitted by the orthotics provider to the MassHealth agency to determine medical necessity in accordance with 130 CMR 442.412: Prior Authorization, 450.204: Medical Necessity, and 450.303: Prior Authorization.

Prosthesis (or Prosthetic Equipment). An artificial replacement for a missing body part, such as an artificial limb or total joint replacement.

Prosthetics Provider. An organization or individual that has enrolled with MassHealth and has signed a provider contract with the MassHealth agency who meets all applicable requirements of 130 CMR 428.404 and 450.000: Administrative and Billing Regulations. Prosthetics providers may include providers also enrolled as MassHealth participating durable medical equipment (DME) and supplies providers, oxygen and respiratory therapy equipment and supplies (OXY) providers, or orthotics services providers, who meet all program-specific requirements.

Prosthetic Service. The purchase, customization, fitting, repair, replacement, or adjustment of a prosthesis or component part, or other activity performed or equipment provided in accordance with 130 CMR 428.000.

Prosthetic Supplies. Products that are: (1) fabricated primarily and customarily to fulfill a medical purpose; (2) used in conjunction with a prosthesis or prosthetic equipment; (3) generally not useful in the absence of a prosthesis; and (4) non-reusable and disposable.

Prosthetics. The design, fitting, and attachment of an artificial replacement of a missing body part.

Service Facility. The place of business, physically accessible to MassHealth members, where prosthetic services, especially those involving fitting, adjustment, repair, and replacement of prostheses, are performed. A service facility does not include a MassHealth member’s place of residence.

428.403 Eligible Members

428.403: Eligible Members

(A) (1) MassHealth Members. MassHealth covers prosthetic services only when provided to eligible MassHealth members, subject to the restrictions and limitations in 130 CMR 428.000 and 450.000: Administrative and Billing Regulations. 130 CMR 450.105: Coverage Types specifically states, for each coverage type, which services are covered and which members are eligible to receive those services.

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(2) Age Limitations. In addition to any other restrictions and limitations set forth in 130 CMR 428.000 and 450.000: Administrative and Billing Regulations, MassHealth covers prosthetic services only when provided to eligible MassHealth members, subject to the age limitations set forth in Subchapter 6 of the Prosthetics Manual.

(3) Recipients of the Emergency Aid to the Elderly, Disabled and Children Program. For information on covered services for recipients of the Emergency Aid to the Elderly, Disabled and Children Program, see 130 CMR 450.106: Emergency Aid to the Elderly, Disabled and Children Program.

(B) For information on verifying member eligibility and coverage type, see 130 CMR 450.107: Eligible Members and the MassHealth Card.

428.404 Provider Eligibility

428.404: Provider Eligibility

(A) Provider Participation Requirements. Payment for services described in 130 CMR 428.000 is made to providers who are participating in MassHealth as prosthetic providers; to providers also enrolled as MassHealth participating DME providers; OXY providers, or orthotic services providers and who meet all program-specific requirements. Applicants must meet the requirements in 130 CMR 450.000: Administrative and Billing Regulations as well as the requirements in 130 CMR 428.000. Participating prosthetic providers must continue to meet provider eligibility participation requirements throughout the period of their provider contract with the MassHealth agency.

(B) In State. To participate in MassHealth, a provider with a service facility in Massachusetts must: (1) primarily engage in the business of providing prosthetic and repair services to the public; (2) meet all state and local requirements for engaging in such business; (3) be or employ a prosthetist currently certified by the American Board for Certification in Orthotics, Prosthetics, and Pedorthics Inc. (ABC), or the Board of Certification/Accreditation, International (BOC), unless the provider intends to solely provide breast prostheses and accessories, in which case the provider must employ, for each service facility location, at least one full-time certified mastectomy fitter, who is currently certified by the ABC or BOC. (4) be a Medicare provider; (5) have a service facility that is physically accessible to MassHealth members during reasonable business hours; (6) maintain a visible sign identifying the business and hours of operation; (7) maintain a primary business telephone listed under the name of the business in a local directory. The exclusive use of a pager, answering machine, or cell phone is prohibited; and (8) obtain a provider number from MassHealth and, if the provider intends to solely provide breast prostheses and accessories, be designated by the MassHealth agency as a specialty provider of certified mastectomy fitter services.

(C) Out of State. A provider with no service facility in Massachusetts may participate in MassHealth only if the provider participates in the Medicaid program of the state in which the provider primarily conducts business and otherwise meets the requirements of 130 CMR 428.404(A). Such a provider may receive payment for MassHealth services only as set forth in 130 CMR 450.109: Out-of-state Services.

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428.405 Provider Responsibility

428.405: Provider Responsibility

(A) The provider must ensure that all prosthetic equipment and supplies are: (1) clean (sterilized when appropriate); (2) in proper working condition; (3) functional; (4) free from defects; and (5) new and unused at the time of purchase.

(B) The provider must ensure that all prosthetic services are the most cost effective, given the medical need for which they are prescribed and the member's physical limitations.

(C) The provider must make a reasonable effort to purchase the item from the least costly reliable source by comparing prices charged by different suppliers for comparable items.

428.406 Covered Services

428.406: Covered Services

The MassHealth agency pays for only those prosthetic services listed in, and subject to the service limitations set forth in, Subchapter 6 of the Prosthetics Manual.

428.407 Service Limitations

428.407: Service Limitations

The service limitations set forth in Subchapter 6 of the Prosthetics Manual apply, subject to the Early and Periodic Screening, Diagnosis, and Treatment provisions set forth in 130 CMR 450.144: EPSDT Services: Diagnosis and Treatment(A).

428.408 Noncovered Services

428.408: Noncovered Services

The MassHealth agency does not pay for any of the following:

(A) any prosthetic services for which, under comparable circumstances, the provider does not customarily bill private patients who do not have health insurance;

(B) nonmedical prosthetic services. Equipment that is used primarily and customarily for a nonmedical purpose is not considered medical equipment, even if such equipment has a medically related use;

(C) storage of prosthetic equipment or associated items; and

(D) prosthetic services that are not both medically necessary in accordance with 130 CMR 450.204: Medical Necessity and reasonable for the treatment of a member's condition. This includes services that: (1) cannot reasonably be expected to make a meaningful contribution to the treatment of a member's condition or the performance of the member's activities of daily living; and (2) are more costly than a medically comparable and suitable alternative or that serve essentially the same purpose as equipment already available to the member.

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428.409 Prescription Requirements

428.409: Prescription Requirements

(A) The purchase of prosthetic equipment requires a written prescription signed by a licensed physician or an independent nurse practitioner. The prescription must be written on the prescriber's prescription form and must include the following information: (1) the member's name and address; (2) the member’s MassHealth identification number; (3) specific identification of the prescribed item; (4) medical justification for the use of the item, including the member’s diagnosis; (5) the prescriber's address and telephone number; and (6) the date on which the prescription was signed by the prescriber.

(B) The provider must keep the prescription on file for the period of time required by 130 CMR 450.205: Recordkeeping and Disclosure.

428.410 Prosthetic Equipment Provided to Institutionalized Members

428.410: Prosthetic Equipment Provided to Institutionalized Members

(A) Nursing Facilities. The MassHealth agency pays prosthetic providers for: (1) the purchase and repair of prosthetic equipment; and (2) prosthetic supplies provided for the personal full-time use of a member residing in a nursing facility.

(B) Institutions Licensed as Hospitals, Chronic Disease Hospitals, and Rehabilitation Hospitals. The MassHealth agency does not pay prosthetic providers for the purchase or repair of prosthetic equipment or for supplies provided to a hospitalized member, except for prosthetic equipment that is prescribed for home use after discharge. The hospital record must document the member’s discharge plan and that the date of discharge was before the purchase or repair of the prescribed item.

(C) Intermediate Care Facilities for the Mentally Retarded with 16 Beds or More (State Schools). (1) The MassHealth agency pays prosthetic providers or the purchase and repair of customized prosthetic equipment provided for the personal full-time use of a member residing in an ICF/MR with 16 beds or more (a state school) only if the customization precludes the use of the equipment by subsequent residents in that institution. (2) The MassHealth agency does not pay prosthetic providers for noncustomized equipment or supplies provided to a member residing in a state school.

(D) Rest Homes. The MassHealth agency pays prosthetic providers for the purchase and repair of prosthetic equipment and for associated supplies provided for the personal full-time use of a member residing in a rest home.

428.411 Repairs of Prosthetic Equipment

428.411: Repairs of Prosthetic Equipment

(A) The MassHealth agency pays for all repair services on an individual-consideration basis as described in 130 CMR 428.421.

(B) The provider of repair services is liable for the quality of the workmanship and parts, and for ensuring that repaired equipment is in proper working condition.

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(C) The provider of repair services must exhaust all manufacturer warrantees before submitting claims for repairs to prosthetic equipment to the MassHealth agency.

428.412 Prior Authorization

428.412: Prior Authorization

(A) Services that require prior authorization as a prerequisite for payment are identified in 130 CMR 428.000 or are listed in Subchapter 6 of the Prosthetics Manual with the designation (P.A.) appearing after the service description. To determine if prior authorization is required, the provider should review both 130 CMR 428.000 and Subchapter 6. Prior authorization determines only the medical necessity of the prescribed item or service and does not waive any other prerequisites to payment such as member eligibility or resort to health-insurance payment.

(B) The provider must request prior authorization in accordance with the billing instructions in Subchapter 5 of the Prosthetics Manual. Before determining the medical necessity of an item or service for which prior authorization is requested, the MassHealth agency may, at its discretion, require the prescriber to submit an assessment of the member's condition and the objectives of the requested service. The MassHealth agency may also, at its discretion, require an evaluation by a licensed prosthetist to determine whether the requested prosthetic service is useful to the member, given the member's physical condition and physical environment.

(C) Notice of Approval, Denial, or Modification of a Standard or Expedited Prior-authorization Request (1) The MassHealth agency or its designee acts on prior authorization requests in accordance with 130 CMR 450.303: Prior Authorization. (2) Notice of Approval. If the MassHealth agency or its designee approves a prior authorization request for DME, the MassHealth agency will send notice of its decision to the member and the DME provider, within the timeframe specified at 130 CMR 450.303: Prior Authorization. (3) Notice of Denial or Modification. If the MassHealth agency or its designee denies or approves with a modification a prior authorization request for DME, the MassHealth agency or its designee will notify the member and the DME provider, within the timeframe specified at 130 CMR 450.303: Prior Authorization. The notice will state the reason for the denial or modification and will inform the member of the right to appeal and of the appeal procedure in accordance with 130 CMR 610.000: MassHealth: Fair Hearing Rules. (4) Right of Appeal. A member may appeal a service denial or modification by requesting a fair hearing in accordance with 130 CMR 610.000: MassHealth: Fair Hearing Rules. (5) Notice of Deferral. If the MassHealth agency or its designee defers a prior authorization request due to an incomplete submission or lack of documentation to support medical necessity, the MassHealth agency or its designee will notify the member and the DME provider of the deferral and the reason for the deferral and will give the provider an opportunity to submit the incomplete or missing documentation. If the provider does not submit the required information within the timeframe specified at 130 CMR 450.303: Prior Authorization, the MassHealth agency or its designee will make a decision on the prior authorization request using all documentation and forms submitted to the MassHealth agency and will send notice of its decision to the provider and the member in accordance with 130 CMR 428.412(C).

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428.413 Procedure for Requesting Prior Authorization

428.413: Procedure for Requesting Prior Authorization

(A) The provider must obtain prior authorization from the MassHealth agency before providing any service that requires prior authorization. The provider must submit the Request for Prior Authorization within 90 days of the date of service requested on the prescription.

(B) The Request for Prior Authorization must document the adjusted acquisition cost (see 130 CMR 428.422) and the medical necessity of the requested service. The Request for Prior Authorization must contain the following documentation: (1) a copy of the invoice or invoices from the manufacturer for the equipment, disclosing all discounts; (2) a copy of a current prescription that must not be older than 90 days from the requested date of service (see 130 CMR 428.409 for information that must be included in the prescription); (3) if requested by the MassHealth agency, a current prosthetic evaluation for the equipment, performed independently of the provider by a licensed physician or prosthetist; (4) the date or projected date of service; (5) the projected duration of need for the equipment; and (6) if replacing existing equipment, the date the existing equipment was purchased.

428.414 Medicare Coverage

428.414: Medicare Coverage

(A) For Medicare and third-party-liability coverage, see 130 CMR 450.316 through 450.318.

(B) For Medicare-covered services that are provided to members who receive Medicare Part B benefits, the MassHealth agency does not require prior authorization.

(C) When Medicare denies a claim for prosthetic services or considers the services uncovered, the MassHealth agency requires prior authorization for those services that would require prior authorization for members without Medicare.

428.415 Early and Periodic Screening, Diagnosis and Treatment (EPSDT) Services

428.415: Early and Periodic Screening, Diagnosis and Treatment (EPSDT) Services

The MassHealth agency pays for all medically necessary prosthetics services for EPSDT- eligible members in accordance with 130 CMR 450.140: Early and Periodic Screening, Diagnosis and Treatment (EPSDT) Services: Introduction., without regard to service limitations described in 130 CMR 428.000, and with prior authorization.

(130 CMR 428.416 through 428.419 Reserved)

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428.420 Payment for Prosthetic Services

428.420: Payment for Prosthetic Services

(A) Payment to a provider for prosthetic equipment and supplies is subject to the conditions and limitations in 130 CMR 428.000 and 450.000: Administrative and Billing Regulations, and will be the lower of: (1) the provider's usual and customary charge to the general public; or (2) the fee set forth in the schedule of maximum allowable fees established by the Massachusetts Executive Office of Health and Human Services.

(B) Payment for the following services is included in the provider payment under 130 CMR 428.420(A). No separate payment is allowed for: (1) the fitting of the prosthesis; (2) instructing the member in the use of the prosthesis; (3) the cost of the component parts and accessory equipment; (4) repairs due to normal wear and tear within 90 days of the date of delivery; and (5) adjustments to the prosthesis and any prosthetic component made when fitting the prosthesis and for 90 days from the date of delivery, when the adjustments are not necessitated by changes in the member's functional abilities.

428.421 Individual Consideration

428.421: Individual Consideration

When the rate of payment for the purchase or repair of certain prosthetic equipment has not been established by the Executive Office of Health and Human Services, the MassHealth agency pays for the service based on individual consideration, subject to all other conditions of payment. Such items are identified in Subchapter 6 of the Prosthetics Manual by the designation (I.C.) next to the description of the item or service. The MassHealth agency determines the rate of payment for an individual-consideration item or service based on the provider’s report of services and a current invoice that indicates the provider’s adjusted acquisition cost as defined in 130 CMR 428.421 and 428.422. Payment for the fitting of a prosthesis is included in the adjusted acquisition cost. Providers must maintain adequate records to document the individual consideration claim and must provide these documents to the MassHealth agency and the Attorney General’s Medicaid Fraud Control Unit upon demand (see 130 CMR 450.205: Recordkeeping and Disclosure). Payment to a provider for an individual consideration claim is the lower of:

(A) the provider’s usual and customary charge to the general public; or

(B) the adjusted acquisition cost of the item plus a markup not to exceed: (1) 70% for any item whose adjusted acquisition cost is less than $100; (2) 50% for any item whose adjusted acquisition cost is $100 or greater and less than $200; (3) 45% for any item whose adjusted acquisition cost is $200 or greater and less than $300; or (4) 40% for any item whose adjusted acquisition cost is $300 or greater.

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428.422 Adjusted Acquisition Cost

428.422: Adjusted Acquisition Cost

(A) The provider must disclose all discounts, as defined in 130 CMR 428.402, and must reflect such discounts in the provider’s claim for payment pursuant to M.G.L. c. 118E, § 41, and U.S.C. § 1320a-7b(b)(3)(A). Any provider who fails to disclose and pass on any discounts to the MassHealth agency may be subject to civil and criminal penalties, including imprisonment, in accordance with state and federal laws.

(B) (1) Except where the manufacturer is the provider, the adjusted acquisition cost must not exceed the manufacturer’s current wholesale price and must be evidenced by the purchase price of the equipment or goods listed on a copy of the supplier’s invoice. (2) Where the manufacturer is the provider, the adjusted acquisition cost must not exceed the actual cost of manufacturing the items.

(C) Where the manufacturer is the provider of any item covered under 130 CMR 428.000, the manufacturer must submit documentation that demonstrates to the MassHealth agency’s satisfaction the actual cost of manufacturing the item, as set forth in 130 CMR 428.422(B).

(D) The provider must maintain the actual receipted invoice in the member’s record, and make it available to the Division and the Attorney General’s Medicaid Fraud Control Unit pursuant to 130 CMR 428.423 and 450.205: Recordkeeping and Disclosure.

(E) The provider may group together low-cost items (those with an adjusted acquisition cost of less than $5 each) to equal $5 or less, and bill the total adjusted acquisition cost plus the allowable markup listed in 130 CMR 428.421(B).

428.423 Recordkeeping Requirements

428.423: Recordkeeping Requirements

The provider must keep a record of all prosthetic services, nursing facility visits, and the medical necessity of such services provided to a member for the period of time required by 130 CMR 450.205: Recordkeeping and Disclosure. This record must include the following:

(A) a prescription for all purchases;

(B) a copy of the approved prior-authorization request for all prosthetic services requiring prior authorization;

(C) an acknowledgment of receipt, signed by the member or the member’s representative, of prescribed equipment or supplies, including: (1) the date of receipt of equipment or supplies; (2) the condition of the equipment or supplies (for example, whether it is in proper working order or is damaged); (3) the manufacturer, brand name, model number, and serial number of the equipment or supplies; (4) for repair services, a complete description of the service, including the manufacturer, brand name, model number, and serial number of the repaired item; and

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(5) next to the signature, an explanation of the representative’s relationship to the member by the individual acknowledging receipt. This individual cannot be associated with either the provider or the delivery service. (a) For routine delivery of supplies, the member must acknowledge receipt at least monthly. (b) A signature stamp may be used by or on behalf of a MassHealth member whose disability inhibits the member’s ability to write. A signature stamp may only be used by a member or the member’s representative, provided that the stamp is used by the member in his or her normal course of conducting business. A signature stamp cannot be used by anyone associated with either the provider or the delivery service;

(D) the actual invoice showing the cost to the provider of the materials (if the provider is not the manufacturer of the materials);

(E) documentation demonstrating the cost of manufacturing the item provided (if the provider is the manufacturer);

(F) copies of written warranties; and

(G) documentation demonstrating efforts under 130 CMR 428.405(C) to purchase the item from the least costly reliable source.

REGULATORY AUTHORITY

130 CMR 428.000: M.G.L. c. 118E, §§ 7 and 12.