Amended IN Senate April 12, 2023 CALIFORNIA LEGISLATURE 20232024 REGULAR SESSION Senate Bill No. 271Introduced by Senator Dodd(Coauthor: Senator Eggman)January 31, 2023An act to add Chapter 8.5 (commencing with Section 21300) to Division 8 of the Business and Professions Code, and to amend Section 14132.85 of the Welfare and Institutions Code, relating to business. powered wheelchairs.LEGISLATIVE COUNSEL'S DIGESTSB 271, as amended, Dodd. Powered wheelchairs: right to repair.Existing law, the Sherman Food, Drug, and Cosmetic Law, regulates the packaging, labeling, and advertising of drugs and devices, and is administered by the State Department of Public Health. Among other things, existing law prohibits a person from conducting a home medical device retail facility business in this state unless the person has obtained a license from the department and sets forth standards for operating that facility.Existing law authorizes the department to waive any licensing requirements for a medical device retail facility when, in the opinion of the department, a high standard of patient safety, consistent with good patient care, can be provided by the licensure of a home medical device retail facility that does not meet all of the requirements for licensure.This bill would would, except as specified, require an original manufacturer, as defined, manufacturer of a powered wheelchair wheelchair, as those terms are defined, to provide documentation, parts, embedded software, firmware, and tools used to inspect, diagnose, maintain, and repair the wheelchair to an owner or an independent repair provider for the purposes of providing service on the equipment in the state, on fair and reasonable terms and costs, as defined. The bill would also require an original manufacturer, for a powered wheelchair that contains an electronic security lock or other security-related function, to provide any documentation, parts, embedded software, firmware, or tools needed to reset the lock or function when disabled in the course of providing services, as specified. The bill would require an independent repair provider to provide a written notice to a customer before providing repair services, as specified. This bill would exempt from these requirements any trade secret information, as specified. The bill would subject an original equipment manufacturer who knowingly violates these provisions to specified civil penalties, and would authorize a person injured by a violation of these provisions and the Attorney General or a district attorney, county counsel, or city attorney to bring a civil action for this purpose. Existing law establishes the Medi-Cal program, which is administered by the State Department of Health Care Services, under which qualified low-income individuals receive health care services pursuant to a schedule of benefits. Existing law imposes requirements relating to complex rehabilitation technology services, including the repair of equipment and parts. Existing law authorizes the department to adopt utilization controls, as specified.This bill would prohibit the department from requiring prior authorization for the repair of a powered wheelchair. The bill would also prohibit a treatment authorization request for repair or replacement of a powered wheelchair from requiring a prescription or documentation of medical necessity from the treating practitioner requesting the repair or replacement if the powered wheelchair has already been approved for use by the patient, as specified.Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: NO Bill TextThe people of the State of California do enact as follows:SECTION 1. Chapter 8.5 (commencing with Section 21300) is added to Division 8 of the Business and Professions Code, to read: CHAPTER 8.5. Consumer Wheelchair Right to Repair21300. For the purposes of this chapter, the following definitions apply:(a) Authorized repair provider means an individual or business who is unaffiliated with an original equipment manufacturer and who has an arrangement with the original equipment manufacturer, for a definite or indefinite period, under which the original equipment manufacturer grants to the individual or business a license to use a trade name, service mark, or other proprietary identifier for the purposes of offering the services of inspection, diagnosis, maintenance, or repair of powered medical equipment under the name of the original equipment manufacturer, or other arrangement with the original equipment manufacturer to offer those services on behalf of the original equipment manufacturer. An original equipment manufacturer who offers the services of inspection, diagnosis, maintenance, or repair of its own powered medical equipment, and who does not have an arrangement described in this subdivision with an unaffiliated individual or business, shall be considered an authorized repair provider with respect to that equipment.(b) Documentation means any manual, diagram, reporting output, service code description, schematic, or other guidance or information used in effecting the services of inspection, diagnosis, maintenance, or repair of powered medical equipment.(c) Embedded software means any programmable instructions provided on firmware delivered with an electronic component of equipment, or with a part for that equipment, for purposes of equipment operation, including all relevant patches and fixes made by the manufacturer of the equipment or part for these purposes.(d) Equipment means a powered wheelchair.(e) (1) Fair and reasonable terms for obtaining a part, tool, documentation, or training course and materials means at costs and terms that are equivalent to the most favorable costs and terms under which an original equipment manufacturer offers the part, tool, documentation, services access method, or training course and materials to an authorized repair provider, including all of the following requirements:(A) Accounting for any discount, rebate, convenient means of delivery, means of enabling fully restored and updated functionality, rights of use, or other incentive or preference the original equipment manufacturer offers to an authorized repair provider, or any additional cost, burden, or impediment the original equipment manufacturer imposes on an independent repair provider.(B) Not conditioned on, or imposing, a substantial obligation or restriction that is not reasonably necessary for enabling a hospital or independent repair provider to engage in the diagnosis, maintenance, or repair of powered medical equipment made by, or on behalf of, the original equipment manufacturer.(C) Not conditioned on an arrangement described in subdivision (a).(2) For documentation, including any relevant updates, fair and reasonable terms also means at no charge, except that, when the documentation is requested in physical printed form, a charge may be included for the reasonable actual costs of preparing and sending the copy.(3) For software tools, fair and reasonable terms also means all of the following:(A) Provided at no charge and without requiring authorization or internet access.(B) Without imposing impediments to access or use, in the course of effecting the diagnosis, maintenance, or repair and without impairing the efficient and cost-effective performance of the diagnosis, maintenance, or repair.(C) Enables full functionality.(4) If an original equipment manufacturer does not utilize an authorized repair provider, fair and reasonable terms means an equitable price in consideration of the actual cost to the original equipment manufacturer to prepare and distribute the part, tool, service access method, or documentation, exclusive of any research and development costs incurred.(f) Firmware means a software program or set of instructions programmed on equipment, or on a part for that equipment, to allow the equipment or part to communicate within itself or with other computer hardware.(g) Independent repair provider means an individual or business, other than the manufacturer, that is engaged in the services of inspection, diagnosis, maintenance, or repair of equipment for purposes of returning it to the safety and performance specifications established by the manufacturer and to meet its original intended use.(h) Original equipment manufacturer means a business engaged in the business of selling, leasing, or otherwise supplying new equipment or parts manufactured by, or on behalf of, itself, to any individual or business.(i) Part means any replacement part, either new or used, made available by an original equipment manufacturer for purposes of effecting the services of inspection, diagnosis, maintenance, or repair of powered medical equipment manufactured by, or on behalf of, sold, or otherwise supplied by the original equipment manufacturer.(j) Powered wheelchair means a motorized wheeled device designed for use by a person with a physical disability.(j)(k) Tools means any software program, hardware implement, or other apparatus used in inspection, diagnosis, maintenance, or repair of powered medical equipment, including software or other mechanisms that provision, program, or pair a new part, calibrate functionality, or perform any other function required to bring the product back to fully functional condition.(k)(l) Trade secret has the same meaning as in subdivision (d) of Section 3426.1 of the Civil Code.21301. (a) For the purpose of providing services for equipment in the state, an original equipment manufacturer shall, with fair and reasonable terms and costs, make available to an independent repair provider or owner of the manufacturers equipment, any documentation, parts, embedded software, firmware, or tools that are intended for use with the equipment or any part, including updates to documentation, parts, embedded software, firmware, or tools.(b) With respect to equipment that contains an electronic security lock or other security-related function, an original equipment manufacturer shall, with fair and reasonable terms and costs, make available to independent repair providers and owners any documentation, parts, embedded software, firmware, or tools needed to reset the lock or function when disabled in the course of providing services. The manufacturer may make the documentation, parts, embedded software, firmware, or tools available to independent repair providers and owners through appropriate secure release systems.(c) For powered wheelchairs subject to Section 14132.8 of the Welfare and Institutions Code, this section shall not apply to any part that would require programmability, calibration, or clinical involvement to ensure appropriate patient seating and positioning. Items included in this section for powered wheelchairs subject to Section 14132.8 of the Welfare and Institutions Code shall include:(1) Batteries.(2) Battery chargers.(3) Nonprogrammable joysticks.(4) Joystick housings or brackets.(5) Wheel assembly.(6) Nonpositioning accessories.(7) Antitip devices.(8) Armrests, excluding positioning components designed for adjustment by a therapist or assistive technology professional.(9) Caster spheres.(10) Cosmetic shrouding.(11) Floor mats.(12) Floor plates.(13) Nonpowered leg lowerers.21302. (a) An original equipment manufacturer who knowingly violates any provision of this chapter, or who reasonably should have known that they violated any provision of this chapter, shall be liable for a civil penalty not to exceed ten thousand dollars ($10,000) per piece of equipment for the first violation, and not to exceed five hundred thousand dollars ($500,000) for each series of related violations.(b) An original equipment manufacturer who violates a court order or injunction issued pursuant to this chapter shall be liable for a civil penalty not to exceed ten thousand dollars ($10,000) per violation.(c) (1) Any person injured by violation of this chapter may bring a civil action for damages or other appropriate relief.(2) The Attorney General, district attorney, county counsel, city prosecutor, or city attorney may bring a civil action in the name of the state for violation of this chapter.(d) If the action is brought by the Attorney General, one-half of the penalty collected shall be paid to the treasurer of the county in which the judgment was entered, and one-half to the State Treasurer. If brought by a district attorney or county counsel, the entire amount of penalty collected shall be paid to the treasurer of the county in which the judgment was entered. If brought by a city attorney or city prosecutor, one-half of the penalty shall be paid to the treasurer of the county and one-half to the city.(e) The penalties collected pursuant to this section by the Attorney General may be expended by the Attorney General, upon appropriation by the Legislature, to enforce this chapter.21303. An independent repair provider that is not an authorized repair provider shall provide a written notice to any customer before providing repairs that contains the following information:(a) The independent repair provider is not an authorized repair provider for the product.(b) The consumer may wish to review the terms and conditions of any warranty for the equipment, as repairs not performed by a designated authorized repair provider could potentially affect the warranty.(c) Warranties for consumer products are governed by the federal Magnuson-Moss Warranty Act (Chapter 50 (commencing with Section 2301) of Title 15 of the United States Code), which gives consumers rights and protections that apply over any conflicting provisions in the warranty.(d) Under Magnuson-Moss, a warranty cannot generally require that maintenance repairs be performed only by an authorized repair provider, unless the Federal Trade Commission waives this prohibition, or the repair is provided free of charge, pursuant to that warranty.(e) Under Magnuson-Moss, if damage to equipment is shown to be caused by faulty nonbrand equipment or by faulty repair by a nonauthorized repair provider, that damage may not be covered by the warranty, but the warranty may otherwise remain in effect.(f) Under Section 14019.4 of the Welfare and Institutions Code, an independent repair provider that is a Medi-Cal enrolled provider is prohibited from seeking reimbursement or attempting to obtain payment for the cost of covered services from a Medi-Cal applicant or recipient, unless the beneficiary owes a share of the cost, as described in subdivision (g) of that section.21303.21304. (a) This chapter does not require an original equipment manufacturer to divulge a trade secret, except as necessary to provide documentation, parts, tools, service access methods, and training courses and materials on fair and reasonable terms.(1) An original equipment manufacturer may redact documentation to remove trade secrets from the documentation before providing access to the documentation if the usability of the redacted documentation for the purpose of providing services is not diminished.(2) An original equipment manufacturer may withhold information regarding a component of, design of, functionality of, or process of developing a part, embedded software, firmware, or a tool if the information is a trade secret and the usability of the part, embedded software, firmware, or tool for the purpose of providing services is not diminished.(b) This chapter does not require an original equipment manufacturer to make available a part if the part is no longer available to the original equipment manufacturer.(c) An original equipment manufacturer is not liable for faulty or otherwise improper repairs provided by independent repair providers or owners.(d) This chapter shall not be construed to alter the terms of any arrangement described in subdivision (a) of Section 21300 in force between an authorized repair provider and an original equipment manufacturer, including, but not limited to, the performance or provision of warranty or recall repair work by an authorized repair provider on behalf of an original equipment manufacturer pursuant to an arrangement described in subdivision (a) of Section 21300, except that any provision that purports to waive, avoid, restrict, or limit the original equipment manufacturers obligations to comply with this chapter shall be void and unenforceable.(e) This chapter shall not be construed to exempt an original equipment manufacturer from a products liability claim that is otherwise authorized by law.21304.21305. This chapter applies with respect to equipment sold or in use on or after January 1, 2024.SEC. 2. Section 14132.85 of the Welfare and Institutions Code is amended to read:14132.85. (a) For purposes of this section, the following definitions apply:(1) Complex needs patient means an individual with a diagnosis or medical condition that results in significant physical impairment or functional limitation. Complex needs patient includes, but is not limited to, individuals with spinal cord injury, traumatic brain injury, cerebral palsy, muscular dystrophy, spina bifida, osteogenesis imperfecta, arthrogryposis, amyotrophic lateral sclerosis, multiple sclerosis, demyelinating disease, myelopathy, myopathy, progressive muscular atrophy, anterior horn cell disease, post-polio syndrome, cerebellar degeneration, dystonia, Huntingtons disease, spinocerebellar disease, and the types of amputation, paralysis, or paresis that result in significant physical impairment or functional limitation. Complex needs patient does not negate the requirement that an individual meet medical necessity requirements under authority rules to qualify for receiving complex rehabilitation technology.(2) Complex rehabilitation technology means items classified within the federal Medicare Program as of January 1, 2021, as durable medical equipment that are individually configured for individuals to meet their specific and unique medical, physical, and functional needs and capacities for basic activities of daily living and instrumental activities of daily living identified as medically necessary. These items include, but are not limited to, complex rehabilitation manual and power wheelchairs, power seat elevation or power standing components of power wheelchairs, seating and positioning items, other specialized equipment such as adaptive bath equipment, standing frames, gait trainers, and specialized strollers, and related options and accessories.(3) Complex rehabilitation technology services includes the application of enabling systems designed and assembled to meet the needs of a patient experiencing any permanent or long-term loss or abnormality of physical or anatomical structure or function with respect to mobility or other function or need. These services include, but are not limited to, all of the following:(A) Evaluating the needs of a patient with a disability, including an assessment of the patient for the purpose of ensuring that the proposed equipment is appropriate.(B) Documenting medical necessity.(C) Selecting, fitting, customizing, maintaining, assembling, repairing, replacing, picking up and delivering, and testing equipment and parts.(D) Training the patient who will use the technology or any individual who assists the patient in using the complex rehabilitation technology.(4) Qualified health care professional means an individual who has no financial relationship to the provider of complex rehabilitation technology and is any of the following:(A) A physical therapist licensed pursuant to Chapter 5.7 (commencing with Section 2600) of Division 2 of the Business and Professions Code.(B) An occupational therapist licensed pursuant to Chapter 5.6 (commencing with Section 2570) of Division 2 of the Business and Professions Code.(C) Other licensed health care professional, approved by the department, and who performs specialty evaluations within the professionals scope of practice.(5) Qualified rehabilitation technology professional means an individual who meets either of the following:(A) Holds the credential of Assistive Technology Professional (ATP) from the Rehabilitation Engineering and Assistive Technology Society of North America.(B) Holds the credential of Certified Complex Rehabilitation Technology Supplier (CRTS) from the National Registry of Rehabilitation Technology Suppliers.(b) A provider of complex rehabilitation technology to a Medi-Cal beneficiary shall comply with all of the following:(1) Meet the supplier and quality standards established for a durable medical equipment supplier under the federal Medicare Program and be enrolled as a provider in the Medi-Cal program.(2) Be accredited by a recognized accrediting organization as a supplier of complex rehabilitation technology.(3) Employ at least one qualified rehabilitation technology professional as a W-2 employee (receiving a W-2 tax form from the provider) for each distribution location.(4) Have the qualified rehabilitation technology professional physically present for the evaluation, either in person or remotely if necessary, directly involved in determining the specific complex rehabilitation technology appropriate for the patient, and directly involved with, or closely supervised in, the final fitting and delivery of the complex rehabilitation technology.(5) Maintain a reasonable supply of parts, adequate physical facilities, and qualified service or repair technicians, and provide patients with prompt services and repair for all complex rehabilitation technology supplied.(6) Provide written information at the time of delivery of complex rehabilitation technology regarding how the patient may receive services and repair.(c) For complex needs patients receiving a complex rehabilitation manual wheelchair, power wheelchair, or seating component, the patient shall be evaluated, either in person or remotely if necessary, by both of the following:(1) A qualified health care professional.(2) A qualified rehabilitation technology professional.(d) A medical provider shall conduct a physical examination of an individual, either in person or remotely if necessary, before prescribing a power wheelchair or scooter for a Medi-Cal beneficiary. The medical provider shall complete a certificate of medical necessity that documents the medical condition that necessitates the power wheelchair or scooter, and verifies that the patient is capable of using the wheelchair or scooter safely.(e) (1) The department may adopt utilization controls, including a specialty evaluation by a qualified health care professional, as defined in paragraph (4) of subdivision (a). The Except as provided in paragraph (2), the department may adopt any other additional utilization controls for complex rehabilitation technology, as appropriate.(2) (A) The department shall not require prior authorization for the repair of a powered wheelchair.(B) A treatment authorization request for repair or replacement of a powered wheelchair shall not require a prescription or documentation of medical necessity from the treating practitioner requesting the repair or replacement if the powered wheelchair has already been approved for use by the patient.(f) The department shall seek any necessary federal approvals for the implementation of this section. This section shall be implemented only to the extent that any necessary federal approvals are obtained and federal financial participation is available and is not otherwise jeopardized.
Amended IN Senate April 12, 2023 CALIFORNIA LEGISLATURE 20232024 REGULAR SESSION Senate Bill No. 271Introduced by Senator Dodd(Coauthor: Senator Eggman)January 31, 2023An act to add Chapter 8.5 (commencing with Section 21300) to Division 8 of the Business and Professions Code, and to amend Section 14132.85 of the Welfare and Institutions Code, relating to business. powered wheelchairs.LEGISLATIVE COUNSEL'S DIGESTSB 271, as amended, Dodd. Powered wheelchairs: right to repair.Existing law, the Sherman Food, Drug, and Cosmetic Law, regulates the packaging, labeling, and advertising of drugs and devices, and is administered by the State Department of Public Health. Among other things, existing law prohibits a person from conducting a home medical device retail facility business in this state unless the person has obtained a license from the department and sets forth standards for operating that facility.Existing law authorizes the department to waive any licensing requirements for a medical device retail facility when, in the opinion of the department, a high standard of patient safety, consistent with good patient care, can be provided by the licensure of a home medical device retail facility that does not meet all of the requirements for licensure.This bill would would, except as specified, require an original manufacturer, as defined, manufacturer of a powered wheelchair wheelchair, as those terms are defined, to provide documentation, parts, embedded software, firmware, and tools used to inspect, diagnose, maintain, and repair the wheelchair to an owner or an independent repair provider for the purposes of providing service on the equipment in the state, on fair and reasonable terms and costs, as defined. The bill would also require an original manufacturer, for a powered wheelchair that contains an electronic security lock or other security-related function, to provide any documentation, parts, embedded software, firmware, or tools needed to reset the lock or function when disabled in the course of providing services, as specified. The bill would require an independent repair provider to provide a written notice to a customer before providing repair services, as specified. This bill would exempt from these requirements any trade secret information, as specified. The bill would subject an original equipment manufacturer who knowingly violates these provisions to specified civil penalties, and would authorize a person injured by a violation of these provisions and the Attorney General or a district attorney, county counsel, or city attorney to bring a civil action for this purpose. Existing law establishes the Medi-Cal program, which is administered by the State Department of Health Care Services, under which qualified low-income individuals receive health care services pursuant to a schedule of benefits. Existing law imposes requirements relating to complex rehabilitation technology services, including the repair of equipment and parts. Existing law authorizes the department to adopt utilization controls, as specified.This bill would prohibit the department from requiring prior authorization for the repair of a powered wheelchair. The bill would also prohibit a treatment authorization request for repair or replacement of a powered wheelchair from requiring a prescription or documentation of medical necessity from the treating practitioner requesting the repair or replacement if the powered wheelchair has already been approved for use by the patient, as specified.Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: NO
Amended IN Senate April 12, 2023
Amended IN Senate April 12, 2023
CALIFORNIA LEGISLATURE 20232024 REGULAR SESSION
Senate Bill
No. 271
Introduced by Senator Dodd(Coauthor: Senator Eggman)January 31, 2023
Introduced by Senator Dodd(Coauthor: Senator Eggman)
January 31, 2023
An act to add Chapter 8.5 (commencing with Section 21300) to Division 8 of the Business and Professions Code, and to amend Section 14132.85 of the Welfare and Institutions Code, relating to business. powered wheelchairs.
LEGISLATIVE COUNSEL'S DIGEST
## LEGISLATIVE COUNSEL'S DIGEST
SB 271, as amended, Dodd. Powered wheelchairs: right to repair.
Existing law, the Sherman Food, Drug, and Cosmetic Law, regulates the packaging, labeling, and advertising of drugs and devices, and is administered by the State Department of Public Health. Among other things, existing law prohibits a person from conducting a home medical device retail facility business in this state unless the person has obtained a license from the department and sets forth standards for operating that facility.Existing law authorizes the department to waive any licensing requirements for a medical device retail facility when, in the opinion of the department, a high standard of patient safety, consistent with good patient care, can be provided by the licensure of a home medical device retail facility that does not meet all of the requirements for licensure.This bill would would, except as specified, require an original manufacturer, as defined, manufacturer of a powered wheelchair wheelchair, as those terms are defined, to provide documentation, parts, embedded software, firmware, and tools used to inspect, diagnose, maintain, and repair the wheelchair to an owner or an independent repair provider for the purposes of providing service on the equipment in the state, on fair and reasonable terms and costs, as defined. The bill would also require an original manufacturer, for a powered wheelchair that contains an electronic security lock or other security-related function, to provide any documentation, parts, embedded software, firmware, or tools needed to reset the lock or function when disabled in the course of providing services, as specified. The bill would require an independent repair provider to provide a written notice to a customer before providing repair services, as specified. This bill would exempt from these requirements any trade secret information, as specified. The bill would subject an original equipment manufacturer who knowingly violates these provisions to specified civil penalties, and would authorize a person injured by a violation of these provisions and the Attorney General or a district attorney, county counsel, or city attorney to bring a civil action for this purpose. Existing law establishes the Medi-Cal program, which is administered by the State Department of Health Care Services, under which qualified low-income individuals receive health care services pursuant to a schedule of benefits. Existing law imposes requirements relating to complex rehabilitation technology services, including the repair of equipment and parts. Existing law authorizes the department to adopt utilization controls, as specified.This bill would prohibit the department from requiring prior authorization for the repair of a powered wheelchair. The bill would also prohibit a treatment authorization request for repair or replacement of a powered wheelchair from requiring a prescription or documentation of medical necessity from the treating practitioner requesting the repair or replacement if the powered wheelchair has already been approved for use by the patient, as specified.
Existing law, the Sherman Food, Drug, and Cosmetic Law, regulates the packaging, labeling, and advertising of drugs and devices, and is administered by the State Department of Public Health. Among other things, existing law prohibits a person from conducting a home medical device retail facility business in this state unless the person has obtained a license from the department and sets forth standards for operating that facility.
Existing law authorizes the department to waive any licensing requirements for a medical device retail facility when, in the opinion of the department, a high standard of patient safety, consistent with good patient care, can be provided by the licensure of a home medical device retail facility that does not meet all of the requirements for licensure.
This bill would would, except as specified, require an original manufacturer, as defined, manufacturer of a powered wheelchair wheelchair, as those terms are defined, to provide documentation, parts, embedded software, firmware, and tools used to inspect, diagnose, maintain, and repair the wheelchair to an owner or an independent repair provider for the purposes of providing service on the equipment in the state, on fair and reasonable terms and costs, as defined. The bill would also require an original manufacturer, for a powered wheelchair that contains an electronic security lock or other security-related function, to provide any documentation, parts, embedded software, firmware, or tools needed to reset the lock or function when disabled in the course of providing services, as specified. The bill would require an independent repair provider to provide a written notice to a customer before providing repair services, as specified.
This bill would exempt from these requirements any trade secret information, as specified. The bill would subject an original equipment manufacturer who knowingly violates these provisions to specified civil penalties, and would authorize a person injured by a violation of these provisions and the Attorney General or a district attorney, county counsel, or city attorney to bring a civil action for this purpose.
Existing law establishes the Medi-Cal program, which is administered by the State Department of Health Care Services, under which qualified low-income individuals receive health care services pursuant to a schedule of benefits. Existing law imposes requirements relating to complex rehabilitation technology services, including the repair of equipment and parts. Existing law authorizes the department to adopt utilization controls, as specified.
This bill would prohibit the department from requiring prior authorization for the repair of a powered wheelchair. The bill would also prohibit a treatment authorization request for repair or replacement of a powered wheelchair from requiring a prescription or documentation of medical necessity from the treating practitioner requesting the repair or replacement if the powered wheelchair has already been approved for use by the patient, as specified.
## Digest Key
## Bill Text
The people of the State of California do enact as follows:SECTION 1. Chapter 8.5 (commencing with Section 21300) is added to Division 8 of the Business and Professions Code, to read: CHAPTER 8.5. Consumer Wheelchair Right to Repair21300. For the purposes of this chapter, the following definitions apply:(a) Authorized repair provider means an individual or business who is unaffiliated with an original equipment manufacturer and who has an arrangement with the original equipment manufacturer, for a definite or indefinite period, under which the original equipment manufacturer grants to the individual or business a license to use a trade name, service mark, or other proprietary identifier for the purposes of offering the services of inspection, diagnosis, maintenance, or repair of powered medical equipment under the name of the original equipment manufacturer, or other arrangement with the original equipment manufacturer to offer those services on behalf of the original equipment manufacturer. An original equipment manufacturer who offers the services of inspection, diagnosis, maintenance, or repair of its own powered medical equipment, and who does not have an arrangement described in this subdivision with an unaffiliated individual or business, shall be considered an authorized repair provider with respect to that equipment.(b) Documentation means any manual, diagram, reporting output, service code description, schematic, or other guidance or information used in effecting the services of inspection, diagnosis, maintenance, or repair of powered medical equipment.(c) Embedded software means any programmable instructions provided on firmware delivered with an electronic component of equipment, or with a part for that equipment, for purposes of equipment operation, including all relevant patches and fixes made by the manufacturer of the equipment or part for these purposes.(d) Equipment means a powered wheelchair.(e) (1) Fair and reasonable terms for obtaining a part, tool, documentation, or training course and materials means at costs and terms that are equivalent to the most favorable costs and terms under which an original equipment manufacturer offers the part, tool, documentation, services access method, or training course and materials to an authorized repair provider, including all of the following requirements:(A) Accounting for any discount, rebate, convenient means of delivery, means of enabling fully restored and updated functionality, rights of use, or other incentive or preference the original equipment manufacturer offers to an authorized repair provider, or any additional cost, burden, or impediment the original equipment manufacturer imposes on an independent repair provider.(B) Not conditioned on, or imposing, a substantial obligation or restriction that is not reasonably necessary for enabling a hospital or independent repair provider to engage in the diagnosis, maintenance, or repair of powered medical equipment made by, or on behalf of, the original equipment manufacturer.(C) Not conditioned on an arrangement described in subdivision (a).(2) For documentation, including any relevant updates, fair and reasonable terms also means at no charge, except that, when the documentation is requested in physical printed form, a charge may be included for the reasonable actual costs of preparing and sending the copy.(3) For software tools, fair and reasonable terms also means all of the following:(A) Provided at no charge and without requiring authorization or internet access.(B) Without imposing impediments to access or use, in the course of effecting the diagnosis, maintenance, or repair and without impairing the efficient and cost-effective performance of the diagnosis, maintenance, or repair.(C) Enables full functionality.(4) If an original equipment manufacturer does not utilize an authorized repair provider, fair and reasonable terms means an equitable price in consideration of the actual cost to the original equipment manufacturer to prepare and distribute the part, tool, service access method, or documentation, exclusive of any research and development costs incurred.(f) Firmware means a software program or set of instructions programmed on equipment, or on a part for that equipment, to allow the equipment or part to communicate within itself or with other computer hardware.(g) Independent repair provider means an individual or business, other than the manufacturer, that is engaged in the services of inspection, diagnosis, maintenance, or repair of equipment for purposes of returning it to the safety and performance specifications established by the manufacturer and to meet its original intended use.(h) Original equipment manufacturer means a business engaged in the business of selling, leasing, or otherwise supplying new equipment or parts manufactured by, or on behalf of, itself, to any individual or business.(i) Part means any replacement part, either new or used, made available by an original equipment manufacturer for purposes of effecting the services of inspection, diagnosis, maintenance, or repair of powered medical equipment manufactured by, or on behalf of, sold, or otherwise supplied by the original equipment manufacturer.(j) Powered wheelchair means a motorized wheeled device designed for use by a person with a physical disability.(j)(k) Tools means any software program, hardware implement, or other apparatus used in inspection, diagnosis, maintenance, or repair of powered medical equipment, including software or other mechanisms that provision, program, or pair a new part, calibrate functionality, or perform any other function required to bring the product back to fully functional condition.(k)(l) Trade secret has the same meaning as in subdivision (d) of Section 3426.1 of the Civil Code.21301. (a) For the purpose of providing services for equipment in the state, an original equipment manufacturer shall, with fair and reasonable terms and costs, make available to an independent repair provider or owner of the manufacturers equipment, any documentation, parts, embedded software, firmware, or tools that are intended for use with the equipment or any part, including updates to documentation, parts, embedded software, firmware, or tools.(b) With respect to equipment that contains an electronic security lock or other security-related function, an original equipment manufacturer shall, with fair and reasonable terms and costs, make available to independent repair providers and owners any documentation, parts, embedded software, firmware, or tools needed to reset the lock or function when disabled in the course of providing services. The manufacturer may make the documentation, parts, embedded software, firmware, or tools available to independent repair providers and owners through appropriate secure release systems.(c) For powered wheelchairs subject to Section 14132.8 of the Welfare and Institutions Code, this section shall not apply to any part that would require programmability, calibration, or clinical involvement to ensure appropriate patient seating and positioning. Items included in this section for powered wheelchairs subject to Section 14132.8 of the Welfare and Institutions Code shall include:(1) Batteries.(2) Battery chargers.(3) Nonprogrammable joysticks.(4) Joystick housings or brackets.(5) Wheel assembly.(6) Nonpositioning accessories.(7) Antitip devices.(8) Armrests, excluding positioning components designed for adjustment by a therapist or assistive technology professional.(9) Caster spheres.(10) Cosmetic shrouding.(11) Floor mats.(12) Floor plates.(13) Nonpowered leg lowerers.21302. (a) An original equipment manufacturer who knowingly violates any provision of this chapter, or who reasonably should have known that they violated any provision of this chapter, shall be liable for a civil penalty not to exceed ten thousand dollars ($10,000) per piece of equipment for the first violation, and not to exceed five hundred thousand dollars ($500,000) for each series of related violations.(b) An original equipment manufacturer who violates a court order or injunction issued pursuant to this chapter shall be liable for a civil penalty not to exceed ten thousand dollars ($10,000) per violation.(c) (1) Any person injured by violation of this chapter may bring a civil action for damages or other appropriate relief.(2) The Attorney General, district attorney, county counsel, city prosecutor, or city attorney may bring a civil action in the name of the state for violation of this chapter.(d) If the action is brought by the Attorney General, one-half of the penalty collected shall be paid to the treasurer of the county in which the judgment was entered, and one-half to the State Treasurer. If brought by a district attorney or county counsel, the entire amount of penalty collected shall be paid to the treasurer of the county in which the judgment was entered. If brought by a city attorney or city prosecutor, one-half of the penalty shall be paid to the treasurer of the county and one-half to the city.(e) The penalties collected pursuant to this section by the Attorney General may be expended by the Attorney General, upon appropriation by the Legislature, to enforce this chapter.21303. An independent repair provider that is not an authorized repair provider shall provide a written notice to any customer before providing repairs that contains the following information:(a) The independent repair provider is not an authorized repair provider for the product.(b) The consumer may wish to review the terms and conditions of any warranty for the equipment, as repairs not performed by a designated authorized repair provider could potentially affect the warranty.(c) Warranties for consumer products are governed by the federal Magnuson-Moss Warranty Act (Chapter 50 (commencing with Section 2301) of Title 15 of the United States Code), which gives consumers rights and protections that apply over any conflicting provisions in the warranty.(d) Under Magnuson-Moss, a warranty cannot generally require that maintenance repairs be performed only by an authorized repair provider, unless the Federal Trade Commission waives this prohibition, or the repair is provided free of charge, pursuant to that warranty.(e) Under Magnuson-Moss, if damage to equipment is shown to be caused by faulty nonbrand equipment or by faulty repair by a nonauthorized repair provider, that damage may not be covered by the warranty, but the warranty may otherwise remain in effect.(f) Under Section 14019.4 of the Welfare and Institutions Code, an independent repair provider that is a Medi-Cal enrolled provider is prohibited from seeking reimbursement or attempting to obtain payment for the cost of covered services from a Medi-Cal applicant or recipient, unless the beneficiary owes a share of the cost, as described in subdivision (g) of that section.21303.21304. (a) This chapter does not require an original equipment manufacturer to divulge a trade secret, except as necessary to provide documentation, parts, tools, service access methods, and training courses and materials on fair and reasonable terms.(1) An original equipment manufacturer may redact documentation to remove trade secrets from the documentation before providing access to the documentation if the usability of the redacted documentation for the purpose of providing services is not diminished.(2) An original equipment manufacturer may withhold information regarding a component of, design of, functionality of, or process of developing a part, embedded software, firmware, or a tool if the information is a trade secret and the usability of the part, embedded software, firmware, or tool for the purpose of providing services is not diminished.(b) This chapter does not require an original equipment manufacturer to make available a part if the part is no longer available to the original equipment manufacturer.(c) An original equipment manufacturer is not liable for faulty or otherwise improper repairs provided by independent repair providers or owners.(d) This chapter shall not be construed to alter the terms of any arrangement described in subdivision (a) of Section 21300 in force between an authorized repair provider and an original equipment manufacturer, including, but not limited to, the performance or provision of warranty or recall repair work by an authorized repair provider on behalf of an original equipment manufacturer pursuant to an arrangement described in subdivision (a) of Section 21300, except that any provision that purports to waive, avoid, restrict, or limit the original equipment manufacturers obligations to comply with this chapter shall be void and unenforceable.(e) This chapter shall not be construed to exempt an original equipment manufacturer from a products liability claim that is otherwise authorized by law.21304.21305. This chapter applies with respect to equipment sold or in use on or after January 1, 2024.SEC. 2. Section 14132.85 of the Welfare and Institutions Code is amended to read:14132.85. (a) For purposes of this section, the following definitions apply:(1) Complex needs patient means an individual with a diagnosis or medical condition that results in significant physical impairment or functional limitation. Complex needs patient includes, but is not limited to, individuals with spinal cord injury, traumatic brain injury, cerebral palsy, muscular dystrophy, spina bifida, osteogenesis imperfecta, arthrogryposis, amyotrophic lateral sclerosis, multiple sclerosis, demyelinating disease, myelopathy, myopathy, progressive muscular atrophy, anterior horn cell disease, post-polio syndrome, cerebellar degeneration, dystonia, Huntingtons disease, spinocerebellar disease, and the types of amputation, paralysis, or paresis that result in significant physical impairment or functional limitation. Complex needs patient does not negate the requirement that an individual meet medical necessity requirements under authority rules to qualify for receiving complex rehabilitation technology.(2) Complex rehabilitation technology means items classified within the federal Medicare Program as of January 1, 2021, as durable medical equipment that are individually configured for individuals to meet their specific and unique medical, physical, and functional needs and capacities for basic activities of daily living and instrumental activities of daily living identified as medically necessary. These items include, but are not limited to, complex rehabilitation manual and power wheelchairs, power seat elevation or power standing components of power wheelchairs, seating and positioning items, other specialized equipment such as adaptive bath equipment, standing frames, gait trainers, and specialized strollers, and related options and accessories.(3) Complex rehabilitation technology services includes the application of enabling systems designed and assembled to meet the needs of a patient experiencing any permanent or long-term loss or abnormality of physical or anatomical structure or function with respect to mobility or other function or need. These services include, but are not limited to, all of the following:(A) Evaluating the needs of a patient with a disability, including an assessment of the patient for the purpose of ensuring that the proposed equipment is appropriate.(B) Documenting medical necessity.(C) Selecting, fitting, customizing, maintaining, assembling, repairing, replacing, picking up and delivering, and testing equipment and parts.(D) Training the patient who will use the technology or any individual who assists the patient in using the complex rehabilitation technology.(4) Qualified health care professional means an individual who has no financial relationship to the provider of complex rehabilitation technology and is any of the following:(A) A physical therapist licensed pursuant to Chapter 5.7 (commencing with Section 2600) of Division 2 of the Business and Professions Code.(B) An occupational therapist licensed pursuant to Chapter 5.6 (commencing with Section 2570) of Division 2 of the Business and Professions Code.(C) Other licensed health care professional, approved by the department, and who performs specialty evaluations within the professionals scope of practice.(5) Qualified rehabilitation technology professional means an individual who meets either of the following:(A) Holds the credential of Assistive Technology Professional (ATP) from the Rehabilitation Engineering and Assistive Technology Society of North America.(B) Holds the credential of Certified Complex Rehabilitation Technology Supplier (CRTS) from the National Registry of Rehabilitation Technology Suppliers.(b) A provider of complex rehabilitation technology to a Medi-Cal beneficiary shall comply with all of the following:(1) Meet the supplier and quality standards established for a durable medical equipment supplier under the federal Medicare Program and be enrolled as a provider in the Medi-Cal program.(2) Be accredited by a recognized accrediting organization as a supplier of complex rehabilitation technology.(3) Employ at least one qualified rehabilitation technology professional as a W-2 employee (receiving a W-2 tax form from the provider) for each distribution location.(4) Have the qualified rehabilitation technology professional physically present for the evaluation, either in person or remotely if necessary, directly involved in determining the specific complex rehabilitation technology appropriate for the patient, and directly involved with, or closely supervised in, the final fitting and delivery of the complex rehabilitation technology.(5) Maintain a reasonable supply of parts, adequate physical facilities, and qualified service or repair technicians, and provide patients with prompt services and repair for all complex rehabilitation technology supplied.(6) Provide written information at the time of delivery of complex rehabilitation technology regarding how the patient may receive services and repair.(c) For complex needs patients receiving a complex rehabilitation manual wheelchair, power wheelchair, or seating component, the patient shall be evaluated, either in person or remotely if necessary, by both of the following:(1) A qualified health care professional.(2) A qualified rehabilitation technology professional.(d) A medical provider shall conduct a physical examination of an individual, either in person or remotely if necessary, before prescribing a power wheelchair or scooter for a Medi-Cal beneficiary. The medical provider shall complete a certificate of medical necessity that documents the medical condition that necessitates the power wheelchair or scooter, and verifies that the patient is capable of using the wheelchair or scooter safely.(e) (1) The department may adopt utilization controls, including a specialty evaluation by a qualified health care professional, as defined in paragraph (4) of subdivision (a). The Except as provided in paragraph (2), the department may adopt any other additional utilization controls for complex rehabilitation technology, as appropriate.(2) (A) The department shall not require prior authorization for the repair of a powered wheelchair.(B) A treatment authorization request for repair or replacement of a powered wheelchair shall not require a prescription or documentation of medical necessity from the treating practitioner requesting the repair or replacement if the powered wheelchair has already been approved for use by the patient.(f) The department shall seek any necessary federal approvals for the implementation of this section. This section shall be implemented only to the extent that any necessary federal approvals are obtained and federal financial participation is available and is not otherwise jeopardized.
The people of the State of California do enact as follows:
## The people of the State of California do enact as follows:
SECTION 1. Chapter 8.5 (commencing with Section 21300) is added to Division 8 of the Business and Professions Code, to read: CHAPTER 8.5. Consumer Wheelchair Right to Repair21300. For the purposes of this chapter, the following definitions apply:(a) Authorized repair provider means an individual or business who is unaffiliated with an original equipment manufacturer and who has an arrangement with the original equipment manufacturer, for a definite or indefinite period, under which the original equipment manufacturer grants to the individual or business a license to use a trade name, service mark, or other proprietary identifier for the purposes of offering the services of inspection, diagnosis, maintenance, or repair of powered medical equipment under the name of the original equipment manufacturer, or other arrangement with the original equipment manufacturer to offer those services on behalf of the original equipment manufacturer. An original equipment manufacturer who offers the services of inspection, diagnosis, maintenance, or repair of its own powered medical equipment, and who does not have an arrangement described in this subdivision with an unaffiliated individual or business, shall be considered an authorized repair provider with respect to that equipment.(b) Documentation means any manual, diagram, reporting output, service code description, schematic, or other guidance or information used in effecting the services of inspection, diagnosis, maintenance, or repair of powered medical equipment.(c) Embedded software means any programmable instructions provided on firmware delivered with an electronic component of equipment, or with a part for that equipment, for purposes of equipment operation, including all relevant patches and fixes made by the manufacturer of the equipment or part for these purposes.(d) Equipment means a powered wheelchair.(e) (1) Fair and reasonable terms for obtaining a part, tool, documentation, or training course and materials means at costs and terms that are equivalent to the most favorable costs and terms under which an original equipment manufacturer offers the part, tool, documentation, services access method, or training course and materials to an authorized repair provider, including all of the following requirements:(A) Accounting for any discount, rebate, convenient means of delivery, means of enabling fully restored and updated functionality, rights of use, or other incentive or preference the original equipment manufacturer offers to an authorized repair provider, or any additional cost, burden, or impediment the original equipment manufacturer imposes on an independent repair provider.(B) Not conditioned on, or imposing, a substantial obligation or restriction that is not reasonably necessary for enabling a hospital or independent repair provider to engage in the diagnosis, maintenance, or repair of powered medical equipment made by, or on behalf of, the original equipment manufacturer.(C) Not conditioned on an arrangement described in subdivision (a).(2) For documentation, including any relevant updates, fair and reasonable terms also means at no charge, except that, when the documentation is requested in physical printed form, a charge may be included for the reasonable actual costs of preparing and sending the copy.(3) For software tools, fair and reasonable terms also means all of the following:(A) Provided at no charge and without requiring authorization or internet access.(B) Without imposing impediments to access or use, in the course of effecting the diagnosis, maintenance, or repair and without impairing the efficient and cost-effective performance of the diagnosis, maintenance, or repair.(C) Enables full functionality.(4) If an original equipment manufacturer does not utilize an authorized repair provider, fair and reasonable terms means an equitable price in consideration of the actual cost to the original equipment manufacturer to prepare and distribute the part, tool, service access method, or documentation, exclusive of any research and development costs incurred.(f) Firmware means a software program or set of instructions programmed on equipment, or on a part for that equipment, to allow the equipment or part to communicate within itself or with other computer hardware.(g) Independent repair provider means an individual or business, other than the manufacturer, that is engaged in the services of inspection, diagnosis, maintenance, or repair of equipment for purposes of returning it to the safety and performance specifications established by the manufacturer and to meet its original intended use.(h) Original equipment manufacturer means a business engaged in the business of selling, leasing, or otherwise supplying new equipment or parts manufactured by, or on behalf of, itself, to any individual or business.(i) Part means any replacement part, either new or used, made available by an original equipment manufacturer for purposes of effecting the services of inspection, diagnosis, maintenance, or repair of powered medical equipment manufactured by, or on behalf of, sold, or otherwise supplied by the original equipment manufacturer.(j) Powered wheelchair means a motorized wheeled device designed for use by a person with a physical disability.(j)(k) Tools means any software program, hardware implement, or other apparatus used in inspection, diagnosis, maintenance, or repair of powered medical equipment, including software or other mechanisms that provision, program, or pair a new part, calibrate functionality, or perform any other function required to bring the product back to fully functional condition.(k)(l) Trade secret has the same meaning as in subdivision (d) of Section 3426.1 of the Civil Code.21301. (a) For the purpose of providing services for equipment in the state, an original equipment manufacturer shall, with fair and reasonable terms and costs, make available to an independent repair provider or owner of the manufacturers equipment, any documentation, parts, embedded software, firmware, or tools that are intended for use with the equipment or any part, including updates to documentation, parts, embedded software, firmware, or tools.(b) With respect to equipment that contains an electronic security lock or other security-related function, an original equipment manufacturer shall, with fair and reasonable terms and costs, make available to independent repair providers and owners any documentation, parts, embedded software, firmware, or tools needed to reset the lock or function when disabled in the course of providing services. The manufacturer may make the documentation, parts, embedded software, firmware, or tools available to independent repair providers and owners through appropriate secure release systems.(c) For powered wheelchairs subject to Section 14132.8 of the Welfare and Institutions Code, this section shall not apply to any part that would require programmability, calibration, or clinical involvement to ensure appropriate patient seating and positioning. Items included in this section for powered wheelchairs subject to Section 14132.8 of the Welfare and Institutions Code shall include:(1) Batteries.(2) Battery chargers.(3) Nonprogrammable joysticks.(4) Joystick housings or brackets.(5) Wheel assembly.(6) Nonpositioning accessories.(7) Antitip devices.(8) Armrests, excluding positioning components designed for adjustment by a therapist or assistive technology professional.(9) Caster spheres.(10) Cosmetic shrouding.(11) Floor mats.(12) Floor plates.(13) Nonpowered leg lowerers.21302. (a) An original equipment manufacturer who knowingly violates any provision of this chapter, or who reasonably should have known that they violated any provision of this chapter, shall be liable for a civil penalty not to exceed ten thousand dollars ($10,000) per piece of equipment for the first violation, and not to exceed five hundred thousand dollars ($500,000) for each series of related violations.(b) An original equipment manufacturer who violates a court order or injunction issued pursuant to this chapter shall be liable for a civil penalty not to exceed ten thousand dollars ($10,000) per violation.(c) (1) Any person injured by violation of this chapter may bring a civil action for damages or other appropriate relief.(2) The Attorney General, district attorney, county counsel, city prosecutor, or city attorney may bring a civil action in the name of the state for violation of this chapter.(d) If the action is brought by the Attorney General, one-half of the penalty collected shall be paid to the treasurer of the county in which the judgment was entered, and one-half to the State Treasurer. If brought by a district attorney or county counsel, the entire amount of penalty collected shall be paid to the treasurer of the county in which the judgment was entered. If brought by a city attorney or city prosecutor, one-half of the penalty shall be paid to the treasurer of the county and one-half to the city.(e) The penalties collected pursuant to this section by the Attorney General may be expended by the Attorney General, upon appropriation by the Legislature, to enforce this chapter.21303. An independent repair provider that is not an authorized repair provider shall provide a written notice to any customer before providing repairs that contains the following information:(a) The independent repair provider is not an authorized repair provider for the product.(b) The consumer may wish to review the terms and conditions of any warranty for the equipment, as repairs not performed by a designated authorized repair provider could potentially affect the warranty.(c) Warranties for consumer products are governed by the federal Magnuson-Moss Warranty Act (Chapter 50 (commencing with Section 2301) of Title 15 of the United States Code), which gives consumers rights and protections that apply over any conflicting provisions in the warranty.(d) Under Magnuson-Moss, a warranty cannot generally require that maintenance repairs be performed only by an authorized repair provider, unless the Federal Trade Commission waives this prohibition, or the repair is provided free of charge, pursuant to that warranty.(e) Under Magnuson-Moss, if damage to equipment is shown to be caused by faulty nonbrand equipment or by faulty repair by a nonauthorized repair provider, that damage may not be covered by the warranty, but the warranty may otherwise remain in effect.(f) Under Section 14019.4 of the Welfare and Institutions Code, an independent repair provider that is a Medi-Cal enrolled provider is prohibited from seeking reimbursement or attempting to obtain payment for the cost of covered services from a Medi-Cal applicant or recipient, unless the beneficiary owes a share of the cost, as described in subdivision (g) of that section.21303.21304. (a) This chapter does not require an original equipment manufacturer to divulge a trade secret, except as necessary to provide documentation, parts, tools, service access methods, and training courses and materials on fair and reasonable terms.(1) An original equipment manufacturer may redact documentation to remove trade secrets from the documentation before providing access to the documentation if the usability of the redacted documentation for the purpose of providing services is not diminished.(2) An original equipment manufacturer may withhold information regarding a component of, design of, functionality of, or process of developing a part, embedded software, firmware, or a tool if the information is a trade secret and the usability of the part, embedded software, firmware, or tool for the purpose of providing services is not diminished.(b) This chapter does not require an original equipment manufacturer to make available a part if the part is no longer available to the original equipment manufacturer.(c) An original equipment manufacturer is not liable for faulty or otherwise improper repairs provided by independent repair providers or owners.(d) This chapter shall not be construed to alter the terms of any arrangement described in subdivision (a) of Section 21300 in force between an authorized repair provider and an original equipment manufacturer, including, but not limited to, the performance or provision of warranty or recall repair work by an authorized repair provider on behalf of an original equipment manufacturer pursuant to an arrangement described in subdivision (a) of Section 21300, except that any provision that purports to waive, avoid, restrict, or limit the original equipment manufacturers obligations to comply with this chapter shall be void and unenforceable.(e) This chapter shall not be construed to exempt an original equipment manufacturer from a products liability claim that is otherwise authorized by law.21304.21305. This chapter applies with respect to equipment sold or in use on or after January 1, 2024.
SECTION 1. Chapter 8.5 (commencing with Section 21300) is added to Division 8 of the Business and Professions Code, to read:
### SECTION 1.
CHAPTER 8.5. Consumer Wheelchair Right to Repair21300. For the purposes of this chapter, the following definitions apply:(a) Authorized repair provider means an individual or business who is unaffiliated with an original equipment manufacturer and who has an arrangement with the original equipment manufacturer, for a definite or indefinite period, under which the original equipment manufacturer grants to the individual or business a license to use a trade name, service mark, or other proprietary identifier for the purposes of offering the services of inspection, diagnosis, maintenance, or repair of powered medical equipment under the name of the original equipment manufacturer, or other arrangement with the original equipment manufacturer to offer those services on behalf of the original equipment manufacturer. An original equipment manufacturer who offers the services of inspection, diagnosis, maintenance, or repair of its own powered medical equipment, and who does not have an arrangement described in this subdivision with an unaffiliated individual or business, shall be considered an authorized repair provider with respect to that equipment.(b) Documentation means any manual, diagram, reporting output, service code description, schematic, or other guidance or information used in effecting the services of inspection, diagnosis, maintenance, or repair of powered medical equipment.(c) Embedded software means any programmable instructions provided on firmware delivered with an electronic component of equipment, or with a part for that equipment, for purposes of equipment operation, including all relevant patches and fixes made by the manufacturer of the equipment or part for these purposes.(d) Equipment means a powered wheelchair.(e) (1) Fair and reasonable terms for obtaining a part, tool, documentation, or training course and materials means at costs and terms that are equivalent to the most favorable costs and terms under which an original equipment manufacturer offers the part, tool, documentation, services access method, or training course and materials to an authorized repair provider, including all of the following requirements:(A) Accounting for any discount, rebate, convenient means of delivery, means of enabling fully restored and updated functionality, rights of use, or other incentive or preference the original equipment manufacturer offers to an authorized repair provider, or any additional cost, burden, or impediment the original equipment manufacturer imposes on an independent repair provider.(B) Not conditioned on, or imposing, a substantial obligation or restriction that is not reasonably necessary for enabling a hospital or independent repair provider to engage in the diagnosis, maintenance, or repair of powered medical equipment made by, or on behalf of, the original equipment manufacturer.(C) Not conditioned on an arrangement described in subdivision (a).(2) For documentation, including any relevant updates, fair and reasonable terms also means at no charge, except that, when the documentation is requested in physical printed form, a charge may be included for the reasonable actual costs of preparing and sending the copy.(3) For software tools, fair and reasonable terms also means all of the following:(A) Provided at no charge and without requiring authorization or internet access.(B) Without imposing impediments to access or use, in the course of effecting the diagnosis, maintenance, or repair and without impairing the efficient and cost-effective performance of the diagnosis, maintenance, or repair.(C) Enables full functionality.(4) If an original equipment manufacturer does not utilize an authorized repair provider, fair and reasonable terms means an equitable price in consideration of the actual cost to the original equipment manufacturer to prepare and distribute the part, tool, service access method, or documentation, exclusive of any research and development costs incurred.(f) Firmware means a software program or set of instructions programmed on equipment, or on a part for that equipment, to allow the equipment or part to communicate within itself or with other computer hardware.(g) Independent repair provider means an individual or business, other than the manufacturer, that is engaged in the services of inspection, diagnosis, maintenance, or repair of equipment for purposes of returning it to the safety and performance specifications established by the manufacturer and to meet its original intended use.(h) Original equipment manufacturer means a business engaged in the business of selling, leasing, or otherwise supplying new equipment or parts manufactured by, or on behalf of, itself, to any individual or business.(i) Part means any replacement part, either new or used, made available by an original equipment manufacturer for purposes of effecting the services of inspection, diagnosis, maintenance, or repair of powered medical equipment manufactured by, or on behalf of, sold, or otherwise supplied by the original equipment manufacturer.(j) Powered wheelchair means a motorized wheeled device designed for use by a person with a physical disability.(j)(k) Tools means any software program, hardware implement, or other apparatus used in inspection, diagnosis, maintenance, or repair of powered medical equipment, including software or other mechanisms that provision, program, or pair a new part, calibrate functionality, or perform any other function required to bring the product back to fully functional condition.(k)(l) Trade secret has the same meaning as in subdivision (d) of Section 3426.1 of the Civil Code.21301. (a) For the purpose of providing services for equipment in the state, an original equipment manufacturer shall, with fair and reasonable terms and costs, make available to an independent repair provider or owner of the manufacturers equipment, any documentation, parts, embedded software, firmware, or tools that are intended for use with the equipment or any part, including updates to documentation, parts, embedded software, firmware, or tools.(b) With respect to equipment that contains an electronic security lock or other security-related function, an original equipment manufacturer shall, with fair and reasonable terms and costs, make available to independent repair providers and owners any documentation, parts, embedded software, firmware, or tools needed to reset the lock or function when disabled in the course of providing services. The manufacturer may make the documentation, parts, embedded software, firmware, or tools available to independent repair providers and owners through appropriate secure release systems.(c) For powered wheelchairs subject to Section 14132.8 of the Welfare and Institutions Code, this section shall not apply to any part that would require programmability, calibration, or clinical involvement to ensure appropriate patient seating and positioning. Items included in this section for powered wheelchairs subject to Section 14132.8 of the Welfare and Institutions Code shall include:(1) Batteries.(2) Battery chargers.(3) Nonprogrammable joysticks.(4) Joystick housings or brackets.(5) Wheel assembly.(6) Nonpositioning accessories.(7) Antitip devices.(8) Armrests, excluding positioning components designed for adjustment by a therapist or assistive technology professional.(9) Caster spheres.(10) Cosmetic shrouding.(11) Floor mats.(12) Floor plates.(13) Nonpowered leg lowerers.21302. (a) An original equipment manufacturer who knowingly violates any provision of this chapter, or who reasonably should have known that they violated any provision of this chapter, shall be liable for a civil penalty not to exceed ten thousand dollars ($10,000) per piece of equipment for the first violation, and not to exceed five hundred thousand dollars ($500,000) for each series of related violations.(b) An original equipment manufacturer who violates a court order or injunction issued pursuant to this chapter shall be liable for a civil penalty not to exceed ten thousand dollars ($10,000) per violation.(c) (1) Any person injured by violation of this chapter may bring a civil action for damages or other appropriate relief.(2) The Attorney General, district attorney, county counsel, city prosecutor, or city attorney may bring a civil action in the name of the state for violation of this chapter.(d) If the action is brought by the Attorney General, one-half of the penalty collected shall be paid to the treasurer of the county in which the judgment was entered, and one-half to the State Treasurer. If brought by a district attorney or county counsel, the entire amount of penalty collected shall be paid to the treasurer of the county in which the judgment was entered. If brought by a city attorney or city prosecutor, one-half of the penalty shall be paid to the treasurer of the county and one-half to the city.(e) The penalties collected pursuant to this section by the Attorney General may be expended by the Attorney General, upon appropriation by the Legislature, to enforce this chapter.21303. An independent repair provider that is not an authorized repair provider shall provide a written notice to any customer before providing repairs that contains the following information:(a) The independent repair provider is not an authorized repair provider for the product.(b) The consumer may wish to review the terms and conditions of any warranty for the equipment, as repairs not performed by a designated authorized repair provider could potentially affect the warranty.(c) Warranties for consumer products are governed by the federal Magnuson-Moss Warranty Act (Chapter 50 (commencing with Section 2301) of Title 15 of the United States Code), which gives consumers rights and protections that apply over any conflicting provisions in the warranty.(d) Under Magnuson-Moss, a warranty cannot generally require that maintenance repairs be performed only by an authorized repair provider, unless the Federal Trade Commission waives this prohibition, or the repair is provided free of charge, pursuant to that warranty.(e) Under Magnuson-Moss, if damage to equipment is shown to be caused by faulty nonbrand equipment or by faulty repair by a nonauthorized repair provider, that damage may not be covered by the warranty, but the warranty may otherwise remain in effect.(f) Under Section 14019.4 of the Welfare and Institutions Code, an independent repair provider that is a Medi-Cal enrolled provider is prohibited from seeking reimbursement or attempting to obtain payment for the cost of covered services from a Medi-Cal applicant or recipient, unless the beneficiary owes a share of the cost, as described in subdivision (g) of that section.21303.21304. (a) This chapter does not require an original equipment manufacturer to divulge a trade secret, except as necessary to provide documentation, parts, tools, service access methods, and training courses and materials on fair and reasonable terms.(1) An original equipment manufacturer may redact documentation to remove trade secrets from the documentation before providing access to the documentation if the usability of the redacted documentation for the purpose of providing services is not diminished.(2) An original equipment manufacturer may withhold information regarding a component of, design of, functionality of, or process of developing a part, embedded software, firmware, or a tool if the information is a trade secret and the usability of the part, embedded software, firmware, or tool for the purpose of providing services is not diminished.(b) This chapter does not require an original equipment manufacturer to make available a part if the part is no longer available to the original equipment manufacturer.(c) An original equipment manufacturer is not liable for faulty or otherwise improper repairs provided by independent repair providers or owners.(d) This chapter shall not be construed to alter the terms of any arrangement described in subdivision (a) of Section 21300 in force between an authorized repair provider and an original equipment manufacturer, including, but not limited to, the performance or provision of warranty or recall repair work by an authorized repair provider on behalf of an original equipment manufacturer pursuant to an arrangement described in subdivision (a) of Section 21300, except that any provision that purports to waive, avoid, restrict, or limit the original equipment manufacturers obligations to comply with this chapter shall be void and unenforceable.(e) This chapter shall not be construed to exempt an original equipment manufacturer from a products liability claim that is otherwise authorized by law.21304.21305. This chapter applies with respect to equipment sold or in use on or after January 1, 2024.
CHAPTER 8.5. Consumer Wheelchair Right to Repair21300. For the purposes of this chapter, the following definitions apply:(a) Authorized repair provider means an individual or business who is unaffiliated with an original equipment manufacturer and who has an arrangement with the original equipment manufacturer, for a definite or indefinite period, under which the original equipment manufacturer grants to the individual or business a license to use a trade name, service mark, or other proprietary identifier for the purposes of offering the services of inspection, diagnosis, maintenance, or repair of powered medical equipment under the name of the original equipment manufacturer, or other arrangement with the original equipment manufacturer to offer those services on behalf of the original equipment manufacturer. An original equipment manufacturer who offers the services of inspection, diagnosis, maintenance, or repair of its own powered medical equipment, and who does not have an arrangement described in this subdivision with an unaffiliated individual or business, shall be considered an authorized repair provider with respect to that equipment.(b) Documentation means any manual, diagram, reporting output, service code description, schematic, or other guidance or information used in effecting the services of inspection, diagnosis, maintenance, or repair of powered medical equipment.(c) Embedded software means any programmable instructions provided on firmware delivered with an electronic component of equipment, or with a part for that equipment, for purposes of equipment operation, including all relevant patches and fixes made by the manufacturer of the equipment or part for these purposes.(d) Equipment means a powered wheelchair.(e) (1) Fair and reasonable terms for obtaining a part, tool, documentation, or training course and materials means at costs and terms that are equivalent to the most favorable costs and terms under which an original equipment manufacturer offers the part, tool, documentation, services access method, or training course and materials to an authorized repair provider, including all of the following requirements:(A) Accounting for any discount, rebate, convenient means of delivery, means of enabling fully restored and updated functionality, rights of use, or other incentive or preference the original equipment manufacturer offers to an authorized repair provider, or any additional cost, burden, or impediment the original equipment manufacturer imposes on an independent repair provider.(B) Not conditioned on, or imposing, a substantial obligation or restriction that is not reasonably necessary for enabling a hospital or independent repair provider to engage in the diagnosis, maintenance, or repair of powered medical equipment made by, or on behalf of, the original equipment manufacturer.(C) Not conditioned on an arrangement described in subdivision (a).(2) For documentation, including any relevant updates, fair and reasonable terms also means at no charge, except that, when the documentation is requested in physical printed form, a charge may be included for the reasonable actual costs of preparing and sending the copy.(3) For software tools, fair and reasonable terms also means all of the following:(A) Provided at no charge and without requiring authorization or internet access.(B) Without imposing impediments to access or use, in the course of effecting the diagnosis, maintenance, or repair and without impairing the efficient and cost-effective performance of the diagnosis, maintenance, or repair.(C) Enables full functionality.(4) If an original equipment manufacturer does not utilize an authorized repair provider, fair and reasonable terms means an equitable price in consideration of the actual cost to the original equipment manufacturer to prepare and distribute the part, tool, service access method, or documentation, exclusive of any research and development costs incurred.(f) Firmware means a software program or set of instructions programmed on equipment, or on a part for that equipment, to allow the equipment or part to communicate within itself or with other computer hardware.(g) Independent repair provider means an individual or business, other than the manufacturer, that is engaged in the services of inspection, diagnosis, maintenance, or repair of equipment for purposes of returning it to the safety and performance specifications established by the manufacturer and to meet its original intended use.(h) Original equipment manufacturer means a business engaged in the business of selling, leasing, or otherwise supplying new equipment or parts manufactured by, or on behalf of, itself, to any individual or business.(i) Part means any replacement part, either new or used, made available by an original equipment manufacturer for purposes of effecting the services of inspection, diagnosis, maintenance, or repair of powered medical equipment manufactured by, or on behalf of, sold, or otherwise supplied by the original equipment manufacturer.(j) Powered wheelchair means a motorized wheeled device designed for use by a person with a physical disability.(j)(k) Tools means any software program, hardware implement, or other apparatus used in inspection, diagnosis, maintenance, or repair of powered medical equipment, including software or other mechanisms that provision, program, or pair a new part, calibrate functionality, or perform any other function required to bring the product back to fully functional condition.(k)(l) Trade secret has the same meaning as in subdivision (d) of Section 3426.1 of the Civil Code.21301. (a) For the purpose of providing services for equipment in the state, an original equipment manufacturer shall, with fair and reasonable terms and costs, make available to an independent repair provider or owner of the manufacturers equipment, any documentation, parts, embedded software, firmware, or tools that are intended for use with the equipment or any part, including updates to documentation, parts, embedded software, firmware, or tools.(b) With respect to equipment that contains an electronic security lock or other security-related function, an original equipment manufacturer shall, with fair and reasonable terms and costs, make available to independent repair providers and owners any documentation, parts, embedded software, firmware, or tools needed to reset the lock or function when disabled in the course of providing services. The manufacturer may make the documentation, parts, embedded software, firmware, or tools available to independent repair providers and owners through appropriate secure release systems.(c) For powered wheelchairs subject to Section 14132.8 of the Welfare and Institutions Code, this section shall not apply to any part that would require programmability, calibration, or clinical involvement to ensure appropriate patient seating and positioning. Items included in this section for powered wheelchairs subject to Section 14132.8 of the Welfare and Institutions Code shall include:(1) Batteries.(2) Battery chargers.(3) Nonprogrammable joysticks.(4) Joystick housings or brackets.(5) Wheel assembly.(6) Nonpositioning accessories.(7) Antitip devices.(8) Armrests, excluding positioning components designed for adjustment by a therapist or assistive technology professional.(9) Caster spheres.(10) Cosmetic shrouding.(11) Floor mats.(12) Floor plates.(13) Nonpowered leg lowerers.21302. (a) An original equipment manufacturer who knowingly violates any provision of this chapter, or who reasonably should have known that they violated any provision of this chapter, shall be liable for a civil penalty not to exceed ten thousand dollars ($10,000) per piece of equipment for the first violation, and not to exceed five hundred thousand dollars ($500,000) for each series of related violations.(b) An original equipment manufacturer who violates a court order or injunction issued pursuant to this chapter shall be liable for a civil penalty not to exceed ten thousand dollars ($10,000) per violation.(c) (1) Any person injured by violation of this chapter may bring a civil action for damages or other appropriate relief.(2) The Attorney General, district attorney, county counsel, city prosecutor, or city attorney may bring a civil action in the name of the state for violation of this chapter.(d) If the action is brought by the Attorney General, one-half of the penalty collected shall be paid to the treasurer of the county in which the judgment was entered, and one-half to the State Treasurer. If brought by a district attorney or county counsel, the entire amount of penalty collected shall be paid to the treasurer of the county in which the judgment was entered. If brought by a city attorney or city prosecutor, one-half of the penalty shall be paid to the treasurer of the county and one-half to the city.(e) The penalties collected pursuant to this section by the Attorney General may be expended by the Attorney General, upon appropriation by the Legislature, to enforce this chapter.21303. An independent repair provider that is not an authorized repair provider shall provide a written notice to any customer before providing repairs that contains the following information:(a) The independent repair provider is not an authorized repair provider for the product.(b) The consumer may wish to review the terms and conditions of any warranty for the equipment, as repairs not performed by a designated authorized repair provider could potentially affect the warranty.(c) Warranties for consumer products are governed by the federal Magnuson-Moss Warranty Act (Chapter 50 (commencing with Section 2301) of Title 15 of the United States Code), which gives consumers rights and protections that apply over any conflicting provisions in the warranty.(d) Under Magnuson-Moss, a warranty cannot generally require that maintenance repairs be performed only by an authorized repair provider, unless the Federal Trade Commission waives this prohibition, or the repair is provided free of charge, pursuant to that warranty.(e) Under Magnuson-Moss, if damage to equipment is shown to be caused by faulty nonbrand equipment or by faulty repair by a nonauthorized repair provider, that damage may not be covered by the warranty, but the warranty may otherwise remain in effect.(f) Under Section 14019.4 of the Welfare and Institutions Code, an independent repair provider that is a Medi-Cal enrolled provider is prohibited from seeking reimbursement or attempting to obtain payment for the cost of covered services from a Medi-Cal applicant or recipient, unless the beneficiary owes a share of the cost, as described in subdivision (g) of that section.21303.21304. (a) This chapter does not require an original equipment manufacturer to divulge a trade secret, except as necessary to provide documentation, parts, tools, service access methods, and training courses and materials on fair and reasonable terms.(1) An original equipment manufacturer may redact documentation to remove trade secrets from the documentation before providing access to the documentation if the usability of the redacted documentation for the purpose of providing services is not diminished.(2) An original equipment manufacturer may withhold information regarding a component of, design of, functionality of, or process of developing a part, embedded software, firmware, or a tool if the information is a trade secret and the usability of the part, embedded software, firmware, or tool for the purpose of providing services is not diminished.(b) This chapter does not require an original equipment manufacturer to make available a part if the part is no longer available to the original equipment manufacturer.(c) An original equipment manufacturer is not liable for faulty or otherwise improper repairs provided by independent repair providers or owners.(d) This chapter shall not be construed to alter the terms of any arrangement described in subdivision (a) of Section 21300 in force between an authorized repair provider and an original equipment manufacturer, including, but not limited to, the performance or provision of warranty or recall repair work by an authorized repair provider on behalf of an original equipment manufacturer pursuant to an arrangement described in subdivision (a) of Section 21300, except that any provision that purports to waive, avoid, restrict, or limit the original equipment manufacturers obligations to comply with this chapter shall be void and unenforceable.(e) This chapter shall not be construed to exempt an original equipment manufacturer from a products liability claim that is otherwise authorized by law.21304.21305. This chapter applies with respect to equipment sold or in use on or after January 1, 2024.
CHAPTER 8.5. Consumer Wheelchair Right to Repair
CHAPTER 8.5. Consumer Wheelchair Right to Repair
21300. For the purposes of this chapter, the following definitions apply:(a) Authorized repair provider means an individual or business who is unaffiliated with an original equipment manufacturer and who has an arrangement with the original equipment manufacturer, for a definite or indefinite period, under which the original equipment manufacturer grants to the individual or business a license to use a trade name, service mark, or other proprietary identifier for the purposes of offering the services of inspection, diagnosis, maintenance, or repair of powered medical equipment under the name of the original equipment manufacturer, or other arrangement with the original equipment manufacturer to offer those services on behalf of the original equipment manufacturer. An original equipment manufacturer who offers the services of inspection, diagnosis, maintenance, or repair of its own powered medical equipment, and who does not have an arrangement described in this subdivision with an unaffiliated individual or business, shall be considered an authorized repair provider with respect to that equipment.(b) Documentation means any manual, diagram, reporting output, service code description, schematic, or other guidance or information used in effecting the services of inspection, diagnosis, maintenance, or repair of powered medical equipment.(c) Embedded software means any programmable instructions provided on firmware delivered with an electronic component of equipment, or with a part for that equipment, for purposes of equipment operation, including all relevant patches and fixes made by the manufacturer of the equipment or part for these purposes.(d) Equipment means a powered wheelchair.(e) (1) Fair and reasonable terms for obtaining a part, tool, documentation, or training course and materials means at costs and terms that are equivalent to the most favorable costs and terms under which an original equipment manufacturer offers the part, tool, documentation, services access method, or training course and materials to an authorized repair provider, including all of the following requirements:(A) Accounting for any discount, rebate, convenient means of delivery, means of enabling fully restored and updated functionality, rights of use, or other incentive or preference the original equipment manufacturer offers to an authorized repair provider, or any additional cost, burden, or impediment the original equipment manufacturer imposes on an independent repair provider.(B) Not conditioned on, or imposing, a substantial obligation or restriction that is not reasonably necessary for enabling a hospital or independent repair provider to engage in the diagnosis, maintenance, or repair of powered medical equipment made by, or on behalf of, the original equipment manufacturer.(C) Not conditioned on an arrangement described in subdivision (a).(2) For documentation, including any relevant updates, fair and reasonable terms also means at no charge, except that, when the documentation is requested in physical printed form, a charge may be included for the reasonable actual costs of preparing and sending the copy.(3) For software tools, fair and reasonable terms also means all of the following:(A) Provided at no charge and without requiring authorization or internet access.(B) Without imposing impediments to access or use, in the course of effecting the diagnosis, maintenance, or repair and without impairing the efficient and cost-effective performance of the diagnosis, maintenance, or repair.(C) Enables full functionality.(4) If an original equipment manufacturer does not utilize an authorized repair provider, fair and reasonable terms means an equitable price in consideration of the actual cost to the original equipment manufacturer to prepare and distribute the part, tool, service access method, or documentation, exclusive of any research and development costs incurred.(f) Firmware means a software program or set of instructions programmed on equipment, or on a part for that equipment, to allow the equipment or part to communicate within itself or with other computer hardware.(g) Independent repair provider means an individual or business, other than the manufacturer, that is engaged in the services of inspection, diagnosis, maintenance, or repair of equipment for purposes of returning it to the safety and performance specifications established by the manufacturer and to meet its original intended use.(h) Original equipment manufacturer means a business engaged in the business of selling, leasing, or otherwise supplying new equipment or parts manufactured by, or on behalf of, itself, to any individual or business.(i) Part means any replacement part, either new or used, made available by an original equipment manufacturer for purposes of effecting the services of inspection, diagnosis, maintenance, or repair of powered medical equipment manufactured by, or on behalf of, sold, or otherwise supplied by the original equipment manufacturer.(j) Powered wheelchair means a motorized wheeled device designed for use by a person with a physical disability.(j)(k) Tools means any software program, hardware implement, or other apparatus used in inspection, diagnosis, maintenance, or repair of powered medical equipment, including software or other mechanisms that provision, program, or pair a new part, calibrate functionality, or perform any other function required to bring the product back to fully functional condition.(k)(l) Trade secret has the same meaning as in subdivision (d) of Section 3426.1 of the Civil Code.
21300. For the purposes of this chapter, the following definitions apply:
(a) Authorized repair provider means an individual or business who is unaffiliated with an original equipment manufacturer and who has an arrangement with the original equipment manufacturer, for a definite or indefinite period, under which the original equipment manufacturer grants to the individual or business a license to use a trade name, service mark, or other proprietary identifier for the purposes of offering the services of inspection, diagnosis, maintenance, or repair of powered medical equipment under the name of the original equipment manufacturer, or other arrangement with the original equipment manufacturer to offer those services on behalf of the original equipment manufacturer. An original equipment manufacturer who offers the services of inspection, diagnosis, maintenance, or repair of its own powered medical equipment, and who does not have an arrangement described in this subdivision with an unaffiliated individual or business, shall be considered an authorized repair provider with respect to that equipment.
(b) Documentation means any manual, diagram, reporting output, service code description, schematic, or other guidance or information used in effecting the services of inspection, diagnosis, maintenance, or repair of powered medical equipment.
(c) Embedded software means any programmable instructions provided on firmware delivered with an electronic component of equipment, or with a part for that equipment, for purposes of equipment operation, including all relevant patches and fixes made by the manufacturer of the equipment or part for these purposes.
(d) Equipment means a powered wheelchair.
(e) (1) Fair and reasonable terms for obtaining a part, tool, documentation, or training course and materials means at costs and terms that are equivalent to the most favorable costs and terms under which an original equipment manufacturer offers the part, tool, documentation, services access method, or training course and materials to an authorized repair provider, including all of the following requirements:
(A) Accounting for any discount, rebate, convenient means of delivery, means of enabling fully restored and updated functionality, rights of use, or other incentive or preference the original equipment manufacturer offers to an authorized repair provider, or any additional cost, burden, or impediment the original equipment manufacturer imposes on an independent repair provider.
(B) Not conditioned on, or imposing, a substantial obligation or restriction that is not reasonably necessary for enabling a hospital or independent repair provider to engage in the diagnosis, maintenance, or repair of powered medical equipment made by, or on behalf of, the original equipment manufacturer.
(C) Not conditioned on an arrangement described in subdivision (a).
(2) For documentation, including any relevant updates, fair and reasonable terms also means at no charge, except that, when the documentation is requested in physical printed form, a charge may be included for the reasonable actual costs of preparing and sending the copy.
(3) For software tools, fair and reasonable terms also means all of the following:
(A) Provided at no charge and without requiring authorization or internet access.
(B) Without imposing impediments to access or use, in the course of effecting the diagnosis, maintenance, or repair and without impairing the efficient and cost-effective performance of the diagnosis, maintenance, or repair.
(C) Enables full functionality.
(4) If an original equipment manufacturer does not utilize an authorized repair provider, fair and reasonable terms means an equitable price in consideration of the actual cost to the original equipment manufacturer to prepare and distribute the part, tool, service access method, or documentation, exclusive of any research and development costs incurred.
(f) Firmware means a software program or set of instructions programmed on equipment, or on a part for that equipment, to allow the equipment or part to communicate within itself or with other computer hardware.
(g) Independent repair provider means an individual or business, other than the manufacturer, that is engaged in the services of inspection, diagnosis, maintenance, or repair of equipment for purposes of returning it to the safety and performance specifications established by the manufacturer and to meet its original intended use.
(h) Original equipment manufacturer means a business engaged in the business of selling, leasing, or otherwise supplying new equipment or parts manufactured by, or on behalf of, itself, to any individual or business.
(i) Part means any replacement part, either new or used, made available by an original equipment manufacturer for purposes of effecting the services of inspection, diagnosis, maintenance, or repair of powered medical equipment manufactured by, or on behalf of, sold, or otherwise supplied by the original equipment manufacturer.
(j) Powered wheelchair means a motorized wheeled device designed for use by a person with a physical disability.
(j)
(k) Tools means any software program, hardware implement, or other apparatus used in inspection, diagnosis, maintenance, or repair of powered medical equipment, including software or other mechanisms that provision, program, or pair a new part, calibrate functionality, or perform any other function required to bring the product back to fully functional condition.
(k)
(l) Trade secret has the same meaning as in subdivision (d) of Section 3426.1 of the Civil Code.
21301. (a) For the purpose of providing services for equipment in the state, an original equipment manufacturer shall, with fair and reasonable terms and costs, make available to an independent repair provider or owner of the manufacturers equipment, any documentation, parts, embedded software, firmware, or tools that are intended for use with the equipment or any part, including updates to documentation, parts, embedded software, firmware, or tools.(b) With respect to equipment that contains an electronic security lock or other security-related function, an original equipment manufacturer shall, with fair and reasonable terms and costs, make available to independent repair providers and owners any documentation, parts, embedded software, firmware, or tools needed to reset the lock or function when disabled in the course of providing services. The manufacturer may make the documentation, parts, embedded software, firmware, or tools available to independent repair providers and owners through appropriate secure release systems.(c) For powered wheelchairs subject to Section 14132.8 of the Welfare and Institutions Code, this section shall not apply to any part that would require programmability, calibration, or clinical involvement to ensure appropriate patient seating and positioning. Items included in this section for powered wheelchairs subject to Section 14132.8 of the Welfare and Institutions Code shall include:(1) Batteries.(2) Battery chargers.(3) Nonprogrammable joysticks.(4) Joystick housings or brackets.(5) Wheel assembly.(6) Nonpositioning accessories.(7) Antitip devices.(8) Armrests, excluding positioning components designed for adjustment by a therapist or assistive technology professional.(9) Caster spheres.(10) Cosmetic shrouding.(11) Floor mats.(12) Floor plates.(13) Nonpowered leg lowerers.
21301. (a) For the purpose of providing services for equipment in the state, an original equipment manufacturer shall, with fair and reasonable terms and costs, make available to an independent repair provider or owner of the manufacturers equipment, any documentation, parts, embedded software, firmware, or tools that are intended for use with the equipment or any part, including updates to documentation, parts, embedded software, firmware, or tools.
(b) With respect to equipment that contains an electronic security lock or other security-related function, an original equipment manufacturer shall, with fair and reasonable terms and costs, make available to independent repair providers and owners any documentation, parts, embedded software, firmware, or tools needed to reset the lock or function when disabled in the course of providing services. The manufacturer may make the documentation, parts, embedded software, firmware, or tools available to independent repair providers and owners through appropriate secure release systems.
(c) For powered wheelchairs subject to Section 14132.8 of the Welfare and Institutions Code, this section shall not apply to any part that would require programmability, calibration, or clinical involvement to ensure appropriate patient seating and positioning. Items included in this section for powered wheelchairs subject to Section 14132.8 of the Welfare and Institutions Code shall include:
(1) Batteries.
(2) Battery chargers.
(3) Nonprogrammable joysticks.
(4) Joystick housings or brackets.
(5) Wheel assembly.
(6) Nonpositioning accessories.
(7) Antitip devices.
(8) Armrests, excluding positioning components designed for adjustment by a therapist or assistive technology professional.
(9) Caster spheres.
(10) Cosmetic shrouding.
(11) Floor mats.
(12) Floor plates.
(13) Nonpowered leg lowerers.
21302. (a) An original equipment manufacturer who knowingly violates any provision of this chapter, or who reasonably should have known that they violated any provision of this chapter, shall be liable for a civil penalty not to exceed ten thousand dollars ($10,000) per piece of equipment for the first violation, and not to exceed five hundred thousand dollars ($500,000) for each series of related violations.(b) An original equipment manufacturer who violates a court order or injunction issued pursuant to this chapter shall be liable for a civil penalty not to exceed ten thousand dollars ($10,000) per violation.(c) (1) Any person injured by violation of this chapter may bring a civil action for damages or other appropriate relief.(2) The Attorney General, district attorney, county counsel, city prosecutor, or city attorney may bring a civil action in the name of the state for violation of this chapter.(d) If the action is brought by the Attorney General, one-half of the penalty collected shall be paid to the treasurer of the county in which the judgment was entered, and one-half to the State Treasurer. If brought by a district attorney or county counsel, the entire amount of penalty collected shall be paid to the treasurer of the county in which the judgment was entered. If brought by a city attorney or city prosecutor, one-half of the penalty shall be paid to the treasurer of the county and one-half to the city.(e) The penalties collected pursuant to this section by the Attorney General may be expended by the Attorney General, upon appropriation by the Legislature, to enforce this chapter.
21302. (a) An original equipment manufacturer who knowingly violates any provision of this chapter, or who reasonably should have known that they violated any provision of this chapter, shall be liable for a civil penalty not to exceed ten thousand dollars ($10,000) per piece of equipment for the first violation, and not to exceed five hundred thousand dollars ($500,000) for each series of related violations.
(b) An original equipment manufacturer who violates a court order or injunction issued pursuant to this chapter shall be liable for a civil penalty not to exceed ten thousand dollars ($10,000) per violation.
(c) (1) Any person injured by violation of this chapter may bring a civil action for damages or other appropriate relief.
(2) The Attorney General, district attorney, county counsel, city prosecutor, or city attorney may bring a civil action in the name of the state for violation of this chapter.
(d) If the action is brought by the Attorney General, one-half of the penalty collected shall be paid to the treasurer of the county in which the judgment was entered, and one-half to the State Treasurer. If brought by a district attorney or county counsel, the entire amount of penalty collected shall be paid to the treasurer of the county in which the judgment was entered. If brought by a city attorney or city prosecutor, one-half of the penalty shall be paid to the treasurer of the county and one-half to the city.
(e) The penalties collected pursuant to this section by the Attorney General may be expended by the Attorney General, upon appropriation by the Legislature, to enforce this chapter.
21303. An independent repair provider that is not an authorized repair provider shall provide a written notice to any customer before providing repairs that contains the following information:(a) The independent repair provider is not an authorized repair provider for the product.(b) The consumer may wish to review the terms and conditions of any warranty for the equipment, as repairs not performed by a designated authorized repair provider could potentially affect the warranty.(c) Warranties for consumer products are governed by the federal Magnuson-Moss Warranty Act (Chapter 50 (commencing with Section 2301) of Title 15 of the United States Code), which gives consumers rights and protections that apply over any conflicting provisions in the warranty.(d) Under Magnuson-Moss, a warranty cannot generally require that maintenance repairs be performed only by an authorized repair provider, unless the Federal Trade Commission waives this prohibition, or the repair is provided free of charge, pursuant to that warranty.(e) Under Magnuson-Moss, if damage to equipment is shown to be caused by faulty nonbrand equipment or by faulty repair by a nonauthorized repair provider, that damage may not be covered by the warranty, but the warranty may otherwise remain in effect.(f) Under Section 14019.4 of the Welfare and Institutions Code, an independent repair provider that is a Medi-Cal enrolled provider is prohibited from seeking reimbursement or attempting to obtain payment for the cost of covered services from a Medi-Cal applicant or recipient, unless the beneficiary owes a share of the cost, as described in subdivision (g) of that section.
21303. An independent repair provider that is not an authorized repair provider shall provide a written notice to any customer before providing repairs that contains the following information:
(a) The independent repair provider is not an authorized repair provider for the product.
(b) The consumer may wish to review the terms and conditions of any warranty for the equipment, as repairs not performed by a designated authorized repair provider could potentially affect the warranty.
(c) Warranties for consumer products are governed by the federal Magnuson-Moss Warranty Act (Chapter 50 (commencing with Section 2301) of Title 15 of the United States Code), which gives consumers rights and protections that apply over any conflicting provisions in the warranty.
(d) Under Magnuson-Moss, a warranty cannot generally require that maintenance repairs be performed only by an authorized repair provider, unless the Federal Trade Commission waives this prohibition, or the repair is provided free of charge, pursuant to that warranty.
(e) Under Magnuson-Moss, if damage to equipment is shown to be caused by faulty nonbrand equipment or by faulty repair by a nonauthorized repair provider, that damage may not be covered by the warranty, but the warranty may otherwise remain in effect.
(f) Under Section 14019.4 of the Welfare and Institutions Code, an independent repair provider that is a Medi-Cal enrolled provider is prohibited from seeking reimbursement or attempting to obtain payment for the cost of covered services from a Medi-Cal applicant or recipient, unless the beneficiary owes a share of the cost, as described in subdivision (g) of that section.
21303.21304. (a) This chapter does not require an original equipment manufacturer to divulge a trade secret, except as necessary to provide documentation, parts, tools, service access methods, and training courses and materials on fair and reasonable terms.(1) An original equipment manufacturer may redact documentation to remove trade secrets from the documentation before providing access to the documentation if the usability of the redacted documentation for the purpose of providing services is not diminished.(2) An original equipment manufacturer may withhold information regarding a component of, design of, functionality of, or process of developing a part, embedded software, firmware, or a tool if the information is a trade secret and the usability of the part, embedded software, firmware, or tool for the purpose of providing services is not diminished.(b) This chapter does not require an original equipment manufacturer to make available a part if the part is no longer available to the original equipment manufacturer.(c) An original equipment manufacturer is not liable for faulty or otherwise improper repairs provided by independent repair providers or owners.(d) This chapter shall not be construed to alter the terms of any arrangement described in subdivision (a) of Section 21300 in force between an authorized repair provider and an original equipment manufacturer, including, but not limited to, the performance or provision of warranty or recall repair work by an authorized repair provider on behalf of an original equipment manufacturer pursuant to an arrangement described in subdivision (a) of Section 21300, except that any provision that purports to waive, avoid, restrict, or limit the original equipment manufacturers obligations to comply with this chapter shall be void and unenforceable.(e) This chapter shall not be construed to exempt an original equipment manufacturer from a products liability claim that is otherwise authorized by law.
21303.21304. (a) This chapter does not require an original equipment manufacturer to divulge a trade secret, except as necessary to provide documentation, parts, tools, service access methods, and training courses and materials on fair and reasonable terms.
(1) An original equipment manufacturer may redact documentation to remove trade secrets from the documentation before providing access to the documentation if the usability of the redacted documentation for the purpose of providing services is not diminished.
(2) An original equipment manufacturer may withhold information regarding a component of, design of, functionality of, or process of developing a part, embedded software, firmware, or a tool if the information is a trade secret and the usability of the part, embedded software, firmware, or tool for the purpose of providing services is not diminished.
(b) This chapter does not require an original equipment manufacturer to make available a part if the part is no longer available to the original equipment manufacturer.
(c) An original equipment manufacturer is not liable for faulty or otherwise improper repairs provided by independent repair providers or owners.
(d) This chapter shall not be construed to alter the terms of any arrangement described in subdivision (a) of Section 21300 in force between an authorized repair provider and an original equipment manufacturer, including, but not limited to, the performance or provision of warranty or recall repair work by an authorized repair provider on behalf of an original equipment manufacturer pursuant to an arrangement described in subdivision (a) of Section 21300, except that any provision that purports to waive, avoid, restrict, or limit the original equipment manufacturers obligations to comply with this chapter shall be void and unenforceable.
(e) This chapter shall not be construed to exempt an original equipment manufacturer from a products liability claim that is otherwise authorized by law.
21304.21305. This chapter applies with respect to equipment sold or in use on or after January 1, 2024.
21304.21305. This chapter applies with respect to equipment sold or in use on or after January 1, 2024.
SEC. 2. Section 14132.85 of the Welfare and Institutions Code is amended to read:14132.85. (a) For purposes of this section, the following definitions apply:(1) Complex needs patient means an individual with a diagnosis or medical condition that results in significant physical impairment or functional limitation. Complex needs patient includes, but is not limited to, individuals with spinal cord injury, traumatic brain injury, cerebral palsy, muscular dystrophy, spina bifida, osteogenesis imperfecta, arthrogryposis, amyotrophic lateral sclerosis, multiple sclerosis, demyelinating disease, myelopathy, myopathy, progressive muscular atrophy, anterior horn cell disease, post-polio syndrome, cerebellar degeneration, dystonia, Huntingtons disease, spinocerebellar disease, and the types of amputation, paralysis, or paresis that result in significant physical impairment or functional limitation. Complex needs patient does not negate the requirement that an individual meet medical necessity requirements under authority rules to qualify for receiving complex rehabilitation technology.(2) Complex rehabilitation technology means items classified within the federal Medicare Program as of January 1, 2021, as durable medical equipment that are individually configured for individuals to meet their specific and unique medical, physical, and functional needs and capacities for basic activities of daily living and instrumental activities of daily living identified as medically necessary. These items include, but are not limited to, complex rehabilitation manual and power wheelchairs, power seat elevation or power standing components of power wheelchairs, seating and positioning items, other specialized equipment such as adaptive bath equipment, standing frames, gait trainers, and specialized strollers, and related options and accessories.(3) Complex rehabilitation technology services includes the application of enabling systems designed and assembled to meet the needs of a patient experiencing any permanent or long-term loss or abnormality of physical or anatomical structure or function with respect to mobility or other function or need. These services include, but are not limited to, all of the following:(A) Evaluating the needs of a patient with a disability, including an assessment of the patient for the purpose of ensuring that the proposed equipment is appropriate.(B) Documenting medical necessity.(C) Selecting, fitting, customizing, maintaining, assembling, repairing, replacing, picking up and delivering, and testing equipment and parts.(D) Training the patient who will use the technology or any individual who assists the patient in using the complex rehabilitation technology.(4) Qualified health care professional means an individual who has no financial relationship to the provider of complex rehabilitation technology and is any of the following:(A) A physical therapist licensed pursuant to Chapter 5.7 (commencing with Section 2600) of Division 2 of the Business and Professions Code.(B) An occupational therapist licensed pursuant to Chapter 5.6 (commencing with Section 2570) of Division 2 of the Business and Professions Code.(C) Other licensed health care professional, approved by the department, and who performs specialty evaluations within the professionals scope of practice.(5) Qualified rehabilitation technology professional means an individual who meets either of the following:(A) Holds the credential of Assistive Technology Professional (ATP) from the Rehabilitation Engineering and Assistive Technology Society of North America.(B) Holds the credential of Certified Complex Rehabilitation Technology Supplier (CRTS) from the National Registry of Rehabilitation Technology Suppliers.(b) A provider of complex rehabilitation technology to a Medi-Cal beneficiary shall comply with all of the following:(1) Meet the supplier and quality standards established for a durable medical equipment supplier under the federal Medicare Program and be enrolled as a provider in the Medi-Cal program.(2) Be accredited by a recognized accrediting organization as a supplier of complex rehabilitation technology.(3) Employ at least one qualified rehabilitation technology professional as a W-2 employee (receiving a W-2 tax form from the provider) for each distribution location.(4) Have the qualified rehabilitation technology professional physically present for the evaluation, either in person or remotely if necessary, directly involved in determining the specific complex rehabilitation technology appropriate for the patient, and directly involved with, or closely supervised in, the final fitting and delivery of the complex rehabilitation technology.(5) Maintain a reasonable supply of parts, adequate physical facilities, and qualified service or repair technicians, and provide patients with prompt services and repair for all complex rehabilitation technology supplied.(6) Provide written information at the time of delivery of complex rehabilitation technology regarding how the patient may receive services and repair.(c) For complex needs patients receiving a complex rehabilitation manual wheelchair, power wheelchair, or seating component, the patient shall be evaluated, either in person or remotely if necessary, by both of the following:(1) A qualified health care professional.(2) A qualified rehabilitation technology professional.(d) A medical provider shall conduct a physical examination of an individual, either in person or remotely if necessary, before prescribing a power wheelchair or scooter for a Medi-Cal beneficiary. The medical provider shall complete a certificate of medical necessity that documents the medical condition that necessitates the power wheelchair or scooter, and verifies that the patient is capable of using the wheelchair or scooter safely.(e) (1) The department may adopt utilization controls, including a specialty evaluation by a qualified health care professional, as defined in paragraph (4) of subdivision (a). The Except as provided in paragraph (2), the department may adopt any other additional utilization controls for complex rehabilitation technology, as appropriate.(2) (A) The department shall not require prior authorization for the repair of a powered wheelchair.(B) A treatment authorization request for repair or replacement of a powered wheelchair shall not require a prescription or documentation of medical necessity from the treating practitioner requesting the repair or replacement if the powered wheelchair has already been approved for use by the patient.(f) The department shall seek any necessary federal approvals for the implementation of this section. This section shall be implemented only to the extent that any necessary federal approvals are obtained and federal financial participation is available and is not otherwise jeopardized.
SEC. 2. Section 14132.85 of the Welfare and Institutions Code is amended to read:
### SEC. 2.
14132.85. (a) For purposes of this section, the following definitions apply:(1) Complex needs patient means an individual with a diagnosis or medical condition that results in significant physical impairment or functional limitation. Complex needs patient includes, but is not limited to, individuals with spinal cord injury, traumatic brain injury, cerebral palsy, muscular dystrophy, spina bifida, osteogenesis imperfecta, arthrogryposis, amyotrophic lateral sclerosis, multiple sclerosis, demyelinating disease, myelopathy, myopathy, progressive muscular atrophy, anterior horn cell disease, post-polio syndrome, cerebellar degeneration, dystonia, Huntingtons disease, spinocerebellar disease, and the types of amputation, paralysis, or paresis that result in significant physical impairment or functional limitation. Complex needs patient does not negate the requirement that an individual meet medical necessity requirements under authority rules to qualify for receiving complex rehabilitation technology.(2) Complex rehabilitation technology means items classified within the federal Medicare Program as of January 1, 2021, as durable medical equipment that are individually configured for individuals to meet their specific and unique medical, physical, and functional needs and capacities for basic activities of daily living and instrumental activities of daily living identified as medically necessary. These items include, but are not limited to, complex rehabilitation manual and power wheelchairs, power seat elevation or power standing components of power wheelchairs, seating and positioning items, other specialized equipment such as adaptive bath equipment, standing frames, gait trainers, and specialized strollers, and related options and accessories.(3) Complex rehabilitation technology services includes the application of enabling systems designed and assembled to meet the needs of a patient experiencing any permanent or long-term loss or abnormality of physical or anatomical structure or function with respect to mobility or other function or need. These services include, but are not limited to, all of the following:(A) Evaluating the needs of a patient with a disability, including an assessment of the patient for the purpose of ensuring that the proposed equipment is appropriate.(B) Documenting medical necessity.(C) Selecting, fitting, customizing, maintaining, assembling, repairing, replacing, picking up and delivering, and testing equipment and parts.(D) Training the patient who will use the technology or any individual who assists the patient in using the complex rehabilitation technology.(4) Qualified health care professional means an individual who has no financial relationship to the provider of complex rehabilitation technology and is any of the following:(A) A physical therapist licensed pursuant to Chapter 5.7 (commencing with Section 2600) of Division 2 of the Business and Professions Code.(B) An occupational therapist licensed pursuant to Chapter 5.6 (commencing with Section 2570) of Division 2 of the Business and Professions Code.(C) Other licensed health care professional, approved by the department, and who performs specialty evaluations within the professionals scope of practice.(5) Qualified rehabilitation technology professional means an individual who meets either of the following:(A) Holds the credential of Assistive Technology Professional (ATP) from the Rehabilitation Engineering and Assistive Technology Society of North America.(B) Holds the credential of Certified Complex Rehabilitation Technology Supplier (CRTS) from the National Registry of Rehabilitation Technology Suppliers.(b) A provider of complex rehabilitation technology to a Medi-Cal beneficiary shall comply with all of the following:(1) Meet the supplier and quality standards established for a durable medical equipment supplier under the federal Medicare Program and be enrolled as a provider in the Medi-Cal program.(2) Be accredited by a recognized accrediting organization as a supplier of complex rehabilitation technology.(3) Employ at least one qualified rehabilitation technology professional as a W-2 employee (receiving a W-2 tax form from the provider) for each distribution location.(4) Have the qualified rehabilitation technology professional physically present for the evaluation, either in person or remotely if necessary, directly involved in determining the specific complex rehabilitation technology appropriate for the patient, and directly involved with, or closely supervised in, the final fitting and delivery of the complex rehabilitation technology.(5) Maintain a reasonable supply of parts, adequate physical facilities, and qualified service or repair technicians, and provide patients with prompt services and repair for all complex rehabilitation technology supplied.(6) Provide written information at the time of delivery of complex rehabilitation technology regarding how the patient may receive services and repair.(c) For complex needs patients receiving a complex rehabilitation manual wheelchair, power wheelchair, or seating component, the patient shall be evaluated, either in person or remotely if necessary, by both of the following:(1) A qualified health care professional.(2) A qualified rehabilitation technology professional.(d) A medical provider shall conduct a physical examination of an individual, either in person or remotely if necessary, before prescribing a power wheelchair or scooter for a Medi-Cal beneficiary. The medical provider shall complete a certificate of medical necessity that documents the medical condition that necessitates the power wheelchair or scooter, and verifies that the patient is capable of using the wheelchair or scooter safely.(e) (1) The department may adopt utilization controls, including a specialty evaluation by a qualified health care professional, as defined in paragraph (4) of subdivision (a). The Except as provided in paragraph (2), the department may adopt any other additional utilization controls for complex rehabilitation technology, as appropriate.(2) (A) The department shall not require prior authorization for the repair of a powered wheelchair.(B) A treatment authorization request for repair or replacement of a powered wheelchair shall not require a prescription or documentation of medical necessity from the treating practitioner requesting the repair or replacement if the powered wheelchair has already been approved for use by the patient.(f) The department shall seek any necessary federal approvals for the implementation of this section. This section shall be implemented only to the extent that any necessary federal approvals are obtained and federal financial participation is available and is not otherwise jeopardized.
14132.85. (a) For purposes of this section, the following definitions apply:(1) Complex needs patient means an individual with a diagnosis or medical condition that results in significant physical impairment or functional limitation. Complex needs patient includes, but is not limited to, individuals with spinal cord injury, traumatic brain injury, cerebral palsy, muscular dystrophy, spina bifida, osteogenesis imperfecta, arthrogryposis, amyotrophic lateral sclerosis, multiple sclerosis, demyelinating disease, myelopathy, myopathy, progressive muscular atrophy, anterior horn cell disease, post-polio syndrome, cerebellar degeneration, dystonia, Huntingtons disease, spinocerebellar disease, and the types of amputation, paralysis, or paresis that result in significant physical impairment or functional limitation. Complex needs patient does not negate the requirement that an individual meet medical necessity requirements under authority rules to qualify for receiving complex rehabilitation technology.(2) Complex rehabilitation technology means items classified within the federal Medicare Program as of January 1, 2021, as durable medical equipment that are individually configured for individuals to meet their specific and unique medical, physical, and functional needs and capacities for basic activities of daily living and instrumental activities of daily living identified as medically necessary. These items include, but are not limited to, complex rehabilitation manual and power wheelchairs, power seat elevation or power standing components of power wheelchairs, seating and positioning items, other specialized equipment such as adaptive bath equipment, standing frames, gait trainers, and specialized strollers, and related options and accessories.(3) Complex rehabilitation technology services includes the application of enabling systems designed and assembled to meet the needs of a patient experiencing any permanent or long-term loss or abnormality of physical or anatomical structure or function with respect to mobility or other function or need. These services include, but are not limited to, all of the following:(A) Evaluating the needs of a patient with a disability, including an assessment of the patient for the purpose of ensuring that the proposed equipment is appropriate.(B) Documenting medical necessity.(C) Selecting, fitting, customizing, maintaining, assembling, repairing, replacing, picking up and delivering, and testing equipment and parts.(D) Training the patient who will use the technology or any individual who assists the patient in using the complex rehabilitation technology.(4) Qualified health care professional means an individual who has no financial relationship to the provider of complex rehabilitation technology and is any of the following:(A) A physical therapist licensed pursuant to Chapter 5.7 (commencing with Section 2600) of Division 2 of the Business and Professions Code.(B) An occupational therapist licensed pursuant to Chapter 5.6 (commencing with Section 2570) of Division 2 of the Business and Professions Code.(C) Other licensed health care professional, approved by the department, and who performs specialty evaluations within the professionals scope of practice.(5) Qualified rehabilitation technology professional means an individual who meets either of the following:(A) Holds the credential of Assistive Technology Professional (ATP) from the Rehabilitation Engineering and Assistive Technology Society of North America.(B) Holds the credential of Certified Complex Rehabilitation Technology Supplier (CRTS) from the National Registry of Rehabilitation Technology Suppliers.(b) A provider of complex rehabilitation technology to a Medi-Cal beneficiary shall comply with all of the following:(1) Meet the supplier and quality standards established for a durable medical equipment supplier under the federal Medicare Program and be enrolled as a provider in the Medi-Cal program.(2) Be accredited by a recognized accrediting organization as a supplier of complex rehabilitation technology.(3) Employ at least one qualified rehabilitation technology professional as a W-2 employee (receiving a W-2 tax form from the provider) for each distribution location.(4) Have the qualified rehabilitation technology professional physically present for the evaluation, either in person or remotely if necessary, directly involved in determining the specific complex rehabilitation technology appropriate for the patient, and directly involved with, or closely supervised in, the final fitting and delivery of the complex rehabilitation technology.(5) Maintain a reasonable supply of parts, adequate physical facilities, and qualified service or repair technicians, and provide patients with prompt services and repair for all complex rehabilitation technology supplied.(6) Provide written information at the time of delivery of complex rehabilitation technology regarding how the patient may receive services and repair.(c) For complex needs patients receiving a complex rehabilitation manual wheelchair, power wheelchair, or seating component, the patient shall be evaluated, either in person or remotely if necessary, by both of the following:(1) A qualified health care professional.(2) A qualified rehabilitation technology professional.(d) A medical provider shall conduct a physical examination of an individual, either in person or remotely if necessary, before prescribing a power wheelchair or scooter for a Medi-Cal beneficiary. The medical provider shall complete a certificate of medical necessity that documents the medical condition that necessitates the power wheelchair or scooter, and verifies that the patient is capable of using the wheelchair or scooter safely.(e) (1) The department may adopt utilization controls, including a specialty evaluation by a qualified health care professional, as defined in paragraph (4) of subdivision (a). The Except as provided in paragraph (2), the department may adopt any other additional utilization controls for complex rehabilitation technology, as appropriate.(2) (A) The department shall not require prior authorization for the repair of a powered wheelchair.(B) A treatment authorization request for repair or replacement of a powered wheelchair shall not require a prescription or documentation of medical necessity from the treating practitioner requesting the repair or replacement if the powered wheelchair has already been approved for use by the patient.(f) The department shall seek any necessary federal approvals for the implementation of this section. This section shall be implemented only to the extent that any necessary federal approvals are obtained and federal financial participation is available and is not otherwise jeopardized.
14132.85. (a) For purposes of this section, the following definitions apply:(1) Complex needs patient means an individual with a diagnosis or medical condition that results in significant physical impairment or functional limitation. Complex needs patient includes, but is not limited to, individuals with spinal cord injury, traumatic brain injury, cerebral palsy, muscular dystrophy, spina bifida, osteogenesis imperfecta, arthrogryposis, amyotrophic lateral sclerosis, multiple sclerosis, demyelinating disease, myelopathy, myopathy, progressive muscular atrophy, anterior horn cell disease, post-polio syndrome, cerebellar degeneration, dystonia, Huntingtons disease, spinocerebellar disease, and the types of amputation, paralysis, or paresis that result in significant physical impairment or functional limitation. Complex needs patient does not negate the requirement that an individual meet medical necessity requirements under authority rules to qualify for receiving complex rehabilitation technology.(2) Complex rehabilitation technology means items classified within the federal Medicare Program as of January 1, 2021, as durable medical equipment that are individually configured for individuals to meet their specific and unique medical, physical, and functional needs and capacities for basic activities of daily living and instrumental activities of daily living identified as medically necessary. These items include, but are not limited to, complex rehabilitation manual and power wheelchairs, power seat elevation or power standing components of power wheelchairs, seating and positioning items, other specialized equipment such as adaptive bath equipment, standing frames, gait trainers, and specialized strollers, and related options and accessories.(3) Complex rehabilitation technology services includes the application of enabling systems designed and assembled to meet the needs of a patient experiencing any permanent or long-term loss or abnormality of physical or anatomical structure or function with respect to mobility or other function or need. These services include, but are not limited to, all of the following:(A) Evaluating the needs of a patient with a disability, including an assessment of the patient for the purpose of ensuring that the proposed equipment is appropriate.(B) Documenting medical necessity.(C) Selecting, fitting, customizing, maintaining, assembling, repairing, replacing, picking up and delivering, and testing equipment and parts.(D) Training the patient who will use the technology or any individual who assists the patient in using the complex rehabilitation technology.(4) Qualified health care professional means an individual who has no financial relationship to the provider of complex rehabilitation technology and is any of the following:(A) A physical therapist licensed pursuant to Chapter 5.7 (commencing with Section 2600) of Division 2 of the Business and Professions Code.(B) An occupational therapist licensed pursuant to Chapter 5.6 (commencing with Section 2570) of Division 2 of the Business and Professions Code.(C) Other licensed health care professional, approved by the department, and who performs specialty evaluations within the professionals scope of practice.(5) Qualified rehabilitation technology professional means an individual who meets either of the following:(A) Holds the credential of Assistive Technology Professional (ATP) from the Rehabilitation Engineering and Assistive Technology Society of North America.(B) Holds the credential of Certified Complex Rehabilitation Technology Supplier (CRTS) from the National Registry of Rehabilitation Technology Suppliers.(b) A provider of complex rehabilitation technology to a Medi-Cal beneficiary shall comply with all of the following:(1) Meet the supplier and quality standards established for a durable medical equipment supplier under the federal Medicare Program and be enrolled as a provider in the Medi-Cal program.(2) Be accredited by a recognized accrediting organization as a supplier of complex rehabilitation technology.(3) Employ at least one qualified rehabilitation technology professional as a W-2 employee (receiving a W-2 tax form from the provider) for each distribution location.(4) Have the qualified rehabilitation technology professional physically present for the evaluation, either in person or remotely if necessary, directly involved in determining the specific complex rehabilitation technology appropriate for the patient, and directly involved with, or closely supervised in, the final fitting and delivery of the complex rehabilitation technology.(5) Maintain a reasonable supply of parts, adequate physical facilities, and qualified service or repair technicians, and provide patients with prompt services and repair for all complex rehabilitation technology supplied.(6) Provide written information at the time of delivery of complex rehabilitation technology regarding how the patient may receive services and repair.(c) For complex needs patients receiving a complex rehabilitation manual wheelchair, power wheelchair, or seating component, the patient shall be evaluated, either in person or remotely if necessary, by both of the following:(1) A qualified health care professional.(2) A qualified rehabilitation technology professional.(d) A medical provider shall conduct a physical examination of an individual, either in person or remotely if necessary, before prescribing a power wheelchair or scooter for a Medi-Cal beneficiary. The medical provider shall complete a certificate of medical necessity that documents the medical condition that necessitates the power wheelchair or scooter, and verifies that the patient is capable of using the wheelchair or scooter safely.(e) (1) The department may adopt utilization controls, including a specialty evaluation by a qualified health care professional, as defined in paragraph (4) of subdivision (a). The Except as provided in paragraph (2), the department may adopt any other additional utilization controls for complex rehabilitation technology, as appropriate.(2) (A) The department shall not require prior authorization for the repair of a powered wheelchair.(B) A treatment authorization request for repair or replacement of a powered wheelchair shall not require a prescription or documentation of medical necessity from the treating practitioner requesting the repair or replacement if the powered wheelchair has already been approved for use by the patient.(f) The department shall seek any necessary federal approvals for the implementation of this section. This section shall be implemented only to the extent that any necessary federal approvals are obtained and federal financial participation is available and is not otherwise jeopardized.
14132.85. (a) For purposes of this section, the following definitions apply:
(1) Complex needs patient means an individual with a diagnosis or medical condition that results in significant physical impairment or functional limitation. Complex needs patient includes, but is not limited to, individuals with spinal cord injury, traumatic brain injury, cerebral palsy, muscular dystrophy, spina bifida, osteogenesis imperfecta, arthrogryposis, amyotrophic lateral sclerosis, multiple sclerosis, demyelinating disease, myelopathy, myopathy, progressive muscular atrophy, anterior horn cell disease, post-polio syndrome, cerebellar degeneration, dystonia, Huntingtons disease, spinocerebellar disease, and the types of amputation, paralysis, or paresis that result in significant physical impairment or functional limitation. Complex needs patient does not negate the requirement that an individual meet medical necessity requirements under authority rules to qualify for receiving complex rehabilitation technology.
(2) Complex rehabilitation technology means items classified within the federal Medicare Program as of January 1, 2021, as durable medical equipment that are individually configured for individuals to meet their specific and unique medical, physical, and functional needs and capacities for basic activities of daily living and instrumental activities of daily living identified as medically necessary. These items include, but are not limited to, complex rehabilitation manual and power wheelchairs, power seat elevation or power standing components of power wheelchairs, seating and positioning items, other specialized equipment such as adaptive bath equipment, standing frames, gait trainers, and specialized strollers, and related options and accessories.
(3) Complex rehabilitation technology services includes the application of enabling systems designed and assembled to meet the needs of a patient experiencing any permanent or long-term loss or abnormality of physical or anatomical structure or function with respect to mobility or other function or need. These services include, but are not limited to, all of the following:
(A) Evaluating the needs of a patient with a disability, including an assessment of the patient for the purpose of ensuring that the proposed equipment is appropriate.
(B) Documenting medical necessity.
(C) Selecting, fitting, customizing, maintaining, assembling, repairing, replacing, picking up and delivering, and testing equipment and parts.
(D) Training the patient who will use the technology or any individual who assists the patient in using the complex rehabilitation technology.
(4) Qualified health care professional means an individual who has no financial relationship to the provider of complex rehabilitation technology and is any of the following:
(A) A physical therapist licensed pursuant to Chapter 5.7 (commencing with Section 2600) of Division 2 of the Business and Professions Code.
(B) An occupational therapist licensed pursuant to Chapter 5.6 (commencing with Section 2570) of Division 2 of the Business and Professions Code.
(C) Other licensed health care professional, approved by the department, and who performs specialty evaluations within the professionals scope of practice.
(5) Qualified rehabilitation technology professional means an individual who meets either of the following:
(A) Holds the credential of Assistive Technology Professional (ATP) from the Rehabilitation Engineering and Assistive Technology Society of North America.
(B) Holds the credential of Certified Complex Rehabilitation Technology Supplier (CRTS) from the National Registry of Rehabilitation Technology Suppliers.
(b) A provider of complex rehabilitation technology to a Medi-Cal beneficiary shall comply with all of the following:
(1) Meet the supplier and quality standards established for a durable medical equipment supplier under the federal Medicare Program and be enrolled as a provider in the Medi-Cal program.
(2) Be accredited by a recognized accrediting organization as a supplier of complex rehabilitation technology.
(3) Employ at least one qualified rehabilitation technology professional as a W-2 employee (receiving a W-2 tax form from the provider) for each distribution location.
(4) Have the qualified rehabilitation technology professional physically present for the evaluation, either in person or remotely if necessary, directly involved in determining the specific complex rehabilitation technology appropriate for the patient, and directly involved with, or closely supervised in, the final fitting and delivery of the complex rehabilitation technology.
(5) Maintain a reasonable supply of parts, adequate physical facilities, and qualified service or repair technicians, and provide patients with prompt services and repair for all complex rehabilitation technology supplied.
(6) Provide written information at the time of delivery of complex rehabilitation technology regarding how the patient may receive services and repair.
(c) For complex needs patients receiving a complex rehabilitation manual wheelchair, power wheelchair, or seating component, the patient shall be evaluated, either in person or remotely if necessary, by both of the following:
(1) A qualified health care professional.
(2) A qualified rehabilitation technology professional.
(d) A medical provider shall conduct a physical examination of an individual, either in person or remotely if necessary, before prescribing a power wheelchair or scooter for a Medi-Cal beneficiary. The medical provider shall complete a certificate of medical necessity that documents the medical condition that necessitates the power wheelchair or scooter, and verifies that the patient is capable of using the wheelchair or scooter safely.
(e) (1) The department may adopt utilization controls, including a specialty evaluation by a qualified health care professional, as defined in paragraph (4) of subdivision (a). The Except as provided in paragraph (2), the department may adopt any other additional utilization controls for complex rehabilitation technology, as appropriate.
(2) (A) The department shall not require prior authorization for the repair of a powered wheelchair.
(B) A treatment authorization request for repair or replacement of a powered wheelchair shall not require a prescription or documentation of medical necessity from the treating practitioner requesting the repair or replacement if the powered wheelchair has already been approved for use by the patient.
(f) The department shall seek any necessary federal approvals for the implementation of this section. This section shall be implemented only to the extent that any necessary federal approvals are obtained and federal financial participation is available and is not otherwise jeopardized.