Insert Date
CMS
Department of Health & Human Services
Attention: CMS-6012-P
P.O. Box 8013
Baltimore, MD 21244-8013
COMMENTS REGARDING PROPOSED RULE CMS-6012-P
Medicare Program; Establishment of Special Payment Provisions and Requirements for Qualified Practitioners and Qualified Suppliers of Prosthetics and Custom-Fabricated Orthotics
Dear Mr. Spiegel:
As a licensed ______therapist in the state of ______, I respectfully oppose CMS-6012-P. The proposed rule would add layers of regulatory requirements on healthcare providers (of which the new administration advocates deregulation); will adversely affect access, quality and continuity of care for the Medicare beneficiary; impose greater expense to CMS; and, dramatically restrict the practice of currently qualified practitioners in every state.
It is believed this rule would exclusively benefit the orthotists and prosthetists. Unless therapists went to extreme lengths to come into compliance with each of these regulatory requirements, the orthotists and prosthetists would become the only qualified practitioner, the only qualified accrediting body and the only provider/supplier to be reimbursed by Medicare for the HCPCS Level II L-codes. There is simply nothing that has changed in decades to suggest therapists are no longer qualified or skilled in orthotics and require supervision and oversight by orthotists.
Specifically, this letter addresses the accreditation requirement, the qualified practitioner, the fabrication facility and most importantly, the impact on the Medicare beneficiary.
Accreditation
First, it is important to realize that therapy facilities have in place regulatory requirements for CMS oversight not imposed on O&P practitioners and suppliers. For example, a large percentage of therapy provider types must undergo a site survey prior to receiving their Medicare billing number. Prior to provider facilities receiving a Medicare number, the provider facilities must be certified by the individual state agency (appointed by CMS). This requires a comprehensive site survey, often performed by the State Board of Health. Subsequently, the revalidation survey is done each five to eight years. The credentialing requirements overlap a majority of the requirements for DMEPOS accreditation. These credentialing requirements, in complement to the 30 quality standards required in the CMS 855S form, cover virtually all DMEPOS accreditation requirements. Since the primary purposes of the requirements are to ensure beneficiary care is provided by a qualified provider and beneficiary safety is prioritized, it is believed this is accomplished through existing requirements.[refer to survey comparison]
Accreditation would serve as a significant expense. When you include the application cost, the professional time to prepare for the survey, the onsite survey cost for the primary location, and the travel cost of the surveyor, it would easily be an additional expense of $3,000 or more to just get the survey completed. To add an extension site can easily cost an additional $3,000. In our case, we have five additional office locations. Once the survey is completed there are annual fees for accreditation. Beyond these expenses there are excessive expenses for adding a fabrication facility. [refer to comments below] A small therapy business would likely make the decision to not proceed with accreditation as the expenses would far exceed the revenue for the orthotics each year. This would limit beneficiary access to services.
Please know therapists and physicians have no interest incorporating orthotists into their practices to serve in a supervisory or oversight capacity as the qualified practitioner. When therapists and physicians need the expertise of orthotists and prosthetists, they reach out to those individuals and make the appropriate referral. When the orthotists and prosthetists need the expertise of occupational therapists and physical therapists they do so. These relationships have been in existence for decades and are in place today in small and large cities all across our country.
Qualified Practitioner
No additional regulations should be imposed upon occupational therapists and physical therapists to serve as a qualified provider, practitioner or supplier to custom-fabricate, fit and dispense orthotics to the Medicare beneficiary. Therapists are fully qualified. Suggesting that orthotists and prosthetists are the one qualified practitioner for custom fabricating orthotics and therapists require additional education and training is highly inaccurate.
Currently, the minimum educational requirement for occupational therapists is a master’s degree (effective 2005) and a clinical doctorate for physical therapists (effective 2015). The occupational therapy profession is considering clinical doctorates by 2022. Thus, the academic educational requirements continue to increase beyond the bachelor’s degree.
Therapists must sit for a national, standardized examination following graduation and successfully pass the examination prior to applying for their state license. Upon successful completion of the national examination, the occupational therapists and physical therapists must become licensed or registered in states in which they practice. State licenses are renewed each three to five years. Over 90% of state license renewals require a specific number of continuing competency hours.
A large percentage of therapists self-impose additional credentialing such as certification. I am one of over 6,000 certified hand therapists (CHT). Extremely high standards are in place for becoming a CHT. Therapists are extremely proud of becoming a CHT and exemplify the highest standards of patient care. This serves to protect the public from unqualified providers.
Orthotists and prosthetists have grandfather clauses within BOC and ABC for certification and for licensure, diluting what is purported as the qualified practitioner requirements for all certification and licensure within O&P. Those requirements are believed to benefit orthotists and prosthetists where experience superseded educational requirements in the past. There are not any grandfathering clauses for occupational therapists or physical therapists.
Fabrication Facility
I oppose the requirement for a fabrication facility.
A comprehensive list of what constitutes the proper tools, equipment, and computers are listed in the proposed rule. These tools are solely indicated for high temperature orthotics and for prosthetics. They are not tools and equipment utilized in the low temperature thermoplastic fabrication by therapists. Of all the equipment listed, periodically therapists may use a sewing machine for strapping and a drill for the orthotic material. For low temperature thermoplastics, the tools and equipment most commonly utilized include: a heat gun, heating element, scissors, hole punches, strapping materials, thermoplastic materials, metal rods, rubber bands, strings and slings, among other supplies.
For practice settings where the qualified practitioner utilizes low temperature thermoplastics and not the high temperature materials, the estimated cost to purchase the entire list of fabrication equipment would be approximately $15,000 - $20,000. Since most therapy facilities fully utilize their existing space, the additional space would require an expansion or relocation of the facility easily costing $10,000 a year or more.The total costs could easily exceed $30,000. These expenses would be in addition to the accreditation survey, and administrative preparation expenses. Unfortunately, with all this additional expense, none of the equipment would ever be utilized by therapists. Again, this is another inequity through the proposed rule.
Medicare Beneficiary
There would be a total disconnect in patient care if the orthotists provide all the orthotics and therapy provides the remainder of the therapy services. The continuity of care would be lost. Efficiency in patient care would be lost. Without the ability to fabricate orthotics “in the moment” and adjust the orthosis as a patient’s condition changes, there would be far greater numbers of therapy visits. Those therapy visits would be spent trying to address what once was addressed with critically important orthotics. Quality of patient care would be markedly impacted in an unfavorable manner. Thus, functional outcomes and potentially independence would suffer. There is simply no way the overall cost for beneficiary care would not rise markedly.
Recognizing it would be virtually impossible for eligible practitioners to become qualified or accredited, a typical scenario where a patient would need therapy and an orthotic under the proposed rule would go something like this:
- The patient would be seen by the physician with one referral to the therapist and one referral to the orthotist. The patient would be evaluated by the therapist with a plan of care established and a therapy program initiated. The patient would leave therapy without the prescribed orthosis. The patient would schedule an appointment with the orthotist. The orthotist in subsequent days would create the mold for the orthosis. Subsequently, on another visit the orthosis would be fitted to the patient. (Both of these appointments would not be necessary in our current system.) Once there would be a change in the patient’s condition (e.g. dressing reduced, edema decreased, motion changed, repositioning of joints necessary at specific time intervals, etc.) the orthosis would need to be adjusted. Understanding the current high temperature materials utilized by orthotists, it is likely a new orthosis would need to be fabricated. In this scenario, the postop patients with fractures, tendon injuries and procedures requiring protection postoperatively, would not have an orthosis for a span of days. This would jeopardize the medical condition, injury or surgery.
In advance, I would like to thank you for giving my letter full consideration. I simply see no way in which this proposed rule benefits CMS or the Medicare beneficiary.
Respectfully,
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