CLIA Regulations Update 2015

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1 Regulations Update KAREN DYER MT(ASCP), DLM ACTING DIRECTOR DIVISION OF LABORATORY SERVICES CENTERS FOR MEDICARE&MEDICAID SERVICES

2 Learning Objectives Understand the impact of the Patient Access regulation on and HIPAA Understand enforcement discretion under the TEST Act and corresponding regulations Identify categories of repeat Proficiency Testing (PT) referral Identify criteria for the one-time narrow exception carve out for intentional PT referral 2

3 law and Regulatory Changes Patient Access to Laboratory Test Results Fecal Occult Blood Proficiency Testing regulations Test Act Test Act Burden Rule #2 3

4 Current Statistics--Enrollment Total Number of Laboratories 250,367 Total Non-Exempt 242,262 Compliance 19,793 Accredited 16,588 Waived 177,104 Provider Performed Microscopy 36,882 CMS data base 1/ Exempt 8,105 NY 4,020 WA 3,085

5 CMS 2319-P: Patient Access Rule 5 Final rule publication date 2/6/14. Laboratories in compliance by 10/6/14 Centers for Disease Control and Prevention (CDC), Office of Civil Rights (OCRadministers HIPAA) & CMS collaborative effort.

6 Regulation (f): 6 Except as provided in (l), test results must be released only to authorized persons, and, if applicable, the persons responsible for using the test results and the laboratory that initially requested the test.

7 New regulation (l): 7 Upon request by a patient (or the patient s personal representative), the laboratory may provide patients, their personal representatives, and those persons specified under 45 CFR (c)(3)(ii), as applicable, with access to completed test reports that, using the laboratory s authentication process, can be identified as belonging to that patient.

8 Changes to HIPAA Privacy Rule 8 Amended 45 CFR (a)(1)(i-iii). Removes exceptions that relate to and -exempt laboratories Aligns the Privacy Rule with the changes to the regulations

9 Key Points for Patient Access HIPAA preempts contrary state laws (laws that prohibit providing individuals with access). HIPAA covered laboratories must continue to abide by state law that provides more stringent access to protected health information (PHI). more stringent means greater rights of access to PHI. 9

10 Key Points for Patient Access 10 Laboratory is considered to be a covered entity (CE) under HIPAA if it performs one or more covered transactions electronically. Some examples: o Transmitting health care claims to a health plan o Requesting prior authorization from a health plan for a health care service

11 Key Points for Patient Access Test reports maintained by or for a CE laboratory are considered part of a designated record set as defined at 45 CFR Patient has the right to all PHI in said designated record set for as long as the information is maintained by the laboratory ( (a)(1)). 11

12 Key Points for Patient Access The CE laboratory is required to provide the individual with a copy of their test report in the form/format that the individual requests if a copy in that form/format is readily producible Must satisfy the verification requirements of (h) before providing an individual with access. 12

13 Key Points for Patient Access 13 CE laboratories subject to as well as exempt from, have the same obligations as other types of covered entities/providers with respect to providing individuals (or their personal representatives) with access to their protected health information in accordance with

14 Fecal Occult Blood (FOB) Testing CMS 3271-P: Proposed rule to amend regulations by: Specifying waived test categorization applies only to non-automated FOB tests Removing copper sulfate method from waived list if comments confirm test no longer in use This regulatory adjustment will permit FDA to categorize FOB tests appropriately. 14

15 Updating Proficiency Testing (PT) Regulations 15 The final version of the revised list of analytes covered in Subpart I has been developed for the NPRM CDC has hired a statistician to work with the CDC for further decision making on target values for the new PT regulation.

16 TEST Act HR 6118 TEST Act - Taking Essential Steps for Testing Act of 2012 Amendment to the statute signed by the President on 12/4/ Clarifies that PT samples are to be tested in the same manner as patient specimens, EXCEPT that no PT samples shall be sent to another laboratory for analysis.

17 TEST Act HR 6118 (continued) 17 Allows the Secretary enforcement discretion for: Revocation of the certificate for PT referral; and Imposition of the 2 year owner/operator ban when sanctioned for PT referral

18 TEST Act : CMS-1443-FC Regulations required to implement the TEST Act changes Published 5/2/14, effective 7/1/14 18

19 TEST Act : CMS-1443-FC Final rule details hierarchical adverse actions for PT referrals by seriousness Defines when discretion will be applied & when revocation will be imposed 19 Added definition to for repeat PT referral

20 Repeat Proficiency Testing Referral 20 A 2 nd instance in which a PT sample, or a portion of a sample, is referred, for any reason, to another laboratory for analysis prior to the laboratory s PT program event cut-off date within the period of time encompassing the two prior survey cycles Applies to all survey types

21 Category 1 21 Repeat PT referral OR lab sends PT samples to another lab and reports that lab s test results as its own Must impose: Revocation of the certificate Civil Money Penalty (CMP)

22 Category 1 22 May impose Owner/operator ban Includes a provision for the use of the discretion in exempting the owner from the ban

23 Category 2 Laboratory sends PT samples and the results of the PT samples to another lab prior to, or on, the event cut-off date Provides opportunity to compare/confirm results Referring lab reports its own PT sample results 23

24 Must impose: Category 2 Suspension/limitation of the certificate CMP Directed plan of Correction May impose: Any other alternative sanctions, as appropriate 24

25 Category 3 The laboratory sends PT samples to another laboratory but no test results were received prior to cut-off date Must impose: CMP Directed plan of correction May impose: 25 Any other alternative sanctions, as appropriate

26 CMS 3267-F :Burden Rule #2 Final rule published 5/12/14, effective 7/11/14 One-time, narrow exception carve- out for intentional PT referral Clarifies intentional referral carve out with addition of the following terms/definitions: Reflex testing Confirmatory testing Distributive testing 26

27 PT Referral Narrow Exception CMS will consider the referral to be improper and subject to alternative sanctions in accordance with (c), but not intentional, if: Not a repeat proficiency testing referral Limited to reflex, confirmatory testing or distributive testing 27

28 Reflex Testing Definition 28 Confirmatory or additional laboratory testing that is automatically requested by a laboratory under its standard operating procedures for patient specimens when the laboratory s findings indicate test results that are abnormal, are outside a predetermined range, or meet other preestablished criteria for additional testing

29 Confirmatory Testing Definition Testing performed by a second analytical procedure that could be used to substantiate or bring into question the results of an initial laboratory test 29

30 Distributive Testing Definition 30 Laboratory testing performed on the same specimen, or an aliquot of it, that requires sharing it between two or more laboratories to obtain all data required to complete an interpretation or calculation necessary to provide a final reportable results for the originally ordered test. When such testing occurs at multiple locations with different certificates, it is considered distributive testing.

31 Self Assessment Question 1 31 What is the major regulatory change as a result of the Patient Access regulation? a. Allows providers to send test results to patients b. Allows patients to request test results directly from laboratory c. Clarifies the HIPAA requirements for data security

32 Self Assessment Question 2 32 The TEST Act allows the Secretary discretion for? a. Revocation of the certificate for PT Referral b. Imposition of the 2 year owner/operator ban when sanctioned for PT referral c. Both a and b

33 Self Assessment Question 3 What are the definitions included under Burden II that clarify intentional PT referral? a. Reflex Testing b. Confirmatory Testing c. Distributive Testing d. All of the above 33

34 Where to Obtain Information 34 CMS/Website: CMS Central Office: Karen Dyer:

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