The Centers for Medicare & Medicaid Services (CMS) published a proposed rule, in the Federal Register on January 12, that, among other things, would establish qualifications and requirements that must be met to be considered a qualified O&P practitioner or supplier; would amend the payment rules to bill Medicare for prostheses and custom-fabricated orthoses; and amend requirements an organization must meet to accredit qualified suppliers to bill Medicare for prostheses and custom-fabricated orthoses. CMS will accept comments on the proposed rule until March 13. Comments may be submitted electronically at www.regulations.gov; enter 2017-00425 in the search bar. For other comment delivery options, see the proposed rule.
Provisions of the Proposed Rule
Define Qualified Practitioner. A qualified practitioner must be licensed by the state, or in absence of licensure requirements is certified by the American Board for Certification in Orthotics, Prosthetics and Pedorthics (ABC) or by the Board for Certification/Accreditation (BOC), or is credentialed and approved by a program that the U.S. Department of Health and Human Services (HHS) secretary determines, in consultation with appropriate experts in O&P, has training and education standards that are necessary to provide such O&P.
CMS is specifically seeking comments on the applicability of these proposed credentialing requirements to physicians. CMS would also identify and define eligible professionals who can become qualified practitioners, specifically: occupational therapist, ocularist, orthotist, pedorthist, physical therapist, physician, and prosthetist.
Define Qualified Supplier. A qualified supplier is a DMEPOS supplier who is also accredited by ABC or by BOC, or accredited and approved by a program that the HHS secretary determines has accreditation and approval standards that are essentially equivalent to those of ABC and BOC. This rule proposes that the alternative to ABC or BOC accreditation is to be accredited by an organization that employs or contracts with someone who is ABC or BOC certified to make the accreditation decision.
Criteria for Fabrication Facilities. CMS has proposed to define the term “fabrication facility” and establish the criteria fabrication facilities must meet. CMS is seeking comments on these proposed criteria.
Requirements for Accrediting Organizations. Qualified suppliers must be accredited by ABC or BOC or by an equivalent accrediting program. CMS is proposing that accreditation by an organization other than ABC or BOC would require that an individual who has been certified by ABC or BOC is authorized to make the decision about accreditation for a particular supplier. CMS is seeking comments on these proposals.
Payment for Prostheses and Custom-fabricated Orthoses. Medicare will only pay claims for prostheses or custom-fabricated orthoses if the item has been furnished and/or fabricated by a qualified practitioner or a qualified supplier at a facility that meets criteria the HHS secretary determines appropriate. Suppliers who do not meet these requirements may be subject to revocation of their Medicare enrollment.
List of Items. Section 1834(h)(1)(F)(ii)(I) of the Social Security Act requires the HHS secretary to develop and maintain a list of items to which this rule would apply. Only qualified practitioners who furnish and fabricate any of the items on the list and qualified suppliers who fabricate and bill for any of the items on the list are subject to the requirements of this rule. The list is available at www.cms.gov/medicareprovidersupenroll. Per the proposed rule, “no orthosis may be included in such list unless the item is individually fabricated for the patient over a positive model of the patient as defined therein.”
Quality Standards. After issuance of the final rule, CMS would update the durable medical equipment, prosthetics, orthotics, and supplies quality standards to reflect the provisions contained in the final rule resulting from this proposed rule. CMS plans to solicit comments on the proposed updates to the quality standards by posting them at www.cms.gov/medicareprovidersupenroll.
Effective Dates of the Provisions. Qualified suppliers who bill Medicare for prostheses and custom-fabricated orthoses would need to meet the requirements included in the final rule no later than one year after the posting date of the final quality standards or at the time of the supplier’s reaccreditation cycle, whichever is later. Qualified practitioners would be expected to meet the licensure and certification requirements within one year of publication of the final rule. CMS is seeking comments on the proposed effective dates.