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Standards for Electronic Transactions and Code
Sets
List of Subjects in 45 CFR Part 162
Administrative practice and procedure, Electronic transactions,
Health facilities, Health insurance, Hospitals, Incorporation by
reference, Medicare, Medicaid, Reporting, and recordkeeping requirements.
For the reasons set forth in the preamble of this final rule, the
Department of Health and Human Services amends 45 CFR subtitle A,
subchapter C, part 162 as follows:
PART 162—ADMINISTRATIVE REQUIREMENTS
1. The authority citation for part 162 continues
to read as follows:
Authority: Secs. 1171 through 1179 of the Social Security
Act (42 U.S.C.1320d-1320d-8), as added by sec. 262 of Pub. L. 104-191,
110 Stat. 2021-2031, and sec. 264 of Pub. L. 104-191, 110 Stat.
2033-2034 (42 U.S.C. 1320d-2 (note)).
2. Section 162.900 is revised to read as follows:
§162.900 Compliance dates for transaction standards and
code sets.
(a) Small health plans. All small health plans must comply with
applicable requirements of subparts I through R of this part no
later than October 16, 2003.
(b) Covered entities that timely submitted a compliance plan.
Any covered entity, other than a small health plan, that timely
submitted a compliance plan with the Secretary under the provisions
of section 2 of Pub. L. 107-105, 115 Stat. 1003 (ASCA) must comply
with the applicable requirements of subparts I through R of this
part no later than October 16, 2003.
(c) Covered entities that did not timely submit a compliance
plan. Any covered entity, other than a small health plan, that
did not timely submit a compliance plan under the provisions of
section 2 of Pub. L. 107-105, 115 Stat. 1003 (ASCA) must comply
with the applicable requirements of subparts I through R of this
part--
(1) Beginning on October 16, 2002 and ending on October 15,
2003--
(i) For the corresponding time period; or
(ii) For the time period beginning on October 16, 2003.
(2) Beginning on and after October 16, 2003 for the corresponding
time period.
3. Section 162.920 is revised to read as follows:
§162.920 Availability of implementation specifications.
A person or an organization may directly request copies of the
implementation standards described in subparts I through R of this
part from the publishers listed in this section. The Director of
the Office of the Federal Register approves the implementation specifications
described in this section for incorporation by reference in subparts
I through R of this part in accordance with 5 U.S.C. 552(a) and
1 CFR part 51. The implementation specifications described in this
paragraph are also available for inspection by the public at the
Office of the Federal Register, 800 North Capitol Street, NW, Suite
700, Washington, DC; and the Centers for Medicare & Medicaid
Services, 7500 Security Boulevard, Baltimore, Maryland 21244. Copy
requests must be accompanied by the name of the standard, number,
if applicable, and version number. Implementation specifications
are available for the following transactions:
(a) ASC X12N specifications. The implementation specifications
for ASC X12N standards may be obtained from the Washington Publishing
Company, PMB 161, 5284 Randolph Road, Rockville, MD, 20852-2116;
Telephone (301) 949-9740; and FAX: (301) 949-9742. They are also
available through the Washington Publishing Company on the Internet
at http://www.wpc-edi.com/. The transaction implementation specifications
are as follows:
(1) The ASC X12N 837 - Health Care Claim: Dental, Version 4010,
May 2000, Washington Publishing Company, 004010X097 and Addenda
to Health Care Claim: Dental, Version 4010, October 2002, Washington
Publishing Company, 004010X097A1, as referenced in §162.1102
and §162.1802.
(2) The ASC X12N 837 - Health Care Claim: Professional, Volumes
1 and 2, Version 4010, May 2000, Washington Publishing Company,
004010X098 and Addenda to Health Care Claim: Professional, Volumes
1 and 2, Version 4010, October 2002, Washington Publishing Company,
004010X098A1, as referenced in §162.1102 and §162.1802.
(3) The ASC X12N 837 - Health Care Claim: Institutional, Volumes
1 and 2, Version 4010, May 2000, Washington Publishing Company,
004010X096 and Addenda to Health Care Claim: Institutional,
Volumes 1 and 2, Version 4010, October 2002, Washington Publishing
Company, 004010X096A1 as referenced in §162.1102 and §162.1802.
(4) The ASC X12N 835 - Health Care Claim Payment/Advice, Version
4010, May 2000, Washington Publishing Company, 004010X091, and
Addenda to Health Care Claim Payment/Advice, Version 4010, October
2002, Washington Publishing Company, 004010X091A1 as referenced
in §162.1602.
(5) ASC X12N 834 - Benefit Enrollment and Maintenance, Version
4010, May 2000, Washington Publishing Company, 004010X095 and
Addenda to Benefit Enrollment and Maintenance, Version 4010,
October 2002, Washington Publishing Company, 004010X095A1, as
referenced in §162.1502.
(6) The ASC X12N 820 - Payroll Deducted and Other Group Premium
Payment for Insurance Products, Version 4010, May 2000, Washington
Publishing Company, 004010X061, and Addenda to Payroll Deducted
and Other Group Premium Payment for Insurance Products, Version
4010, October 2002, Washington Publishing Company, 004010X061A1,
as referenced in §162.1702.
(7) The ASC X12N 278 - Health Care Services Review - Request
for Review and Response, Version 4010, May 2000, Washington
Publishing Company, 004010X094 and Addenda to Health Care Services
Review - Request for Review and Response, Version 4010, October
2002, Washington Publishing Company, 004010X094A1, as referenced
in §162.1302.
(8) The ASC X12N-276/277 Health Care Claim Status Request and
Response, Version 4010, May 2000, Washington Publishing Company,
004010X093 and Addenda to Health Care Claim Status Request and
Response, Version 4010, October 2002, Washington Publishing
Company, 004010X093A1, as referenced in §162.1402.
(9) The ASC 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, as referenced in §162.1202.
(b) Retail pharmacy specifications. The implementation specifications
for retail pharmacy standards may be obtained for a fee from the
National Council for Prescription Drug Programs (NCPDP), 9240
E. Raintree Drive, Scottsdale, AZ 85260; Telephone (480) 477-1000;
and FAX (480) 767-1042. They may also be obtained through the
Internet at http://www.ncpdp.org. The transaction implementation
specifications are as follows:
(1) The Telecommunication Standard Implementation Guide Version
5, Release 1 (Version 5.1), September 1999, National Council
for Prescription Drug Programs, as referenced in §162.1102,
§162.1202, §162.1302, §162.1602, and §162.1802.
(2) The Batch Standard Batch Implementation Guide, Version
1, Release 1 (Version 1.1), January 2000, supporting Telecommunication
Standard Implementation Guide, Version 5, Release 1 (Version
5.1) for the NCPDP Data Record in the Detail Data Record, National
Council for Prescription Drug Programs, as referenced in §162.1102,
§162.1202, §162.1302, and §162.1802.
(3) The National Council for Prescription Drug Programs (NCPDP)
equivalent NCPDP Batch Standard Batch Implementation Guide,
Version 1, Release 0, February 1, 1996, as referenced in §162.1102,
§162.1202, §162.1602, and §162.1802.
4. Section 162.1002 is amended by--
A. Revising the introductory text to the section.
B. Redesignating paragraphs (a) through (f) as paragraphs (a)(1)
through (a)(6).
C. In redesignated paragraph (a)(1), further redesignating paragraphs
(1) through (5) as paragraphs (a)(1)(i) through (a)(1)(v).
D. In redesignated paragraph (a)(2), further redesignating paragraphs
(1) through (4) as paragraphs (a)(2)(i) through (a)(2)(iv).
E. In redesignated paragraph (a)(3), further redesignating paragraphs
(1) and (2) as paragraphs (a)(3)(i) and (a)(3)(ii).
F. In redesignated paragraph (a)(5), further redesignating paragraphs
(1) through (7) as paragraphs (a)(5)(i) through (a)(5)(vii).
G. In redesignated paragraph (a)(6), further redesignating paragraphs
(1) through (3) as paragraphs (a)(6)(i) through (a)(6)(iii).
H. Adding new paragraph (a) introductory text and paragraph (b).
The republication and additions read as follows:
§162.1002 Medical data code sets.
The Secretary adopts the following maintaining organization's code
sets as the standard medical data code sets:
(a) For the period from October 16, 2002 through October 15,
2003:
* * * * *
(b) For the period on and after October 16, 2003:
(1) The code sets specified in paragraphs (a)(1), (a)(2),(a)(4),
and (a)(5) of this section.
(2) National Drug Codes (NDC), as maintained and distributed
by HHS, for reporting the following by retail pharmacies:
(i) Drugs.
(ii) Biologics.
(3) The Healthcare Common Procedure Coding System (HCPCS),
as maintained and distributed by HHS, for all other substances,
equipment, supplies, or other items used in health care services,
with the exception of drugs and biologics. These items include,
but are not limited to, the following:
(i) Medical supplies.
(ii) Orthotic and prosthetic devices.
(iii) Durable medical equipment.
5. Section 162.1102 is revised to read as follows:
§162.1102 Standards for health care claims or equivalent
encounter information transaction.
The Secretary adopts the following standards for the health care
claims or equivalent encounter information transaction:
(a) For the period from October 16, 2002 through October 15,
2003:
(1) Retail pharmacy drug claims. The National Council for Prescription
Drug Programs (NCPDP) Telecommunication Standard Implementation
Guide, Version 5, Release 1, September 1999, and equivalent
NCPDP Batch Standard Batch Implementation Guide, Version 1,
Release 0 February 1, 1996. (Incorporated by reference in §162.920).
(2) Dental health care claims. The ASC X12N 837 - Health Care
Claim: Dental, Version 4010, May 2000, Washington Publishing
Company, 004010X097. (Incorporated by reference in §162.920).
(3) Professional health care claims. The ASC X12N 837 - Health
Care Claim: Professional, Volumes 1 and 2, Version 4010, May
2000, Washington Publishing Company, 004010X098. (Incorporated
by reference in §162.920).
(4) Institutional health care claims. The ASC X12N 837 - Health
Care Claim: Institutional, Volumes 1 and 2, Version 4010, May
2000, Washington Publishing Company, 004010X096. (Incorporated
by reference in §162.920).
(b) For the period on and after October 16, 2003:
(1) Retail pharmacy drug claims. The National Council for Prescription
Drug Programs (NCPDP) Telecommunication Standard Implementation
Guide, Version 5, Release 1, September 1999, and equivalent
NCPDP Batch Standard Batch Implementation Guide, Version 1,
Release 1 (Version 1.1), January 2000, supporting Telecommunication
Version 5.1 for the NCPDP Data Record in the Detail Data Record.
(Incorporated by reference in §162.920).
(2) Dental health care claims. The ASC X12N 837 - Health Care
Claim: Dental, Version 4010, May 2000, Washington Publishing
Company, 004010X097 and Addenda to Health Care Claim: Dental,
Version 4010, October 2002, Washington Publishing Company, 004010X097A1.
(Incorporated by reference in §162.920).
(3) Professional health care claims. The ASC X12N 837 - Health
Care Claim: Professional, Volumes 1 and 2, Version 4010, May
2000, Washington Publishing Company, 004010X098 and Addenda
to Health Care Claim: Professional, Volumes 1 and 2, Version
4010, October 2002, Washington Publishing Company, 004010X098A1.
(Incorporated by reference in §162.920).
(4) Institutional health care claims. The ASC X12N 837 - Health
Care Claim: Institutional, Volumes 1 and 2, Version 4010, May
2000, Washington Publishing Company, 004010X096 and Addenda
to Health Care Claim: Institutional, Volumes 1 and 2, Version
4010, October 2002, Washington Publishing Company, 004010X096A1.
(Incorporated by reference in §162.920).
6. Section 162.1202 is revised to read as follows:
§162.1202 Standards for eligibility for a health plan transaction.
The Secretary adopts the following standards for the eligibility
for a health plan transaction:
(a) For the period from October 16, 2002 through October 15,
2003:
(1) Retail pharmacy drugs. The National Council for Prescription
Drug Programs Telecommunication Standard Implementation Guide,
Version 5, Release 1, September 1999, and equivalent NCPDP Batch
Standard Batch Implementation Guide, Version 1, Release 0, February
1, 1996. (Incorporated by reference in §162.920).
(2) Dental, professional, and institutional health care eligibility
benefit inquiry and response. The ASC X12N 270/271 – Health
Care Eligibility Benefit Inquiry and Response, Version 4010,
May 2000, Washington Publishing Company, 004010X092. (Incorporated
by reference in §162.920).
(b) For the period on and after October 16, 2003:
(1) Retail pharmacy drugs. The National Council for Prescription
Drug Programs Telecommunication Standard Implementation 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. (Incorporated
by reference in §162.920).
(2) Dental, professional, and institutional health care eligibility
benefit inquiry and response. The ASC 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.
(Incorporated by reference in §162.920).
7. Section 162.1302 is revised to read as follows:
§162.1302 Standards for referral certification and authorization
transaction.
The Secretary adopts the following standards for the referral certification
and authorization transaction:
(a) For the period from October 16, 2002 through October 15,
2003: The ASC X12N 278 - Health Care Services Review - Request
for Review and Response, Version 4010, May 2000, Washington Publishing
Company, 004010X094. (Incorporated by reference in §162.920).
(b) For the period on and after October 16, 2003:
(1) Retail pharmacy drug referral certification and authorization.
The NCPDP Telecommunication Standard Implementation 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. (Incorporated
by reference in §162.920).
(2) Dental, professional, and institutional referral certification
and authorization. The ASC X12N 278 - Health Care Services Review
- Request for Review and Response, Version 4010, May 2000, Washington
Publishing Company, 004010X094 and Addenda to Health Care Services
Review - Request for Review and Response, Version 4010, October
2002, Washington Publishing Company, 004010X094A1. (Incorporated
by reference in §162.920).
8. Section 162.1402 is revised to read as follows:
§162.1402 Standards for health care claim status transaction.
The Secretary adopts the following standards for the health care
claim status transaction:
(a) For the period from October 16, 2002 through October 15,
2003: The ASC X12N-276/277 Health Care Claim Status Request and
Response, Version 4010, May 2000,
Washington Publishing Company, 004010X093. (Incorporated by reference
in §162.920).
(b) For the period on and after October 16, 2003: The ASC X12N-276/277
Health Care Claim Status Request and Response, Version 4010, May
2000, Washington Publishing Company, 004010X093 and Addenda to
Health Care Claim Status Request and Response, Version 4010, October
2002, Washington Publishing Company, 004010X093A1. (Incorporated
by reference in §162.920).
9. Section 162.1502 is revised to read as follows:
§162.1502 Standards for enrollment and disenrollment in
a health plan transaction.
The Secretary adopts the following standards for the enrollment
and disenrollment in a health plan transaction:
(a) For the period from October 16, 2002 through October 15,
2003: ASC X12N 834 - Benefit Enrollment and Maintenance, Version
4010, May 2000, Washington Publishing Company, 004010X095. (Incorporated
by reference in §162.920).
(b) For the period on and after October 16, 2003: ASC X12N 834
- Benefit Enrollment and Maintenance, Version 4010, May 2000,
Washington Publishing Company, 004010X095 and Addenda to Benefit
Enrollment and Maintenance, Version 4010, October 2002, Washington
Publishing Company, 004010X095A1. (Incorporated by reference in
§162.920).
10. Section 162.1602 is revised to read as follows:
§162.1602 Standards for health care payment and remittance
advice transaction.
The Secretary adopts the following standards for the health care
payment and remittance advice transaction:
(a) For the period from October 16, 2002 through October 15,
2003:
(1) Retail pharmacy drug claims and remittance advice. The
NCPDP Telecommunication Standard Implementation Guide, Version
5 Release 1, September 1999, and equivalent NCPDP Batch Standard
Batch Implementation Guide, Version 1 Release 0, February 1,
1996. (Incorporated by reference in §162.920).
(2) Dental, professional, and institutional health care claims
and remittance advice. The ASC X12N 835 - Health Care Claim
Payment/Advice, Version 4010, May 2000, Washington Publishing
Company, 004010X091. (Incorporated by reference in §162.920).
(b) For the period on and after October 16, 2003:
Health care claims and remittance advice. The ASC X12N 835 - Health
Care Claim Payment/Advice, Version 4010, May 2000, Washington
Publishing Company, 004010X091, and Addenda to Health Care Claim
Payment/Advice, Version 4010, October 2002, Washington Publishing
Company, 004010X091A1. (Incorporated by reference in §162.920).
11. Section 162.1702 is revised to read as follows:
162.1702 Standards for health plan premium payments transaction.
The Secretary adopts the following standards for the health care
premium payments transaction:
(a) For the period from October 16, 2002 through October 15,
2003: The ASC X12N 820 - Payroll Deducted and Other Group Premium
Payment for Insurance Products, Version 4010, May 2000, Washington
Publishing Company, 004010X061. (Incorporated by reference in
§162.920).
(b) For the period on and after October 16, 2003: The ASC X12N
820 - Payroll Deducted and Other Group Premium Payment for Insurance
Products, Version 4010, May 2000, Washington Publishing Company,
004010X061, and Addenda to Payroll Deducted and Other Group Premium
Payment for Insurance Products, Version 4010, October 2002, Washington
Publishing Company, 004010X061A1. (Incorporated by reference in
§162.920).
12. Section 162.1802 is revised to read as follows:
§162.1802 Standards for coordination of benefits information
transaction.
The Secretary adopts the following standards for the coordination
of benefits information transaction:
(a) For the period from October 16, 2002 through October 15,
2003:
(1) Retail pharmacy drug claims. The National Council for Prescription
Drug Programs Telecommunication Standard Implementation Guide,
Version 5, Release 1, September 1999, and equivalent NCPDP Batch
Standard Batch Implementation Guide, Version 1, Release 0, February
1, 1996. (Incorporated by reference in §162.920).
(2) Dental health care claims. The ASC X12N 837 - Health Care
Claim: Dental, Version 4010, May 2000, Washington Publishing
Company, 004010X097. (Incorporated by reference in §162.920).
(3) Professional health care claims. The ASC X12N 837 - Health
Care Claim: Professional, Volumes 1 and 2, Version 4010, May
2000, Washington Publishing Company, 004010X098. (Incorporated
by reference in §162.920).
(4) Institutional health care claims. The ASC X12N 837 - Health
Care Claim: Institutional, Volumes 1 and 2, Version 4010, May
2000, Washington Publishing Company, 004010X096. (Incorporated
by reference in §162.920).
(b) For the period on and after October 16, 2003:
(1) Retail pharmacy drug claims. The National Council for Prescription
Drug Programs Telecommunication Standard Implementation 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. (Incorporated
by reference in §162.920).
(2) Dental health care claims. The ASC X12N 837 - Health Care
Claim: Dental, Version 4010, May 2000, Washington Publishing
Company, 004010X097 and Addenda to Health Care Claim: Dental,
Version 4010, October 2002, Washington Publishing Company, 004010X097A1.
(Incorporated by reference in §162.920).
(3) Professional health care claims. The ASC X12N 837 - Health
Care Claim: Professional, Volumes 1 and 2, Version 4010, May
2000, Washington Publishing Company, 004010X098 and Addenda
to Health Care Claim: Professional, Volumes 1 and 2, Version
4010, October 2002, Washington Publishing Company, 004010X098A1.
(Incorporated by reference in §162.920).
(4) Institutional health care claims. The ASC X12N 837 - Health
Care Claim: Institutional, Volumes 1 and 2, Version 4010, May
2000, Washington Publishing Company, 004010X096 and Addenda
to Health Care Claim: Institutional, Volumes 1 and 2, Version
4010, October 2002, Washington Publishing Company, 004010X096A1.
(Incorporated by reference in §162.920).
(Catalog of Federal Domestic Assistance Program No. 93.773, Medicare--Hospital
Insurance; and Program No. 93.774, Medicare--Supplementary Medical
Insurance Program)
Dated: ____________________
____________________
Tommy G. Thompson,
Secretary.
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