ANA Comment on HCFA Proposed Rule
Following is the text of ANA's comments on the HCFA Proposed Rule to Revise Medicare B Payment Policies.
The American Nurses Association (ANA) offers the following comments on the proposed rules on nurse practitioner services and clinical nurse specialist services, as included in the notice of proposed rulemaking (NPRM) revising the Medicare fee schedule in the June 5, 1998 Federal Register. Comments on other aspects of the proposed rules will be submitted separately.
ANA represents the nation’s 2.6 million registered nurses through its 53 state and territorial nurses associations. In addition to staff nurses and other nurses in a wide variety of roles, our members include nurse practitioners and clinical nurse specialists practicing in a range of settings providing professional services to Medicare beneficiaries.
ANA is encouraged that HCFA is continuing to move ahead with implementation of Section 4511 of the Balanced Budget Act of 1997 (BBA) which, among other things, expanded Medicare Part B coverage of professional services provided by nurse practitioners (NPs) and clinical nurse specialists (CNSs). We would like to offer the following comments on proposed 42 CFR Sections 410.75 and 410.76 which address, respectively, NP and CNS services.
Because the language of both sections is essentially identical, we will address similar requirements for NP services and for CNS services together. We address the provisions of proposed 410.76(b)(2), which set out qualifications for CNS services, separately at the end of this letter.
1. Sections 410.75(b)(2) and 410.76(b)(2), Qualifications: certification by a professional association
Proposed sections 410.75(b)(2) and 410.76(b)(2) would permit, as one mechanism for establishing an NP’s or a CNS’s qualifications to provide services that may be covered by Part B, certification "by a professional association that has, at a minimum, eligibility requirements that meet the standards in paragraph (b)(1) of this section." ANA proposes inserting the words "or accrediting body" after "professional association," so that the paragraph refers to certification "by a professional association or accrediting body that has, at a minimum . . . ." As you may know, most organizations that certify NPs and CNSs are not professional associations themselves, but rather separately incorporated accrediting bodies. For instance, ANA does not certify NPs or CNSs; the American Nurses Credentialing Center (ANCC), utilizing standards developed by the profession, does. The proposed change would clarify that services of NPs and CNSs certified by appropriate accrediting bodies recognized by HCFA may be covered by Part B.
2. Sections 410.75(c)(2) and 410.76(c)(2), Collaboration
ANA has several concerns regarding the proposed implementation of requirements that services of NPs and CNSs be provided "in collaboration with" a physician. This statutory requirement has existed since the Omnibus Budget Reconciliation Act of 1990 (OBRA '90) provisions on coverage of NP and CNS services in rural areas first went into effect and then, as now, has been based on the definition provided at Section 1861(aa)(6) of the Social Security Act.
We are not aware of any substantial problems in interpreting or implementing this provision in the ensuing seven and a half years, even though carriers have been applying this requirement without the benefit of federal rules. If HCFA is aware of situations in which lack of regulatory guidance -- let alone the detailed and prescriptive rules it has proposed -- has led to problems, or to inappropriate payment for services, it would be extremely helpful to provide that information in the preamble to the proposed rules. As it is, we are at a loss to understand why HCFA has proposed rules which go beyond implementing an existing statutory requirement and, instead, create a de facto federal regulation of NP and CNS practice.
Our specific concerns are as follows.
a. The proposed rules would expand federal authority to determine the nature of collaboration between NPs, CNS and physicians
First, in addition to essentially restating the existing statutory definition of "collaboration," (Sections 410.75 (c)(2)(i) and 410.76(c)(2)(i)), the regulatory definition would expand the statute’s reference to "jointly developed guidelines or other mechanisms as defined by the law of the State in which the services are performed" into a new regulatory requirement for "guidelines jointly developed by the practitioner and the physician, or as provided for by other mechanisms defined by Federal regulations, or by the law of the State in which the services are performed." (proposed Sections 410.75(c)(2)(i) and 410.76(c)(2)(i), emphasis added.) The statutory definition of "collaboration" permits the states to set the parameters of professional practice for NPs and CNSsClike that of all health professionals practicing within their borders. HCFA’s proposed phrasing, on the other hand, inserts a broader federal role in defining the mechanisms of collaboration between NPs and physicians, and between CNSs and physicians, than is contemplated by the statute.
b. The rules would replace state policy with rigid, uniform federal policy on "collaboration"
In furtherance of this broader federal role, Sections 410.75(c)(iv) and 410.76(c)(iv) of the proposed HCFA rules would replace state policy with prescriptive, restrictive federal guidelines, including an additional definition of "collaboration" above and beyond the statutory requirements. This additional definition would provide that:
Collaboration involves systematic formal planning, assessment and a practice arrangement that demonstrates evidence of consultation, recognition of statutory limits, clinical authority and accountability for patient care, according to a mutual agreement that allows the physician and the nurse practitioner to function independently as appropriate.
Virtually every state has laws that address advanced nursing practice. Many require a collaborative relationship between the advanced practice nurse and a physician. Many do not. Some require collaborative agreements for specific, identified functions--such as writing prescriptions--but not for other functions. As HCFA is well aware, the practice of advanced practice nurses and, most specifically, their relationship with physicians, has been a hotly contested issue in a great many states. Where state laws or guidelines do not include a requirement for collaboration, or fail to provide specific detailed requirements for a collaborative relationship, it is not a matter of accident or simple omission, but of conscious state policy regarding professional scope of practice.
While few advanced practice nurses would practice without establishing a relationship with other health professionals, including physicians, for purposes of consultation, referral, back-up, and other considerations, many states have determined that this relationship is best defined by the professionals themselves, rather than through detailed statutory or regulatory prescription. Furthermore, those states that do explicitly require a collaborative relationship between NPs and physicians and/or CNSs and physicians do so in a variety of ways. Congress’ intent to preserve the authority of the states to determine their own policy regarding NP and CNS practice is reflected in the language of 1861(aa)(6) of the Act, which, as noted above, calls for collaboration between physician and NP or CNS to be reflected in "jointly developed guidelines or other mechanisms as defined by the law of the State in which the services are performed." (Emphasis added.)
ANA proposes eliminating Sections 410.75(c)(iv) and 410.76(c)(iv). Unlike the federal statute defining "collaboration," which recognizes the continued authority of the states to determine policy on this matter, the proposed regulations would impose a rigid, uniform federal policy regarding the form that collaboration must take. They would provide detailed prescriptive and restrictive new federal requirements for NP and CNS practice never envisioned in federal law. In attempting to implement a statutory requirement under which many NPs, CNSs, physicians and carriers have operated for over seven years, this proposed language would take a major step into an area--regulation of health professional practice--traditionally occupied by the states.
Further, by tying NP and CNS practice so directly to that of physicians in such a detailed manner, these requirements would serve to frustrate the clear intent of Section 4511 of the Balanced Budget Act--which was to expand access to health care services for currently undeserved Medicare beneficiaries.
c. The language of proposed sections 410.75(c)(iv) and 410.76(c)(iv) is unclear in many respects
In addition, the proposed language is in many respects unclear, and may lead to an even more restrictive interpretation than intended. For instance: what is meant by the regulations’ reference to "formal planning" and "assessment"? What is "formal planning," and how is it distinguished from other types of planning? Does the proposed language mean that the physician is to be involved in "formal planning" of the NP’s or CNS’s care for each patient? That the physician must be involved in "assessment" of each patient? If so, what is the meaning of proposed paragraph (iii), which provides that "the collaborating physician does not need to . . . make an independent evaluation of each patient seen by" the NP or CNS? If not, does "formal planning" and "assessment" mean that the physician must be involved in formally planning and assessing the NP’s practice? If that is the case, this relationship is clearly far more supervisorial and hierarchical in nature than the term "collaboration," or even its statutory definition, would suggest.
Proposed paragraph (iv) would also require a "practice arrangement that reflects and demonstrates . . . recognition of statutory limits." Does this refer to the "statutory limits" applicable to the NP (or CNS), to the physician, or both? How is this "recognition of statutory limits" to be evidenced--particularly in states which provide few formal guidelines for such limits? Moreover, why must a collaborative arrangement between an NP or CNS and physician provide explicit recognition of requirements already governing their practice? And why must rules regarding Medicare Part B reimbursement require recitation of the need to abide by state law, when this requirement is already present both in the federal statute and elsewhere in the proposed rules? (Proposed (c)(1)).
We also fail to understand the need for the collaborative agreement to "reflect and demonstrate . . clinical authority and accountability for patient care." NPs and CNSs are independently practicing professionals, operating under their own licensure and possessing the "authority" for the patient care they provide. Similarly, they are accountable for the care that they provide. A collaborating physician may be responsible and accountable for the collaborative services she or he provides to the NP or CNS or, where applicable, for services she or he provides directly to the patient. We question the need for a written agreement to reflect an NP’s or CNS’s own accountability for the care the she or he provides, since such accountability is inherent in her or his status as an independently licensed professional.
3. Sections 410.75(d), Services and supplies incident to nurse practitioner services, and 410.76(d), Services and supplies incident to clinical nurse specialist services
ANA is encouraged by HCFA’s inclusion of this proposed subsection, which clarifies questions that have been asked by many of our members regarding payment for services furnished incident to those of an NP or a CNS. We would propose that HCFA offer further clarification -- either through regulation or through a carrier instructions -- of paragraphs (3) and (4) such that they reflect current guidelines on payment of services furnished incident to those of a physician. For instance, we believe that the requirement for the NP or CNS to be "physically present and immediately available" should be clarified such that the NP or CNS need not be present in the same room where the service is being provided, but present and available in the office suite.
We also suggest changing proposed paragraph (2), which refers to services being "of the type that are commonly furnished in a physician office," to "of the type that are commonly furnished in a physician or other health professional office."
4. Sections 410.75(e) and 410.76 (e), Professional services
We propose changing the first phrase of the first sentence of this subsection to read:
[NPs or CNSs] can be paid for professional services only when the services have been personally performed by them, except in the case of "incident to" services as described in subsection (d), above . . . .
The second phrase of this sentence restates the statute’s language requiring that payment can be made if "no facility or other provider charges or is paid any amount for the furnishing of such professional services." ANA continues to look forward to continuing to work with HCFA staff to clarify this provision and its application to a number of patient care settings.
5. Sections 410.75(e)(3) and 410.76(e)(3), examples of professional services performed by NPs and CNSs
ANA proposes eliminating these paragraphs. We believe that this list of "examples" is too limited, confusing and ultimately unnecessary. Medicare law allows for payment of NP and CNS professional services that the NP or CNS is authorized to provide under state law. An illustrative list provides no real clarification of the NP or CNS services that may be provided under state law and thus potentially reimbursable by Medicare. It fails to capture the broad variety of professional services that NPs and CNSs provide, including a wide range of evaluation and management services. (It also completely excludes psychotherapy services, commonly provided by psychiatric-mental health CNSs and NPs). The paragraphs’ requirement that NPs and CNSs only provide services they are authorized to provide under state law or regulation is unnecessary because it repeats what is already in Medicare law and in other provisions of the proposed regulations. Finally, the provision’s statement that the kind of services listed "have been traditionally reserved for physicians" is simply inaccurate. Advanced practice nurses have been providing many of these services for over 30 years and, in rural areas, have been reimbursed by Medicare for performing these services for over seven years.
We recognize that this language is derived from Section 2050.3 of the Medicare Carriers Manual, where it was added several years ago. That section of the Carriers Manual was developed in order to provide clarification to the carriers regarding which services provided by "nonphysician practitioners" (including NPs and CNSs) could be paid as incident to the services of a physician. Many carriers had determined that "incident to" payment was unavailable for all but the most simple, routine services provided by NPs, CNSs, physician assistants (PAs) and others. Section 2050.3 of the Carriers Manual provided a broader interpretation of the services that could be paid for under the "incident to" provisions and provided a brief, illustrative list of services. While this language proved useful in that specific context, we believe that it would prove very problematic in the context of implementing direct Medicare Part B coverage of professional services provided by NPs and CNSs. Accordingly, we urge that it be deleted.
6. Section 410.76(b), Definition of Clinical Nurse Specialist
The BBA provides a simple definition of a CNS:
The term "clinical nurse specialist" means, for the purposes of this title, an individual who--
- (i) is a registered nurse and is licensed to practice nursing in the State in which the clinical nurse specialist services are performed; and
- (ii) holds a master’s degree in a defined clinical area of nursing from an accredited educational institution.
Social Security Act Section 1861(aa)(5)(B).
Proposed 42 CFR Section 410.76(b) changes that definition. It would allow an individual to be considered a CNS in any of three ways:
(b)(1) Be a registered nurse who is currently licensed to practice in the state in which he or she practices, be authorized to perform the services of a clinical nurse specialist in accordance with State law, and have a master’s degree in a defined clinical area of nursing from an accredited educational institution;
(b)(2) Be certified as a clinical nurse specialist recognized by HCFA that has, at a minimum, eligibility requirements that meet the standards in paragraph
(b)(1) of this section, or
(b)(3) Meet the requirements for a clinical nurse specialist set forth in paragraph (b)(1) of this section, except for the master’s degree requirement, and have received before [insert 3 years from effective date of final rule] a certificate of completion from a formal advanced practice program that prepares registered nurses to perform an expanded role in the delivery of primary care.
The requirement that the CNS "be authorized to perform the services of a clinical nurse specialist in accordance with State law" may prove confusing, since many states do not explicitly recognize CNSs as a separate category of registered nurses. In those states, CNSs practice under the same laws that apply to all other registered nurses. The BBA provision defining CNSs--requiring that the CNS be licensed in the state in which she or he practices, and hold a master’s degree in a defined clinical area of nursing--specifically avoids tying reimbursement of CNS services to the presence or absence of state laws on CNS practice. Under the statute, then, a CNS may be reimbursed by Medicare for professional services whether there is specific state legislation regarding CNSs or not.
Accordingly, we propose changing paragraph (b)(1) to read as follows:
Be a registered nurse who is currently licensed to practice in the state in which he or she practices, be authorized to perform the services of a clinical nurse specialist in accordance with State law, and have a master’s degree in a defined clinical area of nursing from an accredited educational institution.
We propose changing paragraph (b)(2), so that it reads "by a professional association or accrediting body that has, at a minimum . . . ," for reasons discussed earlier in these comments (see discussion under "1. Sections 410.75(b)(2) and 410.76(b)(2), Qualifications: certification by a professional association," above.)
Finally, we propose deleting proposed paragraph (b)(3) from Section 410.76. It is inapplicable to CNS practice and fails to reflect the statutory definition of CNS. There is no need to provide for an exception to the requirement that a CNS hold a master’s degree. The nursing profession has long held consensus on this requirement. Unlike NPs and other categories of advanced practice nurses, CNS education has always been at the master’s degree level, so no "grandparenting" for non-master’s-prepared CNSs is necessary. Moreover, CNS education is not limited to "an expanded role in the delivery of primary care" -- a great many CNSs provide one or another form of specialty care. Finally, we believe that the BBA definition of CNS makes it clear on its face that a CNS must hold a masters degree.