DRAFT

January 8, 1999

Ms. Nancy Ann Min DeParle
Administrator
Health Care Financing Administration
Department of Health and Human Services
Room 309-G
Hubert H. Humphrey Building
200 Independence Avenue, S.W.
Washington, D.C. 20201

Attention: HCFA - 1005 - P

Medicare Program: Prospective Payment System for Hospital Outpatient Services; 63 Federal Register 47551, September 8, 1998

Dear Ms. Min DeParle:

The National Electrical Manufacturers Association (NEMA) appreciates the opportunity to supplement its comments of November 9, 1998, on the September 8, 1998 Notice of Proposed Rulemaking for establishing a prospective payment system for hospital outpatient services. NEMA is the largest trade association representing America's electroindustries. The Diagnostic Imaging and Therapy Systems Division of NEMA represents over 95% of the U.S. manufacturers of diagnostic ultrasound, nuclear medicine imaging equipment, x-ray imaging, computed tomography, radiation therapy, magnetic resonance and medical imaging informatics systems.

On September 8, 1998, HCFA published a proposed rule in 63 Federal Register 47551, which was designed to accomplish several purposes, including:

Elimination of the "formula-driven overpayment" for co-payments associated with hospital outpatient services;
Reduction in the payments for hospital outpatient services;
Establishment of a prospective payment system (PPS) for hospital outpatient services;
Imposition of civil money penalties against any individual or entity who knowingly and willfully presents a bill for a non-physician for bundled services;
Creation of additional requirements for "provider-based" entities, including additional physician supervision requirements for diagnostic and other services.

In its November 9th submission, NEMA expressed several major concerns with regard to the proposed rule including:

First, the rule would unfairly penalize hospitals by failing to include an outlier adjustment for new technology. NEMA believes that an outlier adjustment for new technology must be incorporated within the PPS to ensure an equitable payment system.
Second, the proposed requirement that non-physician services rendered in a "provider-based" entity must be performed under "direct" supervision contradicts accepted standards of medical practice for many types of radiology services. Accordingly, such services as most X-ray, CT, MRI and general ultrasound examinations, with the exception of transesophageal echocardiography, use of contrast media, or x-rays other than chest, abdominal or skeletal, should require only "general" supervision.

NEMA is concerned that HCFA policies have unnecessarily restricted the role of imaging and other technologies with respect to the provision of quality and affordable health services, and fly in the face of generally accepted, and emerging, patterns of practice. These policies also do not take into account how technologies should best be applied with regard to cost-effective delivery of appropriate health care.

Recently adopted and pending regulations concerning, among other things, hospital outpatient prospective payment (63 Federal Register 47551), as well as provisions adopted for Payment for Teleconsultations in Rural Health Professional Shortage Areas, (63 Federal Register 58879-58886), continue a pattern of depriving patients in rural and underserved areas access to quality medical care.

Technology Can Help to Bridge Gaps in Service

HCFA should recognize that many diagnostic procedures routinely involve a range of health-care professionals who are located at some physical distance from each other. In some cases the providers are hundreds of miles apart, in others they are across town. Sometimes they are apart but on the same campus or even in the same building, just not in the same room together.

In all of these cases, appropriate levels of physician supervision should be based upon presently accepted medical practice for quality patient care-- not previously established HCFA policies and terminology which are not current with today's technologically sophisticated health-care environment.

The challenge is to bring the necessary expertise together virtually, seamlessly and in a cost-effective manner. The use of advanced telecommunications should be carefully considered as an aid in solving some of the supervisory issues which the agency is so concerned about.

Advanced telecommunications can render both time and distance meaningless, bringing the judgements of decision-makers (physicians and other clinicians) in close proximity to a range of supportive allied health practitioners proficient at performing various tests and procedures.

HCFA has thus far not understood that interactive telecommunications, both "store and forward" and "real-time" technologies, are tools designed to bridge the gaps which otherwise exist in the system. It should matter less whether "referring" and "consulting" practitioners meet previously strict definitions of "patient interaction" or "face-to-face" encounters since the meaning of both change with the introduction of new technology tools.

Presentation of patients at a distance is a perfect example of HCFA's unwillingness to challenge a body of previously established regulatory determinations which likely no longer serve the purpose for which they were originally intended.

Advanced telecommunications give physicians and other clinicians more, rather than less, information and control over the patient care process. Telecommunications in health care will allow appropriately trained health-care professionals of all disciplines to more effectively collaborate as a team in pursuit of the best possible patient care.

NEMA continues to express concern over the adverse impact of the proposed outpatient payment rule and previously adopted rules upon the current and future use of telemedicine technology. The proposed rule will further seriously impair patients' access to quality health care through its unnecessary restriction on the utilization of telemedicine in the diagnosis and treatment of disease.

First, the proposed rule, as in the telemedicine payment rule, would exclude allied health professionals such as radiation technologists, nuclear medicine technologists and sonographers from presenting the patient to a consulting practitioner. Current HCFA rules restrict a referring and consulting practitioner to one of the following:

Physician
Physician Assistant
Clinical Nurse Specialist
Certified Registered Nurse Anesthetist or Anesthesiologist's Assistant
Certified Nurse-Midwife
Clinical Social Worker
Clinical Psychologist

However, radiation technologists, nuclear medicine technologists and sonographers, in clearly defined circumstances, are fully capable of performing diagnostic procedures safely and effectively. Their ineligibility as a referring practitioner will eliminate the benefits of telemedicine technology for many millions of patients who undergo x-rays, nuclear medicine scans and sonograms daily.

Sonographers, radiation technologists and nuclear medicine technologists undergo rigorous training and must pass examinations in order to practice in their fields. The use of sonographers, radiation technologists and nuclear medicine technologists in conducting examinations is well established and accepted clinical practice. Clearly, the designation of the health professionals listed above in the current HCFA rules as eligible referring and consulting practitioners, and the exclusion of sonographers, radiation technologists and nuclear medicine technologists, is an arbitrary distinction which is without clinical justification. We therefore urge HCFA to permit their inclusion as referring practitioners and thus permit the use of telemedicine technology in these areas of practice.

NEMA is also concerned that under the proposed rule, and current HCFA rules, HCFA has unnecessarily restricted the kinds of technologies which may be employed in a telemedicine consultation. Under current HCFA policy, Medicare eligibility for payment is limited to those consultations utilizing interactive audiovideo telecommunications systems. Recently adopted teleconsultation payment rules require at a minimum audiovideo equipment permitting two-way, "real time" consultation among patient, consulting practitioner and referring practitioner. Telephones, facsimile machines, and electronic mail do not satisfy the requirements of interactive telecommunications systems. HCFA has stated that "store and forward" technology, which allows for a review of a prior examination, test or procedure, is not eligible for Medicare reimbursement. While we are encouraged that HCFA is planning to study "store and forward" technologies for possible future reimbursement, we are deeply concerned about the lag in HCFA policies which prohibit reimbursement for use of currently effective technologies.

Health care delivery is practiced asynchronously. Rarely are the various practitioners and other participants in the same room at the same time, and rarely are they in respective remote locations at the same time. The evolution of telemedicine technologies suggests that one of the least disruptive and most effective ways to bring these practitioners together as a team on behalf of the patient is through the use of asynchronous or "store and forward" technologies. The use of "store and forward" can help augment rather than impede the established routine of busy practitioners. Not all conditions require instantaneous judgements on the part of clinicians, and a presumption in favor of "real time" interactive video may end up costing the Medicare program more in the long run. At the same time, emergency consults of various types are a good example of the need for "real time" consultation between practitioners.

In short, telemedicine is a rapidly evolving technology. The lines between the various types of technologies have become blurred. Telemedicine is being used in clinical practice today in ways which were inconceivable just a few short years ago.

This rapid rate of technological innovation is expected to continue. The use of telemedicine in medical practice permits increased cost-effectiveness in the delivery of patient care. Due to the emergence of telemedicine technology, physicians can now render medical consultations without their physical presence with the patient during the examination. Medicare patients should not be deprived of telemedicine's significant benefits.

Conclusion

In conclusion, NEMA respectfully urges HCFA to permit radiation technologists, nuclear medicine technologists and sonographers to be included under eligible referring practitioners, and to expand the definition of the kinds of telemedicine technologies which may receive Medicare reimbursement under HCFA rules.

We also urge HCFA to adjust its Medicare reimbursement policy on an ongoing basis to be consistent with the latest medically accepted developments in telemedicine technology.

We applaud HCFA's willingness to work with the Agency for Health Care Policy and Research and the telemedicine grant awardees of several federal agencies to gain a better understanding of current and projected uses of "store and forward" technologies.

NEMA stands ready to assist HCFA in gaining a better understanding of new and emerging information and related technologies. We would be happy to assist in these efforts or to participate in any workgroups or study sections related to these complicated issues.

In the meantime, HCFA should not establish additional presumptive policies which further serve to stifle the very innovations which may help solve so many of our health problems.

If you need further information, or we can be of any assistance, please feel free to contact me at (703) 841 - 3241.

Sincerely,

Robert G. Britain,
Vice President Medical Products