Congress Passes O&P Clinical Notes Provision

In the early morning hours today, Congress passed and the President signed a massive budget agreement that sets budget levels for two years, continues to fund the federal government through March 23rd, and sets up a massive omnibus spending bill to fund the federal government through the remainder of fiscal year 2018.  One of the provisions in this bill directly impacts the O&P community:  Recognition of the prosthetists’ and orthotists’ clinical notes as part of the Medicare patient’s record for purposes of determining the medical necessity of O&P care.


‘‘(5) DOCUMENTATION CREATED BY ORTHOTISTS AND PROSTHETISTS.—For purposes of determining the reasonableness and medical necessity of orthotics and prosthetics, documentation created by an orthotist or prosthetist shall be considered part of the individual’s medical record to support documentation created by eligible professionals described in section 1848(k)(3)(B).’’

This provision addresses a problem that started in 2011 with publication by CMS of a “Dear Physician” letter that stated that the physician’s notes, not the prosthetist’s, determine medical necessity.  This letter, and subsequent CMS guidance, resulted in a raft of unnecessary Medicare denials of O&P claims, many of which still sit at the ALJ level of review awaiting hearings.  The clinical notes of the prosthetist or orthotist will now be recognized along with the records of physicians and other professionals involved with O&P care.  NAAOP expects this provision to impact the reversal rate of Medicare O&P denials in favor of O&P practitioners at all levels of administrative appeal.

NAAOP congratulates and thanks AOPA and its lobbyists for their leadership on this provision, as well as NAAOP’s membership, the O&P Alliance organizations, the Amputee Coalition, and the ITEM Coalition, all of which worked to achieve enactment of this legislation.  NAAOP and the O&P community will continue the fight to enact two additional provisions from the Medicare O&P Improvement Act (S. 1191 and H.R. 2599), namely:

  • Section 7 of the Medicare O&P Improvement Act: This provision clarifies Congressional intent regarding the definition of “minimal self-adjustment,” which defines off-the-shelf orthotics for purposes of competitive bidding.
  • Section 8 of the Medicare O&P Improvement Act: This provision would direct CMS to finally implement long-overdue regulations for Section 427 of the Benefits Improvement and Protection Act of 2000 (BIPA), which links the right to bill the Medicare program for custom fabricated orthotics and prosthetics with the qualifications of the practitioner or supplier. This is an important fraud & abuse and patient protection.
  • Written by NAAOP

VA Choice of Practitioner and Medicare Competitive Bidding

Two major issues are heating up in Washington, veterans’ right to choose their O&P practitioner and Medicare competitive bidding of an expanded range of durable medical equipment, prosthetics, orthotics and supplies (DMEPOS).

VA Choice of Practitioner

The VA published a proposed rule in October making the VA the “sole” authority in choosing the O&P practitioner who will provide services to each veteran.  By doing so, VA proposes to fundamentally change the right that veterans have had for five decades to choose the O&P practitioner who best meets their needs, whether that practitioner is a VA employee or a private provider with a VA.  NAAOP strongly opposes this proposed change and will be working with its O&P Alliance partners to maintain veteran choice.

This “right” is included in the Injured and Amputee Veterans Bill of Rights (H.R. 2322), bipartisan legislation introduced by Congressman Tim Walberg (R-MI).  NAAOP is working with Cong. Walberg to advance the bill or, in the alternative, to try to impact the pending VA CHOICE 2.0 legislation.  This bill would make permanent the VA CHOICE program enacted several years ago.  The bill would expand veterans’ choice of private health care providers, exactly the opposite direction than the VA’s proposed rule on prosthetics.  Look for more information as to how NAAOP members can help on these issues in the coming days.

Expanding Medicare Competitive Bidding

On November 2, the Medicare Payment Advisory Commission (MedPAC) hosted a meeting entitled:  Medicare payment policy for non-competitively bid DMEPOS.  MedPAC staff opened the session by presenting the slide deck accessed here. MedPAC reviewed spending trends and pricing accuracy of non-competitively bid DMEPOS.  Staff indicated that across its top 25 DME items, Medicare spending rates had decreased about 50 percent since 2010 while, during the same period, non-CBP Medicare spending had increased by 24%, with no significant negative changes in beneficiary health outcomes.  (Many in the disability and rehabilitation community would argue this point.)  MedPAC’s staff stated that Medicare could have saved approximately $47 million in 2015 if Medicare rates were equal to median private payer rates for off-the-shelf orthotics alone.

The presentation concluded with the issuance of two policy options for the Commission to consider, one to expand the use of CBP to more items of DMEPOS, and to reduce payment rates for certain non-CBP products annually until they are in line with private rates. To protect beneficiaries from adverse balance billing practices, MedPAC recommended placing a cap on balance billing and paying non-participating suppliers 5% less than participating suppliers.  NAAOP will be monitoring this debate closely and will address significant concerns with MedPAC along with its Alliance partner organizations.

  • Written by NAAOP

BIPA Section 427 Update and Other Health Care Developments

There were significant developments on health care issues this month, both broad and narrowly focused on O&P Care.  First off, the Senate was not able to muster a majority to pass the so-called Graham/Cassidy ACA repeal and replace legislation, which means that for the foreseeable future, persons in need of orthotic and prosthetic care will be able to access coverage under Medicaid and private, individual insurance.  This is because O&P care is typically considered an essential health benefit under the Affordable Care Act.  In related news, the House and Senate are moving closer to reauthorizing the Children’s Health Insurance Program (CHIP) for a 5-year period.  CHIP covers over 9 million children with health insurance that includes coverage of O&P care.

With respect to BIPA Section 427, CMS announced that it is “withdrawing” the proposed rule published on January 12, 2017, comments for which were due in March.  CMS received over 5,000 comments and the strongest objections came from physicians, PTs, and OTs, who arguably were exempted from the rule by statute.  By mandating that these providers obtain state licenses to provide O&P care or get certified by ABC or BOC, CMS generated tremendous opposition to the proposed rule.  In the end, these organizations overwhelmed CMS and were able to convince the Trump Administration to pull the rule in the name of regulatory relief.

There is no way paint a rosy picture of this development.  After years spent trying to finally get CMS to issue these regulations in final form, this is a significant step backwards.  However, there are some glimmers hope that we hope to build on.  First, the announcement stated that the rule was being withdrawn to “assure agency flexibility in re-examining the issues and exploring options and alternatives with stakeholders.”  We have already communicated with CMS and plan to meet with them soon to discuss how to proceed from here.

Second, this development heightens the need to rally behind passage of the Medicare O&P Improvement Act (S. 1191 and H.R. 2599) which includes provisions compelling CMS to finally issue regulations interpreting Section 427 of BIPA.  The bill explicitly exempts physicians, PTs and OTs, which would remove the majority of the opposition to the rule.  NAAOP will continue to work for passage of the O&P Medicare Improvement Act and seek alternative ways to implement the letter and spirit of BIPA Section 427.

  • Written by NAAOP

Congress Returns to Packed Legislative Agenda

Congress Returns to Packed Legislative Agenda

As Congress returns to Washington in the month of September, it faces a daunting set of challenges. The federal debt limit needs to be increased in order for the federal government to continue meeting its financial obligations. The federal government’s agencies need to be funded by October 1, 2017 or the government will shut down, and the State Children’s Health Insurance Program (SCHIP) needs to be reauthorized by the end of September or authority to run SCHIP will expire.

Complicating this packed legislative agenda is the need for federal funding to address the immediate and ongoing needs created by Hurricane Harvey.   The O&P community will be discussing the profession’s response to this colossal storm and seek ways to assist those impacted.  More to follow….

Several orthotic and prosthetic policy issues continue to be front and center for NAAOP.  CMS recently signaled that it may withdraw BIPA section 427 regulations linking provider and supplier qualifications with Medicare billing privileges. While it appears that CMS has not yet made a final decision, NAAOP and its Alliance partners are working hard to ensure that CMS presses forward with final publication of regulations involving this section of the law, which was passed 17 years ago but never implemented in full.

The Interagency Workgroup on Lower Limb Prosthetics, which was convened in the wake of the draft local coverage determination (LCD) for lower limb prostheses is expected to release a consensus statement at some point in the near future.  However, timing on this is still unclear. Once the Workgroup releases its statement, NAAOP will submit public comments on it.

Meanwhile, Congress continues to address O&P legislation by passing in the House legislation to recognize the relevance of prosthetists’ and orthotists’ clinical documentation as part of the patients’ medical records for purposes of determining the medical necessity of submitted claims. NAAOP is working with its Alliance partners to ensure that Congress passes this provision, along with other aspects of the Medicare O&P Improvement Act this year.

NAAOP also continues to work toward passage of the Injured and Amputee Veterans Bill of Rights, H.R. 2322, which is designed to educate veterans of their rights to quality O&P care and enable them to become their own best advocate in securing such care.

Finally, NAAOP acknowledges and congratulates AOPA on its 100th Anniversary, a true milestone.  We are also very proud to recognize our own 30-year anniversary as NAAOP. Our unending gratitude goes out to our members and supporters who have enabled us to speak on behalf of O&P practitioners and the patients they serve for the past three decades.

  • Written by NAAOP

Major Legislative Developments Impact O&P Care

Two major legislative efforts impacted orthotics and prosthetics in July as the House adjourned for their August recess and the Senate delayed their break to proceed to critical votes on other matters.

  1. ACA Repeal and Replace: The Senate debated whether to repeal and replace the Affordable Care Act at length and voted on several different versions of the bill.  Other than the “motion to proceed” with debate on the overall subject (which passed 51 to 50), all amendments were not able to attain the fifty votes needed for Vice President Pence to break the tie vote.  With all Democrats and Independents firmly against repeal and replace, Majority Leader McConnell (R-KY) could not lose more than two of the 52 Republican votes.  In the end, Senators Collins (R-ME), Murkowski (R-AK) and McCain (R-AZ) prevented the bill from proceeding and the Majority Leader was forced to pull the bill from consideration at 1:40 a.m., Friday, July 28th.  The main reason cited by these senators was the expected impact of coverage losses in their states.  This is a major development considering the long-standing call to repeal the ACA, but the effort to reform American health care will no doubt continue given the fragile condition of the private insurance market and the ever-growing federal investment in the Medicare and Medicaid programs.From an O&P perspective, failure of a repeal and replace effort temporarily removes a threat to O&P access and coverage across the private insurance market and Medicaid expansion programs.  There may be additional legislative efforts later this year as well as efforts that do not require legislative action.  For instance, the Secretary of Health and Human Services has significant authority to redesign regulations that impact the essential benefit package and the category of benefits known as “rehabilitative and habilitative services and devices.”  NAAOP expects proposed regulations in the near future that will give states much more flexibility in designing essential benefits, and O&P benefits are likely to be among the benefits that are limited or restricted in certain ways.  NAAOP will continue monitoring this situation closely to ensure maximum coverage of O&P care for the benefit of patients and their providers.
  1. Recognition of Clinical Notes of the O&P Practitioner: On July 25th, the House of Representatives passed bipartisan Medicare legislation, H.R. 3178, to recognize that “documentation created by an orthotist or prosthetist shall be considered part of the individual’s medical record to support documentation created by eligible professionals…”   This declaration will be tremendously useful in demonstrating medical necessity when Medicare contractors determine whether to deny O&P claims.  NAAOP recognizes and thanks AOPA for its extensive efforts on this achievement as well as the House sponsors including Glenn Thompson (R-PA), Mike Bishop (R-MI) and Mike Thompson (D-CA).  The bill now proceeds to the Senate where Senators Grassley (R-IA), and Warner (D-VA) have introduced the Medicare O&P Improvements Act, S. 1191, bipartisan legislation that includes this provision, as well as a number of other critical policy changes that benefit O&P.
  • Written by NAAOP

Congressional Briefing on the Value of Rehabilitation and Habilitation

Please see linked below the video to the entire one-hour Congressional Briefing on the Value of Rehabilitation and Habilitation Services and Devices in America’s Healthcare System held on earlier this week in the Dirksen Senate Office Building:

Table of contents

  • Peter Thomas begins the briefing
  • At 3:24, Senator Tammy Duckworth (D-IL) begins speaking
  • At 11:38, Representative Glenn Thompson (R-PA) begins speaking
  • At 23:58, Eric LeGrand begins speaking
  • At 32:53, Roseann Sdoia begins speaking
  • At 45:45, Lisa Smith begins speaking
  • At 51:06, Gregory J. O’Shanick, MD begins speaking
  • At 54:49, Peter Thomas begins the conclusion of the briefing

Thank you for your continued advocacy!

  • Written by NAAOP

SPECIAL ALERT:  Senate Health Reform Bill and Congressional Briefing

The Senate is scheduled to vote this week on its ACA Repeal and Replace legislation which was released in draft form on Thursday.  The bill would undermine essential health benefit coverage, including orthotic and prosthetic coverage, in the private insurance market and under the Medicaid program.

NAAOP is taking a lead role in working with a large group of rehabilitation and disability organizations to conduct a Congressional Briefing on the “Value of Rehabilitative and Habilitative Services and Devices in America’s Health Care System” along with over fifty Senate staff visits to drive home our message.

The briefing will be live streamed and will be available for viewing on NAAOP’s website at  The briefing is on Tuesday, June 27, 2017, from 12:15 to 1:30 p.m.  Special guests include Sen. Tammy Duckworth, Cong. Brian Mast, and others who will tell their story of injury, recovery, and the importance of rehabilitation services and devices.

  • Written by NAAOP

As ACA Repeal Vote Looms, O&P Issues Progress

The House continues to struggle to achieve enough votes within the Republican Party to repeal the Affordable Care Act (ACA) and replace it with the American Health Care Act (AHCA). Despite extensive pressure on Republican moderates, the House does not have enough votes at the present time to pass the bill and send it to the Senate for further consideration. Of greatest concern to House moderates is how the bill will impact those with pre-existing conditions and those who rely on Medicaid for their health care access. One of the biggest concerns for NAAOP is a recent amendment to the AHCA that would allow states to opt-out of providing Essential Health Benefits (EHB), which includes coverage for “rehabilitative services and devices.” This language is why the vast majority of ACA health plans and Medicaid expansion plans cover orthotics and prosthetics. NAAOP strongly supports continued access to O&P care in any bill passed by Congress on health reform.

As the ACA repeal debate continues, Medicare and other developments impact O&P:

  • Injured and Amputee Veterans Bill of Rights: NAAOP is working to reintroduce federal legislation to help educate veterans of their rights to obtain O&P care under the VA health care program. The bill seeks to make veterans aware of their right to select the practitioner of their choice and to obtain appropriate prosthetic technology that meets their needs. A new bipartisan bill is expected to be introduced soon.
  • Performant Audits: The nationwide Medicare Recovery Auditor for O&P claims (Performant) recently posted an approved issue on their website that signaled a new round of audits on knee stance flexion, HCPCS code L-5845, used with a wide variety of single axis knee codes. NAAOP and its O&P Alliance partners view the approval of this audit issue as a major overreach by Performant/CMS and have taken aggressive steps to oppose this issue and request withdrawal of this audit approval. The audit would change current Medicare coverage and coding guidance which RACs do not have authority to do. Progress is being made as Performant recently removed the audit announcement from its website without explanation.
  • LCD Legislation: In 2015, the DME MACs issued a draft Local Coverage Determination (LCD) for Lower Limb Prostheses (LLP) that would have dramatically restricted access to the current standard of O&P care. That draft LCD was placed on hold while CMS studies the issue through an Interagency Workgroup on LLP. That debacle has contributed to the reintroduction of legislation to change the LCD process. The Local Coverage Determination Clarification Act, S. 794, was recently introduced in the U.S. Senate and aims to make the LCD process more transparent and accountable. (A House bill is under development.) The bill requires public notice and comment and other processes to improve the development of LCDs, so experiences like the LLP draft LCD do not occur again. Special thanks to the Amputee Coalition for its leadership on this important bill. To send your two Senators an email encouraging them to cosponsor the legislation, go to the Congressional Action Center at
  • Written by NAAOP

Major Policy Priorities Confront O&P

        Major public policies that impact orthotics and prosthetics were in play during the month of March including the following:

  1. ACA Repeal and Replace Falters:  House Republicans were unable to bridge differences between their conservative and moderate factions on the ACA repeal and replace legislation known as the American Health Care Act (AHCA).  All Democrats opposed the bill.  This resulted in the bill being pulled from the House floor before a vote was taken.  The bill is indefinitely on hold and the Senate is not likely to take up health reform any time soon.  NAAOP’s major concern with the AHCA centered on preservation of access to orthotic and prosthetic care.  The bill would have repealed the essential health benefits (EHB) package for Medicaid expansion populations, which currently includes coverage of “rehabilitative and habilitative services and devices.”  This statutory language, coupled with the regulations that interpret the statute, was instrumental in securing coverage of O&P care across the country in both Medicaid expansion states and ACA individual insurance plans.  As negotiations on the AHCA continued before its ultimate demise, there were tentative agreements to extend the repeal of the EHB from Medicaid expansion states to private plans as well.  But with the bill’s failure, EHB dodged a bullet.  Ultimately, health reform is not over.  The threat to O&P coverage will continue, especially through the regulatory process.  But for the time being, the effort to repeal and replace the Affordable Care Act is in disarray.
  2. BIPA Section 427 Proposed Rule:  Over 5,000 individuals and organizations commented on the proposed regulations interpreting Section 427 of the Benefits Improvement and Protection Act (BIPA), which were due on March 13th.  This regulation would implement the statutory provision enacted in the year 2000 that would limit  Medicare payment for custom orthotics and prosthetics only to qualified practitioners and suppliers.  Much of the proposed rule defined exactly which health care professionals will be considered qualified and which will not.  NAAOP will be working in concert with the O&P Alliance to continue to engage CMS to publish a final regulation at the earliest possible time.  However, with the Trump Administration’s regulatory relief initiative, we have a stiff headwind in our efforts to secure a final rule.
  3. AHRQ Issues Revised Protocol for Lower Limb Prosthetic Evidence Base:  A contractor of the Agency for Healthcare Research and Quality (AHRQ) recently released a revised “protocol” addressing the evidence base for lower limb prostheses.  The revised protocol ominously entitled, “Error Rate Reduction for Lower Limb Prostheses,” seeks information from researchers on evidence that answers a series of research questions.  The revised protocol adopted many comments drafted by the O&P Alliance, in which NAAOP participated.  Therefore, far more studies will be considered relevant under the new study protocol.  More information will be distributed when it becomes available.
  • Written by NAAOP

NAAOP Comments on Section 427 of the Benefits Improvement and Protection Act of 2000 (BIPA 2000); CMS-6012-P


March 13, 2017

Patrick Conway, M.D.
Acting Administrator Centers for Medicare and Medicaid Services
U.S. Department of Health and Human Services
Attention: CMS-6012-P
P.O. Box 8013
Baltimore, MD 21244-8013

Re: NAAOP Comments on Section 427 of the Benefits Improvement and Protection Act of 2000 (BIPA 2000); CMS-6012-P

Dear Acting Administrator Conway:

The National Association for the Advancement of Orthotics and Prosthetics (NAAOP) is pleased to submit these comments on behalf of our members who design, fit, fabricate, supply, manufacture, and use prosthetic limbs and custom-fabricated orthotic braces (prostheses and custom-fabricated orthoses). NAAOP is a national, nonprofit organization that seeks to advance orthotic and prosthetic care in order to meet the needs of children and adults with limb loss and a wide variety of injuries, disabilities, and chronic conditions who require the use of orthoses and prostheses. We measure our policy positions based on what is best for the O&P patient.

As such, we are proud to strongly support the proposed rule interpreting Section 427 of the Benefits Improvement and Protection Act of 2000 (BIPA). We have a number of suggested recommendations to meet the O&P needs of Medicare beneficiaries and believe that CMS must amend some aspects of the rule to comport with current practice in the health care and rehabilitation continuum. But we applaud the Centers for Medicare and Medicaid Services (CMS) for finally issuing this proposed rule and strongly urge the agency to consider the comments received and timely publish and implement a final regulation.

BIPA Section 427 was intended to protect patients from unqualified practitioners and suppliers of custom-fabricated orthoses and prostheses while, at the same time, protect the integrity of the Medicare program by linking practitioner and supplier qualifications to the right to receive Medicare payment for these services. The proposed rule generally meets these objectives. Rather than detailing a separate set of positions and recommendations, however, the NAAOP worked in concert with members of the Orthotic and Prosthetic Alliance (O&P Alliance), a coalition of the five major national O&P organizations , to develop a comprehensive statement on the proposed rule, along with specific recommendations for CMS’s consideration.

We are proud to align ourselves with this consensus statement of the O&P provider community and look forward to discussing the substance of this proposed rule in further depth in the future. Attached please find a copy of the O&P Alliance consensus statement for your review and consideration.

For additional information or to speak with our General Counsel, please contact Peter Thomas at 202-466-6550 or


David McGill, JD
National Association for the Advancement of Orthotics and Prosthetics

Attachment: O&P Alliance Comments to BIPA Section 427 Proposed Rule



March 13, 2017

Patrick Conway, M.D.
Acting Administrator Centers for Medicare and Medicaid Services
U.S. Department of Health and Human Services
Attention: CMS-6012-P
P.O. Box 8013
Baltimore, MD 21244-8013

Re: CMS-6012-P: Orthotic and Prosthetic Alliance Comments on Section 427 of the Benefits Improvement and Protection Act of 2000 (BIPA 2000)

Dear Acting Administrator Conway:

On behalf of the Orthotic & Prosthetic Alliance (O&P Alliance), a coalition of the five major national orthotic and prosthetic organizations representing over 13,000 O&P professionals and 3,575 accredited O&P facilities, please accept the attached comments on Section 427 of the Benefits Improvement and Protection Act of 2000 (BIPA 2000), CMS-6012-P. Publication of this proposed rule has been a long-standing goal of the orthotic and prosthetic provider and patient organizations for the past 17 years, since passage of BIPA. We are grateful for its publication and strongly support what it seeks to accomplish: improvement in the quality of care provided to Medicare beneficiaries in need of custom orthotics and prosthetics through the establishment of practitioner and supplier qualifications, while at the same time reducing the likelihood of waste, fraud and abuse in the O&P benefit.

Therefore, we strongly support the major thrust of the proposed rule and its recognition that patients requiring custom orthotic and prosthetic care should be treated by those with the required training, education and necessary licensure and/or certification to do so. We also recognize that there are several aspects of the rule that require modification, and suggest the changes outlined below. Above all, the O&P Alliance seeks timely publication of a final rule that meets the original goal of the statute, to permit Medicare payment only for those practitioners and suppliers who are qualified to provide custom orthotics and prosthetics.

We acknowledge and appreciate CMS’s recognition in the proposed rule of orthotists and prosthetists as health professionals/providers. Orthotists and prosthetists are the members of the rehabilitation team who are most qualified to provide custom orthotic and prosthetic services, and the only group with extensive formal training in all aspects of orthotic and prosthetic care. To become certified and/or licensed in their state, graduates of orthotic and prosthetic training programs complete formal graduate-level training that is two-three years in length, as well as formal residencies in orthotics and/or prosthetics.

Licensed and/or certified prosthetists are the only clinicians specifically trained to provide comprehensive prosthetic care, and we therefore recommend that the final rule limit the provision of comprehensive prosthetic care to prosthetists with formal certification from the credentialing organizations referenced in the statute and/or state licensure to provide prosthetic services.

The O&P Alliance understands that certain groups or individuals with specialized training and education are qualified to provide certain custom orthoses within current practice guidelines. Some of these groups include certified hand therapists, physical or occupational therapists with additional training in orthotic management, and some physicians with the qualifications to provide this care.

Our comments below elaborate on our positions summarized above and also include recommendations related to other aspects of the proposed rule.


BIPA Section 427 prohibits Medicare payment for prosthetics and custom-fabricated orthotics unless they have been (1) furnished by a qualified practitioner and, (2) fabricated by a qualified practitioner or qualified supplier at a facility that meets criteria the Secretary determines appropriate. To implement this section of BIPA, the proposed rule specifies:

  1. The qualifications needed for qualified practitioners to furnish and fabricate prosthetics and custom-fabricated orthotics;
  2. The qualifications needed for qualified suppliers to fabricate and bill for prosthetics and custom-fabricated orthotics;
  3. Requirements that an organization must meet in order to accredit qualified suppliers to bill for prosthetics and custom-fabricated orthotics;
  4. A timeframe by which qualified practitioners and qualified suppliers must meet the applicable licensure, certification, and accreditation requirements;
  5. The removal of the current exemption from accreditation and quality standards for certain practitioners and suppliers; and,
  6. The sanction for submitting claims for payment of custom-fabricated orthotics or prosthetics without the required qualifications.

History of this Regulation

The proposed rule recounts the history of this regulation. This is important context for the new administration to consider as it implements its stated goal of limiting unnecessary federal regulation. Issuance of final regulations on BIPA Section 427 is long overdue, necessary to implement the statute—which is designed to protect patients and the integrity of the Medicare custom O&P benefit—and can be implemented in a way that is not financially burdensome on practitioners and suppliers of custom orthotics and prosthetics.

The concept behind BIPA Section 427 was first recommended by the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) in a 1997 report entitled, “Medicare Orthotics.1 The OIG report concluded that “durable medical equipment companies are more likely than orthotists to supply questionable orthotics.” The OIG recommended that the Health Care Financing Administration (now CMS) “consider stricter standards for who is allowed to bill for orthotics, such as requiring professional credentials for orthotic suppliers.” HCFA agreed with the findings in the OIG report.

BIPA Section 427 was enacted in the year 2000. The statute actually set a deadline of one year from the date of enactment for CMS to issue regulations using a Negotiated Rulemaking Committee. This committee met nine times between 2002 and 2003 but failed to reach consensus. Years passed with no public action on the proposed rule.

In the meantime, Congress passed Section 302 of the Medicare Modernization Act (MMA) of 2003, which required all suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) to meet quality standards and accreditation requirements. Specific quality standards were developed for custom-fabricated orthotics and prosthetics—Appendix C of the DMEPOS Quality Standards—but neither the MMA nor its regulations (which were published in 2006) addressed the O&P-specific provisions of BIPA Section 427. Three years later, eleven accreditation organizations (AOs) were approved to accredit DMEPOS suppliers, of which nine still hold this deemed status.

In 2008, the Medicare Improvements for Providers and Patients Act (MIPPA) was enacted. Section 154(b) of this Act established certain exemptions from the DMEPOS2 quality standards and accreditation requirements for “eligible professionals” and “other persons,” unless the Secretary determines that the standards are designed specifically to be applied to such eligible professionals or other persons. The term “eligible professionals” is defined as physicians and physician extenders, clinical social workers, psychologists, physical or occupational therapists, or a qualified speech-language pathologist. Orthotists and prosthetists are specifically referenced in the statute as “other persons.” As a result, to date, all eligible professionals and other persons, including orthotists and prosthetists that furnish, fabricate, and bill for prosthetics and customfabricated orthotics are currently exempt from the quality standards and accreditation requirement. However, O&P suppliers that also bill Medicare for durable medical equipment lose this exemption.

In October 2012, the HHS Office of Inspector General issued Report No. OEI-07-10-00410, entitled, “CMS Has Not Promulgated Regulations To Establish Payment Requirements For Prosthetics And Custom-Fabricated Orthotics.” The report concluded that CMS should proceed with implementation of regulations on Section 427 of BIPA. In addition, Congressional interest began to grow in recent years as O&P patients and providers continued to advocate for publication of the regulations. Bipartisan support for publication of these regulations can be seen most recently and specifically in S. 829, the Medicare Orthotics and Prosthetics Improvement Act of 2015.

Definitions in the Proposed Rule

The preamble and the proposed rule itself define a number of important terms that are necessary to understanding the regulation. The O&P Alliance offers the following comments on each of these definitions:

Definition of “Supplier”: The preamble clarifies that the term “supplier” refers to “a physician or other practitioner, facility or an entity other than a provider of services that furnishes items or services under Medicare.” It also defines “supplier” as physicians, nurse practitioners and physical therapists. The preamble states:

If the supplier such as a physician, nurse practitioner, or physical therapist also furnishes DMEPOS to a patient and bills for those items, then the supplier is also considered to be a DMEPOS supplier and must be screened and enrolled in Medicare as a DMEPOS supplier, meeting all standards and requirements applicable to DMEPOS suppliers in order to be enrolled in and bill Medicare.

Suppliers must obtain a Medicare DMEPOS supplier number in order to bill the program.

O&P Alliance Comment: The definition of “supplier” under the preamble is confusing because the proposed regulation also separately defines the term “qualified supplier” for the purposes of fabricating and furnishing custom orthotics and prosthetics. “Suppliers” as defined in the preamble refers to physicians and physical therapists—individuals as opposed to entities—even though the proposed regulation defines a “qualified supplier” as a DMEPOS supplier that is accredited by a CMS-approved accreditation organization. We urge CMS to clarify this language in the final rule.

In addition, we view this proposed rule as applying to services provided to Part B Medicare beneficiaries who receive custom-fabricated orthoses and prostheses from practitioners and suppliers who submit claims to the Durable Medicare Equipment Medicare Administrative Contractors (DME MACs). The rule itself does not clearly address this issue but we believe the rule may have unintended consequences if applied to Part A, institution-based providers. These providers operate under bundled payment systems known as “prospective payment systems” where orthotics and prosthetics are not separately billed to the program. We therefore urge CMS to clarify in the final rule that BIPA Section 427 only applies to items and services billed to Part B of the program.

Orthotics and Prosthetics: The proposed rule also clarifies that the rule incorporates the definition of the term “orthotics and prosthetics” from the Medicare statute, specifically, Section 1861(s)(9), which states “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.” Prefabricated orthotics and “off-the-shelf” orthotics—which are defined under Medicare law as orthoses that may be used by the patient with only “minimal self-adjustment”—are not impacted by this rule. In addition, post-mastectomy items and services and cranial remolding orthoses (represented by HCPCS code S-1040) are similarly not affected by this rule.

O&P Alliance Comment: We support use of the proposed definition of orthotics and prosthetics under Section 1861(s)(9) of the Medicare statute. However, the final rule should reflect the following variants of the term “orthotics and prosthetics”:

  • Orthotics and Prosthetics: The category of orthotic and prosthetic services and related devices; also used to describe the orthotic and/or prosthetic profession.
  • Orthosis or Prosthesis: A single orthotic brace or prosthetic limb.
  • Orthoses or Prostheses: The plural form of orthosis or prosthesis.

Custom-Fabricated Orthotics: The statutory language of BIPA Section 427 describes custom- fabricated orthotics as “individually fabricated for the patient over a positive model of the patient” requiring “education, training and experience to custom fabricate.” The proposed rule elaborates on this statutory language. It states that custom-fabricated orthotics are “individually made for a specific patient, constructed using one of the positive model techniques (defined below), and is made based on clinically derived and rectified castings, tracings, measurements, and other images of the body part and may involve the use of calculations, templates, and components.” The proposed regulation explicitly describes basic materials that constitute custom-fabricated orthotics, such as plastic, metal, vacuum forming, molding, etc.

The proposed rule also defines the term, “positive model of the patient” as a particular type of custom-fabrication involving one of the following modeling techniques:

  1. Molded to the patient model as a negative impression of the patient’s body part and a positive model is rectified and constructed;
  2. Computer Aided Design—Computer Aided Manufacturing (CAD-CAM) system by use of digitizers which transmit surface contour data through software that the practitioner uses to rectify or modify the model on the computer screen; and,
  3. Direct formed model where the patient serves as the positive model. The device is constructed over the model of the patient and then fabricated to the patient.

O&P Alliance Comment: We generally agree with the definition of both “custom- fabricated orthosis” as well as “positive model of the patient” proposed in the rule. However, the definition is not written in a manner that reflects the inevitability of advances in technology, manufacturing techniques and methodologies, or material applications that are bound to affect the field over time. We strongly urge CMS to delete many of the very specific references in the final rule to materials (e.g., leather, cloth), manufacturing techniques (e.g., laminating, sewing), and, instead, anticipate the expected influx of technological advances in design, fabrication, and fitting of custom orthoses and prostheses.

The “List of Items” to Which BIPA Section 427 Applies: BIPA Section 427 contains specific language that calls on CMS to issue a “list of items” to which this section of the law applies. In addition to the extensive proposed definition of “custom-fabricated orthotics” detailed above, CMS references in the proposed rule Transmittal 656 (CR 3959) published on August 19, 2005, which has been updated to reflect new billing codes added to the HCPCS Level II code set. This list, which can be accessed on the CMS website, will serve as a starting point for custom- fabricated orthoses and prostheses to which this section of the law applies.

O&P Alliance Comment: The list of Level II Healthcare Common Procedure Coding System (HCPCS) codes describing custom orthoses and prostheses to which BIPA Section 427 applies is a good starting point for CMS to use in implementing this rule. The list is reserved for orthoses and prostheses that are truly custom-fabricated. As such, practitioners and suppliers who provide off-the-shelf orthoses, “soft goods,” and similar types of orthoses that require minimal fitting and adjustment will not be held to the requirements of BIPA Section 427, as the statute intended. We urge CMS to commit to periodically updating this list of HCPCS codes as new coding for custom O&P care is created under the annual Level II coding process.

“Professionals” Defined by the Proposed Rule: In connection with the definition of “qualified practitioner,” the proposed rule defines a number of professionals who will be required to comply with BIPA Section 427, including:

  • Physician
  • Physical Therapist
  • Occupational Therapist
  • Ocularist
  • Orthotist
  • Prosthetist
  • Pedorthist

O&P Alliance Comment: We have no objection to CMS’s definitions used in the proposed rule for physicians, physical therapists, occupational therapists, and ocularists; however, we discuss these professionals in depth under the section titled, “Qualified Practitioner” below.

With respect to the terms, “orthotist” and “prosthetist,” however, we believe the proposed rule is in need of revision. The rule references the American Council on Education (ACE) and the American Board for Certification of Orthotists and Prosthetists (ABC) as the accrediting bodies for orthotic and prosthetic education. Neither of these organizations accredit educational institutions. The Commission on Accreditation of Allied Health Education Programs (CAAHEP) overseen by the Council on Higher Education Accreditation (CHEA) is the primary accrediting organization for university-based education programs in orthotics and prosthetics. CAAHEP currently accredits all of the graduate level educational programs in orthotics and prosthetics, while the National Commission on Orthotic and Prosthetic Education (NCOPE) currently accredits all clinical residency programs as required for certification in orthotics and prosthetics. “CAAHEP” should replace these references to both “ABC” and “ACE” in the final rule.

Once a formal training program and subsequent residency in orthotics and/or prosthetics is completed, orthotists and prosthetists undergo subsequent certification by, as of this writing, the American Board for Certification in Orthotics, Prosthetics & Pedorthics, Inc. (ABC). The Board for Orthotist/Prosthetist Certification International, Inc. (BOC) also accepted new applicants for O&P practitioner certification between 1984 and 2016, and may offer the certifications again in the future.

To more closely match the intent of the rule, CAAHEP-recognized training programs must be explicitly accepted under the final rule. In addition, the O&P Alliance recommends that CMS clarify in the final rule that all ABC and BOC certified prosthetists, orthotists, and pedorthists, who received certification prior to the implementation of the current education, residency and certification requirements, will qualify under BIPA Section 427. To omit language to this effect in the final rule could place these long-standing O&P practitioners at risk of not being considered qualified practitioners under the final rule.

Finally, the definition of pedorthist must be refined in the final rule. “Pedorthist” means an individual with specific training in footwear which includes other pedorthic devices to solve problems in, or related to, the foot and is licensed in the state they provide services, if required, or certified by any of the following:

(i) ABC;
(ii) BOC; or,
(iii) A Secretary-approved organization that has certification requirements equivalent to ABC or BOC

Comments on Specific Provisions in the Proposed Rule

I.    The qualifications needed for qualified practitioners to furnish and fabricate prosthetics and custom-fabricated orthotics

To reiterate, BIPA 2000, Section 427, states that “no payment shall be made for custom- fabricated orthotics or for an item of prosthetics unless furnished by a qualified practitioner and fabricated by a qualified practitioner or a qualified supplier at a facility that meets criteria the Secretary determines appropriate.” There are many concepts in this general statement that the proposed rule seeks to interpret, and overall, CMS has interpreted the statute broadly.

Qualified Practitioner: The proposed rule states that a qualified practitioner is any of the following eligible professionals (i.e., physicians, physical therapists, occupational therapists, orthotists, prosthetists, pedorthists, and ocularists) or other persons who furnish or fabricate prosthetics or custom-fabricated orthotics and must meet either of the following licensure or certification requirements:

  1. Licensed in orthotics, pedorthics or prosthetics by the state in which they practice. 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 [certification organizations]:
      1. American Board for Certification in Orthotics, Prosthetics and Pedorthics (ABC);
      2. Board for Orthotist/Prosthetist Certification International, Incorporated (BOC);
      3. A Secretary-approved organization that has the standards equivalent to the ABC or BOC.

The proposed rule applies these requirements to all persons including physicians, physical therapists (PTs), occupational therapists (OTs), prosthetists, orthotists, pedorthists, and others. It does not appear to permit existing state licensure of physicians, PTs, and OTs, to qualify under the rule, which means that in order to bill the program for custom O&P care, these professionals would need to demonstrate that they are “specifically trained and educated to provide and manage the provision of pedorthics, prosthetics and orthotics,” and obtain a separate certification from ABC, BOC, or a credentialing organization with equal standards. Notably absent from the proposed rule is any discussion of requirements on durable medical equipment suppliers or pharmacies, two prevalent billers of Medicare custom O&P care.

O&P Alliance Comments: We believe that all practitioners and suppliers of custom orthotics and prosthetics must be qualified to provide custom orthotic and prosthetic services to Medicare beneficiaries in order to receive payment for their services. Adhering to this rule will help protect patients from unqualified practitioners and suppliers while protecting the integrity of the Medicare program. We are particularly pleased that in interpreting the scope of BIPA Section 427 expansively, CMS implicitly acknowledges and recognizes positions the O&P community has taken for many years. These positions include the following principals:

  • Specific education, training, and expertise are required to provide custom orthoses and prostheses to Medicare beneficiaries;
  • The provision of custom orthotic and prosthetic care is “multifaceted and complex” and fundamentally different from the sale of most forms of durable medical equipment; and,
  • O&P practitioners are those most qualified to provide comprehensive O&P care to Medicare beneficiaries, and the only group with extensive formal education and clinical training in the provision of custom orthotics and prosthetics.

We do recognize that there are some providers that routinely provide certain types of custom orthoses to Medicare beneficiaries with little demonstrable evidence of patient harm. Certain occupational therapists and physical therapists have obtained a separate credential for the provision of custom-fabricated hand orthoses. Some physicians and physical therapists routinely provide custom knee orthoses to their patients without referring those patients to an orthotist. Medicare data suggests that this is limited to a few particular orthotic code sets that are similar for therapists and physicians. These suggested code sets for each type of professional are listed under paragraph 3 below.

The O&P Alliance believes that BIPA Section 427 was not intended to disrupt appropriate care provided by specifically trained health care professionals. BIPA Section 427 was enacted to prevent unqualified practitioners and suppliers from billing the Medicare program for these services and to protect the patient population from sub- standard care. Yet the proposed rule omits any specific mention of DME suppliers and pharmacists and, instead, focuses only on health care professionals. Medicare data highlights the importance of focusing on both. For instance, based on 2011 Medicare data, twenty percent of allowed charges for custom-fabricated and fit orthotic base codes were provided by pharmacists and DME suppliers with no orthotic personnel, while only five percent were provided by the category “Other,” which consists largely of physical and occupational therapists.

Unlike rehabilitation professionals, who undergo extensive education and training in rehabilitation medicine, pharmacists and DME suppliers have no training in prosthetics and custom-fabricated orthotics. Yet, the proposed rule omits any explicit discussion of what is expected of these suppliers in terms of specific education, training and expertise in custom O&P care in order to submit claims. If they are barred from doing so without full compliance with the proposed rule, then the final rule should state this explicitly.

CMS has options to revise the proposed rule to accommodate the concerns of professionals identified in the rule who may object to being required to undergo specific training and education and separate certification by ABC, BOC, or an equivalent credentialing organization. Each of the following alternatives could accommodate the concerns of those professionals to varying degrees, while largely maintaining the true intent of the statute. For instance, in the final rule, CMS could:

  1. Defer to State Scope of Practice for Physicians: Rather than considering all physicians qualified to bill Medicare for custom orthotic care under their generic physician license, CMS could state in the final rule that if a physician specialty can demonstrate education and training specific to custom orthotics, those physicians’ licenses would meet the definition of a “qualified practitioner” for purposes of billing Medicare for those orthoses. For instance, physicians specializing in physical medicine and rehabilitation, orthopedics, orthopedic surgery, vascular surgery, rheumatology, hand surgery, and perhaps other physician specialties could be deemed by CMS to meet the requirements of BIPA Section 427 for purposes of orthotic patient management by virtue of their physician license and their specialty designation. Under this alternative, all other physicians would not be considered qualified under the statute and would have to obtain specific training, education, and credentialing.
  2. Qualified Physical Therapists and Qualified Occupational Therapists: BIPA Section 427 states that “qualified physical therapists” and “qualified occupational therapists” will be considered qualified practitioners under the statute. But the meaning of “qualified” is left unresolved in the statute. The O&P Alliance proposes clarification of that language to include specific areas of focus where OTs and PTs have specific training, education, or qualifications to provide custom orthotic care. For instance, these additional qualifications should include certified hand therapists who frequently create custom, low- temperature orthoses that are molded directly to the patient.
  3. Link Specific Professionals to Permissible HCPCS Codes: CMS could examine the qualifications of a variety of professionals listed in the proposed rule and assign ranges of HCPCS codes to each discipline that would be permissible for each set of professionals to directly bill to the Medicare program, assuming the care is otherwise reasonable and necessary. In other words, CMS could determine in the final rule each professionals’ qualifications to provide custom-fabricated orthoses and deem each type of professional compliant with BIPA Section 427 when providing custom orthoses within a designated range of HCPCS Level II codes. For example:
    • Physicians: L-0112 – L-4631 (Orthoses)3
    • Physical Therapists: L-1844-1846 (Lower limb orthoses) and L-3702-3935 (Upper limb orthoses)
    • Occupational Therapists: L-3702-3935 (Upper limb orthoses)
    • Hand Therapists: L-3702-3935 (Upper limb orthoses)
    • Ocularists: V-2623 – 2629 (Ocular prostheses)
    • Prosthetists: L-5000 – L-8499 (Limb prostheses)
    • Orthotists: L-0112 – L-5000 (Orthoses)
    • Pedorthists: (HCPCS codes within their licensure or certification scope of practice)
    • Podiatrists: L-1940 – 1970 and L3000 – L3030

    (The above HCPCS code subsets reflect largely L-Codes, but do not include the A-codes used to describe diabetic shoes, most notably the diabetic shoe and insert codes A-5500 through A-5513 widely used by licensed and/or credentialed orthotic practitioners.)

    Use of 855-S and NPI Numbers: CMS could align these professional designations and HCPCS codes using the categories that are already in use in CMS Form 855-S under Section 3, “Products/Accreditation Information.” CMS could also instruct contractors to implement claim edits that reject Medicare payment when a practitioner’s or supplier’s qualifications do not match the range of HCPCS codes previously approved by CMS. The assignment of separate National Provider Identifier (NPI) numbers to all practitioners submitting claims for custom O&P care would help facilitate this process. CMS should also implement a requirement that all qualified practitioners submit their NPI number when submitting a claim for custom fabricated orthoses or prostheses. This is the most efficient and effective method for the Medicare program to ensure that any claim submitted by a qualified supplier of custom orthoses or prostheses was furnished by a qualified Practitioner.

  4. Create New HCPCS Codes for Non-Orthotist Professionals: CMS could limit the current L-codes to licensed and/or certified orthotists and prosthetists and establish specific new HCPCS codes for claims for custom-fabricated orthoses submitted by other professionals. The rationale for these new codes is two-fold. First, CMS would be able to better track exactly which types of professionals are submitting custom O&P claims. Second, it would prevent CMS from overpaying for custom-fabricated orthoses from these professionals.The L-codes are considered bundled payment codes that include all labor and clinical care provided by the practitioner and the physical orthosis itself. When a professional sees a patient in need of an orthosis and custom-fabricates the orthosis him- or herself, the professional submits a claim for his or her professional services and a separate claim for an orthosis (which already includes a fee for the clinical care associated with that orthosis). In essence, professionals who submit claims for custom-fabricated orthoses to the DME MACs are being paid twice for the same service. A separate set of HCPCS codes—and payment levels—reserved for certain non-orthotist professionals to bill certain custom-fabricated orthoses would help CMS reduce waste and overpayments for these services.Again, a major goal of the O&P Alliance is to ensure that the proposed rule, with certain important revisions, is issued in final form and becomes effective in a timely manner. We recognize the role played by qualified health care professionals referenced above in the provision of this type of care. We also reiterate that to protect the Medicare beneficiary, DME suppliers, pharmacists, and other suppliers with virtually no education, training, and expertise in servicing the custom orthotic and prosthetic needs of Medicare beneficiaries should be explicitly limited in the final rule from providing custom orthotic and prosthetic care and from billing Part B of the program for such care. We believe that CMS has multiple alternatives that would fulfill the intent of BIPA Section 427 in a manner that protects both patients and the integrity of the Medicare program.Finally, the actual language of the proposed regulation raises a question that does not seem to be addressed in the preamble language. The actual proposed regulation states, “A qualified practitioner who is not enrolled in Medicare as a DMEPOS supplier must meet either of the following licensure and certification requirements…(described above).” [Emphasis added] This raises a question as to whether this language (a) is a typographical error, (b) only applies to practitioners not otherwise enrolled as suppliers, (c) is intended to somehow “grandfather” existing practitioners, (d) is intended to recognize that beneficiaries—not just suppliers—may also file Medicare claims, or (e) has some other meaning. We urge CMS to clarify this statement in the regulation to ensure a clear understanding of the intent of the regulatory language.

II.   The qualifications needed for qualified suppliers to fabricate and bill for prosthetics and custom-fabricated orthotics

Qualified Supplier: All DMEPOS suppliers must enroll in the Medicare program, meet CMS’s supplier standards, and receive a supplier number in order to provide services to Medicare beneficiaries and bill the program. DMEPOS suppliers fabricating or billing prosthetics and custom-fabricated orthotics must meet additional requirements. In order to be a “qualified supplier” under BIPA Section 427, “the DMEPOS supplier must be accredited by a CMS- approved accreditation organization to fabricate prosthetics and custom-fabricated orthotics” and meet the DMEPOS quality standards. All “professionals and others” are currently exempted from this requirement under the MIPPA law, but the rule proposes to lift this exemption from all of these professionals (including physicians, PTs, OTs, orthotists, prosthetists, pedorthists, and ocularists) and hold them to the BIPA Section 427 requirements. The accreditation must indicate the specific products and services for which the DMEPOS supplier is accredited.

O&P Alliance Comment: We generally support the proposed rule’s requirements that suppliers must meet before billing the Medicare program for prosthetics and custom- fabricated orthotics. (See also comments in Section III of this letter.) However, in the proposed rule there is confusion between accreditation requirements and quality standards (that pertain to suppliers) and the lifting of the MIPPA exemption of these requirements on professionals (who as individuals—not entities—typically do not bill the Medicare program). We urge CMS to clarify these distinctions in the final rule.

Fabrication Facility: The statute requires the qualified supplier to fabricate the orthoses or prostheses at a “facility that meets such criteria as the Secretary determines appropriate.” The proposed rule creates a new definition for the term “fabrication facility.” These facilities must be U.S.-based businesses organized under applicable state and federal laws that include appropriately credentialed staff, a laboratory area with appropriate safety equipment, a separate waiting area and chairs with armrests, a patient care and fitting room with appropriate levels for privacy, a fabrication facility information system, parallel bars and a full-length mirror, proper tools, equipment, and computers commonly used in the fabrication of orthotics and prosthetics, and many other detailed requirements. The proposed regulations go so far as to define specific equipment a fabrication facility must have, including a band saw, welding equipment, a drill press, milling machines, ovens capable of heating plastics, and many other highly specific tools of the O&P profession.

These requirements apply whether or not the fabrication facility is the same location as that of the DMEPOS supplier. Accreditation organizations (AOs) cannot accredit or renew the accreditation of a qualified supplier unless the qualified supplier uses a fabrication facility that meets these criteria. Qualified suppliers also must meet the DMEPOS quality standards, including Appendix C, which pertains specifically to custom-fabricated orthotics and prosthetics. Once the final rule is issued, CMS will update these quality standards via its sub-regulatory process.

O&P Alliance Comments: CMS has conflated “fabrication facilities” with “patient care facilities” in the proposed rule. To accurately reflect the various practice arrangements used across the country including the practice of central fabrication, the final rule must separately define these two very different entities. In addition, the definition of “fabrication facility” in the proposed rule is fundamentally inaccurate and does not reflect the contemporary practice of typical custom-orthotics and prosthetics facilities. It “locks- in” a definition that would fail to keep pace with technological transitions in the field, including new materials, manufacturing techniques, and practice arrangements. It is far too prescriptive and antiquated in its detailed listing of required elements.

Rather than codifying in regulations a static, one-size-fits-all definition of “fabrication facility,” the final rule should defer to the long-standing standards for both central fabrication facilities and fabrication facilities housed within patient care facilities that have been developed and maintained by both ABC and BOC as part of the accreditation process. ABC and BOC standards on this issue are consistent with the intent of the statute and would be able to be seamlessly monitored and enforced as part of the accreditation process laid out in the proposed rule.

III.   Requirements that an organization must meet in order to accredit qualified suppliers to bill for prosthetics and custom-fabricated orthotics

In order to accredit qualified suppliers of prosthetics and custom-fabricated orthotics, the proposed regulation states that “an independent accreditation organization must be one of the following:

  • American Board for Certification in Orthotics and Prosthetics, Incorporated (ABC).
  • Board of Orthotist/Prosthetist Certification International, Incorporated (BOC).
  • An organization that—
    • Employs or contracts with an orthotist, prosthetist, occupational therapist or physical therapist who—
      • Meets the definition of qualified practitioner (specified in the regulations); and
      • Is utilized for the purpose of surveying the supplier or practitioner for compliance; and
    • Has the authority granted by CMS to approve or deny the accreditation of qualified suppliers as defined [under the regulation] based on a determination that the organization has standards equivalent to the ABC or BOC.” See Proposed Rule at Section 424.58.

The proposed rule also requires that qualified suppliers notify the accreditation organization of any changes in conditions, practices, or operations that were relied upon by the accrediting organization at the time of accreditation. As the preamble explains, this would include, but not be limited to, a requirement for notifying the accreditation organization 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, once accredited, qualified suppliers continue to meet all of the accreditation and other supplier standards.

O&P Alliance Comments: We strongly support this requirement but request that CMS explicitly clarify in the final rule some key issues. First, it appears from the plain language of the regulation, as well as the preamble language, that CMS intends ABC and BOC to be deemed qualified—by virtue of the BIPA statute itself and publication of the final rule—to accredit suppliers of prosthetics and custom-fabricated orthotics.

It also appears that CMS intends to rescind the deemed status of the other eight DMEPOS accreditors (that are currently permitted to accredit DMEPOS suppliers) with respect to their accreditation of suppliers who bill the Medicare program for prosthetics and custom-fabricated orthotics. The proposed rule suggests that CMS will make a new determination as to which accrediting organizations (in addition to ABC and BOC) will be able to accredit suppliers of custom O&P care in the future, “based on a determination that the organization has standards equivalent to the ABC or BOC.” If this is indeed the intent of the proposed rule, the O&P Alliance strongly supports it and urges CMS to clarify this by changing the phrase “based on a determination” to the phrase “based on a new determination.”

However, the proposed rule does not clarify exactly which ABC and BOC standards need to be met by other accrediting organizations in order to obtain CMS approval to accredit suppliers of prosthetics and custom-fabricated orthotics. Both ABC and BOC have educational and experiential requirements that must be met in order to be certified as a prosthetist/orthotist and accredited as a prosthetic/orthotic facility. Both ABC and BOC require that the supplier have a licensed or certified orthotist/prosthetist on staff in order to be accredited to provide limb prosthetics and custom-fabricated orthotics. The final rule should clarify which specific ABC/BOC standards apply when other AOs seek equivalency. The most important standards that CMS references in the final rule for purposes of determining equivalency with ABC or BOC involve requirements related to specialty personnel (qualified practitioners) and standards related to the physical patient care location.

The O&P Alliance also supports the reporting requirement in the proposed rule, so that, once accredited, suppliers continue to meet the required standards in order to bill the Medicare program for prosthetics and custom-fabricated orthotics. However, we believe this requirement should be limited to reporting personnel changes that impact patient care. Depending on the size of a supplier’s workforce, this requirement may place a significant burden on suppliers to ensure they remain in compliance once they receive accreditation. To limit this burden, and to fulfill the intent of this provision, we believe the reporting of patient care personnel only is reasonable and appropriate.

Finally, the proposed rule incorrectly cites the formal names of both ABC and BOC. The final rule should reflect the correct names as follows and should include language that clarifies that minor future name changes in these accreditors do not impact the application of the final regulation:

  • ABC: American Board for Certification in Orthotics, Prosthetics,& Pedorthics, Inc. or its successor organization;
  • BOC: Board of Certification/Accreditation International, Inc. or its successor organization.

IV.   A timeframe by which qualified practitioners and qualified suppliers must meet the applicable licensure, certification, and accreditation requirements.

Qualified practitioners must meet the licensure and certification requirements proposed and subsequently finalized via rulemaking within one year of publication of the final rule. Qualified suppliers who bill Medicare for prosthetics and custom-fabricated orthotics must meet a similar timeframe. Suppliers would need to meet the requirements of the final rule no later than one year after the posting date of the updated and final quality standards, or at the time of the supplier’s re-accreditation cycle, whichever is later. CMS has mandated the re-accreditation cycle as once every three years. The preamble notes that this takes into account the average length of time (5.5 months) needed by a DMEPOS supplier to complete the DMEPOS accreditation process, in addition to the time needed for an eligible professional to become a qualified practitioner (licensed or certified). CMS seeks comments on this timeframe to ensure that patient access is not compromised.

O&P Alliance Comments: The proposed rule needs to be refined. As written, the rule could take as long as three years to apply to suppliers because of the length of the re- accreditation cycle. On the other hand, it may not offer enough time for certain practitioners to secure appropriate licensure or certification. The O&P Alliance believes that an effective date for both practitioners and suppliers of eighteen months after publication of the final rule would strike an appropriate balance and offer finality to patients, providers, and the Medicare program.

V.   The removal of the current exemption from accreditation and quality standards for certain practitioners and suppliers.

In order to implement the proposed rule on BIPA Section 427, CMS proposes to remove the current MIPPA exemption from the quality standards and accreditation requirements for DMEPOS suppliers and “certain eligible professionals and other persons” who bill Medicare for prosthetics and custom-fabricated orthotics. This exemption was premised on MIPPA statutory language that allowed an exemption unless the Secretary determined that the standards were designed specifically to be applied to such eligible professionals and other persons, or that licensure, accreditation or other quality requirements applied to such persons.

The preamble to the proposed rule states:

Through this proposed rule, we are now designing standards specifically to apply to such eligible professional 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 [BIPA Section 427] were enacted to achieve that objective.

Therefore, the proposed rule removes the existing exemption for certain eligible professionals and other persons (including physicians, PT’s, OT’s, prosthetists, orthotists, pedorthists, and ocularists) to satisfy the DMEPOS quality standards and accreditation requirements in order to bill Medicare for prosthetics and custom-fabricated orthotics.

O&P Alliance Comments: Lifting the exemption under MIPPA for some or all “eligible professionals and other persons” is the flip side of establishing a requirement for these professionals to comply with BIPA Section 427 standards. In the proposed rule, CMS would lift a blanket exemption across all professionals. We support this as a general matter, but we also believe that CMS should selectively re-impose this exemption with greater specificity for each type of professional, depending on how those professionals can demonstrate their specific qualifications to provide—and bill Part B for—custom orthoses, discussed in detail in Section I of this comment letter.

Importantly, CMS’s preamble seems to misinterpret the statute with respect to the licensure and certification requirement on qualified practitioners. The preamble states, “We believe that it is imperative to have both licensure and certification requirements for all qualified practitioners…” But the statute makes clear that qualified practitioners must be either licensed (in states that have O&P licensure statutes) or specially trained, educated and certified by an appropriate entity described in the statute. It is important that the final rule accurately reflect the statutory requirements in this regard.

VI.   The sanction for submitting claims for payment of custom-fabricated orthotics or prosthetics without the required qualifications.

The proposed rule goes beyond the statutory requirements of BIPA Section 427 by creating a serious sanction for practitioners and suppliers who bill the Medicare program for custom- fabricated orthotics and prosthetics but are not considered “qualified” under the new rule. Rather than denying payment on the claim, as BIPA Section 427 specifically mandates (i.e., “No payment shall be made…”), the proposed rule seeks to revoke enrollment and billing privileges of such practitioners/suppliers in the Medicare program. According to the preamble, the revocation decision will be made based on the facts and circumstances of the particular situation. The preamble also states that “a single individual billing or miscoding mistake alone on the part of a supplier” will not trigger this sanction.

O&P Alliance Comments: Revocation of Medicare enrollment and billing privileges is a serious sanction. While it may serve as an effective enforcement mechanism for the proposed rule, it also has the potential to ensnare well-intentioned practitioners and suppliers who may lose their Medicare billing privileges following an oversight in reporting the status of an employee, for instance, to their accrediting organization. The statements in the preamble referencing single reporting errors or mistakes are not part of the proposed regulatory language. Based on providers’ experience with the Medicare claims auditing process, the O&P Alliance takes little comfort in the preamble’s assertion that single errors will not trigger revocation.

The final rule would be more consistent with the statute if the sanction consists of denial of payment, not revocation of billing privileges. Selective denial of payment could be triggered by having CMS instruct its DME MACs to establish and implement payment edits linked to practitioner and supplier qualifications under the rule. The assignment of separate NPI numbers for practitioners submitting claims for custom-fabricated orthotics and prosthetics, as discussed above, would facilitate this sanction for failure to comply with BIPA Section 427. Revocation should be reserved for instances where a distinct pattern of abuse can be demonstrated. But if CMS disagrees, a process should be established where practitioners and suppliers can obtain a warning and be offered an opportunity to cure any reporting defects before revocation is imposed.

* * * * * * * *

Thank you for the opportunity to submit these comments. We look forward to timely publication of a final rule that makes important revisions as described above to the proposed rule and, ultimately, serves the needs of Medicare beneficiaries in need of custom O&P care and preserves the integrity of the Medicare program.

If you have questions of the O&P Alliance regarding these comments or would like to meet to discuss this letter in more depth, please contact Peter Thomas, O&P Alliance Counsel, at 202-872-6730 or



David McGill, JD President

National Association for the Advancement of Orthotics and Prosthetics


Eric Ramcharran, CPO President

American Board for Certification in Orthotics, Prosthetics and Pedorthics, Inc.


Richard W. Miller, CO, FAAOP President

American Academy of Orthotists and Prosthetists


Michael Oros, CPO, FAAOP President

American Orthotic & Prosthetic Association


L. Bradley Watson, BOCO, BOCP, LPO Chair, Board of Directors

Board of Certification/Accreditation (BOC)


  1. Medicare Orthotics, Department of Health and Human Services, Office of Inspector General, OEI-02-95-00380 (October 1997), pp. 8 and 15.
  2. “DMEPOS” is an acronym for “durable medical equipment, prosthetics, orthotics, and supplies.”
  3. For ease of reference, ranges of recommended HCPCS codes constitute all orthotic codes, including prefabricated and off-the-shelf orthotic codes, despite the fact that those orthoses are not impacted by BIPA Section 427.
  • Written by NAAOP