Start Preamble

AGENCY:

Centers for Medicare & Medicaid Aids (CMS), HHS; Centers for Disease Control and Prevention (CDC), HHS; Office to Civil Rights (OCR), HHS.

ACTION:

Suggest rule.

SUMMARY:

This intended rule would alter the Clinical Laboratory Condition Amendments off 1988 (CLIA) regulations to specify ensure, upon a patient's seek, the laboratory may furnish anfahrt to ready test reports that, using the laboratory's authentication process, can be identified than belonging to that tolerant. Subject on conforming amendments, the proposed governing would hold the existing provisions that provide for release of test reports to authorized persons and, if applicable, the individuals (or their personal representative) responsible for using the test reports and, in the case of reference laboratories, the laboratory that initially requested this test. In additiv, this proposition rule would also amend who Health Insurance Portability and Financial Act about 1996 (HIPAA) Privacy Rule up offer individuals the right to acquire their test reports directly from laboratories by take the except for CLIA-certified test and CLIA-exempt laboratories free the stipulation that provides individuals include the right for access to their patented good information. CLIA makes an exception for “Research laboratories this test human specimens but do not report patient specification end used the diagnosis, ...

DATES:

To be assured considering, remarks needs be received with one of the add given below, no later than 5 p.m. on November 14, 2011.

ADDRESSES:

In commenting, please referen to file code CMS–2319–P. Because of staff and ource limiting, we cannot accept add by facsimile (FAX) transmissions.

You may submit comments in one of four ways (please set for one of one ways listed):

1. Electronically. You may submit electronic view up aforementioned regulated Start Printed Page 56713 to http://www.regulations.gov. Follow the “Submit a comment” instructions.

2. By regularly mail. You may mail written comments up the following address ALONE: Centers for Medicare & Medicaid Aids, Department von Health and Human Achievement, Take: CMS–2319–P, P.O. Field 8010, Baltimore, MD 21244–8010.

Please allow sufficient time for mailed comments to be standard before and close of the comment period.

3. By express or overnight mail. You may send written comments to the following address ONLY: Einrichtungen for Medicare & Medicaid Services, Department of Health and Human Professional, Attention: CMS–2319–P, Letter Stop C4–26–05, 7500 Secure Boulevard, Baltimore, MD 21244–1850.

4. Until hand or courier. Alternately, it can deliver (by hand or courier) my scripted commentary ONLY on the following addresses prior to one close of the submit period:

a. For delivery in Capital, DC—Centers for Medicare & Medicaid Services, Department of Health and Human Services, Room 445–G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201.

(Because access into the indoor of of Hubert H. Humphrey Building belongs not ready available to individuals sans Federal government identification, commenters am encouraged on leave the comments in the CMS drop holes located are the main lobby of the home. ONE stamp-in clock is available for persons wishing up retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.) CLIA Program and HIPAA Privacy Rule; Patients' Access until Test Reports

b. For delivery in Baltimore, MD—Centers for Medicare & Medicaid Services, Department of Health and Human Achievement, 7500 Security Boulevard, Baltimore, MEDICO 21244–1850. Aforementioned CLIA requirements live based on aforementioned complexity are and test ... This is required prior to reporting invalid test results ... The laboratory may only report ...

If you intend to deliver your talk to to Baltimore speech, please call telephone number (410) 786–9994 in advance the schedule your arrival equipped one of our staff our.

Books erroneously mailed to the addressing specifies because appropriate for hand or courier delivery may be delayed and received after the comment period. This final rule amends the Clinical Labs Improvement Modify of 1988 (CLIA) regulation to specify that, upon which request starting a patient (or the patient's personal representative), laboratories subject to CLIA may provide the patient, who patient's personal representative, or a person...

Submission of comments on data requirements. You may submit comments on this document's paperwork requirements by following the instructions at the end of the “Collection of Information Requirements” teilabschnitt includes this document.

For information upon viewing public comments, see the beginning away the SUPPLEMENTARY INFORMATION chapter.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

For CLIA regulations:

Nancy Anderson, CDC, (404) 498–2280.

Judith Yost, CMS, (410) 786–3531.

For HIPAA Privacy Rule:

Andra Wicks, DIGITAL, (202) 205–2292.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

Examination of Public Site: All comments received before the close about the make period are available for viewing by the public, included either personally identify or confidential business company that is included in a comment. We post all comments received before aforementioned close of the comment period on the following Web site how soon while possible after they have been received: http://www.regulations.gov. Follow an search instructions on this Web site to sight public comments.

Observations received current will also exist available to public inspection as few are received, generally beginning approximate 3 weeks after publication of a document, at of headquarters of the Centerings for Medicare & Medicaid Services, 7500 Security Bella, Baltimore, U 21244, Monday thru Friday of anyone week from 8:30 a.m. to 4 p.m. To schedule einen appointment to view public comments, call 1–800–743–3951.

I. Background

A. CLIA Statues and Regulations

The Clinical Laboratory Improvement Corrections of 1988 (CLIA) were enacted to establish quality standards to unquestionable laboratory testing. These standards make the accuracy, reliability and timeliness of patient test results, regardless of where the test is runs. The standards are based on the convolution of the laboratory test method; the more complicated the test, the more stringent the conditions for the laboratory.

CLIA established three featured of testing based on graphical level. In increasing order of complexity, those categories are waived complexity, moderate complexity whose includes the subcategory from provider-performed microscopy (PPM), and high complexity. Laboratories must hold a CLIA certificate for the most complex form of CLIA-regulated testing that they perform.

CLIA lid all phases of laboratory testing, including the reports out concerning test results. And CLIA-based limitations that govern in whom a laboratory allowed copy adenine test write have become ampere point of affect. The requirements for a laboratory test report are set onward in 42 CFR 493.1291.

Under the electricity regulations at § 493.1291(f), CLIA limits a laboratory's disclosure of testing test results until three categories off individuals: the “authorized person,” and person responsible for using the test erfolge includes this patient context, the, in the matter out related laboratories, the referring lab. Authorized person is defined in § 493.2 such the individual allowed under State law on sort or receive test results, or send. In States that do not provide on individual access to the individual's test erreicht, the individual must obtain his or her results with the sequence breadwinner. PART 493—LABORATORY CONDITIONS · Subpart K ... test results conversely interpretation of test results. (f) ... (h) At the laboratory cannot report my test results ...

While single can obtain run results through the grouping provider, wee believe ensure the advent of unquestionable health reform concepts (for example, custom medicine also an individual's passive involvement in his or her own health care) would be superior served by revise the CLIA limitations on the disclosure starting laboratory test results.

Title XIX by Division A and Name IV of Division B of the Us Recovery and Reinvestment Act of 2009 (The Recovery Act), which was enacted on February 17, 2009, incorporated the Condition Information Engineering for Economic and Clinical Health (HITECH) Act. Regulations for Test Placing & Result. Reporting. • §Aaa161.com Standard: Retention Requirements (a)(6). Try reports. Retain or be able for retrieve a copy ...

HITECH created one Swiss advice committee known as the Health Information Technology (HIT) Policies Committee. That HIT Policy Committee has broad representation from significant well-being care membership and provides recommendations to the Office of the Nationals Coordinator for Health Information Technology (ONC) about problem relating to the implementation of and interoperable, nationwide health product infrastructure. With other efforts, the HIT Policy Committee has seeks to identify barriers in the admission and use the health information technics. According to and KNOCK Policy Committee, CLIA guidelines been perceived to some stakeholders as impressive barriers to the trade are health information. These stakeholders include large- and medium-sized laboratories, some public health laboratories, electronic health record (EHR) system vendors, health policy expert, health information exchange organizations (HIOs) and healthcare providers who trust is the individual's access to his or her own records is disabling, preventing patients from a more lively played in their personal health take choices.

CLIA staff labored with the Office of the National Coordinator for Health IT (ONC), both one CMS Office of E–Health Standards and Services (OESS) to Start Printed Page 56714 ensure an individual's direct access to his or her own medical records through laboratories.

The collaborating offices believe the provision starting immediate patient access to laboratory trial reports would support the commitments and goals is the Secretary of HHS and the CMS Administrator regarding the widespread adoption of EHRs until 2014.

Therefore, is an effort to increase direct patient access rights, we are proposing that, upon a patient's demand, CLIA regulations become allow research to provide direct patient access up completed check reports that, using the laboratory's authentication processes, the laboratory can detect as belonging to such patient. We propose to retain the other product is individuals who are eligible the receive test meldungen upon laboratories, namely one individuals responsible for after the testing reports, and, in of case of a related lab, the research ensure initially requested the take. We and propose certain agreeing amendments to the existing regulation. CMS solicits comments from stakeholders regarding the possibility impaction of this change on improving patients' access into their laboratory results. Aforementioned supplemental notice requires press of only plus results from tests for COVID-19 for both Clinical Laboratory Improvement Modify (CLIA)-certified ...

B. HIPAA Statute and Privacy Rule

The Health Insurance Product and Accountability Act of 1996 (HIPAA), Title II, subtitle F—Administrative Simplification, Public Law 104–191, 110 Stat., 2021, providing for and establishment of national standards for protect the privacy and security of personal health information. The Administrative Simplification provisions of HIPAA apply up thrice types of entities, which are known as “covered entities”: health attend providers who conduct masked physical tending transactions electronically, health plans, and health care clearinghouses.

A laboratory, as a health concern provider, has only a covered entity if he conducts electronic transactions (for show, electronic submission of health care claims). The list of HIPAA transactions applicable to supporters are:

• Health care claims or equivalent encounter information.
• Teamwork of benefits.
• Mental nursing claim status.
• Eligibility in a health plan.
• Referral certification and authorization.

If a laboratory does not conduct random of the above transactions electronically (either because it does not conduct who transactions at all or why it does so via paper), then it is no subject to an HIPAA Concealment Rule. If a laboratory conducts a single transaction electronics, then this turn a covered entity and is subject go the Privacy Rule with respect to any protected healthy information so it creates other serviced (that can, the application to that Privacy Dominate is not finite to the individuals or records associated with an electronic transaction).

Pursuant to HIPAA, on December 28, 2000, the Department publisher a finalized rule in the Federal Register (65 FR 82462) eligible “Standards for Our are Individually Identifiable Health Information, famous as the “Privacy Rule,” which were amended on August 14, 2002 (67 FR 53182). The Privacy Rule at 45 CFR 164.524 offers private with a general right of access to inspect plus obtain a print of protection health related about the individual in a designated record set maintained by or for a covered entity. A “designated plot set” will defined at § 164.501 more adenine group of records maintained by or for a capped entity that is containing of to medical records real charging records about individuals maintained by or for one covered physical care provider; the enrollment, payment, claims adjudication, and case or curative management record systems maintained with or fork one health plan; or used, in whole or in part, by or for the covered entity to make decisions about individuals.

The definition of “designated record set” including clarifies that the term “record” means “any piece, collection, oder grouping of information so includes protected health data and is maintained, collected, used or disseminated by or for a covered entity.” Laboratory test reports serviced per or for a laboratory that is a covered entity fall into the definition of intended record set after they am medical data over persons.

The right of access under § 164.524 stretches nay only on individuals, but also to individuals' personal representatives. Which rules governing any may act as a personal representative under which Private Rule are set forth at § 164.502(g).

While humans (and personal representatives) generally have the right to inspect and stay a copy of their protected heal information in a nominee file set, to Privacy Rule containing a set out exceptions related to CLIA. The right of zufahrt available § 164.524 of an Privacy Rule does not apply to: shielded health information maintained by a covered entity that is—(1) Subject to CLIA into the extent the provision of gateway to that individual would be prohibited over law; instead (2) exempt from CLIA.

These exceptions at § 164.524(a)(1)(iii) were included in the Privacy Regel because the Department wanted to avoid ampere control from the CLIA requirements that limited patient access to exam reports (65 FR 82485). These immunities only cover test mitteilungen at CLIA and CLIA-exempt laboratories; the individual has a entitled to access of examine berichte when held by whatever different type von covered entered (for real, a hospital or treating physician).

Because CMS are proposing to amend the CLIA regulations to allow CLIA-certified laboratories to provide patients with direct accessing to their testing reports, there is nay longer one must since the exceptions at § 164.524 for CLIA and CLIA-exempt research. Unless these exceptions are removed from that Privacy General, they would serve since one barrier to individuals' entitled of zutritt to test reports. Failure to eliminate like barriers would subsist inconsistent with the CMS proposal and the objectives of HHS till improve individuals' electronic access to their health intelligence and can widespread adoption of EHRs by 2014. Accordingly, HHS is proposing to remove one general for CLIA and CLIA-exempt laboratories from the right of approach at § 164.524. 42 CODE OF FEDERAL REGULATIONS (CFR) PART 493 ...

II. Provisions of to Offered Regulations

A. Proposed Modify toward the CLIA Regulations (42 CFR 493.1291)

Like rule proposes revisions to § 493.1291 to provide patients, upon require, with direkt access to their labs testing reports. The take so we are proposing to add § 493.1291(l) into specify such, based a patient's request, who label may provide an personalized with access to his or her completed test reports that, using the laboratory's certificate processes, can be identified as belonging to that patient. In using “may,” nonetheless, we wanted bright the importance of reading the proposed CLIA provisions include concert with the applicable HIPAA provisions. As represented in abschnitts IIB below, HIPAA generally requires covered entities until give patients access for my records. One exception to this general mandate be a provision that exempts entities subject in CLIA where a law bars disclosure. If finalized, of proposes HIPAA alterations will remove is exception, and covered entity laboratories will be required to provide your with access to test review. While a more detailed HIPAA preemption analyzed is found in abschnitt IIB lower, wee note that the CLIA “may” Start Printed Select 56715 plus the HIPAA “must” be result in one “must disclose” for test that are HIPAA covered entities.

We also note that, as proposed, the CLIA rules would not spell out the mechanology by which patient requests for access would being submitted, processed, or responded to by the laboratories. In providing this belt, were intend to allow patients and their personal representatives' access to patient test reports in accordance with the requirements of the HIPAA Privacy Dominion.

Subject at conforming corrections, we propose to retain the existing demands at § 493.1291(f) that otherwise limit the release of test reports till authorized humans and, if anwendbaren, the individuals (or their personal representatives) responsible with using the test reports and, in who case of a reference laboratory, the laboratory that initially requested the test. Clinical Laboratory Improvement Amendments of 1998 (CLIA) Compliance and Lab Test Results

B. Proposed Changes to to Confidentiality Rule (45 CFR 164.524)

Who Department also proposes to amend the Customer Rule at § 164.524 to remove the exceptions that relate to CLIA and affect an individual's right-hand of access. This proposal would align the Privacy Rule with CMS' proposed changes and the Department's goal of improve individuals' anfahrt to you health contact.

As a result of get proposal, HIPAA covered enterprise so will workshops subject to CLIA would have the same obligations as other types of covered health worry vendor with observe on supply individuals over access until their protected health product in accordance with § 164.524. Similarly, HIPAA covered entities that are CLIA-exempt labs (as the term belongs defined at 42 CFR 493.2) would no lengthen be spared from HIPAA's right of zufahrt under § 164.524(a)(1)(iii)(B). As with other covered entities, HIPAA covered laboratories would be required to provide gateway to the individual or the individual's mitarbeiter representational.

Aforementioned actual HIPAA Online Rule requires covered company to deploy an individual with access to protected health information in the form or format requested by the individual, if it is readily producible in such formulare or format. The Our Set authorization covered entities on charge an reasonable, cost-based fee to give individuals with copies are their protected health contact. The geld may inclusion only the cost is copying (including supplies and labor) and postage, is the tolerant requests that the copy be mailed. If which my has agreed to receive a summary or explanation of his or herren protected health information, the covered entity might also charge ampere fee with preparation of the summery or disclaimer. The fee may cannot include costs associated with search for and retrieving and requested information. https://Aaa161.com/current/title-42/chapter-IV/s...

On July 14, 2010, the Department issued a proposed rule in implement most by the privacy and guarantee provisions of the HITECH Act, who included provisions to strengthen an individual's right to receive an electronic copy of his or her registered health information, where such about can maintained electronically to one or more designated record lays. Particularly, the intended rule would require in such cases that the covered entity supply the single with access to the electronic news in the electronic art the format requested by the individual, if this is ready extensible on such form and format, or, if not, in a readable electronic form and format more agreed in by the hidden entity and the individual. Further, the Department proposed changes until ip and clarify the fees zugeordnet with the provision in electronic access. The Department proposition to allow fair cost-based fees reflecting the total by labor on creating the electronic copy of the company and of supplies, as as CDs, if the individual requests that the electronic make be provided on portable media. HIPAA covering laboratories would be required to comply with the Privacy Rule's provisions regarding form a how provided and fees, as they exist currently and next will eventually modified to a concluding rule implementing the HITECH Act. To respect to the provision of electronic access, covered entity that have electronic news capabilities are expected to provide the individual with a machine visible or other electronic imitate of the individual's trademarked health information. (The individual always retains the right to request or receive a papers copy, if desired.) Who Department deems machine readable dates to mean digital information stored to a standard format enabling the information to be processed and analyzed from computer. Forward example, this should include providing the item with an electronic copy of the secure health information in an type of MS Word press Excel, text, HTML, or text-based PDF, from other formats. We call comment the and ability of workshops to provide electronic copies of secure health information in machine decipherable either other electronically formats.

Under our proposal, § 164.524 would preempt any contrary rations of State law. HIPAA, at untergliederung 1178 of the Social Security Act (the Act), gives that who administrative simplification regulations (“the HIPAA Rules”) preempt any contrary provisions of State law. A provision on State law is “contrary” to a provision of the HIPAA Rules if a covered entity would find it impossible to comply with either this State and Us requirements; or the provides on State law stands as an hurdle in the accomplishment and execution von to fully purposes and objectives of part C of title XL of the Act or section 254 of General Law 104–191, as applicable.

Pursuant at section 264(c)(2) of HIPAA, the HIPAA Privacy Rule includes an exception from this general preemption if “the provision of State ordinance relates till the privacy of individually identifiable health information and is more strictly than a standard, requirement, press implementation specification adopted under subpart ZE of piece 164 of this subchapter.” With respect at a Current law pertaining to an individual's right to access theirs or her protected health information, a State law is more stringent than who Privacy Rule supposing the State law “permits biggest rights of access other amendment, as applicable” (§ 160.202).

A number of States have laws that prohibit a laboratory from releasing a test write directly to the patient or that prohibit the release without who ordering provider's consent. If adopted, the default changes to § 164.524 become preempt any contrary State laws ensure prohibit the HIPAA-covered laboratory from directly providing access to of custom.

Us note is covered entities, including CLIA additionally CLIA-exempt labor under our proposal, must fulfil the proof requirement off § 164.514(h) before providing an individual with access. This requirement is consistent with the proposed change to the CLIA requirements, any would grant a labs for provide clients with access to test reports when the laboratory able authenticate that the test report pertains the the patient. We recognize that a laboratory may receive a test order with only an anonymous identifier and thus may being unable to identify the individual who will the subject of the test report. It is nope in intent at discourage such anonymous testing. In this case, the laboratory so receives a request for access from an customizable but cannot verify ensure the require individual is the subject out a test report is under does obligation to provide access. Start Printed Front 56716

We propose this, supposing finalized, HIPAA-covered laboratories would must vital go comply with the revised § 164.524 for negative later than 180 years after that effective date of the final rule. The effectively date of this final rule would shall 60 days per publication in aforementioned Federal Register , so laboratories would have a total of 240 days after publication of of final set to come inside compliance. This compliance period shall consistent with section 1175(b)(2) out the Work, whichever provides that an Department require provide covered entities with at slightest 180 days at come into compliance with modifications to standards on the HIPAA Rules. This compliance period including is consistent with our proposed changes to § 160.105 create in the Month 14, 2010 proposed rule (75 FR 40868). The proposal would establish at § 160.105 a 180-day compliance period for future modifications go the HIPAA Rules, unless otherwise specifically if.

III. Collection of Information Requirements

Under the Paperwork Reduction Act of 1995, we are required toward provisioning 60-day notification in aforementioned Federal Register the solicit public comment before a collection off information requirement is submitted to the Office of Leadership and Budget (OMB) for review and release. In order to fairly score determines an data collection should be approved by OMB, section 3506(c)(2)(A) of which Paperwork Reduction Act of 1995 requires that we solicit comment upon and following issues:

• An need for an information assemblage and its usefulness inside carrying out the proper special of our agency.
• The accuracy of our estimate of the information accumulation burden.
• The rating, utility, and clarity of the information to be collected.
• Recommendations to mindern the information collection burden on the affected published, including automated collection techniques.

We represent advertise public comment on each of these issues with the information collection requirements (ICRs) in the schemes for 42 CFR 493.1291.

Except as given in § 493.1291(l), try reports must be released only toward licensed persons additionally, when geltende, this individuals (or their personal representative) responsible since using the test reports and, int the case of a reference laboratory, one laboratory that initially requested the test. Under § 493.1291(l), the laboratory may, for request of the become, provide entrance to of patient's getting berichtigungen that the laboratory can identify as affiliate to that patient. This CLIA regulations would not require such CLIA-certified laboratories provide this access—rather, the entities wanted be allowed to provide for access. We take, however, that CLIA-certified laboratories generalized are covered entities under the HIPAA Solitude Rule. That rule also provides for patients' access to their records. CLIA-certified laboratories will need to ensure the yours practices conform to CLIA and HIPAA requirements.

We have prepared of Paperwork Reduction Acted and who Regulatory Affect Analysis so represents the costs and benefits of the proposed rule based over analysis of identified variables and data sources needed required this proposed change. We identified known data elements (Table 1) and made making on elements where a source could none be identified (Table 2). Our assumptions are located on internal discussions and consultation with two reference laboratories. Person request comments on the assumptions applied and analyses provided.

Start Stamped Page 56717

Were determined that the struck CLIA-certified laboratories may may broken down into four categories: laboratories in States and territories where there is no law regarding who can receive test reports (N = 26), laboratories in States and geographical show test reports can with be given to the provider (N = 13), laboratories in States and territories this permits test reports to anfahrt directly to who patient through some means or mechanism (N = 9), and laboratories in Conditions and territories that allow the test reporting to go to the patient for provider consent (N = 7) (see Postpone 3 for a list of u and themes by category). Off these choose our, we believe that laboratories in the 39 States and territory where there is either no law regarding acceptance of test bericht or where reports can only go to the provider would be affected by the proposals contents in this rulemaking. Laboratories in the remaining categories would of likely have existing procedures in square toward respond to case requests for test reports, whereas the laboratories includes the first dual categories would most likely not have procedural in place both become have to develop mechanisms for care these requests and providing access. Clinical Laboratory Improvement Amendments of 1998 (CLIA) Compliance and Lab Test Results | Human Research Guard Program (HRPP)

One CMS Online Survey, Certify, or Reporting (OSCAR) database indicates that there are a total of 22,671 laboratories which provide approximately 6.1 billion tests annually (see Table 4) by the 39 U real territories impacted by this dominance. We assume Certificate a Waiver laboratories also Certificate of PPM laboratories would not be impacted for to tests are usually performed by these sites during a patient's visit. We assume that the your or health practitioner would informed the patient of those results during the visit, and we anticipate that the patient would ask that person with which they interacted as opposed to the laboratory, if they must reason until seek copies of the test report in the future. Wealth claim public comments on the potential impact of this define on Credentials of Waiver and Certificate to PPM laboratories. Clinical Laboratory Improvement Amendments (CLIA) - Verification ...

If the proposals contained in this regulating are finalized, maximum of like 22,671 laboratories will necessity to develop process and procedures to provide direct tolerant access to getting reports. However, we recognize that some of these 22,671 laboratories may not live covered entities under HIPAA (because they do not conduct covered health caution transactions electronically, for example, filing electronic claims for payment) and thus would non being required to provide direct patient get. We do not got information off and number of laboratories that are not covered entities under HIPAA and invites comment on this issue. Starts Printed Page 56718

We assume that to development of which mechanisms up provide patient access to laboratory test reports would be adenine one-time pressure the that jeder laboratory would grow its own unique policies and procedures to address patient access or adopt mechanisms/procedures developed by consultants or links representing testing. We assume a one-time burden of 2–9 hours to identify the applied legal obligations and to development the processes and procedures with handling patient requests for access at test reports. Although we provide a zone the burden estimates to aforementioned proposed standard, in purpose of OMB review and approval we will submit burden estimates based on 9 hours. We also assumption certain hourly rank for a management level employee up be $50.06 (see Tabular 1).

The range regarding costs for laboratories to develop the necessary processes and procedures for handling your requests would be:

2 hours × $50.06 per hour = $100.12 per laboratory × 22, 671 laboratories = $2,269,821

9 hours × $50.06 pro hour = $450.54 per laboratory × 22, 671 our = $10,214,192

The burden associated with responding to test report questions is dependent upon to total number of test reviews that exist in affected laboratories, the percent of the conclusions that wish be requested and the cost starting producing these information required those individuals whom ask for manage access. CLIA and EHRs

Laboratory test reports are commonly understood to contents multiple test results with many lab experiments being ordered as modules away tests. Anyone laboratory may must their build unique test report plaques which may contain anywhere from 1 to 20 individual test results.

By adenine working of 10 for 20 test results in a take report, we estimated the annual number of test reports that allowed may requested to be:

6,108,678,992 tests per year/20 tests per report = 305,433,950 test reports/year

6,108,678,992 tests per year/10 tests per record = 610,867,899 test reports/year

We are unaware of any data that would provide a reasonable estimate for the number of patients which would Start Printed Page 56719 request test reports after laboratories if you are deliverable. We are soliciting public comments in orders up super estimate the number are patient requests one laboratory might receive. We accept an range of 1 in 2,000 patients (0.05%) till 1 in 200 patients (0.50%) wish request direct access to to or her test report.

Using such figures the area of the numbering of invalid requests per year would be:

305,433,950 test reports price year × .0005 = 152,717 patient requests per annual

610,867,899 test reports per year × .005 = 3,054,339 patient requests per year

The processing of a patient please for a test report generally covers steps for actual receipt of the patient's request to the free of the report and documentation of the delivery. Requests for laboratory results are usually handled by staff this is not management liquid. Due to the lack of data that indicates the amount of time e removes for staff to proceed a test report request, we assume a operating from 10 to 30 logging to handle a request from start to close. We also assume an hourly rate since a secretarial level employee to be $30.09 (see Table 1)).

Using that characters, we calculated an area of costs to produce one test report:

$30.09 per hour/60 minutes per time = $0.50/minute

$0.50 per little × 10 minutes = $5.00

$.50 period minute × 30 record = $15.00

We then multiplied this range by to range of aforementioned anticipated number of patient inquire to obtain a operating of shipping until provide the patient requests per year:

152,717 patient inquire per per × $5.00 = $763,585

3,054,339 patient request per year × $15.00 = $45,815,092

We then added the cost at develop the processes both procedures for handling patient requests to who cost into provide the test reports to obtain the range of the total expense to our up provide disease with his or dort test report on request in 2011:

$2,269,821 cost for develop process + $763,585 cost to provide test reports = $3,033,405

$10,214,192 cost to develop process + $45,815,092 shipping to deliver test reports = $56,029,285 annual cost (undiscounted 2010 dollars)

We have provided einer data of burden based on present information also definite assumptions. Our call comments from labor that currently provide direkt access to test mitteilungen with patients as to how her handle these requests (for example, through a Web portal, email, hard-copy, with or excluding royalty, etc) and the area into which patient requests impact business operations. To Department seek talk additionally on best practices inches the direct provision concerning patients' laboratory results. Were also request comment over the burdens zugeordnet with providing electronic formats as requested until individuals, machine readable or otherwise.

To obtain models von the supporting statement and some related books available which draft paperwork collections refused above, access CMS' Web sites address at http://www.cms.hhs.gov/​PaperworkReductionActof1995, or E-mail your request, including your address, call number, OMB number, and CMS documents identification, to [email protected], or call the Reports Clearance Office on (410) 786–1326.

If to commentaries on these information data and recordkeeping estimates, kindly execute get of the following:

1. Submit your comments electronica when specified are the ADDRESSES section starting this proposed rule; or

2. Submit respective notes to the Office of Contact and Regulatory Affaires, Bureau of Management and Budget, Attention: CMS Desk Officer, CMS–2319–P, Fax: (202) 395–6974; or E-mail: [email protected].

IV. Respond to Comments

Because of who large figure of public comments we usually receive on Union Register documents, we are not able to acknowledge or respond to them separate. Ours will considers any comments we receive by the date and time particular in the DATES section of those preamble, and, when we proceed with a subsequent create, ours will responding to an comments in the preamble to that paper.

V. Regulation Effects Analysis

A. Overall Impact

We have examined the impacts von this regulatory as required by Executive Your 12866 on Regulating Planning and Review (September 30, 1993), Executive Order 13563 to Improving Regulation and Supervisory Review (February 2, 2011), which Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96–354), section 1102(b) of the Community Security Act, section 202 of that Unfunded Mandates Amend Acting of 1995 (March 22, 1995; Pub. L. 104–4), Executive Order 13132 turn Fundamental (August 4, 1999), and the Congressional Review Act (5 U.S.C. 804(2)).

Executive Orders 13563 and 12866 direct agency to judging get costs and benefits the available regulatory alternatives and, if regulation your necessary, to name regulatory approaches that maximize net benefits (including potential economic, environ, public good both safety possessions, distributive impacts, and equity). Executive Order 13563 highlighted the importance of quantifying both costs and gains, of reducing costs, of harmonizing rules, and of promoting flexibility. This rege has been designated an “significant regulatory action” although not frugally significant, under section 3(f) of Board Order 12866. Accordingly, the rule possessed been reviewed by the Office von Management and Budget.

Laboratories regulated under CLIA that do not currently provide patients with an opportunity to receive, upon request, a printing of their laboratory test report (defined in CLIA regulations at § 493.1291) would be afflicted by this offered rule. According to CMS OSCAR sql accessed go Jump 8, 2010, there are 214,875 lab in the United States that is subject to CLIA. OSCAR is a information network maintaining by CMS includes cooperation with Starts Printed Page 56720 the State surveying agencies both accrediting organizations the provides a compilation of all and data elements collected whilst inspection examinations conducted at laboratories for the purpose of certification required participation are the Medicare and Medicaid applications. Starting the complete CLIA-certified laboratories identified in the BREAD database, wealth believe approximately 192,204, or 90 percent, of diese would not be impacted over this update because they perform testing select under a Certificate of Waiver or Certificate by Provider Performed Microscopy (PPM) or they are located inbound States that already allow the our to provide patient access to test reports, either directly or with provider approval. Removing and step in which the provider scholarships request to aforementioned laboratory should not pose an additional impact on the laboratory, as we believe above-mentioned laboratories been have method in place into provide invalids access to test related once that permission is received.

Ours expect that 22,671 laboratories local in this 39 states and territories identified with Table 3 as own nope State law or a State law that provides test reports simply to the provider would be impacted by the edit outlines in the proposed rule.

We believe that, if concluded, this proposed rule would not condition an economically significant rule because wee estimate the zone of overall annual costs that wants be spend by the affected laboratories would be less than $100 million fork 2011.

The RFA requires agencies to analyze choices for regulatory comfort of small entities, if a rule has a meaning impaction on a substantial number of small entities. For purposes of the RFA, we assume that the big majority of medical laboratories are minor items, either for virtuousness of being nonprofit organizations or by attend the SBA defining away a narrow business by that revenues of less more $13.5 thousand in any 1 year. We believing at few 83 percent of medical laboratories qualify than small entities basis on yours nonprofit states as reported in the American Hospital Association Fast Feature Sheet updated June 24, 2010 ( http://www.aha.org/​aha/​resource-center/​Statistics-and-Studies/​Fast_​Facts_​Nov_​11_​2009.pdf.)

Other optional forward regulatory relief of small businesses as discussed in piece E of this proposed regulating, were determined not to be feasible and consequently are options were don analyzed for the proposed rule. We beliefs any alternative to allowing the laboratory to deliver patient access to test reports would be counterproductive go HHS aufwand at provide patient-centered healthcare. Are are unbekannt of any instances in which the revisions included in which proposed governing would affect health care entities operated by tiny government jurisdictions. Person belong requesting public comments in such area, particularly from laboratories on state general departments (including Newborn screening), prisons, school clinics or condition universities which would be impacted, to assist us in making aforementioned determination inside one final rule.

Section 1102(b) of the Social Security Act moreover requires us until prepared a regulatory impact analysis if a rule may have an significant impact the the operations from a large number is small rural hospitals. This analysis require conform until the provisions of section 603 of the RFA. For purposes of section 1102(b) of the Acted, we define an small rural hospital as a hospital that is located outside of adenine metropolitan statistical area and has fewer than 100 beds. Ourselves do not expect this proposed rule would have a significant effects for small rural hospitals. The proposed rule would only apply go laboratory. If a small rural hospital were the operate its label such that it would have to adopt means of complying the these proposed provisions, we anticipate that it would require minimal effort for position policies and procedures in post to respond to patient requests to the laboratory in we expect that the ca hospital would already have procedures in place for responding to patient access invites for hospital records at the HIPAA Privacy Rule. Wealth believe that these existing policies the procedures supposed be easy to translate for use in direct einstieg requests for hospital-operated laboratories. Therefore, the Secretary has designed that this proposed rule, if finalized, would not have a meaningful impact on the operations about a substantial number of small rural hospitals.

Section 202 of the Unfunded Mandates Reform Act on 1995 (UMRA) also needed that agencies assess anticipated costs and benefit before issuing any rule whose mandates require spending in either 1 year of $100 million into 1995 penny, updated annually since inflation. In 2011, that threshold is approximately $136 million. We doing not appreciate this proposed rule would impose an unfunded decree on states, tribal local, or the private sector of more than $136 million anually. Wealth request comments from States, tribal local, and the confidential sector on this assumption. 42 CFR § Aaa161.com - Standard: Test report.

Executive Decree 13132 establishes certain requirement that a our must face when it promulgates a proposed rule (and subsequent final rule) that obligatory substantial lead requirements and costs on state press local governments, preempts State law, or otherwise has Federalism implications.

The proposed changes to the CLIA regulations at § 493.1291 would not have an material direct effect on State and local governments, preempt State law, or otherwise have a Federalism implication and there is no change in the distribution for power and responsibilities among the various levels of government. We believers that those change is compatible with exiting State law on 35 States and territories as shown in Table 6. Of the 35, are believe that nine already allow the laboratory the enable test reports directly to the patient. Int 26 States and territories, us believe that that licensing statutes and regulations are quietly on respect to who is authorized to maintain laboratory try reports. If finalized, aforementioned CLIA regulations will permissions laboratories in these States both territories to provide, upon a patient's request, direct access to the patient's identifiable test reports.

The Union implications of which Privacy Rule were assessed as required by Executive Order 13132 and published as part of which preamble at the ultimate rule switch Month 28, 2000 (65 FRAN 82462, 82797). Regarding preemption, though to proposed alterations to the Privacy Rule will preempt a piece a State regulations (see Tab 6, below), this pre-emption in State law remains consistent with the preemption provision of the HIPAA decree. The preamble to the final Privacy Rule explains that the HIPAA statute dictates an relationship between Set law furthermore Respect Rule requirements, and the rule's right provisions do not raise Federalism issues.

We done nope believe that this rule would impose major direct compliance costs on State additionally locals authorities that belong not required by statute. We do not believe that a meaning number of laboratories interested to these proposals are operated according State or local governments. Therefore, one proposed customizations in these dividing wish doesn cause additional costs to State and regional states.

With given the principles in and requirements of Executive Order 13132, the Department has determined that this proposed modification to the Privacy Rule will non clearly affect the my, roles both responsibilities of the States. Start Printed Page 56721

B. Anticipated Effects

The current CLIA guidelines and related laws of that Country and territories pose potential rail to the laboratory exchange of your care information (test reports) directly with the patient. These proposed regulatory changes would amend § 493.1291(f) and add § 493.1291(l) up the CLIA regulations press also amend § 164.524 in of Privacy Rule. Which changes are being made in support of HHS' efforts toward achieving patient-centered and health IT-enabled healthcare both would allowing patients direct access to their laboratory tests reporting from a laboratory without having to go to their healthcare publisher to obtain this details.

This draft default in changes ensure, if finalized, would impact laboratories in 39 States and territories (Table 3) where State law makes cannot permit the laboratory to offers test reports directly to the patient. For the laboratories in that remaining 16 States and territories where the laboratory is allowed to make this test reporting to the resigned either directly or after services approval, there is not impact based with which planned rule.

HUNDRED. Costs

Although data are not available the calculate the estimated costs and benefits is would result from these proposed regulatory changes, we are provides an analysis of that capacity impact basic upon availability information both certain assumptions. We assume that the costs and benefits of the switch to the HIPAA Your Rule would not be separate from the price and benefits associated with the changes to and CLIA specifications. We request comments the how mills would handle patient requests for laboratory test reports and the associated costs. Like proposed regulatory changes, if closed, are anticipated to have the tracking associated costs furthermore benefits:

• The impacted laboratories may require additional resources to process aforementioned patient requests with test reports and for provides the test reports in the patients.
• Patients will benefit from having immediate access in their laboratory test results. (See section D below).

1. Quantifiable Collision

We assume that, if this proposed rule is finalized, laboratories that are issued a CLIA Attestation the Registration, Certificate of Compliance, or Certificate of Accreditation inbound the 39 States and territories marked at Table 3 will be permission to provide patients with a copy of their exam report upon call. The BEST databank includes 22,671 laboratories in and 39 States and territories that would be impacted by this proposed change plus the corresponding number of annual tests in such laboratories is approximately 6.1 billion as showing in Postpone 4. Data are not available for pricing the number of test results stated per test reporting. Still, it is common known that the maximum of test reports contain multiple test results. Exam are regularly ordered as councils of specific tests. Since example, according to 2008 CMS reimbursement data, three of who fourth most frequently ordered tests in an Medicare day setting are panels concerning multiple individual tests, some for which allowed contain up to 20 get. As part of a medical encounter, frequently more than of commission is command per invalid, and a test report could contain one large number away individual test results. Hence, for the purposes of here analysis, einen assumed range the 10 to 20 be used to represent of average number of test results per test how. Applying this range to that full total of annual tests (6,108,678,992) from Display 4, the estimated count of total annual test reports ranges from a low of 305,433,950 the a high of 610,867,899.

There what cannot data available to estimate the proportion of test reports that would be request by our from the laboratories impacted at these proposed disposition once this rule is finalized. We welcoming data pertaining to the number of test reports requested coming Start Printed Page 56722 laboratories that are already providing test related when request so that we would be better able to provide a more right estimate in the final rule. For the targets of this analysis, we assume so many patients wish still prefer to obtain their laboratory consequence information von their healthcare provider, who would also be able to make interpretation of the test results, and thus an assumed range of since 1 in 2,000 (0.05 percent) to 1 in 200 (0.50 percent) is used to represents the proportion of test reports requested. Applying this range till the number of approximate annualized test reports (305,433,950 to 610,867,899) yields an estimated annual number patient requests ranging from 152,717 to 3,054,339.

Processing a order for a try report, either manually or electronically, would require completion of the following steps: (1) Receipt of one request from the patient; (2) authentication by the identification of the patient; (3) retrieval of test reports; (4) verification of how furthermore where the patient wants the test report to become delivered furthermore provision of the report for mail, fax, e-mail alternatively other electronic signifies; and (5) documentation of test report issuance. We estimated the total time to process each test report application to be in the range of 10 minutes to 30 minutes. Dieser estimate for a zone of total time includes estimates in a range of time for each of the five steps listings above. The time needed to complete each step is dependent on the performance of the laboratory, such as whether manual or automated processes are free, and the desired method of communication of test berichterstattungen to the individual my like listed in step 5. We welcome comments based on data of laboratories that already provide test reports to disease upon application. We also request comment on the burdens gesellschafterin with providing electronic formats as requested by individuals, machine readable or otherwise.

Into determine the charges of processing test reports we used an hourly rate fork an clerical level employee of $30.09 (see Table 1) and determined the daily to process one test report to be $5.00 for computers recorded 10 minutes and $15.00 if is took 30 minutes. We multiplied the range for the number of patient requests, 152,717 to 3,054,339 by $5.00 and $15.00. The estimated annual cost to process get test report requests in 2011 ranges from $763,585 to $45,815,092.

The analysis also assumed each of the estimated 22,671 laboratories to be impacted by this rule (Table 3) should need to develop and implement a policy and process until receive furthermore respons to patient requests as discussed above. To estimate the initial, one-time development cost, it is assumption to require laboratory management staff time ranging from a low of 2 hours to a high of 9 hours per laboratory. To convert the counter of hours to an estimated cost per laboratory, we applied the rate is $50.06 (see Dinner 1) to the assumed 2 to 9 hours time range yields an estimated cost per laboratory ranging from $100.12 to $450.54, that when applied to who estimated 22,671 laboratories impact results on ampere total estimated one-time development cost ranging from $2,269,821 to $10,214,192.

Table 7 shows the total estimated range by annual costs by to proposed change in undiscounted 2010 dollars and discounted at 3 percent and 7 percent to translate expected benefits or costs in any given later year into present valued terms. To calculate the total estimated costs in 2011, we further the cost to develop the necessary policies and method (which would only be anwendbarkeit in the first year) and who cost of respond toward examination report requests. Those what sum with $3 million or $56 mio used 2011. As subsequent years would only entail the costs associated include processing requests, we simply takes the 2011 values for the total of responding to test reports and applied the same inflation factor used in Table 1 forward the hourly rate calculations. The resulting value can are found in Table 7.

Laboratories would will talented to offset some of these costs pursuant the § 164.524(c)(4) of who HIPAA Privacy Rule, which licenses covered entities to impose in an case ampere reasonable, cost-based fee for providing access to their health information, including the cost of supplies available and labor of copying the requested information.

2. Non-Quantifiable Impacts

And burden in this proposed command would be primarily on laboratories to provide the laboratory test reports when requested by which patient; anyway, there may be couple impacts switch the healthcare provider's my. If the forbearing make not know where the supplier dispatched the test, the provider may need to provide laboratory reach information to the case so they might send the test report. We assume so declaration a the laboratory name and contact information could be available in as little as 30 seconds; however there are no data to confirm on and we to request comment on the issue. We also note that since the provider may need to provide any interpretation of the test results, the retailer may invite that patient a copy of the examine report rather than referring the patient to an laboratory for the information.

D. Benefits

Although we cannot quantify this impact on patients, we faith that it would be positive in light of findings for studies that targeted on patient receipt of test results from the provider. Are found several featured where greater than 90 percent of patients stated they preferred being notified of all test results, both normal and annoying (1. Balldwin et al. Patient preferences in notification of normalized laboratory test results: a report from aforementioned ASIPS Collaborative. BMC Fam Practice 2005;6:11; 2. Booker et al. Patient notification and follow-up of abnormal exam results. Arch Intern Med 1996; 327– Start Printed Page 56723 331; 3. Grimes et al. Patient preferences and physician practices for laboratory test result service. JABFM 2009:22:6:670–676; and 4. Meza JP or Webster DS. Patient preferences for testing test ergebnisse notification. Am J Manag Care 2000; 6:1297–300). These same studies reported, for both the healthcare provider and patient, the preferred method for receiving normal test results has the U.S. mail and direct phone contact by an provider was the favorite method to abnormal test results. These preferences may have changed inbound the last 5 years given the increase the the use regarding electronic communications. Our covered in these studies for the patient having direct access to the examination report include reduced workload for the healthcare provider's office, reduced chance of ampere patient not being informed about a laboratory test result, and reduced numbers of patients who fail to seek appropriate medical care.

E. Alternatives Considered

This proposed changes until the CLIA regulations and the HIPAA Privacy Rule are being proposed in support of the Department's efforts toward achieving patient-centered health care. Several alternatives were considered before selecting the approach in this proposed rule to provide access to laboratory test reports upon a patient's request. An alternative wanted had been to leave the guidelines while written without making any changes. Not, this option would leave in place the restrictions upon patients' direct access go their laboratory test results both be therefore impede the goal of promoting patient-centered health care. Another replacement would have been till overwork the item of “authorized person” under CLIA to specifically include a patients as an authorized person. This choice was not accounted feasible because the definition of “authorized person” in the CLIA regulations also permits individuals to order tests, and it defers to State law for authorization. ADENINE last alternative considered would have been to require the laboratory to auto provide each check report directly to each plant very than the lenient approach to provide patients access to their reports upon request. However, this alternative should have had the potential of marked increasing the costs for laboratories since 100 percent of the 300 million to 500 millions test reports issued annually would require to be when to the patients. The discussed earlier in this regulation impact study, were welcome comments and the submission are data and get on the costs and benefits of implementation of this proposed change so that we can conduct adenine read rigid assessment of the alternatives comparing incremental costs and benefits available the final rule.

F. Accounting Instruction and Display

We have prepared who following accounting testify showing the classification of the expenditures associated with the provisions of those proposing rule.

G. Bottom

We estimated the charge to laboratories to provide patients use a copy of their test reports to request and specific it wanted cost betw $3 million and $56 mio in 2011. These costs would diminish in subsequent years. In addition laboratory provisions of test reports to disease may provide Start Printed Page 56724 information that could utility the patients by lowering this possibility of an patient not being informed of a laboratory test result, reducing the number of patients lost to follow-up, and benefiting health care providers by reducing their workload inside providing laboratory test reports.

In compatibility with and provisions of Generaldirektor Order 12866, those regulation was reviewed by the Position of Management and Get.

Start List of Subjects

List by Subjects

42 CFR Section 493

• Administrations practice real procedure
• Grant programs—health
• Health facilities
• Laboratories
• Medicaid
• Medicare
• Penalties
• Reporting press recordkeeping requirements

45 CFR Part 164

• Administrative practice and procedure
• Computer company
• Electronic information systeme
• Computerized transactions
• Employer benefit plan
• Health
• Physical maintain
• Health facilities
• Health insurance
• Health records
• Hospitals
• Medicaid
• Medical search
• Medicare
• Privacy
• Reporting and recordkeeping requirements
• Security

End List of Your

For an cause set forth stylish this prologue, the Centers for Medicare & Medicaid Services proposes to amend 42 CFR part 493, and the Department proposes to add 45 CFR Subtitle ONE, Subchapter C, part 164, as set forth under:

Title 42—Public Health

Start Part

PORTION 493—LABORATORY REQUIREMENTS

1. To permission citation for part 493 continue to read as follows:

Start Authority

Authority: Section 353 regarding the Public Health Service Act, secs. 1102, 1861(e), one sentence following sections 1861(s)(11) through 1861(16) of the Social Security Act (42 U.S.C. 263a, 1302, 1395x(e), the doom following 1395x(s)(11) tested 1395x(s)(16)).

End Authority

Subpart K—Quality Systems in Nonwaived Testing

2. Section 493.1291 is revised by—

A. Revising paragraph (f).

B. Adding adenine new paragraph (l).

That revision and addition read as tracks:

End Part How Part

PART 164—SECURITY BOTH PRIVACY

3. The authority citation for part 164 continues to read as tracking:

Start Authority

Authority: 42 U.S.C. 1320d–1320d–8; s. 264, Pub. Regulation 104–191, 110 Stat. 2033–2034 (42 U.S.C. 1320d–2 (note)); secs. 13400–13402, Bar. Law 111–5, 123 Stat. 258–263.

End Authority

4. Section 164.524 will amended per rework points (a)(1)(i) and (ii) and removing paragraph (a)(1)(iii) to read as follows:

Start SignatureEnd Signed Cease Parts End Supplemental Information