Speak Out on Proposed Orthotics and Prosthetics Rule: Here’s How!

By Gail Zitterkopf, PT, DPT

A proposed rule from the Centers for Medicare and Medicaid Services (CMS) is drawing criticism from physical therapists (PTs) over additional requirements that PTs would need to meet to qualify as providers of custom orthoses and prostheses—and the Section on Women’s Health is making it easy for members to let CMS know what they think!

Please use the attached template to notify CMS of your concern, since CMS is accepting comments until March 13. This would impact members’ ability to determine the need and fitting for pessaries.

CMS’s proposal is to eliminate the Medical Improvements for Patients and Providers Act exemption and require physical therapists to become qualified practitioners subject to the licensure and accreditation requirements of § 424.57(d)(3).

These additional proposed licensure and accreditation requirements are unnecessary, because licensed physical therapists already receive extensive education in orthotics and prosthetics, and orthotics and prosthetics are part of the recognized practice of physical therapy.

For these reasons, the Section on Women’s Health is asking members and others to send this letter to CMS as soon as possible. We thank you in advance for your much-needed advocacy for the profession and will keep you posted on this important issue.

AUTHOR: Gail Zitterkopf, PT, DPT, is chair of the SOWH Federal Affairs Subcommittee.

• YOUR ADDRESS:
• DATE
• Patrick Conway, MD, MSc,
• Acting Administrator
• Centers for Medicare & Medicaid Services
• Department of Health and Human Services
• Room 445-G, Hubert H. Humphrey Building
• 200 Independence Avenue SW
• Washington DC, 20201

Re: CMS-6012-P; Proposed Rule: Medicare Program; Establishment of Special Payment Provisions and Requirements for Qualified Practitioners and Qualified Suppliers of Prosthetics and Custom-Fabricated Orthotics

Dear Acting Administrator:

I would like to submit the following comments in response to the Establishment of Special Payment Provisions and Requirements for Qualified Practitioners and Qualified Suppliers of Prosthetics and Custom-Fabricated Orthotics proposed rule. The standards that CMS is putting forth in the proposed rule are so restrictive that the effect will be to limit Medicare beneficiaries’ access to my services that are safe and effective.

• Include a paragraph about yourself, the O&P services you provide, your practice setting, the patients you serve, and how the proposed rule would negatively impact you and your patients, etc.

CMS’s proposal to eliminate the MIPPA exemption and require physical therapists to become qualified practitioners subject to the licensure and accreditation requirements of § 424.57(d)(3). These additional proposed licensure and accreditation requirements are unnecessary as licensed physical therapists already receive extensive education in orthotics and prosthetics, and orthotics and prosthetics are part of the recognized practice of physical therapy.  In addition, pelvic floor physical therapist must obtain additional training beyond that which is required for licensure to treat in this practice pattern.

The use of orthotic devices, such as a pessary is an integral part of the practice of physical therapy.  Physical therapists use specific tests and measures to determine the need for a pessary, in patients not currently using them and to evaluate the appropriateness and fit of pessaries presently in use. Physical therapists have extensive training and education in the fabrication of pessaries which makes additional regulations and certifications are needless, anti-competitive, and serve no practical purpose.

It is not uncommon for a woman to need a pessary after the birth of a child or before having pelvic surgery. It is most often used for prolapse of the uterus which is caused by the weakening or sagging of the muscles and/or ligaments. Pessaries are often used in conjunction with pelvic floor therapy to assist the patient in successfully achieving their health goals.

A vaginal pessary is a plastic, or rubber device inserted through the vagina to help support the uterus, vagina, bladder or rectum. This device is also helpful if you have stress urinary incontinence (the leaking of urine when you cough, strain or exercise), or experience incontinence while pregnant.

Prohibiting physical therapists from performing interventions with orthotics including pessaries would place an undue burden on patients by forcing them to see alternative providers.  This would increase the cost to the patient and the amount of time spent using health care practitioners. Currently no U.S. jurisdictions prohibit physical therapists’ ability to use orthotics and prosthetics as a component of physical therapist practice.

The proposed rule specifies that a qualified practitioner needs to be certified either by the American Board for Certification in Orthotics, Prosthetics & Pedorthics (ABC) or the Board of Certification/Accreditation (BOC). The proposed rule also states that certification may be granted by “A Secretary-approved organization that has standards equivalent to the ABC or BOC.”  At the current time, there are no Secretary-approved organizations with standards equivalent to ABC or BOC that are granting certification.  The fact that there are currently only two organizations granting certification will make it difficult for any provider seeking to become a qualified practitioner to meet the certification requirements of the proposed rule. In addition, neither of these two organizations provide regulation nor training for pessaries, thus eliminating orthotic fitting of pessaries from daily practice.

HOW TO SUBMIT YOUR LETTER:

In commenting, please refer to file code CMS-6012-P. You may submit comments in one of four ways (please choose only one of the ways listed):

1. Electronically.You may submit electronic comments on this regulation to http://www.regulations.gov. Follow the “Submit a comment” instructions.
2. By regular mail.You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-6012-P, P.O. Box 8013, Baltimore, MD 21244-8013.

Please allow sufficient time for mailed comments to be received before the close of the comment period.

By express or overnight mail.You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-6012-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.