Office of Advocacy

December 23, 1998

Ms. Allison Eydt
HCFA Desk Officer
Office of Information and Regulatory Affairs
Office of Management and Budget
Executive Office Building
Washington, DC 20503

Re: HCFA OASIS Regulations—Paperwork Impact on Small Businesses; 62 Fed. Reg. 11,035 (March 10, 1997).

Dear Ms. Eydt:

Thank you for the opportunity to comment on the Outcomes and Assessment Information Systems (OASIS) regulation proposed by the Health Care Financing Administration (HCFA). The Office of Advocacy is well aware of the necessity and importance of collecting outcome data as HCFA and the industry move toward the Prospective Payment System (PPS). The data to be collected is vital to formulating appropriate case mix adjusters for PPS; and most of the industry embraces the concept of OASIS data collection as a means of quality control. Inasmuch as the majority of home health agencies that will be impacted most by the OASIS regulations are small by SBA standards, the Office of Advocacy would like to urge HCFA to consider a few modifications of its proposal to reduce the start-up burdens associated with implementation of the regulations.

According to HCFA, the OASIS demonstration project has shown that the collection of information burden associated with the regulations is less than originally anticipated. Nevertheless, HCFA has made a number of modifications to its proposal to further reduce burden based on public comments submitted when the rule was published. Some of those modifications include: 1) an additional one-time cost factor of $280 to print OASIS forms; 2) flexibility and clarification of data collection time points; 3) recognition of clinician involvement in the integration of OASIS information into existing forms; 4) increasing the learning curve or proficiency time from 5 uses to 8 uses, and not projecting gains or losses to completion time based on when proficiency is likely to be achieved; 5) and clarifying that a patient’s eligibility for Medicare home health benefits (including homebound status) does not apply to Medicaid patients, beneficiaries receiving Medicare outpatient services or private pay patients.

The Office of Advocacy is not familiar with the parameters of the demonstration project, but for purposes of these comments we will assume that the data and information obtained from agencies participating in the demonstration was more or less averaged. This is to say that some agencies may have reported greater burden. More than likely, those reporting greater burden were the smallest and newest agencies already reeling from implementation of other Medicare reforms contained in the Balanced Budget Act of 1997. These small agencies have the least staff and the least resources to comply with the OASIS regulations that include new forms, new procedures, training, software, hardware, etc. Therefore, the Office of Advocacy believes that HCFA has underestimated the impact of the regulations with regard to some of the smaller and newer agencies, and overestimated the number of agencies (30%) that will benefit from add-on/reimbursement under their annual per beneficiary limits. To help preserve the agencies facing the greatest compliance hurdles while also preserving the integrity of the OASIS system, the following recommendations are proffered for your consideration.

• Apply OASIS to Medicare patients only. Although HCFA interprets its authorizing statute as allowing the collection of information of non-Medicare patients,(1) it is within HCFA’s discretion to depart from that policy as it has in the past. Such a departure would be consistent with HCFA’s decision to not require non-Medicare patients to establish eligibility for Medicare home health benefits. Moreover, agencies would at least have the option of not collecting data they would not otherwise collect for internal recordkeeping purposes.
• When caring for long-term or chronic patients whose condition, prognosis or care is not likely to change until discharge, give agencies the option to submit a one-page follow-up form essentially indicating "no change." By way of example, a patient with terminal testicular cancer who is incontinent is likely to remain incontinent. A chronic diabetic is likely to remain on insulin therapy. The complete 15-page follow-up form proposed by HCFA should only be required when changes in treatment or condition occur.
• Collect only the data items that are required for use as case-mix adjusters in developing PPS. Ability to perform housekeeping and laundry, and descriptions of the patient’s living arrangements do not seem to be relevant when assessing the core data needed for PPS.
• Finally, it seems that the area with the greatest amount of room for flexibility is enforcement. Many agencies, particularly larger ones or ones that participated in the demonstration, are already on track with respect to compliance. HCFA should be conservative, at least initially, in its enforcement of the OASIS regulations on small agencies that have not yet fully implemented the regulations. Agencies should not have to fear receiving a notice of deficiency when surveyed by HCFA (for a reasonable period of time) as long as training is in progress and movement toward OASIS exists. Or, in keeping with the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), allow an agency to use its valuable resources for rather than fines for first time offences.(2)

Implementation of PPS has been delayed due to serious Year 2000 computer problems at HCFA. Home health agencies should be able to benefit from this delay by being allowed some degree of flexibility in the initial phases of OASIS implementation. Thank you for your consideration of these alternatives. The Office of Advocacy believes that all parties involved will benefit from the adoption of all or some of the recommendations contained herein. Please do not hesitate to contact my office if you have any questions, 202-205-6533 or 202-205-6945.

Sincerely,

Jere W. Glover
Chief Counsel for Advocacy

Shawne Carter McGibbon
Asst. Chief Counsel for Advocacy

ENDNOTES

1. HCFA already includes non-Medicare patient information in a number of areas (i.e., conditions of participation standards and clinical record requirements).

2. Section 223(a) of SBREFA states: "--Each agency regulating the activities of small entities shall establish a policy or program . . . to provide for the reduction, and under appropriate circumstances for the waiver, of civil penalties for violations of a statutory or regulatory requirement by a small entity. Under appropriate circumstances, and agency may consider ability to pay in determining penalty assessments on small entities."