Source: https://www.federalregister.gov/documents/2005/02/04/05-1773/medicare-program-e-prescribing-and-the-prescription-drug-program
Timestamp: 2019-09-17 16:20:26
Document Index: 714896971

Matched Legal Cases: ['§\u2009423', '§\u2009423', '§\u2009162', '§\u2009162', '§\u2009162', '§\u2009162', 'art 423', '§\u2009423', '§\u2009423', '§\u2009423', '§\u2009423', '§\u2009423', '§\u2009423', '§\u2009423', '§\u2009423', 'art 423', '§\u2009423', '§\u2009423', '§\u2009423', 'art 51']

Federal Register :: Medicare Program; E-Prescribing and the Prescription Drug Program
A Proposed Rule by the Centers for Medicare & Medicaid Services on 02/04/2005
70 FR 6255
6255-6274 (20 pages)
Section 423.160 Standards for an Electronic Prescribing Program
https://www.federalregister.gov/d/05-1773 https://www.federalregister.gov/d/05-1773
1. Electronically. You may submit electronic comments to http://www.cms.hhs.gov/​regulations/​ecomments (attachments should be in Microsoft Word, WordPerfect, or Excel; however, we prefer Microsoft Word).
2. By mail. You may mail written comments (one original and two copies) to the following address only: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-0011-P, PO Box 8014, Baltimore, MD 21244-8014.
3. By hand or courier. If you prefer, you may deliver (by hand or courier) your written comments (one original and two copies) before the close of the comment period to one of the following addresses. If you intend to deliver your comments to the Baltimore address, please call telephone number (800) 743-3951 in advance to schedule your arrival with one of our staff members. Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201; or 7500 Security Boulevard, Baltimore, MD 21244-1850.
Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. After the close of the comment period, CMS posts all electronic comments received before the close of the comment period on its public website. Comments received timely will be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, please call (800) 743-3951.
On January 28, 2005, we published the Medicare Prescription Drug Benefit final rule that establishes the Prescription Drug Benefit Program and cost control and quality improvement requirements for prescription drug benefit plans. One of the provisions in that final rule requires Prescription Drug Plan (PDP) sponsors, Medicare Advantage (MA) Organizations offering Medicare Advantage-Prescription Drug (MA-PD) plans, and other Part D sponsors to support and comply with electronic prescribing standards once Start Printed Page 6257final standards are in effect, including any standards that are in effect before the drug benefit begins in 2006.
Section 1860D-4(e)(1) of the Act states that the final e-prescribing standards will govern “prescriptions and other information described in paragraph (2)(A) for covered part D drugs prescribed for part D eligible individuals that are transmitted electronically. * * *” We believe the best reading of this language, as well of the intent of the Congress, is that the e-prescribing standards apply only to information regarding Part D eligible individuals enrolled in Part D plans—that is, enrollees of prescription drug plans (PDPs) (including employer-sponsored PDPs); fallback PDPs; Medicare Advantage Prescription Drug plans (MA-PD plans); and private fee for service plans, Medicare cost reimbursement plans, or PACE programs receiving Part D reimbursement. We believe this interpretation realizes the intent of the Congress, which in the Conference Report for the MMA, stated that e-prescribing standards are standards that apply to information, transmitted “under an electronic prescription drug program conducted by a PDP or MA plan.” (H.R. Conf. Rep. 108-391, 108th Cong., 1st Sess. at 455 (2003)) This statement contemplates that the e-prescribing standards would apply solely to information regarding Part D enrolled individuals, not simply to information regarding Part D eligible individuals who are not enrolled in a Part D plan. We have attempted to clarify the scope of these standards in the proposed definition of “electronic prescription drug program” in proposed § 423.159, and the “General Rules” in proposed § 423.160.
In the preamble of the Medicare Prescription Drug Benefit proposed rule, published in the Federal Register August 3, 2004 (69 FR 46632-46863), Start Printed Page 6258we solicited comments to help us identify consensus on e-prescribing standards ahead of the statutory timeframe and to help us identify and evaluate whether there is adequate industry experience with those standards. Concurrently, the NCVHS held hearings with various groups of constituencies on e-prescribing standards while identifying and examining standards for possible adoption by the Secretary. We attended each of these hearings as an active participant.
Nearly every State allows for the electronic transmission of prescriptions. In recent years, many States have more actively legislated in this area. The scope and substance of this State activity, however, varies widely among the States.[1] The MMA addresses preemption of State laws at section 1860D-4(e)(5) of the Act as follows:
We propose to interpret this section of the Act as preempting State law provisions that conflict with Federal electronic prescription program drug requirements that are adopted under Part D. We view it as mandating Federal preemption of State laws and regulations that are either contrary to the Federal standards, or that restrict the ability to carry out (that is, stand as an obstacle to) the electronic prescription drug program requirements, and that also pertain to the electronic transmission of prescriptions or certain information regarding covered Part D drugs for Part D enrolled individuals. Consequently, for a State law or regulation to be preempted under this express preemption provision, the State law or regulation would have to meet the requirements of both paragraphs (A) and (B). Furthermore, there would have to be a Federal standard adopted through rulemaking that creates a conflict for a State law to be preempted. This interpretation closely reflects the language of the statute, and it is consistent with the presumption against Federal preemption of State law [2] and with the fundamental Federalism principles set forth in section 2 of Executive Order 13132. It is also consistent with the Department of Health and Human Service's (HHS) general position of deferring to State laws regulating the practice of pharmacy and the practice of medicine.
We understand that some industry representatives believe that the Congress intended this preemption provision to be much broader. For instance, some expressed the position that this statutory provision preempts all State laws that would in any way restrict the development of e-prescribing for all providers and payors. This position is based on the belief that the Congress Start Printed Page 6259intended to preempt the field of e-prescribing through this provision in the MMA. It would require an interpretation that the word “and” between paragraphs (A) and (B) is disjunctive, that is, that “and” means “or” in this context. Under this interpretation, the operative language would be “restricts the ability to carry out this part” in paragraph (A), which arguably would enable the standards and requirements adopted for the Federal electronic prescription drug program to preempt all State laws and regulations that restrict the Secretary's ability to carry out the goals of an electronic prescription drug program, even if they are not related to covered Part D drugs, or Part D covered individuals. They contend that some States have existing statutory or regulatory barriers that could impede the success of e-prescribing; for example, laws and regulations that were drafted with only paper prescriptions in mind, which may not be well-suited to e-prescribing applications.
To fulfill its responsibilities under the MMA's amendments to the Act, the NCVHS' Subcommittee on Standards and Security held public hearings on issues related to e-prescribing on March 30 and 31, 2004; May 25, 26, and 27, 2004; July 28-30, 2004; and August 17-19, 2004. These hearings included testimony from e-prescribing networks, providers, software vendors, and industry experts on patient safety, drug knowledge databases, and standards currently in use by the industry. Industry experts involved in e-prescribing studies and initiatives also presented information on the progress and findings of these studies. Following the hearings by the NCVHS Subcommittee on Standards and Security, the Subcommittee developed observations and associated recommended actions and presented them to the full NCVHS Committee for consideration. On September 2, 2004, the NCVHS sent a letter to the Secretary containing the observations and associated recommended actions for an electronic prescription drug program. The document included recommendations for the foundation standards that we are proposing and other long-term recommendations regarding pilot testing of other standards. For specific details, refer to the letter, available at http://www.ncvhs.hhs.gov/​040902lt2.htm.
In order to develop and provide future recommendations to the Secretary, the NCVHS Subcommittee on Standards and Security plans to hold additional hearings on the state-of-the-art in e-prescribing, including testimony from a broad range of stakeholders. The NCVHS will be developing Start Printed Page 6260recommendations for additional standards for consideration by the Secretary for testing and ultimate adoption through the rulemaking process. Readers interested in the NCVHS' hearing schedule, testimony presented at the hearings, and standards recommendations should consult the NCVHS Web site at http://www.ncvhs.hhs.gov.
Today, physicians and other health care providers make their drug-prescribing decisions using whatever medical, medication, and eligibility information that is known or available to them. Then they give a handwritten prescription to the patient or fax it to the patient's pharmacy of choice. At the pharmacy, tasks are somewhat more automated. Through electronic claims, eligibility, and benefits submission, the dispensing pharmacist may learn about drug interactions, disease management concerns, the need for prior authorization, or lower cost alternatives. The pharmacist may then contact the prescriber by phone for approval of changes, refills, or renewals. This process can be very repetitive and time consuming for both the pharmacist's and the prescriber's office staff. According to some estimates, almost 30 percent of prescriptions require pharmacy call backs, resulting in 900 million prescription-related telephone calls that are placed annually.[3]
Many witnesses before the NCVHS have stated that the current prescribing process is prone to errors. Prescribers may not have access to the latest drug knowledge. They often do not have a completely accurate medication list or even medical history for their patient, and, as a result, may be unaware of potential drug-drug or drug-disease interactions or duplicate therapies. Pharmacists often have difficulty reading handwritten prescriptions and frequently have little or no information about the patient's condition for which the prescription is written. Contacting the prescriber by phone to clarify what is ordered and to make changes often results in delays for the patient and is time consuming for the prescriber and the pharmacist. There are disconnects between the prescriber and patient in the medication process, and little or no feedback is given to the prescriber on whether a prescription was filled or refilled. These disconnects can lead to preventable adverse drug events (ADEs) that are common and can be serious. According to the Center for Information Technology Leadership, more than 8.8 million ADEs occur each year in ambulatory care, of which over three million are preventable.[4] Medication errors account for one out of 131 ambulatory deaths.[5] In addition, the current system results in numerous and pervasive administrative and workflow inefficiencies, which affect costs and quality of care.
Speeding up the process of renewing medications. An article reported that in a large primary care practice in Kokomo, Indiana, of 206 daily prescription-related calls, 97 calls were renewal requests; [6] and
According to industry surveys, usage rates for e-prescribing vary in number and in the level of sophistication of the electronic prescription system used. Somewhere between 5 percent and 18 Start Printed Page 6261percent of physicians are estimated to be using e-prescribing of one sort or another, although usage is slowly increasing. Some of the barriers to increased usage of e-prescribing by physicians are the costs of buying and installing a system, the training involved, time and workflow impact, lack of reimbursement for costs and resources, and lack of knowledge about the benefits related to quality of care.
While it is important to note that, to the extent Part D sponsors, prescribers, and dispensers are covered entities under HIPAA, they must continue to abide by the applicable HIPAA standards, including those for privacy and security. All Part D Plans are covered entities under HIPAA, and we assume that many of the providers participating in Part D will likewise be covered entities. Providers are HIPAA covered entities if they engage in electronic transactions for which there are HIPAA standards. In general terms, under HIPAA, a covered entity is a health plan, a health care clearinghouse, and a health care provider who transmits any health information in electronic form in connection with a standard transaction. A standard transaction is defined as a transaction that complies with the applicable standards at § 162.1101 through § 162.1802. Two of the eight Administrative Simplification Standard Transactions conducted between providers and health plans at § 162.1101 through § 162.1802 (the NCPDP Telecommunication Standard for Health Care Claims, and the ASC X12N 270/271 Eligibility Inquiry and Response Standard for eligibility for a health plan queries), are proposed in this rule for e-prescribing foundation standards. The NCPDP Telecommunication Standard is proposed for eligibility inquiries and responses between pharmacies and health plans, and the ASC X12N 270/271 is proposed for eligibility inquiries between prescribers and health plans. Complete definitions for HIPAA covered entities and standard transactions are available at 45 CFR 160.103 and 45 CFR 162.103. Start Printed Page 6262
If a provider is not otherwise a covered entity under HIPAA, it would become a covered entity if it conducts an e-prescribing transaction that is also a HIPAA transaction, such as the 270/271 eligibility and response transactions. It should also be noted that disclosures of protected health information (PHI) in connection with an e-prescribing transaction that is not a HIPAA transaction would have to meet the minimum necessary requirements of the Privacy Rule if the entity is a covered entity. The Privacy Rule excludes from the minimum necessary requirements those disclosures that are required to comply with a HIPAA transaction standard. However, this exclusion would not apply to e-prescribing standards that are not also HIPAA standards, making compliance with minimum necessary a requirement, unless another exception applies.
NCVHS Standards Recommendations— HHS Should:
Provider and Dispenser Identifiers Adopt NPI when it becomes available No.
Prescription (Clinical drug) Include in the 2006 pilot tests the RxNorm terminology in the NCPDP SCRIPT Standard No.
Drug order for new, renewals, cancellations, and change orders Recognize, as a foundation standard, the most current version of NCPDP SCRIPT for new prescriptions, prescription renewals, cancellations, and changes between prescribers and dispensers Yes.
Drug orders for fill status notification Should include the fill status notification function of the NCPDP SCRIPT Standard in the 2006 pilot tests No.
Patient instructions (SIG) Support NCPDP, HL7, and others (especially including the prescriber community) in addressing SIG (patient instruction) components in their standards No.
Medication history Participate in and support rapid development of an NCPDP standard for a medication history message for communication from a payer/PBM to a prescriber Standard functionality identified.
Formulary and benefit coverage information Participate in and support the rapid development of an NCPDP standard for formulary and benefit information file transfer Standard functionality identified.
Eligibility inquiry and response Recognize, as a foundation standard, the NCPDP Telecommunication Standard and the ASC X12N 270/271-Health Care Eligibility Benefit Inquiry and Response Yes.
Prior authorization Support ASC X12N in their efforts to incorporate functionality for real-time prior authorization messages for drugs in the ASC X12N 278 Health Care Services Review No.
Drug-drug Interaction No recommendations advanced. Subject to future NCVHS hearings No.
Medical History No recommendations advanced. Subject to future NCVHS hearings No.
Exchange of medication history, and medical history for e-prescribing program No recommendations advanced. Subject to future NCVHS hearings No.
Electronic signature No recommendations advanced. Subject to future NCVHS hearings No.
Provider and Dispenser Identifiers. The MMA does not expressly direct the Secretary to require the use of unique identifiers for prescribers and dispensers in e-prescribing transactions. However, the NCVHS found that it was important to address the issue of provider identifiers for various e-Start Printed Page 6263prescribing standards it reviewed and, more generally, for an electronic prescription drug program. We agree. After assessing a number of candidate identifiers, the NCVHS further recommended the use of the National Provider Identifier (NPI) as the primary identifier for dispensers and prescribers, once it becomes available.
Drug Information. Section 1860D-4(e)(2) of the Act specifies that an electronic prescription drug program Start Printed Page 6264will include information on drug-drug interactions, warnings or cautions, and when indicated, dosage adjustments. Given that relevant e-prescribing standards must permit electronic exchange of drug labeling and drug listing information maintained by the FDA and the NLM, medication history standards should be compatible with those standards when they are adopted by the Secretary. While drug information standards will not be foundation standards, they will be supported in the future by the structured product label. While standards for providing this type of information on drugs have not yet been considered by the NCVHS and are not yet proposed, we anticipate proposing standards in the future through rulemaking because they are required by MMA and we believe that providing this information is essential to improving the safety and quality of medication management. We invite public comment on standards that should be required to support an electronic prescription drug program required under the Part D benefit.
Subpart D of part 423 implements provisions of several sections of the Act, including sections 1860D-4(c), 1860D-4(d), 1860D-4(e), 1860D-4(j), and 1860D-21(d)(3), as well as sections 102(b) and 109 of Title I of the MMA. Because section 1860D-4(e) of the Act pertains to standards for electronic prescription drug programs which require compliance by e-prescribing entities other than Part D plans, we propose to explicitly broaden the scope of subpart D. Therefore, we are proposing to modify the title of subpart D to read, “Cost Control and Quality Improvement Requirements,” and revise the description of the scope at § 423.150(c) to state expressly that this subpart sets forth requirements relating to electronic prescription drug programs Start Printed Page 6265for prescribers, dispensers, and Part D sponsors.
We propose to amend § 423.159 of the Medicare Prescription Drug Benefit final rule to add definitions pertinent to the e-prescribing process and to amend the title of the section to be consistent with the term “Electronic Prescription Drug Program” which we are proposing to define below. The proposed definitions are as follows:
Part D sponsors would be required to comply with the applicable proposed standards in new § 423.160(b) when electronically transmitting prescriptions and prescription-related information. If prescribers and dispensers electronically transmit prescriptions and prescription-related information, they also would be required to comply with the applicable proposed standards in proposed § 423.160(b). These entities would be required to comply with the standards whether they transmit prescriptions or prescription-related information using electronic media, either directly or through an intermediary, through, for example, an e-prescribing network.
We propose, in new § 423.160(b)(1), to adopt the following transactions of the NCPDP SCRIPT Standard, for communication of prescription information between prescribers and dispensers, as part of an electronic prescription drug program:
We have determined that these transactions of the NCPDP SCRIPT Start Printed Page 6266Standard meet our proposed criteria for adequate industry experience for the following reasons:
We are proposing, at new § 423.160(b)(2)(i), to adopt the ASC X12N 270/271 Transaction, for conducting eligibility and benefits inquiries between prescribers and Part D sponsors.
We are proposing to adopt, at proposed § 423.160(b)(2)(ii), the NCPDP Telecommunication Standard, for conducting eligibility transactions between dispensers and Part D sponsors. We have determined that the NCPDP Telecommunication Standard meets our proposed criteria for adequate industry experience for the following reasons:
Second, these standards are adopted HIPAA standards. In addition to being required standards for eligibility inquiries and responses between retail pharmacy dispensers and health plans, they are also required for submitting retail pharmacy drug claims. Start Printed Page 6267According to the NACDS, over 4 billion claims were transmitted in 2003 using NCPDP standards. In May 1998, when adoption of these standards was proposed through notice and comment rulemaking, the majority of comments received expressed support for adoption.
Therefore, as a third-party disclosure requirement subject to the PRA, Part D sponsors offering qualified prescription drug coverage must support and must comply with electronic prescription standards relating to covered Part D drugs, for Part D enrolled individuals as would be required under § 423.160.
Centers for Medicare & Medicaid Services, Office of Strategic Operations and Regulatory Affairs, Regulations Development and Issuances Group, Attn: John Burke, CMS-0011-P Room C5-14-03, 7500 Security Boulevard, Baltimore, MD 21244-1850; and
Office of Information and Regulatory Affairs, Office of Management and Budget, Room 10235, New Executive Start Printed Page 6268Office Building, Washington, DC 20503, Attn: Christopher Martin, CMS Desk Officer, CMS-0011-P, Christopher_Martin@omb.eop.gov. Fax (202) 395-6974.
We have examined the impacts of this rule as required by Executive Order 12866 (September 1993, Regulatory Planning and Review), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) and Executive Order 13132 on Federalism, and the Congressional Review Act (5 U.S.C. 804(2)).
According to testimony before the NCVHS and in the written comments in response to the Medicare Prescription Drug Benefit proposed rule (69 FR 46632-46863), between 5 and 18 percent of prescribers are conducting e-prescribing.[7] However, some studies have indicated increased prescriber interest and plans to move to e-prescribing. We anticipate that the use of the standards proposed in this rule, and the fact that we are proposing that these standards be available for the January 2006 implementation of the Medicare Prescription Drug Program, will accelerate adoption of e-prescribing due to heightened awareness of the benefits, the variety of devices and connections available for prescribers, and the fact that the standards are already successfully being used. While there are no detailed models predicting specific rates of adoption for this technology, based on our sense of the likely expert consensus, we think it likely that the proportion of prescribers using e-prescribing will increase by about 10 percent annually over the next five years. The 10 percent annual growth in prescriber participation is a rough estimate, based on our expectations of—
In addition to the anticipated reductions in adverse health events associated with anticipated improvements in prescription drug compliance, we believe that many elements of the Medicare prescription drug benefit, including quality assurance, better information on drug costs (for example, through generic substitution), and medication therapy management which are designed to improve medication use and reduce the risk of adverse events, including adverse drug interactions, will be enhanced by e-prescribing. We believe that these improvements, enabled by e-prescribing programs, will occur through enhanced beneficiary education, health literacy and compliance programs; improved prescription drug-related quality and disease management efforts; and ongoing improvements in the information systems that are used to Start Printed Page 6269detect various kinds of prescribing errors, including duplicate prescriptions, drug-drug interactions, incorrect dosage calculations, and problems relating to coordination between pharmacies and health providers. We also believe that additional reductions in errors and additional improvements in prescription choices based on the latest available evidence will occur over time as the electronic prescription program provisions of the MMA are implemented. (To Err is Human: Building a Safer Health System, Institute of Medicine of the National Academies, 1999, pp. 191-193, http://www.iom.edu or http://www.nap.edu.)
Health plans have a substantial incentive to subsidize the cost of physicians' adoption of E-prescribing because the plans would share in the likely savings in health care spending through reductions in adverse events and improved compliance. Thus, it is likely that the net effect on plans would be positive rather than negative. Moreover, there is no reason to expect Start Printed Page 6270health plans to incur costs without the expectation of a positive return. However, we have no basis at this time for estimating the precise timing or magnitude of either gross or net savings. We request public comments and information on this topic that we can utilize when revising this analysis for the final rule.
As can be seen from this discussion, there are both potential costs and potential benefits for providers that implement e-prescribing. The number of prescriptions that a provider writes is a critical issue for providers in determining whether an e-prescribing system will be cost beneficial to them. Although a cost of approximately $1500, Start Printed Page 6271amortized over several years, would appear very small in the context of even a solo practitioner's overall practice costs (and certainly far below the threshold of 3 to 5 percent of revenues that we normally use for economic significance determinations under the RFA), it is possible that some providers may be negatively affected. However, the voluntary nature of e-prescribing for prescribers makes this unlikely, since each is free to make its own business decision regarding whether and how to implement e-prescribing. Prescribers that have already implemented e-prescribing are also unlikely to be negatively affected, because the standards we are proposing are currently used by most e-prescribing software products in use.
We do not expect to see a material change in the volume of prescriptions written for pharmacies to fill because of e-prescribing. While we expect to see the efficiencies (discussed at the beginning of this section) at pharmacies with some possible reductions in administrative staff time, we do not expect to see a significant economic effect from the implementation of e-prescribing in the Medicare Part D program. The industry has provided information indicating that 75 percent [8] of the 57,208 pharmacies [9] in the U.S. already have e-prescribing capability which suggests that pharmacies already find this a beneficial investment. In this respect, we note that the great majority of pharmacies are already highly networked for other reasons, and, therefore, assume that the marginal costs of e-prescribing are likely to be small. For example, as indicated earlier in this preamble, we believe that over 95 percent of pharmacy systems are already compatible with the NCPDP retail pharmacy drug claim standard. Since adoption is likely to be profitable, and voluntarily undertaken only where expected to be profitable, we would expect any net effects to be positive. We do, however, request additional information on pharmacy impacts.
E-prescribing has the potential for improving beneficiary health outcomes. E-prescribing systems enable appropriate drug compliance management and improved medication use, and provide information to prevent adverse drug events. E-prescribing systems can improve patient safety by detecting various kinds of prescribing errors, including duplicate prescriptions; drug-drug, drug-allergy and drug-disease interactions; incorrect dosage strengths prescribed; and problems relating to coordination between health care providers and pharmacies. These reductions in errors and improvements in regimens would occur over time as more and more providers use the e-prescribing systems for the Medicare Prescription Drug Benefit.[10] E-prescribing can also drive physicians to appropriate formulary choices, which can save money for the health plans, patients, and health care system.
The RFA requires agencies to analyze options for regulatory relief for small businesses when proposed rules may create a significant impact on a substantial number of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of less than $6 million a year. For purposes of the RFA, approximately 95 percent of pharmacy firms, which account for about 51 percent of pharmacy establishments, are small business based upon 1997 Census data. There are 57,208 retail pharmacy establishments based upon “2004 National Community Pharmacists Association Pfizer Digest.” Therefore, we estimate that more than 29,000 pharmacy establishments would be considered small entities. Almost all physicians in private practice (or the practices of which they are members) are small entities because their annual revenues do not meet the Small Business Administration's $8.5 million threshold for “small” physician practices. Individuals and States are not included in the definition of a small entity, and this proposed rule has no Start Printed Page 6272effect on small governmental jurisdictions.
Two sets of standards that we are proposing in this rule already are required standards under the Administrative Simplification provisions of HIPAA. The ASC X12N Start Printed Page 6273270/271—Health Care Eligibility Benefit Inquiry and Response and NCPDP Telecommunication Standard are adopted standards and required when conducting standard transactions. We are proposing these standards for e-prescribing because they are already adopted standards for HIPAA transactions and meet some of the requirements specified in Title I, section 1860D-4(e) of the Act, as amended by section 101 of the MMA.
For reasons set forth in the preamble in this proposed regulation, the Centers for Medicare & Medicaid Services proposes to amend 42 CFR part 423 (to be published on January 28, 2005 and effective on March 22, 2005) as follows:
Authority: Secs 1102, 1860D-1 through 1860D-42, and 1871 of the Social Security Act (42 U.S.C. 1302, 1395w-101 through 1395w-152, and 1395hh).
3. In § 423.150, paragraph (c) is revised to read as follows:
§ 423.150
§ 423.159
Electronic Prescription Drug Program.
(ii) The National Council for Prescription Drug Programs Telecommunication Standard Guide, Version 5, Release 1 (Version 5.1), September 1999, and equivalent NCPDP Start Printed Page 6274Batch Standard Batch Implementation Guide, Version 1, Release 1 (Version 1.1), January 2000 supporting Telecommunications Standard Implementation Guide, Version 5, Release 1 (Version 5.1) for the NCPDP Data Record in the Detail Data Record, for transmitting eligibility inquiries and responses between dispensers and Part D sponsors.
(c) Incorporation by reference. The Director of the Federal Register approves, in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51, the incorporation by reference of the National Council for Prescription Drug Programs SCRIPT Standard, Version 5, Release 0, May 12, 2004, excluding the Prescription Fill Status Notification Transaction (and its three business cases; Prescription Fill Status Notification Transaction—Filled, Prescription Fill Status Notification Transaction—Not Filled, and Prescription Fill Status Notification Transaction—Partial Fill); the American Standards Committee X12N 270/271—Health Care Eligibility Benefit Inquiry and Response, Version 4010, May 2000, 004010X092 and Addenda to Health Care Eligibility Benefit Inquiry and Response, Version 4010, October 2002, Washington Publishing Company, 004010X092A1, and the National Council for Prescription Drug Programs Telecommunication Standard Guide, Version 5, Release 1 (Version 5.1), September 1999, and equivalent NCPDP Batch Standard Batch Implementation Guide, Version 1, Release 1 (Version 1.1), January 2000 supporting Telecommunications Standard Implementation Guide, Version 5, Release 1 (Version 5.1) for the NCPDP Data Record in the Detail Data Record. You may inspect copies of these materials at the headquarters of the Centers for Medicare & Medicaid Services (CMS), 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday from 8:30 a.m. to 4 p.m. or at the National Archives and Records Administration (NARA). For information on the availability of this material at CMS, call 410-786-0273. For information on the availability of this material at NARA, call 202-741-6030, or go to http://www.archives.gov/​federal_​register/​code_​of_​federal_​ regulations/ibr_locations.html. You may obtain a copy of the National Council for Prescription Drug Programs SCRIPT Standard, Version 5, Release 0, May 12, 2004, from the National Council for Prescription Drug Programs, Incorporated, 9240 E. Raintree Drive, Scottsdale, AZ 85260-7518; Telephone (480) 477-1000; and FAX (480) 767-1042 or http://www.ncpdp.org. You may obtain a copy of the American Standards Committee X12N 270/271—Health Care Eligibility Benefit Inquiry and Response, Version 4010, May 2000, Washington Publishing Company, 004010X092 and Addenda to Health Care Eligibility Benefit Inquiry and Response, Version 4010, October 2002, Washington Publishing Company, 004010X092A1 from the Washington Publishing Company, PMB 161, 5284 Randolph Road, Rockville, MD, 20852-2116; Telephone (301) 949-9740; and FAX: (301) 949-9742 or http://www.wpc-edi.com/​. You may obtain a copy of the National Council for Prescription Drug Programs Telecommunication Standard Guide, Version 5, Release 1 (Version 5.1), September 1999, and equivalent NCPDP Batch Standard Batch Implementation Guide, Version 1, Release 1 (Version 1.1), January 2000 supporting Telecommunications Standard Implementation Guide, Version 5, Release 1 (Version 5.1) for the NCPDP Data Record in the Detail Data Record, from the National Council for Prescription Drug Programs, Incorporated, 9240 E. Raintree Drive, Scottsdale, AZ 85260-7518; Telephone (480) 477-1000; and FAX (480) 767-1042 or http://www.ncpdp.org.