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(6/30/98) - Letter of Comment to HCFA regarding Transactions NPRM
June 30, 1998
Health Care Financing Administration
U.S. Department of Health and Human Services
Attention: HCFA-0149-P
P.O. Box 31850
Baltimore, MD 21207-8850
RE: HCFA-0149-P
Dear Sirs:
The following represent the comments of the Workgroup on Electronic Data Interchange (WEDI) on the proposed rule regarding the adoption of the Standards for Electronic Transactions which are mandated by the Health Insurance Portability and Accountability Act of 1996 (HIPAA). This proposed rule is referred to in the Federal Register as HCFA-0149-P.
Following its publication in the Federal register, the proposed rule was posted to the WEDI web site, along with a document generated by WEDI s Transaction Policy Advisory Group (PAG) which specifically highlighted the issues which the PAG felt it should carefully examine and comment upon. Then, WEDI hosted a two day session in Chicago on June 8 and 9, 1998, during which the Transaction PAG and other industry representatives reviewed both the rule in general and the specific areas within the rule on which comments were directly solicited. The session was open to both WEDI members and non-members, and it was well attended by representatives of the payer, provider and vendor communities.
The results of that session were a series of recommended comments to the proposed rule that were presented to WEDI s Board of Directors. On June 23, 1998 the Board met to review each such recommendation. The following comments are the product of the Board s deliberations and, therefore, represent the organization s official positions on these issues. We believe that our comments represent the views of the broadest coalition in the health care industry, and we hope that they can contribute significantly to the timely preparation of the final rule on Standards for Electronic Transactions.
For ease of reference, each comment is identified as to the page number in the Federal Register and the issue to which it pertains.
Page 25274 (Background)
As noted in the proposed rule, the provisions of Part C of Title XI of HIPAA, as well as any standards established under them, supersede any state law that is contrary to them. However, the Secretary may waive this provision.
WEDI notes that the proposed rule does not describe how such waivers would be granted, and we recommend that this process be clarified in the proposed rule. More importantly, WEDI believes that waivers in general should NOT be granted. If waivers are requested, they should be evaluated to determine their net regional and national effect (costs, benefits, overall effect on the volume and value of EDI within the healthcare industry, etc.) before the Secretary takes action.
WEDI believes that an accelerated schedule of changes to the standards to ensure that the needs of the states are met would be more effective and less detrimental to the objectives of HIPAA than waivers of those standards.
Page 25276 (Provisions/Applicability)
The proposed rule requires some clarification regarding the interaction between computers (e.g., interactive, fast batch, DDE, etc.) Will the regulations apply to transactions from dumb terminals (e.g., direct data entry, point of service terminals)? WEDI suggests that HHS define these interactions as person-to-computer or computer-to-computer without human interaction from one organization to another in order to better clarify the intent of the exclusion.
WEDI also believes that the data content must be equal to that required for the standards regardless of how the transaction occurs. The current language in the proposed rule implies that hypertext language is the only thing excluded, which may have a tendency to stifle future technological innovations. WEDI believes that future technology should not be precluded.
Page 25276 (Provisions/Applicability)
The proposed rule would permit a person or entity to meet the requirements of Section 142.104 by submitting nonstandard data elements to a health care clearinghouse for processing into standard data elements & WEDI believes that if a non-standard transaction is transmitted to a clearinghouse, it must include the data required for the standards unless the clearinghouse otherwise has access to any missing data elements. Otherwise, the clearinghouses may be forced to submit to the ultimate recipient either incomplete transactions or transactions in which some of the data is filled in by default or assumption.
Pages 25279-80 (Provisions/Effective dates)
The proposed rule notes a recommendation made at the WEDI Healthcare Leadership Summit held on August 15, 1997. WEDI affirms that earlier recommendation that & health care providers not be required by health plans (words added here for clarification) to use any of the standards during the first year after the adoption of the standards. However, willing trading partners could implement any or all of the standards by mutual agreement at any time during the 2-year implementation phase (3-year implementation phase for small health plans). In addition, it was recommended that a health plan give its health care providers at least 6 months notice before requiring them to use a given standard.
WEDI recommends that this language be included in the final rule.
Page (not specified) (Provisions)
The term sponsor is not defined in the proposed rule. WEDI recommends that the term sponsor be defined as an entity that makes premium payments to (or, if self insured, contracts with) other organizations such as health plans and managed care organizations for the purpose of providing health care to the employees or members of the entity. WEDI believes that all employers providing health care to employees would be considered sponsors; however, not all sponsors would be employers.
Page 25280 (Provisions/Data Element and Record/Segment Content)
WEDI endorses the language in the proposed rule that states Once we publish the final rule in the Federal Register and it is effective, there will be no additional data element or record/segment content modifications in any of the transactions for at least one year.
Page 25280 (Provisions/Data Element and Record/Segment Content)
The proposed rule states that all data elements would be governed by the principle of a maximum defined data set and no one would be able to exceed the data sets defined in the final rule until that rule is amended one or more years from the effective date of the final rule. The proposed rule further states that if a transaction contains all of the data described in the maximum data set then a health plan would have to accept the transaction and process it. The proposed rule also states that a health plan would not be permitted to reject a transaction because it contains more data than a plan wants or needs if that data is permitted by the maximum data set.
WEDI endorses the principle of the maximum defined data set. WEDI further agrees that health plans (or others) should not be permitted to require more than the data defined in the maximum data set, and that health plans (or others) can not require less than the data defined in the maximum data set. In other words, a health plan should not be permitted to reject a transaction which contains data defined in the maximum data set
Pages 25282-3 (Code Sets)
The proposed rule notes that comments on the use of UPNs as a national coding system are being sought. WEDI recognizes the potential breadth and value of UPN usage but believes that it is important that comments received on this issue be carefully reviewed and that considerable study is necessary to determine if expanded UPN usage would further the objectives of administrative simplification and reduced costs within the health care system.
Page 25283 (Code Sets)
The proposed rule recommends the elimination of J codes from alphanumeric HCPCS codes in the year 2000.
WEDI recommends that NDC codes should only be required for Prescription Drug Programs, retail pharmacy claims and claims for Durable Medical Equipment (DME) that do not have J codes.
Pages 25283-4 (Code Sets)
The proposed rule recommends that beginning in the year 2000, local codes be eliminated and that a national process be established for reviewing and approving codes that are needed by any public or private health insurer. The proposed rule further states that By eliminating duplicative and otherwise unnecessary local codes and adding national temporary codes through the centralized process & we believe we are being consistent with the intent of HIPAA to simplify the administration of the claims review, payment and monitoring process.
WEDI agrees with this conclusion and endorses the objectives and processes described in the proposed rule. However, we further recommend that any local codes established through these processes be temporary, and then moved as expeditiously as possible into the appropriate national code sets.
Pages 25284-6 (Code Sets)
WEDI endorses the codes sets selected in the proposed rule.
Page 25286 (Code Sets)
WEDI believes that the final rule should make it clear that the version of the approved codes sets which is applicable to a specified timeframe (e.g. calendar year)is the version specified by the developer for that specified timeframe. Furthermore, WEDI recommends that the Department of Health and Human Services (HHS) establish a list of the current accepted version(s) of these code sets and make this list available to the public. Applicable transactions must contain codes from the approved version(s) to be considered standard.
Page 25287 (Recommended Standards/Implementation Guides)
WEDI endorses the selection of the Health Care Claims or Equivalent Encounter Information transaction standards specified in the proposed rule.
Page 25289 (Recommended Standards/Implementation Guides)
WEDI endorses the selection of the Health Care Claim Payment/Advice transaction specified in the proposed rule.
Page 25290 (Recommended Standards/Implementation Guides/COB)
The proposed rule describes the two models currently used for conducting the coordination of benefits for patients covered by multiple health plans. The first model is provider-to-plan; the second is plan-to-plan. The proposed rule notes that primary insurers are not required to participate in COB transactions as described in the second model (plan-to-plan). However, those which perform COB using this model would have to send and receive the proposed Health Care Claim standards.
WEDI agrees with the descriptions and conclusions contained in the proposed rule. HIPAA does not require that health plans conduct business using the plan-to-plan model of conducting coordination of benefits and, in fact, most current commercial (as opposed to government) claim transactions involving COB utilize the provider-to-plan model. WEDI recommends that business be permitted to continue utilizing either model until systems and processes for the plan-to-plan model are enhanced. We believe that the industry will then move of its own accord to the plan-to-plan model, thus relieving patients and providers of the burdensome chore which current COB processes often imposes on them.
Page 25291 (Recommended Standards/Implementation Guides)
WEDI endorses the selection of the Health Claim Status transaction specified in the proposed rule.
Page 25292 (Recommended Standards/Implementation Guides)
WEDI endorses the selection of the Enrollment and Disenrollment in a Health Plan transaction standard specified in the proposed rule.
With respect to the request for comments on the practical utility of the ASC X12 834 enrollment transaction as a vehicle for collecting demographic information on individuals and its value as an adjunct to claims and encounter in this regard , WEDI believes that the ASC X12 834 should not be used for this purpose.
Page 25293 (Recommended Standards/Implementation Guides/Eligibility for a Health Plan)
WEDI endorses the selection of the Health Care Eligibility Benefit Inquiry and the companion Health Care Eligibility Benefit Response transactions specified in the proposed rule.
The proposed rule notes that another part of the ASC X12N 271 is designed to handle requests for eligibility rosters & and that this use is not being currently recommended because the roster implementation guide is not millennium compliant and the standards development process for the implementation guide is not completed.
WEDI agrees that the roster use of the ASC X12N 271 is not yet complete and that this usage for this transaction should be considered for adoption as a national standard in a subsequent regulation.
Page 25295 (Standard:Health Plan Premium Payment)
WEDI endorses the selection of the Health Plan Premium Payment transaction standard specified in the proposed rule. The proposed rule notes that this transaction (ASC X12 820) is currently used in applications other than health care but is not widely used by the health insurance industry. WEDI believes that market forces will encourage employers and others to adopt and use this transaction for electronic health care premium payment.
Page 25295 (Standard:Referral Certification and Authorization)
WEDI endorses the selection of the Health Care Services Review Information (ASC X12N 278) transaction standard for referral certification and authorization specified in the proposed rule.
In addition, however, WEDI notes that other uses of the ASC X12N 278 (i.e. for Inquiry and Response, and for Notification) fall under HIPAA and when these implementation guides are fully compliant, they should be included in future regulations.
Page 25296 (Standard:First Report of Injury)
The proposed rule discusses the ASC X12N 148 transaction set and concludes that it should not be adopted as a national standard at this time. WEDI believes that many of the objections to the ASC X12 148 have been eliminated and that significant progress has been made towards making this transaction fully compliant with the criteria for standards adoption. Therefore, WEDI recommends that HHS accelerate its evaluation of the ASC X12N 148 as the national transaction standard for First Report of Injury. If the transaction set meets the necessary criteria, it should be included in the final rule.
Page 25297 (Implementation: Compliance Testing)
The proposed rule identifies and discusses three levels of testing that must be completed in the implementation of the specified standards. In its analysis of the third level (Production Testing), the proposed rule notes that we believe that the industry should sponsor pilot production projects to test transaction standards that are not currently in full production prior to the effective date of adoption. However, the proposed rule further states that For the claim and equivalent encounter transactions, we believe that posting pilot production projects and results to a web site must be mandatory.
WEDI agrees that pilot production projects are valuable, and we would extend the posting of results to all transactions rather than just to claims and encounters. However, for a variety of reasons, WEDI does not believe that the posting of results to web sites should be made mandatory and we urge that this requirement be stricken from the final rule.
Page 25298 (Implementation: Enforcement)
The proposed rule notes that failure to comply with standards may result in financial penalties of up to $25,000 in each calendar year for violations of each requirement. WEDI recommends that the term requirement be clarified in the final rule. For example, if a person or entity submits a batch of 10,000 transactions each of which is missing or mis-uses a required code, is that a violation of that requirement one time & or ten thousand times?
Further, the proposed rule, in the Enforcement discussion, solicits comments on appropriate mechanisms to permit independent assessment of compliance. WEDI strongly believes that independent compliance mechanisms and organizations are critical to the long-term, successful adoption of the proposed standards. We are not currently prepared to offer specific recommendations in this regard, but we believe that we are uniquely qualified by our breadth of membership and our status as an independent consensus builder within the industry to play some defined role in this process. We would be pleased to discuss this further with the HHS.
Page 25298 (New Standards)
The proposed rule describes processes by which waivers to standards might be granted. WEDI believes that the term exemption is preferable to waiver since it makes it clearer that standards should generally not be waived.
In addition, WEDI proposes the following changes in language to the criteria listed on page 25298:
1. In the first item marked with a + , replace would be a clear improvement with is believed to be a clear improvement
2. Add a bullet stating Approval by the committee to pilot test .
3. The following bullet should be modified as follows with modification underlined;
The committee s evaluation of the pilot would, at a minimum, be based on the following:
4. Under this same bullet above, the following item (+) should be added; + Successful pilot.
WEDI further recommends that the process not be unduly restrictive, and the cost benefit analysis should apply to the report developed after the pilot study and not the application phase of the temporary waiver/exemption.
Pages 25298-99 (Revised Standards: Data Content Committees)
The proposed rule notes that WEDI has previously endorsed the roles of NUBC, NUCC and the ADA as the appropriate organizations to specify data content. WEDI affirms that endorsement and further suggests that their roles be expanded to include non-claim transactions if the expertise and breadth of the committees should so warrant.
The proposed rule also describes alternative steps for ensuring that any body with responsibility for maintaining a standard under this proposed rule must allow public access to their decision making processes. We believe that such open processes are critical.
Finally, WEDI agrees with the language in the proposed rule that states that all approved changes, not including medical code sets, would need to fit into the appropriate ASC X12N implementation guide(s)& . However, we agree that the NCPDP would continue to operate as currently for data content.
Page 25299 (Collection of Information Requirements: PRA)
WEDI does not believe that a regulation that adopts an EDI standard used to exchange certain information constitutes an information collection subject to the PRA. Therefore, we believe references to the PRA and the requirements referenced in this proposed rule should be eliminated from the final rule.
Pages 25310-20 (Implementation Guides and Source)
Addenda to the proposed rule identify the various implementation guides which govern the format and use of the selected transaction standards. WEDI wishes to make the following comments regarding these guides:
a. Adobe Acrobat Notes:
WEDI recommends that the notes which apply to the implementation guides should be considered part of the implementation guides and should be reviewed along with the proposed rule.
b. ASC X12N 277:
WEDI believes that the 277-Unsolicited Claims Status Implementation Guide has a very specific use that differs from that of the 276/277-Claims Status Request and Response. However, when the 277-Unsolicited Claims Status Implementation Guide is finalized, WEDI believes that it should be considered in a future regulation.
c. ASC X12N 837-Institutional, Professional, Dental:
WEDI recommends that if the NPI is implemented as the identifier for providers, and if payers do not have access to the provider s tax ID in the NPS, a specific data element or qualifier should be included in the claims transaction implementation guides in order to report provider tax ID for the pay-to provider(s) for the purpose of 1099 reporting.
d. All Implementation Guides:
WEDI supports and recommends the Trading Partner Agreement language included in the notes of the implementation guides.
e. ASC X12N 834:
WEDI recommends that in addition to its other uses, the ASC X12N 834 should be used for the initial file load as well as for file replacements for individuals enrolled in a plan. This usage (initial file load) needs to be identified at the header level, and the implementation guide needs to be changed to accommodate this.
f. ASC X12N 278:
WEDI recommends that the 278 implementation guide be modified if necessary to support both batch and real time applications.
In concluding our comments regarding HCFA-0149-P, WEDI wants to take this opportunity to express our gratitude to the various federal government employees and others outside of the government (including WEDI s own Policy Advisory Group members) who have worked so long and so hard to prepare the proposed rule on these very complex transactions and issues. With their publication, our industry has taken a significant step toward the realization of the benefits of administrative simplification that Secretary of Health and Human Services Dr. Louis Sullivan and the first members of WEDI articulated in 1991. We are now eager to take the next steps in this process. Certainly, that includes clarifying or expanding upon any of these comments during the upcoming review period and offering any other assistance that is requested and appropriate to ensure the timely preparation and publication of the final rule.
Sincerely,
Richard P. Caliri
Chairman, WEDI
cc: WEDI Board of Directors
WEDI Policy Advisory Group Co-chairs
James A. Schuping, WEDI Executive Vice President
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