Medicare Program; Establishment of Special Payment Provisions and Requirements for Qualified Practitioners and Qualified Suppliers of Prosthetics and…
Medicare Program; Establishment of Special Payment Provisions and Requirements for Qualified Practitioners and Qualified Suppliers of Prosthetics and Custom-Fabricated Orthotics
Proposed rule.
CFR Part: "42 CFR Part 424"
RIN Number: "RIN 0938-AR84"
Citation: "82 FR 3678"
Document Number: "CMS-6012-P"
Page Number: "3678"
"Proposed Rules"
SUMMARY: This proposed rule would specify the qualifications needed for qualified practitioners to furnish and fabricate, and qualified suppliers to fabricate prosthetics and custom-fabricated orthotics; accreditation requirements that qualified suppliers must meet in order to bill for prosthetics and custom-fabricated orthotics; requirements that an organization must meet in order to accredit qualified suppliers to bill for prosthetics and custom-fabricated orthotics; and a timeframe by which qualified practitioners and qualified suppliers must meet the applicable licensure, certification, and accreditation requirements. In addition, this rule would remove the current exemption from accreditation and quality standards for certain practitioners and suppliers.
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I. Background
A. General Overview
Medicare services are furnished by two types of entities, providers and suppliers. The term "provider of services" is defined in sections 1861(u) and 1866(e) of the Social Security Act (the Act). Based on the statute definition of "provider of services" in sections 1861(u) and 1866(e) of the Act we define and use the term "provider" in our regulations. At
The term supplier is defined in section 1861(d) of the Act. Supplier is defined as a physician or other practitioner, facility or an entity other than a provider of services that furnishes items or services under
Section 1861(n) of the Act defines "durable medical equipment." See https://www.ssa.gov/OP_Home/ssact/title18/1861.htm. Also, the term DME is included in the definition of "medical and other health services" in section 1861(s)(6) of the Act, see https://www.ssa.gov/OP_Home/ssact/title18/1861.htm and also included in the definition of medical equipment and supplies in section 1834(j)(5) of the Act. See https://www.ssa.gov/OP_Home/ssact/title18/1834.htm. Furthermore, the term is defined in
* Can withstand repeated use;
* Effective for items classified as DME after
* Is primarily and customarily used to serve a medical purpose;
* Generally, is not useful to an individual in the absence of an illness or injury; and
* Is for use in the home.
Prosthetics and orthotics which are defined under section 1861(s)(9) of the Act as leg, arm, back, and neck braces and artificial legs, arms, and eyes, including replacements if required because of a change in the patient's physical condition, are included under the coverage definition under section 1861(s)(9) of the Act. We are using this definition of prosthetics and orthotics for the purposes of this proposed rule. They are also described in the Medicare Benefit Policy Manual (100-02), Chapter 15, Section 130 that specifies that these appliances are covered under Part B when furnished incident to physicians' services or on a physician's order.
B. Legislative History
1.
Section 427 of the
A qualified practitioner is defined by BIPA as a physician or other individual who is a qualified physical therapist or a qualified occupational therapist; or is licensed in orthotics or prosthetics, in the cases where the state provides such licensing; or, in states where the state does not provide such licensing, is specifically trained and educated to provide or manage the provision of prosthetics and custom-designed or fabricated orthotics and is certified by the
A qualified supplier is defined by BIPA as any entity that is accredited by the
The Congress directed the Secretary to implement section 427 of BIPA no later than 1 year after the date of the enactment using a negotiated rulemaking process. The negotiated rulemaking committee (the Committee) on Special Payment Provisions for Prosthetics and Certain Custom-Fabricated Orthotics was established following the requirements set forth by the Federal Advisory Committee Act (FACA). The Committee held nine meetings from
2. Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA)
Section 302(a)(1) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) added a new paragraph (20) to section 1834(a) of the Act requiring the Secretary to establish and implement DMEPOS quality standards that suppliers must meet in order to furnish and bill for covered items and services described in new section 1834(a)(20)(D) of the Act, which includes prosthetics and orthotics. The new paragraph (20) also required the Secretary to designate and approve one or more independent accreditation organizations to apply the quality standards. In addition, the new section 1834(a)(20) of the Act required that to obtain or retain a Medicare Part B billing number DMEPOS suppliers must be accredited by one of the approved accreditation organizations.
The DMEPOS quality standards were posted on our Web site at www.cms.gov/medicareprovidersupenroll as required by section 1834(a)(20)(E) of the Act. On
All DMEPOS suppliers must meet the quality standards. The quality standards required by section 1834(a)(20) of the Act are used by the approved accrediting organizations as the basis for their accrediting decisions.
3. Medicare Improvement for Patients and Providers Act of 2008 (MIPPA)
Section 154(b) of the Medicare Improvement for Patients and Providers Act of 2008 (MIPPA) (Pub. L. 110-275 amended section 1834(a)(20) of the Act by adding a new subparagraph (F) to require DMEPOS suppliers furnishing covered items and services, directly or as a subcontractor for another entity, to have submitted to the Secretary evidence of being accredited as meeting the applicable quality standards on or after
To date there have not been accreditation or quality requirements designed specifically to be applied to such eligible professionals and thus as a result, all eligible professionals and other persons, including orthotists and prosthetists, that furnish, fabricate, and bill for prosthetics and certain custom-fabricated orthotic items are currently exempt from the quality standards and the accreditation requirement.
II. Provisions of the Proposed Regulations
This proposed rule would implement certain provisions of section 1834(h)(1)(F) of the Act. It would establish the qualifications and requirements that must be met in order to be considered a qualified practitioner or a qualified supplier. This proposed rule would also amend the special payment rules for items furnished by DMEPOS suppliers set forth at
Specifically, we are proposing the following:
* Removing the exemption from quality standards and accreditation that is currently in place in accordance with section 1834(a)(20) of the Act for certain practitioners and suppliers who furnish or fabricate prosthetics and custom-fabricated orthotics.
* Revising SEC 424.57 to include a definition of custom-fabricated orthotics as an item as listed in section 1861(s)(9) of the Act that must be individually made for a specific patient, constructed using one of the positive model techniques listed in
* Revising SEC 424.57(a) to include a definition of positive model of the patient as a particular type of custom fabrication in which one of the following modeling techniques is used:
++ Molded to the patient model as a negative impression of the patient's body part and a positive model rectification are constructed.
++ Computer Aided Design-Computer Aided Manufacturing (CAD-CAM) system.
++ Direct formed model.
* Defining "qualified supplier" as a DMEPOS supplier that is accredited in accordance with the section 1834(a)(20) of the Act.
* Defining "qualified practitioner" as an eligible professional or other person that meets the education, training, licensure, and certification requirements of the section 1834(h)(1)(F)of the Act.
* Specifying training, licensure, and certification requirements that qualified practitioners must meet in order to furnish or fabricate prosthetics and custom-fabricated orthotics.
* Requiring that claims for prosthetics and custom-fabricated orthotics that are submitted by qualified suppliers or by beneficiaries must have been furnished by a qualified practitioner and fabricated by a qualified practitioner or a qualified supplier as defined in this proposed rule. Suppliers that do not meet these requirements are at risk of revocation of their
* Defining the requirements that must be met by organizations that are designated and approved by CMS to accredit suppliers that bill for prosthetics and custom-fabricated orthotics.
* Define "fabrication facility" and specify the requirements that a facility must meet in order for qualified practitioners and qualified suppliers to be able to fabricate prosthetics and custom-fabricated orthotics that can be paid for by
Separately, in this proposed rule we also--
* Describe our intent to modify the DMEPOS quality standards to reflect the provisions of this rule, including the effective date for meeting the revised quality standards; and
* Provide the list of services and supplies subject to the requirements of this rule (www.cms.gov/medicareprovidersupenroll).
We provide a link to the list of items and describe our intent to revise the quality standards as information only. We are not soliciting comments on the content of or the process for updating the quality standards, which will be addressed through the regulatory process we reference in section II.A.6.a. of this proposed rule. Nor are we soliciting comment on the content of or process for updating the list of items and supplies, which is described in section II.B. of this proposed rule. Comments on those matters will be considered outside the scope of this rule.
A. Updating of Accreditation and Certification Requirements
1. Removing the MIPPA Exemptions for DMEPOS Suppliers and Certain Eligible Professionals and Other Persons Who Furnish or Fabricate Prosthetics and Custom-Fabricated Orthotics
Consistent with the provisions of the Act, including those provisions added by BIPA, MMA, and MIPPA, we have put in place a framework for accreditation of suppliers that fabricate DMEPOS and bill for DMEPOS services. However, qualified practitioners and qualified suppliers are currently exempt from having to meet the quality standards or to be accredited as suppliers in order to be able to bill
As noted previously, section 1834(a)(20)(F)(ii) of the Act provided the Secretary the authority to exempt "eligible professionals" (as defined in section 1848(k)(3)(B) of the Act) and such "other persons" from the quality standards and accreditation requirement unless the Secretary determined that the standards are designed specifically to be applied to such eligible professionals and other persons or if the Secretary determined that licensing, accreditation or other mandatory quality requirements apply to such eligible professionals and other persons. The Secretary did not determine that there were standards designed specifically to be applied to such eligible professionals and other persons and the Secretary did not determine that licensing, accreditation or other mandatory quality requirements apply to such eligible professionals and other persons. Therefore, we issued a fact sheet on our Web site announcing the exemption at www.cms.gov/medicareprovidersupenroll.
Through this proposed rule, we are now designing standards specifically to apply to such eligible professionals and other persons. We believe that it is imperative to have both licensure and certification requirements for all qualified practitioners (eligible professionals and other persons who furnish or fabricate prosthetics and custom-fabricated orthotics) and to have accreditation requirements for all qualified suppliers (DMEPOS suppliers that fabricate or bill for prosthetics and custom-fabricated orthotics that are subject to the requirements of this proposed rule). Moreover, we believe that the provisions in section 1834(a)(20) of the Act were enacted to achieve that objective.
Therefore, in order to ensure that only those who are qualified to do so can furnish, fabricate, and bill for the prosthetics and custom-fabricated orthotics addressed by this proposed rule, we would remove the exemption from having to meet the quality standards and the exemption from having to be accredited that currently exist for eligible professionals and other persons that furnish, fabricate or bill for prosthetics and custom-fabricated orthotics.
2. Definition and Accreditation Requirements for Qualified Suppliers
Consistent with the provisions in section 1834(h)(1)(F) of the Act, which require that no payment will be made unless those furnishing prosthetics and custom-fabricated orthotics are qualified to do so, we are proposing to define qualified supplier, in
* Enrolled in
* Accredited by one of the CMS-approved accreditation organizations that meets the proposed requirements that an organization must meet to accredit qualified suppliers of prosthetics and custom-fabricated orthotics in
In our existing regulations at
* Redesignating the existing text as paragraph (c)(22)(i). We would also make clarifying, technical, and conforming changes. We note that changes would not modify the intent of this provision. We also note that this requirement would still be applicable to all DMEPOS suppliers.
* Adding a new paragraph (c)(22)(ii) to state the additional accreditation requirements for DMEPOS suppliers that would be fabricating and billing for prosthetics and custom-fabricated orthotics. In order to be a qualified supplier, the DMEPOS supplier must be accredited by a CMS-approved accreditation organization for prosthetics and custom-fabricated orthotics as described in
Section 1834(h)(1)(F) of the Act requires, in part, that no payment can be made for prosthetics or custom-fabricated orthotics unless the item is fabricated by a qualified practitioner or a qualified supplier at a facility that meets such criteria as the Secretary determines appropriate. Therefore, we are proposing to define and establish the criteria that such a facility must meet. We are proposing to define "fabrication facility" to distinguish this facility type from others referenced in our regulations. In
* Meets the requirements in
* Is utilized by a qualified practitioner or a qualified supplier to fabricate prosthetics or custom-fabricated orthotics.
In SEC 424.57(d)(4), based on input from other government agencies and contractors that are involved in ensuring that prosthetics and custom-fabricated orthotics are furnished, fabricated and paid for properly, we would specify that the fabrication facility at which qualified suppliers and qualified practitioners fabricate prosthetics and custom-fabricated orthotics, as defined in
* Be located within
* Be a business that is organized, established and licensed under applicable state and federal laws.
* Have a process for maintenance and production of fabrication records including the following:
++ Job/work orders.
++ Record tracking systems.
++ Real time recordkeeping, for example, ensuring that records are updated as the fabrication takes place.
++ Secure storage of records with electronic and hard copy back-up.
* Have a quality assurance process to identify non-standard production outcomes, and improve fabrication outcomes.
* Have a periodic review and employee demonstration of fabrication/safety/communication/operations competencies with corrective action plans for staff that do not meet the minimal standards.
* Have full time appropriately credentialed staff member(s) who are (qualified practitioners or qualified suppliers) onsite to fabricate and to supervise fabrication.
* Have a laboratory area with appropriate safety equipment (for example, flammable material storage, gloves, safety glasses, and proper ventilation).
* Have a separate waiting area and chairs with armrests, as necessary.
* Have patient care and fitting rooms with appropriate levels of privacy and sanitation. Patient fitting and care areas should be separate from the fabrication area.
* Have disinfecting supplies, gloves, masks, and plastic for containing contaminated materials.
* Have a fabrication facility information system, paper or digital, that can track the production, list component part number (and serial number if available) and quantity, and that is linked to patient information and be Health Insurance Portability and Accountability Act compliant. Such a system must allow facility staff and management, including those fabricating, to identify any parts that could be recalled at a later date.
* Have parallel bars, a full-length mirror, and other appropriate assessment tools.
* Have a process that mandates following precautions to handle used patient devices that are contaminated.
* Have repair and disinfecting areas clearly labeled.
* Have the ability to handle all potentially hazardous materials in facility properly.
* Have an emergency management plan and a safety management plan.
* Have policy for detecting/reporting counterfeit supplies.
* Have the proper tools, equipment, and computers commonly used in the fabrication of particular items and typically associated with the particular technical approach (negative impression/positive model, CAD-CAM, or direct formed), as applicable. These tools and equipment would include, but are not limited to the following:
++ Computers with appropriate graphics/modeling capacity and technology.
++ Band saw.
++ Disc sander.
++ Sanding paper.
++ Flexible shaft sander.
++ Lathe.
++ Drill press.
++ Sewing machine.
++ Grinding equipment.
++ Paint-spraying equipment.
++ Welding equipment.
++ Alignment jig.
++ Ovens capable of heating plastics for molding.
++ Computer controlled milling machine.
++ Lockable storage areas for raw materials and finished devices.
++ Air compressor.
We note that these requirements would apply even if the fabrication facility is the same location as that of the DMEPOS supplier.
We intend to require that AO's cannot accredit a qualified supplier or renew the accreditation of a qualified supplier unless the qualified supplier uses a fabrication facility that meets these criteria. We are seeking comment on the definition of a fabrication facility and its requirements.
3. Definition of Qualified Practitioner
We are also proposing to define qualified practitioner in
a. Specific Eligible Professionals and Other Persons
In SEC 424.57(a), we would identify and define the types of eligible professionals and other persons who can become qualified practitioners, and therefore, in accordance with the BIPA provisions, furnish or fabricate prosthetics and custom-fabricated orthotics. Specifically, we propose to identify and to add definitions for the following practitioners: (1) Occupational therapist; (2) ocularist; (3) orthotist; (4) pedorthist; (5) physical therapist; (6) physician; and (7) prosthetist.
* Occupational Therapist. Our current regulations at
* Ocularist.
* Orthotist. Our current regulations in
++ Be licensed by all states in which practicing, if applicable.
++ Have successfully completed a training program in orthotics that is jointly recognized by the
++ Be eligible to take that Board's certification examination in orthotics.
We are proposing to define an orthotist as an individual who meets the personnel qualifications in
* Pedorthist.
* Physical Therapist. Our current regulations at
* Physician. Our current regulations at
Doctors of dental surgery or dental medicine, doctors of optometry, psychiatrists, and chiropractors do not customarily furnish or fabricate prosthetics and custom-fabricated orthotics. Therefore, we have not proposed requirements for these eligible professionals or any others who do not typically furnish or fabricate the prosthetics and custom-fabricated orthotics that are subject to the provisions of this proposed rule. However, any qualified practitioner who furnishes or fabricates prosthetics or custom-fabricated orthotics and any qualified supplier that fabricates or bills for such services must meet the applicable requirements as specified in this rule.
* Prosthetist. A prosthetist is able to provide all types prosthetics, with the exception of facial prosthetics. Our current regulations at
++ Be licensed by all states in which they are practicing, if applicable.
++ Have successfully completed a training program in prosthetics that is jointly recognized by the
++ Be eligible to take that Board's certification examination in prosthetics.
We are proposing to define a prosthetist as an individual who meets the personnel qualifications in
b. Training, Licensure, and Certification Requirements for Qualified Practitioners
In addition to defining the types of professionals that would be eligible to furnish and fabricate prosthetics and custom-fabricated orthotics, we are proposing certain licensure, training, and certification requirements that these practitioners must meet to be qualified practitioners who furnish or fabricate prosthetics or custom-fabricated orthotics that are billed to
Therefore, in proposed
++ Licensed in orthotics, pedorthics or prosthetics by the state.
++ In states that do not provide licenses for orthotics, pedorthics or prosthetics, must be both of the following:
--Specifically, trained and educated to provide and manage the provision of pedorthics, prosthetics, and orthotics.
--Certified by the one of the following:
+++
+++ BOC.
+++ A Secretary-approved organization that has standards equivalent to the
We believe these proposed requirements would ensure that the specialized needs of
We also clarify that, to the extent that a qualified supplier does not fabricate a prosthetic or a custom-fabricated orthotic, such prosthetic or custom-fabricated orthotic must be fabricated by a qualified practitioner, and that it is the responsibility of the qualified supplier to verify the practitioner's qualified status.
4. Claims for Prosthetics and Custom-Fabricated Orthotics
As stated previously, we are proposing that all DMEPOS suppliers that bill for prosthetics and custom-fabricated orthotics must meet the supplier standards in
We have proposed in
5. Requirements for Accreditation Organizations
Section 1834(a)(20)(B) of the Act requires the Secretary to designate and approve one or more independent accreditation organizations to apply the quality standards required in section 1834(a)(20)(A) of the Act. In the
* The
* The BOC.
* An approved DMEPOS accreditation organization that has standards equivalent to the
We are proposing to define "a DMEPOS accreditation organization that has standards equivalent to the
We believe that these proposed requirements are in concert with the provisions of section 1834(h) of the Act requiring that the supplier be accredited by the
6. Quality Standards Required in Section 1834(a)(20) of the Act
a. Overview of and Process for Updating the Quality Standards
The quality standards required by section 1834(a)(20) of the Act are used by the accreditation organizations in order to determine whether a supplier meets statutory and regulatory requirements and therefore can be accredited. Any supplier would have to maintain these standards in order to meet the accreditation requirements and be approved as a qualified supplier to bill, continue to bill or fabricate Medicare Part B prosthetics and custom-fabricated orthotics.
After issuance of the final rule, we would update the DMEPOS quality standards to reflect the provisions contained in the final rule resulting from this proposed rule. The revised quality standards would include specifically the requirements that qualified practitioners must meet to furnish and fabricate prosthetics and custom-fabricated orthotics and that qualified suppliers must meet in order to fabricate and bill
b. Effective Date for Compliance With New Quality Standards
We are proposing in
If an ocularist, orthotist, prosthetist, physicians, pedorthist, occupational therapist, physical therapist or any other eligible professional is not furnishing or fabricating prosthetics or custom-fabricated orthotics, then they would not need to meet the specific prosthetics and custom-fabricated orthotics requirements in this proposed rule. Similarly, if an enrolled DMEPOS supplier is not billing for the prosthetics and custom-fabricated orthotics subject to the provisions of this proposed rule, then the supplier would not need to meet the specific prosthetics and custom-fabricated orthotics requirements in this proposed rule.
The requirements of section 1834(h)(1)(F) of the Act apply to all prosthetics and certain custom-fabricated orthotics described in section 1834(h)(1)(F)(ii) of the Act. Section 1834(h)(1)(F)(ii)(I) of the Act, as added by section 427 of BIPA, states that an item described in this clause is an item of custom-fabricated orthotics that requires education, training, and experience to custom-fabricate and that is included in a list established by the Secretary. Section 1834(h)(1)(F)(ii)(I) of the Act also specifies that an item of custom-fabricated orthotics does not include shoes and shoe inserts.
Section 1834(h)(1)(F)(ii)(II) of the Act as added by section 427 of BIPA states that the Secretary, in consultation with appropriate experts in orthotics (including national organizations representing manufacturers of the same), shall establish and update as appropriate a list of items to which this subparagraph applies. No orthotic may be included in such list unless the item is individually fabricated for the patient over a positive model of the patient as defined later. On
In keeping with the statute's intent to consult with appropriate experts in developing the list, we not only reviewed the Committee's recommendations, but also consulted with the following:
*
* Medicare Pricing, Data, Analysis and Coding (PDAC) contractor(s).
*
*
*
* The
To implement this statutory provision, we propose to add the following definitions in
* Positive model of the patient means a particular type of custom fabrication in which one of the following occurs:
++ Is molded to the patient model as a negative impression taken of the patient's body part and a positive model rectification are constructed.
++ A Computer Aided Design-Computer Aided Manufacturing (CAD-CAM) system, by use of digitizers, transmits surface contour data to software that the practitioner uses to rectify or modify the model on the computer screen. The data depicting the modified shape is electronically transmitted to a commercial milling machine that carves the rectified model.
++ A direct formed model is one in which the patient serves as the positive model. The device is constructed over the model of the patient and is then fabricated to the patient. The completed custom fabrication is checked and all the necessary adjustments are made.
* Custom-fabricated means an item that is individually made for a specific patient. Specifically, a custom-fabricated item is a device that is fabricated based on clinically derived and rectified castings, tracings, measurements, and other images such as x-rays of the body part. The fabrication may involve using calculation, templates and components. This process requires the use of basic materials including, but not limited to plastic, metal, leather or cloth in the form of uncut or unshaped sheets, bars or other basic forms and involves substantial work such as vacuum forming, cutting, bending, molding, sewing, drilling, laminating, and finishing prior to fitting on the patient. An item is considered custom-fabricated if it is constructed by using one of the positive model techniques described in the definition of positive model of the patient.
Lastly, we would specify in
The list would be updated through periodic program instructions to reflect any changes. We intend to update the list as needed on the CMS Web site at www.cms.gov/medicareprovidersupenroll. We note that the list of services and supplies that are subject to the provisions of this proposed rule is being provided for information only. We are not, in this proposed rule, soliciting comments on the list.
We would continue to consult with experts in orthotics as changes in positive model techniques occur that might impact the definition and list of items subject to section 1834(h)(1)(F) of the Act. Any such changes to the list of items would be issued through program instructions. We would continue to ensure that any change to the list of prosthetics and custom-fabricated orthotics is done in concert with our established processes.
We would issue contractor instructions and a provider educational article detailing the list of HCPCS codes for the prosthetics and custom-fabricated orthotic items to which the requirements apply, as well as instructions to DMEPOS suppliers regarding billing, data collection, and systems operations following the publication of the final rule. Any changes to the list items would also be published in future CMS contractor instructions.
III. Collection of Information Requirements
A. Background
Under the Paperwork Reduction Act of 1995, we are required to provide 60-day notice in the
* The need for the information collection and its usefulness in carrying out the proper functions of our agency.
* The accuracy of our estimate of the information collection burden.
* The quality, utility, and clarity of the information to be collected.
* Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.
B. ICRs Regarding DMEPOS Suppliers and Eligible Professionals Providing Custom-Fabricated Orthotics (
1. Accreditation for Physicians and Practitioners Enrolled as DMEPOS Suppliers
Under SEC 424.57(c)(22), DMEPOS suppliers that furnish, fabricate and bill for prosthetics or custom-fabricated orthotics must meet all accreditation requirements specified in these provisions, and be licensed in orthotics, pedorthics, or prosthetics in the state in which its practice is located (if the state requires such licensure). Table 1 identifies categories and approximate numbers of individuals who, as of
Table 1--Prosthetics Category Number Number enrolled who as are ABC DMEPOS or suppliers BOC certified Prosthetists 8,000 5,000 Physicians 5,000 3,000 Physical and Occupational Therapists 1,000 500 Ocularists 400 200 Orthotists 1,500 800 Pedorthists 900 500 Total 16,800 10,000
The 10,000 physicians and practitioners in Table 1 who are enrolled as DMEPOS suppliers and are accredited would meet the requirements of proposed
Table 2 identifies categories and approximate numbers of individuals who, as of
Category Number Number enrolled who as are ABC DMEPOS or suppliers BOC certified Prosthetists 4,000 2,000 Physicians 3,000 1,500 Physical and Occupational Therapists 1,000 500 Ocularists 300 200 Orthotists 4,000 2,500 Pedorthists 700 400 Total 13,000 7,100
The 7,100 physicians and practitioners in Table 2 who are currently enrolled as DMEPOS suppliers and are accredited would meet the requirements of proposed
Although it is highly likely that some of the individuals in Tables 1 and 2 provide both prosthetics and custom-fabricated orthotics, we have chosen to assume that the tables reflect unduplicated counts of physicians and practitioners.
We cannot estimate the number of physicians and practitioners in the universe of 12,700 (6,800 + 5,900) who would either decline to obtain accreditation because of cost, other factors or inability to meet the accreditation requirements. We believe that the overwhelming majority of the 12,700 physicians and practitioners would elect to and become accredited to continue to provide, bill, or both provide and bill for these devices. We expect that a lower percentage of physicians, physical therapists, and occupational therapists would seek accreditation than would prosthetists, orthotists, pedorthists, and ocularists. This is because furnishing prosthetics and custom-fabricated orthotics traditionally constitutes a smaller portion of their practices than is the case with the latter four practitioner types. For purposes of this burden estimate only, and as outlined in Table 3, we project that--(1) all prosthetists, orthotists, ocularists, and pedorthists would pursue accreditation; and (2) 90 percent of physicians, physical therapists, and occupational therapists would seek accreditation. This results in a base figure of 12,250 physicians and practitioners that is only slightly less than the 12,700-person universe mentioned previously.
Table 3--Number of Physicians and Practitioners Seeking Accreditation Category Approximate Number percentage of universe * Prosthetists 40.8 5,000 Physicians 25.7 3,150 Physical and Occupational 7.3 900 Therapists Ocularists 2.5 300 Orthotists 18.0 2,200 Pedorthists 5.7 700 Total 12,250 * Rounded to nearest tenth.
The hour and cost burdens on these physicians and practitioners of completing and submitting the paperwork associated with accreditation would vary because each physician's and practitioner's specific circumstances differ. However, we believe that an average per physician/practitioner time burden of 10 hours is reasonable, though we welcome comments on this estimate. This 10-hour period would include the time involved in completing and submitting the necessary accreditation paperwork, including obtaining any required supporting documentation.
Many of the 12,250 physicians and practitioners are part of group practices that have administrative personnel who handle various paperwork functions on behalf of the group's physicians and practitioners. It is probable that some administrative personnel would complete and submit the physicians' and practitioners' accreditation paperwork. However, we have no data that can help us predict the number of instances in which this would occur. In an effort not to underestimate the potential cost burden, we will assume for purposes of our analysis that physicians and practitioners would complete and submit their accreditation applications.
Table 4 identifies the mean hourly wages for the
Table 4--BLS Mean Hourly Wages UsingMay 2015 Data BLS category BLS mean Hourly hourly wage wage with ( ] fringe benefits and overhead ( ] Orthotists and Prosthetists * 33.63 67.26 Physicians and Surgeons 97.33 194.66 Physical Therapists 41.25 ** 82.50 Occupational Therapists 39.27 ** 78.54 * Includes ocularists and pedorthists. ** The average mean hourly wage for physical and occupational therapists combined, which we will use in our analysis, is$80.52 (or ($82.50 +$78.54 )/2).
Table 5 identifies the total hour and cost burdens for enrolled physicians and practitioners seeking accreditation. The cost burdens are based on the wage estimates in Table 4.
Table 5--Total Hour and Costs Burdens for Enrolled Physicians and Practitioners Seeking Accreditation Category Number of Hour burden Total hour Hourly wage Total cost physicians per burden ( ] burden and submission ( ] practitio- ners Prosthetists 5,000 10 50,000 67.26 3,363,000 Physicians 3,150 10 31,500 194.66 6,131,790 Physical and 900 10 9,000 80.52 724,680 Occupational Therapists Ocularists 300 10 3,000 67.26 201,780 Orthotists 2,200 10 22,000 67.26 1,479,720 Pedorthists 700 10 7,000 67.26 470,820 Total 12,250 122,500 12,371,790
Although this burden would be incurred in the first year of our proposed requirement, 3 years is the maximum length of an OMB approval. Therefore, we must average the totals in Table 5 over a 3-year period. This result in the following average annual figures of: (1) 4,083 affected physicians and practitioners; (2) 40,830 ICR burden hours; and (3)
2. Accreditation for Newly Enrolling Physicians and Practitioners
Table 6 outlines the annual number of physicians and practitioners who, based on historical CMS data, would--(1) seek accreditation in accordance with
Table 6--Annual Number of Physicians and Other Practitioners Seeking Accreditation, Enrolling inMedicare as DMEPOS Suppliers, and Billing for Prosthetics or Custom-Fabricated Orthotics Category Number of enrollees Prosthetists 400 Physicians 250 Physical and Occupational Therapists 100 Ocularists 40 Orthotists 400 Pedorthists 100 Total 1,290
Table 7 outlines the annual hour and cost burdens for newly enrolling physicians and practitioners. The table applies the 10-hour and BLS wage estimates mentioned previously.
Table 7--Annual Hour and Cost Burdens for Newly Enrolling Physicians and Practitioners Seeking Accreditation Category Number of Hour burden Total hour Hourly wage Total cost physicians per burden ( ] burden and submission ( ] practitio- ners Prosthetists 400 10 4,000 67.26 269,040 Physicians 250 10 2,500 194.66 486,650 Physical and 100 10 1,000 80.52 80,520 Occupational Therapists Ocularists 40 10 400 67.26 26,904 Orthotists 400 10 4,000 67.26 269,040 Pedorthists 100 10 1,000 67.26 67,260 Total 1,290 12,900 1,199,414
3. Reporting Accreditation via the CMS-855S (Medicare Enrollment Application: Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Suppliers)
The CMS-855S is currently approved under OMB control number 0938-1056. In order to account for the application information collection requirements contained in this notice of proposed rulemaking, we will submit a revised information collection request for OMB review and approval.
a. Enrolled Physicians and Practitioners
Upon becoming accredited, physicians and practitioners would need to report the accreditation to us via a CMS-855S change of information request. We estimate that it would take physicians and practitioners 30 minutes to complete and submit this change request. Table 8 outlines the total hour and cost burdens of this requirement.
Table 8--Total Hour and Cost Burdens for Enrolled Physicians and Practitioners Reporting Accreditation via CMS-855S Category Number of Hour burden Total hour Hourly wage Total cost physicians per burden ( ] burden and submission ( ] practitio- ners Prosthetists 5,000 0.5 2,500 67.26 168,150 Physicians 3,150 0.5 1,575 194.66 306,590 Physical and 900 0.5 450 80.52 36,234 Occupational Therapists Ocularists 300 0.5 150 67.26 10,089 Orthotists 2,200 0.5 1,100 67.26 73,986 Pedorthists 700 0.5 350 67.26 23,541 Total 12,250 6,125 618,590
Although this burden would be incurred in the first year of our proposed requirement, we must average the totals in Table 8 over a 3-year period. This results in: (1) 4,083 affected physicians and practitioners; (2) 2,042 ICR burden hours; and (3)
b. Newly Enrolling Physicians and Practitioners
When completing the CMS-855S initial enrollment application, physicians and practitioners would have to furnish accreditation information on the form. We estimate that this would take 30 minutes per application. Table 9 outlines the total annual hour and cost burdens.
Table 9--Total Annual Hour and Cost Burdens for Newly Enrolling Physicians and Practitioners Reporting Accreditation via CMS-855S Category Number of Hour burden Total hour Hourly wage Total cost physicians per burden ( ] burden and submission ( ] practitio- ners Prosthetists 400 0.5 200 67.26 13,452 Physicians 250 0.5 125 194.66 24,333 Physical and 100 0.5 50 80.52 4,026 Occupational Therapists Ocularists 40 0.5 20 67.26 1,345 Orthotists 400 0.5 200 67.26 13,452 Pedorthists 100 0.5 50 67.26 4,026 Total 1,290 645 60,634
4. Requirements for Becoming a Qualified Practitioner
Under SEC 424.57(d)(3), all eligible professionals who wish to become qualified practitioners, to provide prosthetics or custom-fabricated orthotics, and who are not enrolled in
* Be licensed in orthotics, pedorthics, or prosthetics in the state in which his or her practice is located if the state requires such licensure; or
* If the state does not require such licensure--
* Be specifically trained and educated to provide and manage the provision of pedorthics, prosthetics, or orthotics; and
* Meet the certification requirements specified in
Specifically, this section discusses the hour and cost burdens for physicians and practitioners who are--(1) not enrolled in
Approximately 15 states require licensure to furnish prosthetics and custom-fabricated orthotics. However, we do not have concrete data regarding the number of unenrolled and unlicensed individuals in the 35 other states or the territories who provide these items, for these persons do not bill
As we lack sufficient data regarding the number of qualified practitioners, who fall within the universe of 5,000 physicians and practitioners, we will use the figures in Table 3 as a baseline estimate. To illustrate, orthotists represented 18 percent of the 12,250 suppliers referenced in Table 3 (or 2,200 out of 12,250); we project that 18 percent of the 5,000-person universe (or 900) would consist of orthotists. We also utilized the wage estimates and the 10-hour projection. This results in the following Year 1 hour and cost burdens associated with
Table 10--Hour and Cost Burdens Associated With S. 424.57(d) *3 in Year 1 Category Number of Hour burden Total hour Hourly wage Total cost physicians per burden ( ] burden and submission ( ] practitio- ners Prosthetists 2,040 10 20,400 67.26 1,372,104 Physicians 1,285 10 12,850 194.66 2,501,381 Physical and 365 10 3,650 80.52 293,898 Occupational Therapists Ocularists 125 10 1,250 67.26 84,075 Orthotists 900 10 9,000 67.26 605,340 Pedorthists 285 10 2,850 67.26 191,691 Total 5,000 50,000 5,048,489
Table 11 reflects the annual hour and cost burdens in Year 2 and each year thereafter. The figures are based on the 500-individual universe.
Table 11--Annual Hour and Cost Burdens of S. 424.57(d) *3 in Year 2 and Subsequent Years Category Number of Hour burden Total hour Hourly wage Total cost physicians per burden ( ] burden and submission ( ] practitioners Prosthetists 204 10 2,040 67.26 137,210 Physicians 128 10 1,280 194.66 249,165 Physical and 36 10 360 80.52 28,987 Occupational Therapists Ocularists 13 10 130 67.26 8,744 Orthotists 90 10 900 67.26 60,534 Pedorthists 29 10 290 67.26 19,505 Total 500 5,000 504,145
We averaged the totals in Tables 10 and 11 over a 3-year period. This results in the following annual figures of: (1) 2,000 affected physicians and practitioners; (2) 20,000 burden hours; and (3)
C. Final ICR Hour and Cost Burdens
We estimate the following total ICR burdens associated with our proposed provisions in each of the first 3 years of this rule.
Table 12--Summary of Annual Information Collection Burdens Regulation OMB Number of Number of Burden per section(s) Control No. respondents responses response (hours) S. 424.57(c)(22)--Enrolled 0938-New 12,250 12,250 10 seeking accreditation S. 424.57(c)(22)--Newly 0938-New 1,290 1,290 10 enrolling seeking accreditation S. 424.57(c)(22)--Enrolled 0938-1056 4,083 4,083 0.5 reporting accreditation via 855S SS 424.57(c)(22)--Newly 0938-1056 1,290 1,290 0.5 enrolling reporting accreditation via 855S S. 424.57(d) *3 * * * 0938-New 2,000 2,000 10 Total 12,746 12,746
Table 12--Summary of Annual Information Collection Burdens Regulation Total Hourly Total Total section(s) annual labor labor cost cost burden cost ( ] ( ] (hours) ( ] S. 424.57(c)(22)--Enrolled 122,250 + 4,123,930 4,123,930 seeking accreditation S. 424.57(c)(22)--Newly 12,290 ++ 1,199,414 1,199,414 enrolling seeking accreditation S. 424.57(c)(22)--Enrolled 2,042 +++ 206,197 206,197 reporting accreditation via 855S SS 424.57(c)(22)--Newly 645 ++++ 60,634 60,634 enrolling reporting accreditation via 855S S. 424.57(d) *3 * * * 20,000 +++++ 2,018,926 2,018,926 Total 75,807 7,609,101 7,609,101 Note: There are no capital/maintenance costs associated with the information collection requirements contained in this rule; therefore, we have removed the associated column from Table 1. + See the values listed in Table 5. ++ See the values listed in Table 7. +++ See the values listed in Table 8. ++++ See the values listed in Table 9. * * * The values are based on the 3-year average of the values listed in tables 10 and 11. Three years is the maximum length of an OMB approval. +++++ See the values listed in Tables 10 and 11.
We welcome comments on all burden estimates contained in the collection of information section of this notice of proposed rulemaking.
If you comment on these information collection and recordkeeping requirements, please do either of the following:
1. Submit your comments electronically as specified in the ADDRESSES section of this proposed rule; or
2. Submit your comments to the
IV. Regulatory Impact Statement
This proposed rule would implement a statutory mandate that only individuals and suppliers qualified to do so can furnish, fabricate or bill for prosthetics and custom fabricated orthotics. The statute was enacted to ensure quality of care and eliminate care or services furnished or fabricated by individuals who were not qualified to do so. The idea inherent in the statute is not to deny necessary services but to ensure that the individuals and suppliers furnishing or fabricating these items are qualified to do so. As with all program changes, whether undertaken by us or in response to statutory imperative--as is the case with this rule--we always consider the impact of the proposed changes on access to care. In the case of the statutory provisions being implemented via this rule, we do not believe beneficiary access to care will be significantly affected. This rule involves only a very small percentage of the overall universe of physician, non-physician practitioner, and organizational suppliers. Of those affected, we believe that many either already comply with our proposed requirements or would come into compliance. We acknowledge that there may be some discontinuity of care in instances where a beneficiary seeks or has been receiving items from an individual or supplier that does not meet the requirements of the statute. However, we believe it will be minimal, and the benefit in improved quality of care outweighs the possible discontinuity. In addition, the phased in effective dates for compliance will allow reasonable time for practitioners and suppliers to meet the statutory and regulatory requirements thus minimizing any disruption in access to needed services. We welcome comment on these assumptions.
In summary, we believe that our proposed rule would, as the
We have examined the impact of this rule as required by Executive Order 12866 on Regulatory Planning and Review (
Executive Order 12866 and 13563 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects (
As previously stated in section III. of this proposed rule, we estimate that 12,250 physicians and practitioners who are enrolled as DMEPOS suppliers and who have billed
The RFA requires agencies to analyze options for regulatory relief of small businesses. For purposes of the RFA, small entities include small businesses, nonprofit organization and small governmental jurisdictions. Most entities and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of
In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 603 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area for
Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipates costs and benefits before issuing any rule whose mandates require spending in any 1 year of
Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement cost on state and local governments, preempts state law, or otherwise has Federalism implications. Since this rule does not impose any costs on state or local governments, the requirements of Executive Order 13132 are not applicable.
There were several uncertainties associated with our proposed projections. First, we could not determine precisely the number of DMEPOS suppliers who would choose not to pursue accreditation or be unable to become accredited. Second, we had no data on which to base our 5,000-person and 500-person estimates in Tables 10 and 11. As such, these estimates are merely designed to solicit comment on the number of individuals who would be affected by
We note that by limiting payment to the circumstances described in this rule, our regulations would likely reduce the provision of and billing for these items to instances consistent with the statute. We believe, however, that this would enhance the quality of services and items by ensuring that unqualified entities and individuals are not furnishing such goods, while simultaneously having no real effect on how prices are set for them.
In accordance with the provisions of Executive Order 12866, this proposed rule was reviewed by the
V. Response to Comments
Because of the large number of public comments we normally receive on
List of Subjects for 42 CFR Part 424
Emergency medical services, Health facilities, Health professions,
For the reasons set forth in the preamble, the
PART 424--CONDITIONS FOR MEDICARE PAYMENT
1. The authority citation for part 424 continues to read as follows:
Authority: Sections 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
2. Section 424.57 is amended as follows:
a. In paragraph (a) by adding the definition of "Custom-fabricated orthotics," Fabrication facility", "Occupational therapist", "Ocularist", "Orthotist", "Pedorthist", "Physical therapist", "Physician", "Positive model of the patient", "Prosthetics", "Prosthetist", "Qualified practitioner", and "Qualified supplier" in alphabetical order and in the definition of "DMEPOS supplier" by removing the reference "paragraphs (c) and (d) of this section" and adding in its place the reference "paragraphs (c) and (h) of this section".
b. Revising paragraph (c)(22);
c. In paragraph (c)(26) removing the reference "paragraph (d) of this section" and adding in its place the reference "paragraph (h) of this section";
d. Redesignating paragraph (d) as paragraph (h) and adding a new paragraph (d);
e. In newly designated paragraph (h)(1)(i) and (ii), removing the reference "paragraph (d)(15) of this section" and adding in its place the reference "paragraph (h)(15) of this section".
f. In newly designated paragraphs (h)(1)(i), (ii), (h)(4)(ii)(B), (h)(5)(iii) introductory text, (h)(12), and (h)(15)(ii), removing the reference "paragraph (d)" of this section and adding in its place the reference "paragraph (h)" of this section.
g. In newly designated paragraphs (h)(2)(i), (ii), and (iii) removing the reference "paragraph (d)(3) of this section" and adding in its place the reference "paragraph (h)(3) of this section".
h. In newly designated paragraphs (h)(3)(i), removing the references "paragraph (d)(2) of this section" and adding in its place the reference "paragraph (h)(2)" and removing the reference "paragraph (d)(3)(ii) of this section" and adding in its place the reference "paragraph (h)(3)(ii) of this section".
i. In newly designated paragraph (h)(15)(ii), removing the reference "paragraph (d)(15)(i) of this section" and adding in its place "paragraph (h)(15)(i) of this section".
The revisions and additions read as follows:
(a) * * *
Custom-fabricated orthotic means an item as listed in section 1861(s)(9) of the Act that meets all of the following:
(i) Is individually made for a specific patient.
(ii) Is constructed using one of the positive model techniques (as defined in this paragraph).
(iii) Is made based on clinically derived and rectified castings, tracings, measurements, and other images (such as x-rays) of the body part and may involve the use of calculations, templates, and components.
(iv) Is made using basic materials including, but not limited to the following:
(A) Plastic.
(B) Metal.
(C) Leather or cloth in the form of uncut or unshaped sheets or bars.
(D) Other basic forms and involves substantial work such as the following:
( 1) Vacuum forming.
( 2) Cutting.
( 3) Bending.
( 4) Molding.
( 5) Sewing.
( 6) Drilling.
( 7) Laminating.
* * * * *
Fabrication facility means the physical structure that--
(1) Meets the requirements in paragraph (d)(4) of this section; and
(2) Must be used by a qualified practitioner or a qualified supplier to fabricate prosthetics or custom-fabricated orthotics that are billed to and paid for by
* * * * *
Occupational therapist means an individual who meets the personnel qualifications for an occupational therapist as specified in
Ocularist means a trained technician skilled in the arts of fitting, shaping, and painting ocular prostheses who is certified by the National Examining
Orthotist means an individual who meets the personnel qualifications for an orthotist as specified in
Pedorthist means an individual with specific training in footwear which includes other pedorthic devices to solve problems in, or related to, the foot.
* * * * *
Physical therapist means an individual who meets the personnel qualifications for a physical therapist as specified in
Physician means an individual who meets the personnel qualifications for a physician as specified in
Positive model of the patient means a particular type of custom fabrication in which one of the following modeling techniques is used:
(i) Molded to the patient model as a negative impression of the patient's body part and a positive model rectification are constructed.
(ii) Computer Aided Design-Computer Aided Manufacturing (CAD-CAM) system.
(iii) Direct formed model.
Prosthetics means an item as described in section 1861(s)(9) of the Act.
Prosthetist means an individual who meets the personnel qualifications for a prosthetist as specified in
Qualified practitioner means one of the following eligible professionals or other persons defined in paragraph (a) of this section who meets the prosthetic and custom-fabricated orthotic requirements specified in paragraph (d)(3) of this section:
(i) Occupational therapist.
(ii) Ocularist.
(iii) Orthotist.
(iv) Pedorthist.
(v) Physical therapist.
(vi) Physician.
(vii) Prosthetist.
Qualified supplier means a DMEPOS supplier as defined in paragraph (a) of this section that is accredited by a CMS-approved accreditation organization to fabricate prosthetics and custom-fabricated orthotics as described in
* * * * *
(c) * * *
(22)(i) DMEPOS supplier requirements. A DMEPOS supplier must be accredited by a CMS-approved accreditation organization in order to receive and retain a supplier billing number and to enroll in
(ii) Requirements for DMEPOS suppliers fabricating or billing prosthetics and custom-fabricated orthotics. Effective 1 year after the posting of the final revised quality standards or the next revalidation, whichever is later, a DMEPOS supplier fabricating or billing for prosthetics or any of the custom-fabricated orthotics identified on the list described in paragraph (d)(2) of this section must do all of the following:
(A) Meet the requirements specified in paragraph (c)(22)(i) of this section.
(B) Be accredited by a CMS-approved accreditation organization for orthotics and prosthetics as described in
(C) Notify the AO of any change in conditions, practices, or operations that were relied upon by the AO at the time of accreditation. This would include, but not be limited to, a requirement for notifying the AO of any changes in personnel, including changes in status or qualifications of employees of the qualified supplier or of any personnel utilized by the qualified supplier via contract or other business relationship. This requirement is included to ensure that qualified suppliers, once accredited, continue to meet all of the accreditation and other supplier standards.
* * * * *
(d) Additional standards for qualified suppliers fabricating or billing for prosthetics or custom-fabricated orthotics, or qualified practitioners furnishing or fabricating prosthetics and custom-fabricated orthotics.
(1) General rule. CMS makes payment for a bill or claim for a prosthetic or custom-fabricated orthotic identified on the list in paragraph (d)(2) of this section and meets all of the following:
(i) Furnished by a qualified practitioner.
(ii) Fabricated by a qualified practitioner or qualified supplier at a fabrication facility as defined in paragraph (a) of this section.
(iii)(A) Billed by a qualified supplier; or
(B) Submitted as a claim by a
(2) List of prosthetics and custom-fabricated orthotics subject to the additional standards. CMS maintains a list of prosthetics and custom-fabricated orthotics subject to the requirements in this section. The list is--
(i) Updated as necessary; and
(ii) Posted on the CMS Web site.
(3) Training, licensure, and certification requirements for qualified practitioners. (i) A qualified practitioner who is not enrolled in
(A) Licensed in orthotics, pedorthics or prosthetics by all States in which they practice.
(B) In States that do not provide licenses for orthotics, pedorthics or prosthetics a qualified practitioner must be--
( 1) Specifically trained and educated to provide and manage the provision of pedorthics, prosthetics, and orthotics; and
( 2) Certified by any of the following:
( i)
( ii) BOC.
( iii) A Secretary-approved organization that has standards equivalent to the
(ii) Qualified practitioners must meet the licensure, training, education and certification requirements specified in this section within 1 year of publication of the final rule.
(4) Fabrication facility requirements. A fabrication facility at which qualified suppliers and qualified practitioners fabricate prosthetics and custom-fabricated orthotics, as defined in
(i) Be located within
(ii) Be a business that is organized, established and licensed under applicable state and federal laws.
(iii) Have a process for maintenance and production of fabrication records including the following:
(A) Job/work orders.
(B) Record tracking systems.
(C) Real time recordkeeping, for example, ensuring that records are updated as the fabrication takes place.
(iv) Have a quality assurance process to identify non-standard production outcomes, and improve fabrication outcomes.
(v) Have a periodic review and employee demonstration of fabrication/safety/communication/operations competencies with corrective action plans for staff that do not meet the minimal standards.
(vi) Have full time appropriately credentialed staff member(s) who are (qualified practitioners or qualified suppliers) onsite to fabricate and to supervise fabrication.
(vii) Have a laboratory area with appropriate safety equipment (for example, flammable material storage, gloves, safety glasses, proper ventilation).
(viii) Have a separate waiting area and chairs with armrests, as necessary.
(ix) Have a patient care and fitting rooms with appropriate levels of privacy and sanitation. Patient fitting and care areas should be separate from the fabrication area.
(x) Have disinfecting supplies, gloves, masks, and plastic for containing contaminated materials.
(xi) Have a fabrication facility information system, paper or digital, that can track the production, list component part number (and serial number if available), quantity, that is linked to patient information and be Health Insurance Portability and Accountability Act compliant. Such a system must allow facility staff and management, including those fabricating, to identify any parts that could be recalled at a later date.
(xii) Have parallel bars, a full-length mirror, and other appropriate assessment tools.
(xiii) Have a process using precautions to handle used patient devices that are contaminated.
(xiv) Have repair and disinfecting areas clearly labeled.
(xv) Have the ability to handle all potentially hazardous materials in facility properly.
(xvi) Have an emergency management plan and a safety management plan.
(xvii) Have policy for detecting/reporting counterfeit supplies.
(xviii) Have the proper tools, equipment, and computers commonly used in the fabrication of particular items and typically associated with the particular technical approach (negative impression/positive model, CAD-CAM, or direct formed), as applicable: These tools and equipment would include, but are not limited to the following
(A) Computers with appropriate graphics/modeling capacity and technology.
(B) Band saw.
(C) Disc sander.
(D) Sanding paper.
(E) Flexible shaft sander.
(F) Lathe.
(G) Drill press.
(H) Sewing machine.
(I) Grinding equipment.
(J) Paint-spraying equipment.
(K) Welding equipment.
(L) Alignment jig.
(M) Ovens capable of heating plastics for molding.
(N) Computer controlled milling machine.
(O) Lockable storage areas for raw materials and finished devices.
(P) Air compressor.
* * * * *
3. Section 424.58 is amended as follows:
a. Revising the section heading.
b. Redesignating paragraphs (c) through (e) as paragraphs (d) through (f) respectively.
c. Adding a new paragraph (c).
The revision and addition read as follows:
* * * * *
(c) Additional requirements for accrediting qualified suppliers. To accredit qualified suppliers that fabricate or bill
(1)
(2)
(3) An organization that--
(i) Employs or contracts with an orthotist, prosthetist, occupational therapist or physical therapist who--
(A) Meets the definition of qualified practitioner specified in
(B) Is utilized for the purpose of surveying the supplier or practitioner for compliance; and
(ii) Has the authority granted by CMS to approve or deny the accreditation of qualified suppliers as defined in
* * * * *
4. Section
a. Revising the section heading.
b. In paragraph (a)(2) introductory text by removing the phrase "the provider or supplier is--" and adding in its place "the provider or supplier is any of the following:".
c. In paragraph (a)(2)(ii) by removing the phrase "Is debarred, suspended, or" and adding in its place the phrase "Debarred, suspended or".
d. Adding paragraph (a)(2)(iii).
The revision and addition reads as follows:
(a) * * *
(2) * * *
(iii) A qualified supplier as defined in
(A) Furnished by a qualified practitioner; and
(B) Fabricated by a qualified practitioner or qualified supplier as defined in
* * * * *
Dated:
Acting Administrator,
Dated:
Secretary,
[FR Doc. 2017-00425 Filed 1-11-17;
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