February 16, 1999

Office of the Inspector General
Department of Health and Human Services
Attention: OIG-5-CPG
Room 5246
Cohen Building
330 Independence Avenue, SW
Washington, DC 20201

Dear Inspector General:

I am writing on behalf of the American Association for Respiratory Care (AARC) in response to the December 18, 1998, Federal Register notice on developing a compliance program guidance for the nursing home industry.

The AARC is a national provider association representing 37,000 respiratory therapists who practice in all care settings, including skilled nursing facilities (SNFs). The AARC commends the Office of the Inspector General (OIG) for proposing a compliance program that establishes internal controls and implements monitoring procedures to identify, correct, and prevent fraud and abuse in SNFs.

Of the seven fundamental elements that the OIG considers necessary for a comprehensive compliance program, the AARC wishes to focus its comments primarily on the third element: "the development and implementation of effective training and education programs." In complying with the OIG's request for comments, the AARC presents its recommendations and suggestions for competency requirements for effective respiratory therapy training and education as they relate to the nursing home industry.

Patient Safety

On July 1, 1998, the Medicare structure for Part A SNFs began a dramatic transition from a cost/charge reimbursement system to one of prospective payment. The AARC is concerned that the new per diem prospective payment system (PPS) places the financial risk of providing services on the individual nursing facility. Individual facilities will have the discretion to determine which health care providers will render a given health service. Because the new PPS will result in the overall reduction in reimbursement, SNFs may have a financial incentive to decrease costs by using other health care providers who are not qualified to render respiratory therapy. The AARC has serious concerns that the use of health care providers with inadequate training and competency testing in respiratory therapy will, if substandard, compromise clinical effectiveness and jeopardize patient safety.

Respiratory Therapy in SNFs

In 1998, the AARC commissioned Muse & Associates, an independent health care consulting firm, to conduct a study which 1) determined the growth, scope and extent of respiratory therapy in Medicare inpatient settings using the most recent data, 2) determined that significant numbers of Medicare beneficiaries are intense users of respiratory therapy, and 3) discussed how these intense users might receive care under the SNF PPS.

According to the study (Respiratory Care Services in Medicare, June 1998), data from the Health Care Financing Administration (HCFA) show that approximately 363,000 (24 percent) of the 1.6 million Medicare beneficiaries who were in a SNF setting in 1996 received respiratory therapy. The top 100 diagnoses account for 98.6 percent of all respiratory therapy services. The top 10 diagnoses account for approximately half of all respiratory therapy payments, and the top five diagnoses account for one-third of all payments.

In 1996, the average length of stay for SNF patients who received respiratory therapy from respiratory therapists was 22.6 days. This is significantly less than the 1996 average length of stay of 26.2 days for all 1.6 million Medicare SNF patients. Costs per day for respiratory care services for the top 10 diagnoses ranged from $39 to $85, with the average of all diagnoses being $47. More importantly, within this category, the top five primary diagnoses for respiratory care services, which ranged in cost from $58 to $85 per day, were all diseases of the lung. These data clearly show a group of Medicare beneficiaries that have high respiratory care needs and relatively short SNF stays.

Provision of Respiratory Therapy

Respiratory therapy is a highly specialized allied health discipline focused on the management and treatment of lung disease and illness. Respiratory therapists treat patients with acute and complex respiratory problems in a broad spectrum of settings. They also assess and develop patient care plans as part of their scope of practice. Respiratory therapists initiate, conduct and modify prescribed therapeutic procedures, assist physicians performing special procedures and conduct pulmonary rehabilitation. They select, assemble, and assure that equipment will not contribute to nosocomial infections. In addition, they verify proper equipment operation and correct malfunctioning equipment. Respiratory therapists maintain patient records and communicate relevant information to other members of the health care team.

Moreover, respiratory therapists utilize clinical decision-making skills to assess resident health, analyze pathophysiology, recommend medications, design, implement and modify respiratory therapy treatment plans. They implement protocol-based care, in which respiratory therapists work with physicians to develop the most appropriate treatment plan to meet a resident's changing respiratory therapy needs. Respiratory therapists rely upon a combination of intervention and clinical thinking skills developed through experience in actual clinical practice. They utilize their training in and knowledge of the latest complex respiratory care technology to make resident care decisions.

Standards of Care

The criteria for determining if respiratory therapy is reasonable and necessary in SNFs is outlined in section 230.10 C.3 of the Skilled Nursing Facility Manual (SNFM) that states:

"To be considered reasonable and necessary for the diagnosis or treatment of an individual's illness or injury, respiratory therapy services furnished to a beneficiary must be (1) consistent with the nature and severity of the individual's complaints and diagnosis, (2) reasonable in terms of modality, amount, frequency and duration of the treatments, and (3) generally accepted by the professional medical community as being safe and effective treatment for the purpose used."

In order to provide this care, respiratory therapists receive more advanced, specialized training and education in respiratory therapy than any other health care provider. More importantly, respiratory therapists are tested on their competency through a rigorous examination administered by the National Board for Respiratory Care (NBRC). Respiratory therapists must pass this examination in order to be credentialed. The NBRC examination is the only examination that tests the competency of health care providers to render respiratory therapy.

The high standards of the NBRC credentialing process have been recognized within the medical community. For example, the National Association for Medical Direction of Respiratory Care (NAMDRC) supports the fact that "the hours of education and the curriculum required for credentialing of a respiratory care practitioner [therapist] should be the standard for all non-physician providers of respiratory care services." (See enclosed statement.)

In addition to NAMDRC, several state and national medical associations and societies have gone on record in support of the continued use of nationally credentialed respiratory therapists working under the supervision of a qualified medical director as being the most highly qualified health care providers to deliver respiratory therapy to patients. These organizations include the American College of Chest Physicians (ACCP), the American Society of Anesthesiologists (ASA), and the California Thoracic Society. (See enclosed statements.) We would note that these statements support federal criteria that provision of respiratory therapy in SNFs be "generally accepted by the professional community as being safe and effective treatment for the purpose used." (SNFM, section 230.10 C.3.c.)

Use of Substitutes

The key to successful patient outcomes and protection of the patient is to ensure that a respiratory therapist is available at the SNF to oversee the diagnostic evaluation, therapy, and education of the patient, family and the public. The AARC acknowledges that there may be cases in which other health care providers may be asked to administer certain respiratory procedures after undergoing specialized post-graduate education. However, that is not necessarily an indication that they are qualified to 1) deliver all forms of such care, 2) that the respiratory therapy they provide is of the same acceptable quality as that provided by respiratory therapists, or 3) that they are qualified to assess the appropriateness and continued need for a particular modality of respiratory therapy.

In fact, this concern is expressed in the current Long Term Care Resident Assessment Instrument (RAI) User's Manual regarding the definition of a "trained nurse" that states:

"Trained Nurse" refers to a nurse who received specific training on the administration of respiratory treatments and procedures. This training may have been provided at the facility during a previous work experience or as part of an academic program. Nurses may not necessarily learn these procedures as part of formal Nursing training."

As stated in the AARC's position on the use of substitute providers for respiratory therapy (enclosed), the respiratory therapist "is the only health care provider with comprehensive education, training and competency testing in the provision of respiratory care services and is essential to provide the level of assessment, care and evaluation of patients required to achieve effective and efficient outcomes of care for patients with cardiopulmonary abnormalities. Health care providers other than the RCP ["respiratory care practitioner"] do not receive this comprehensive education, training and competency testing in respiratory care procedures."

Averting Negative Patient Outcomes

Respiratory therapy rendered by health care providers who do not have documented competency in respiratory therapy present a danger to patients and can result in numerous negative outcomes including:

1. Providing services that are inappropriate for the patient's condition; 2. Providing unnecessary respiratory therapy services; 3. Increasing hospital readmission rates due to pulmonary complications; 4. Increasing costs and lengths of stay; 5. Providing ineffective services, thereby increasing morbidity rates, and 6. Jeopardizing patient safety, thereby increasing mortality rates.

Since November 1997, the AARC has urged HCFA to revise applicable Medicare nursing home documents (i.e., the Long Term Care Resident Assessment Instrument (RAI) User's Manual and the Medicare Survey and Certification Manual) as they pertain to the provision of respiratory therapy. The AARC has recommended that the following statement be included in the aforementioned documents:

"Respiratory therapy services may be provided by respiratory therapists or other health care provider who have been trained, educated, and have demonstrated competency in respiratory therapy services through a valid competency examination."

The AARC and HCFA have been unable to come to an agreement on the inclusion of this statement. This situation adversely affects the quality of respiratory therapy services and the health outcomes of Medicare beneficiaries.

In addition, for the purpose of the development of the OIG's compliance program, the AARC recommends including Competency Requirements for the Provision of Respiratory Therapy Services (enclosed) developed by the AARC. These standards for formal training and demonstration of competency should be required of any health care provider regardless of their credential, educational degree, or state license.

Cost Effectiveness and Competency Testing

In today's complex and ever-changing health care system, the need for more cost-effective measures in the delivery of health care, while preserving the quality of care to patients, is ever present. The AARC recognizes the need for prospective payment for SNFs. However, we have serious concerns regarding the way respiratory therapy is treated in the development of this significant new Medicare payment mechanism. Safeguards that assure safe and effective care are not currently in place.

Respiratory therapists are best qualified to render respiratory therapy just as physical therapists, occupational therapists, and speech therapists are superior in their roles. Respiratory patients have a right to receive care from qualified health care providers.

Through its compliance program guidance, the OIG should recognize that respiratory therapy must be provided by trained, skilled and experienced health care providers who have been competency tested.

In reviewing the above comments, if additional clarification is needed, please contact Jill A. Eicher, MPA, AARC Director of State Government Affairs at 703/548-8538.

Sincerely,

Sam P. Giordano, MBA, RRT
Executive Director
American Association for Respiratory Care