BCBS Evidence Street Announcement 201612; Belinson Interview 201808

https://www.bcbs.com/news/press-releases/blue-cross-blue-shield-association-launches-evidence-street-website-streamline

Blue Cross Blue Shield Association Launches Evidence Street Website to Streamline Evaluations of Medical Devices, Diagnostics and Pharmaceuticals

CHICAGO – Blue Cross Blue Shield Association (BCBSA) announced a new web-based platform that provides health care decision-makers easy access to impartial medical evidence reviews for devices, diagnostics and pharmaceuticals.

The platform Evidence Street™ was created to make BCBSA’s evidence review process of medical technologies and therapies more transparent, efficient and comprehensive. BCBSA collects and analyzes available peer-reviewed evidence on devices, diagnostics and pharmaceuticals, then synthesizes that data and ascertains if the evidence is sufficient or insufficient to determine the effect on health outcomes.

By developing an online platform, health care product manufacturers are able to monitor when BCBSA is reviewing particular medical categories and are able to easily submit their peer-reviewed evidence for consideration during the review process. In addition, those subscribers who submit evidence will receive a customized report providing feedback about any relevant gaps in the findings from BCBSA.

Reviews are subsequently published on the Evidence Street website, which is accessible to Blue Cross and Blue Shield (BCBS) companies and subscribing health care device, diagnostic and pharmaceutical manufacturers. Medical societies, health care associations and academic medical research centers may also subscribe to the service.

“Today, as medical technology, treatment protocols and new discoveries accelerate and continue to evolve, Evidence Street provides an efficient platform to facilitate collaborative exchange of information between health care decision makers about the state of the evidence to inform health care decisions,” said Dr. Trent Haywood, senior vice president and chief medical officer for BCBSA. “Blue Cross and Blue Shield companies have long been committed to improving population health outcomes, and one of the most important ways we do that is by determining if current use of devices, diagnostics and pharmaceuticals is rooted in clinical evidence.”

BCBSA, which will provide about 460 medical reviews a year, does not determine whether each of the 36 Blue Cross and Blue Shield companies nationwide cover a medical technology. However, it provides BCBS companies with evidence opinions they often use as an input into those decisions.

Evidence Street builds on BCBSA’s history and commitment to evidence-based medicine and technology assessment. BCBSA pioneered the development of scientific criteria for assessing medical technologies through objective, comprehensive reviews of clinical evidence with a mission to provide health care decision-makers with rigorous and credible assessments from available evidence.

"Evidence Street is a destination where the market meets the evidence," Haywood added. “Our goal is to create clarity, efficiency and transparency for health care decision-makers regarding the current state of the evidence.”

About Evidence Street® (“Site”) Disclaimer
Evidence submitted to BCBSA via the Site is considered in the same impartial manner as other evidence provided manually by Subscribers, non-Subscribers, and other sources. Subscription or use of this Site will not enhance review of the submitted evidence or influence BCBSA’s impartial evaluation of all relevant evidence from all appropriate sources.

This Site and BCBSA do not determine medical policy, provide health insurance benefits information, or adjudicate coverage claims for any Blue Plan; do not provide medical, legal, or financial advice; and are not intended for consumer use.

Each local Blue Plan, as an independent entity, determines its own medical policies and benefits, adjudicates its own members’ claims, and may accept or reject information on this Site in its own discretion.

Neither BCBSA nor any Blue Plan recommends, endorses, warrants, or guarantees, nor are they responsible for damages based on any program, provider, product, or service whose information may appear on this Site. Site content expresses the opinion of BCBSA and/or the respective authors cited therein, not those of any Blue Cross Blue Shield Plan. For details, see Terms of Use and Privacy Policy.No subscriber or manufacturer may promote a BCBSA Evidence Review finding without the consent of the Strategic Services Department at BCBSA.

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https://www.nextgenerationdx.com/Suzanne_Belinson_Transcript

Walking Down Evidence Street™: Where the Market Meets Evidence

Mana Chandhok:
Hi everyone. Welcome to this podcast from Cambridge Healthtech Institute for the Next Generation Diagnostic Summit, which runs August 15th to the 18th in Washington D.C. I'm Mana Chandhok, an associate producer. We have with us today one of our keynote speakers from the coverage and reimbursement of Advanced Diagnostics Tract, Dr. Susanne Belinson, executive director of clinical markets at Blue Cross Blue Shield Association. Dr. Belison, thank you for joining us.

Susanne Belinson:
My pleasure. Thank you.

Mana Chandhok:
Would you mind telling us a little bit about the Evidence Street program that you are leading?

Susanne Belinson:
So Evidence Street is a web-based platform that was launched out of the Blue Cross Blue Shield Association's office of clinical affairs. It focuses on providing a place where the market can meet the evidence, a place where stakeholders in the evidence review process can come and access a standard set of evidence reviews and access a transparent process by which those evidence reviews get updated. The primary vision around that process is that if we can get all of the evidence out into the market, that benefits all stakeholders through transparency and engagement in an efficient process.

Mana Chandhok:
We are also planning a panel discussion on evidence with payers like yourself and Alberto Gutierrez from the FDA. Do you think it is possible to come up with more standardized requirements for the evidence that companies need to generate for payers and regulators?

Susanne Belinson:
I do think that it is possible to get to a place of greater standardization, and I think that that is part of the vision of Evidence Street and the work that we are undertaking at this time. I do think that at times the requirements of a regulator such as the FDA and the evidentiary requirements for payers may be slightly different or they may require some elements that are the same and some elements that may be different. I do think that it is essential as we move forward to provide very clear and actionable information to manufacturers and those researchers who may work with them that the FDA collaborates with other HTA organizations and payers collaborate together to begin to generate a common set of standards that can be communicated out into the marketplace.

Mana Chandhok:
We are looking forward to the summit and hope it to be productive for each and every participant. What do you expect to gain from the meeting as a speaker and an attendee?

Susanne Belinson:
I think what I always look to gain in these types of interactions is just engagement and the opportunity to hear others' perspectives. I think that we often work in very siloed environments and I've had the great opportunity and pleasure over the last couple of years to engage with a lot of stakeholders across the market and I find that all of these opportunities really provide me an opportunity to grow in my understanding of other peoples' businesses and the way in which my business fits into the overall marketplace. I really just look forward to the open engagement and dialogue and hopefully learning a few new things.

Mana Chandhok:
Dr. Belinson, thank you for your time and insights today.

Susanne Belinson:
Thank you very much.

Mana Chandhok:
That was Dr. Susanne Belinson of the Blue Cross Blue Shield Association. She'll be speaking at the Coverage and Reimbursement of Advanced Diagnostics Track at the upcoming Next Generation Diagnostics Summit, taking place August 15th to the 18th in Washington D.C. Thank you for listening.

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CMS Request for Info on SUPPORT 2005 New Medicare Benefit (83 Fed Reg 59497, 2018/11/23)

Federal Register
Friday, November 23, 2018
CMS PFS Final Rulemaking for CY2019
83 Fed Reg 59497

Request for comment on how to implement SUPPORT Section 2005, New Opioid Abuse Benefit for CY2020. 

(Comment closed 12/31/2018).

Statute Section 2005, Text here.
________

b. Medicare Payment for Certain 
Services Furnished by Opioid 
Treatment Programs (OTPs)—Request 
for Information 

Section 2005 of the SUPPORT Act
establishes a new Medicare benefit
category for opioid use disorder
treatment services furnished by OTPs
under Medicare Part B, beginning on or
after January 1, 2020.

This provision
requires that opioid use disorder
treatment services would include:

• FDA-approved opioid agonist and antagonist treatment medications, 
• the dispensing and administration of such medications (if applicable), 
• substance use disorder counseling, 
• individual and group therapy, 
• toxicology testing, and 
• other services determined appropriate (but in no event to include meals and transportation). 

The provision defines
OTPs as those that enroll in Medicare
and are certified by the Substance
Abuse and Mental Health Services
Administration (SAMHSA), accredited
by a SAMHSA-approved entity, and
meeting additional conditions as the
Secretary finds necessary to ensure the
health and safety of individuals being
furnished services under these programs
and the effective and efficient
furnishing of such services.

We note that there is a 60-day period
for the public to comment on the
provisions of the interim final rule
described previously to implement
section 2001 of the SUPPORT for
Patients and Communities Act. During
that same comment period, we are 
requesting information regarding 
services furnished by OTPs, payments 
for these services, and additional 
conditions for Medicare participation 
for OTPs that stakeholders believe may 
be useful for us to consider for future 
rulemaking to implement this new 
Medicare benefit category.

SUPPORT Section 2005 / MEDICARE COVERAGE OF CERTAIN SERVICES FURNISHED BY OPIOID TREATMENT PROGRAMS.

https://www.congress.gov/115/bills/hr6/BILLS-115hr6enr.xml#toc-H11E33AD3BDB9499A992CF4C8B59BFFF4


(CMS request for information on how to implement, comment period closed 12/31/2018, see request here.)

SEC. 2005. 
MEDICARE COVERAGE OF CERTAIN SERVICES 
FURNISHED BY OPIOID TREATMENT PROGRAMS.

(a) Coverage.—Section 1861(s)(2) of the Social Security Act (42 U.S.C. 1395x(s)(2)) is amended—

(1) in subparagraph (FF), by striking at the end “and”;

(2) in subparagraph (GG), by inserting at the end “and”; and

(3) by adding at the end the following new subparagraph:

“(HH) opioid use disorder treatment services (as defined in subsection (jjj)).”.

(b) Opioid Use Disorder Treatment Services And Opioid Treatment Program Defined.—Section 1861 of the Social Security Act (42 U.S.C. 1395x) is amended by adding at the end the following new subsection:

“(jjj) Opioid Use Disorder Treatment Services; Opioid Treatment Program.—

“(1) OPIOID USE DISORDER TREATMENT SERVICES.—The term ‘opioid use disorder treatment services’ means items and services that are furnished by an opioid treatment program for the treatment of opioid use disorder, including—

“(A) opioid agonist and antagonist treatment medications (including oral, injected, or implanted versions) that are approved by the Food and Drug Administration under section 505 of the Federal Food, Drug, and Cosmetic Act for use in the treatment of opioid use disorder;

“(B) dispensing and administration of such medications, if applicable;

“(C) substance use counseling by a professional to the extent authorized under State law to furnish such services;

“(D) individual and group therapy with a physician or psychologist (or other mental health professional to the extent authorized under State law);

“(E) toxicology testing, and

“(F) other items and services that the Secretary determines are appropriate (but in no event to include meals or transportation).

“(2) OPIOID TREATMENT PROGRAM.—The term ‘opioid treatment program’ means an entity that is an opioid treatment program (as defined in section 8.2 of title 42 of the Code of Federal Regulations, or any successor regulation) that—

“(A) is enrolled under section 1866(j);

“(B) has in effect a certification by the Substance Abuse and Mental Health Services Administration for such a program;

“(C) is accredited by an accrediting body approved by the Substance Abuse and Mental Health Services Administration; and

“(D) meets such additional conditions as the Secretary may find necessary to ensure—

“(i) the health and safety of individuals being furnished services under such program; and “(ii) the effective and efficient furnishing of such services.”.

(c) Payment.—

(1) IN GENERAL.—Section 1833(a)(1) of the Social Security Act (42 U.S.C. 1395l(a)(1)) is amended—

(A) by striking “and (BB)” and inserting “(BB)”; and

(B) by inserting before the semicolon at the end the following “, and (CC) with respect to opioid use disorder treatment services furnished during an episode of care, the amount paid shall be equal to the amount payable under section 1834(w) less any copayment required as specified by the Secretary”.

(2) PAYMENT DETERMINATION.—Section 1834 of the Social Security Act (42 U.S.C. 1395m) is amended by adding at the end the following new subsection:

“(w) Opioid Use Disorder Treatment Services.—

“(1) IN GENERAL.—The Secretary shall pay to an opioid treatment program (as defined in paragraph (2) of section 1861(jjj)) an amount that is equal to 100 percent of a bundled payment under this part for opioid use disorder treatment services (as defined in paragraph (1) of such section) that are furnished by such program to an individual during an episode of care (as defined by the Secretary) beginning on or after January 1, 2020. The Secretary shall ensure, as determined appropriate by the Secretary, that no duplicative payments are made under this part or part D for items and services furnished by an opioid treatment program.

“(2) CONSIDERATIONS.—The Secretary may implement this subsection through one or more bundles based on the type of medication provided (such as buprenorphine, methadone, naltrexone, or a new innovative drug), the frequency of services, the scope of services furnished, characteristics of the individuals furnished such services, or other factors as the Secretary determine appropriate. In developing such bundles, the Secretary may consider payment rates paid to opioid treatment programs for comparable services under State plans under title XIX or under the TRICARE program under chapter 55 of title 10 of the United States Code.

“(3) ANNUAL UPDATES.—The Secretary shall provide an update each year to the bundled payment amounts under this subsection.”.

(d) Including Opioid Treatment Programs As Medicare Providers.—Section 1866(e) of the Social Security Act (42 U.S.C. 1395cc(e)) is amended—

(1) in paragraph (1), by striking at the end “and”;

(2) in paragraph (2), by striking the period at the end and inserting “; and”; and

(3) by adding at the end the following new paragraph:

“(3) opioid treatment programs (as defined in paragraph (2) of section 1861(jjj)), but only with respect to the furnishing of opioid use disorder treatment services (as defined in paragraph (1) of such section).”.

CMS Gene Language for 2019: Existed Nov 21-Dec 12, 2018

6. All genomic sequencing procedures and molecular
multianalyte assays (e.g., CPT codes 81410-81471), many
multianalyte assays with algorithmic analyses (e.g., CPT codes
81493-81599, 0004M-XXXXM), and many Proprietary Laboratory
Analyses (PLA) (e.g., CPT codes 0001U-XXXXU) are DNA or RNA
analytic methods that simultaneously assay multiple genes or
genetic regions.  A physician shall not additionally separately
report testing for the same gene or genetic region by a
different methodology (e.g., CPT codes 81105-81408, 81479,
88364-88377).  CMS payment policy does not allow separate
payment for multiple methods to test for the same analyte.

INTRODUCED NOVEMBER 22, 2018 FOR EFFECT JANUARY 1, 2019
DELETED BY CMS ON DECEMBER 12, 2018

7. A Tier 1 or Tier 2 molecular pathology procedure CPT 
code shall not be reported with a genomic sequencing procedure, 
molecular multianalyte assay, multianalyte assay with 
algorithmic analysis, or proprietary laboratory analysis CPT 
code where the CPT code descriptor includes testing for the 
analyte described by the Tier 1 or Tier 2 molecular pathology 
code. 

8. If one laboratory procedure evaluates multiple genes 
utilizing a next generation sequencing procedure, the laboratory 
shall report only one unit of service of one genomic sequencing 
procedure, molecular multianalyte assay, multianalyte assay with 
algorithmic analysis, or proprietary laboratory analysis CPT 
code.  If no CPT code accurately describes the procedure 
performed, the laboratory shall report CPT code 81479 (unlisted 
molecular pathology procedure) with one unit of service.  The 
laboratory shall not report multiple individual CPT codes 
describing the component test results.  If a single procedure is 
performed, only one HCPCS/CPT code with one unit of service may 
be reported for the procedure. 

9. Procedure-to-procedure edits bundling two Tier 1 
molecular pathology procedure CPT codes describe procedures that 
should not routinely be performed and reported together.  For 
example CPT code 81292 describes full sequence gene analysis of 
MLH1, and CPT code 81294 describes duplication/deletion variant 
gene analysis of MLH1.  In evaluating a patient with colon 
carcinoma (vs. constitutional genetic disorder), it may be 
appropriate to perform duplication/deletion testing if the 
disease variant(s) is (are) not identified by performing full 
gene sequencing.  The same principle applies to other code pair 
combinations of testing for the same gene (e.g., 81295/81297, 
81298/81300). 

December 2018 Parrish CGM Case Filed in Court

Medicare Coverage Class Action Filed Against Health and Human Services Secretary on Behalf of Diabetes Patients Case here (36pp): https://files.constantcontact.com/8f33fe5c401/de1cdd2e-a94b-4504-939c-ffe5f4f9fdca.pdf Lowenstein Sandler and Parrish Law Offices filed a class action in the U.S. District Court for the District of Columbia today against Alex Azar in his capacity as Secretary of the U.S. Department of Health and Human Services (HHS) on behalf of diabetic Medicare recipients denied reimbursement coverage for use of medically prescribed continuous glucose monitors (CGMs). The complaint seeks a declaration that federal law requires HHS to reimburse for CGMs; compensation for Medicare beneficiaries’ past out-of-pocket costs to purchase these devices, the claims for which HHS improperly denied; and a ruling to establish a precedent for all Medicare beneficiaries filing claims for CGMs in the future. This action asserts that HHS has routinely ignored past court and administrative law decisions and improperly denied CGM users’ Medicare reimbursement requests on the contention that CGMs do not qualify as durable medical equipment (DME) that is primarily or customarily used to serve a medical purpose. As the plaintiffs detail in their complaint, HHS’s decisions violate several federal statutes and are arbitrary and capricious, disregard Congressional intent, and ignore the fact that these devices meet Medicare coverage requirements. Plaintiffs ask the court to reverse HHS’s erroneous past decisions and issue an order finding that a CGM and its related supplies do, in fact, serve an essential medical purpose. Jointly filed by the Parrish Law Offices and Lowenstein Sandler, the class action complaint asserts that HHS’s coverage denials have serious consequences for patients’ health outcomes and have an impact on health care costs at both the individual and national level. For many who suffer from diabetes, the only way to adequately and consistently monitor their glucose levels is through a CGM, which continually tests those levels and transmits detailed data to patients and caregivers. Such data, especially in instances of dramatic changes in glucose levels, can mean the difference between just-in-time treatment and serious, even fatal, complications that can result from the delays in care that are all too common with older, more traditional monitoring methods. “The Department has continued to deny diabetes patients potentially lifesaving and cost-reducing medical devices and care,” said James Pistorino, a lawyer with the Parrish Law Offices and lead representative for the plaintiff class. “Nonsensically, the department has claimed that CGMs do not serve a medical purpose and are not necessary, despite their being an FDA-approved and verified method for preventing those with diabetes from facing dangerous consequences, such as falling into a diabetic coma or, even worse, death.” More than 98 percent of private insurance companies cover CGMs, which are FDA-approved, lifesaving devices providing a proven, 24/7 way to test glucose levels and prevent complications and, potentially, death from diabetes. Nevertheless, in too many instances, Medicare will not cover CGM use, which means that patients must pay for this costly equipment on their own. Those who simply cannot afford the cost must forgo the device completely and risk acute health complications. “Health and Human Services has a duty to live up to its name and provide coverage to the distressed populations it claims to assist,” said Jeffrey Blumenfeld, partner at Lowenstein Sandler. “Providing adequate medical coverage to those in need makes common and ethical sense and, in the case of CGMs, is also exactly what Congress intended. By improving and saving lives and boosting positive health care outcomes, CGMs also save the general public, the government, and the economy in terms of short- and long-term costs.” Plaintiffs Carol A. Lewis and Douglas B. Sargent are both filing the suit after being denied coverage from the Medicare Appeals Council and are represented by James Pistorino and Debra Parrish of the Parrish Law Offices in conjunction with Jeffrey Blumenfeld and Gavin J. Rooney of Lowenstein Sandler. To see a copy of the complaint, click here.

Sincerely, Debra M. Parrish Parrish Law Offices Phone: 412-561-6250 ___ Quinn local file as: 2018 Court Parrish 1213 CGM Case Filed Against HHS 36pp.pdf

Cloud Posting: Five Amazingly Complex SEP1 Documents

As of 2018.12.10, links to five amazingly complex SEP1 process documents. 

Also in one ZIP file here.

This is a document file only.

I wrote actual essays on CMS SEP1 in August (first data release) and in November (performance of academic hospitals).

For a contrasting 2018 article by Walkey on the value of keeping it simple in Sepsis measures, here.

https://www.ihconline.org/media/cms/Sepsis_Bundle_Project_SEP_Measure_Set.pdf

63 page CMS measure guide

https://www.qualityreportingcenter.com/wp-content/uploads/2018/07/IQR_QA-Transcript_Sepsis_v5.4_04302018_vFINAL508.pdf

256 questions (73pp)

https://www.qualityreportingcenter.com/wp-content/uploads/2018/02/IQR_slides_Sepsis_v5.3a_20180227_vFINAL508.pdf

62 page webinar slides

https://www.acep.org/globalassets/uploads/uploaded-files/acep/advocacy/federal-issues/equal/sep-1-data-submission-guide_.pdf

4 page SEP1 tabular summary

https://highvaluehealthcare.org/resource%20files/CMS%20SEP-1%20Measure%20Summary%20Diagram%20v5.1.pdf

4 page SEP1 flow chart diagram

1997 Balanced Budget Act, Section 4554: Uniform CMS Lab Claims Policies

https://www.gpo.gov/fdsys/pkg/PLAW-105publ33/html/PLAW-105publ33.htm

SEC. 4554. IMPROVEMENTS <<NOTE: 42 USC 1395u note.>>  IN ADMINISTRATION 
            OF LABORATORY TESTS BENEFIT.

    (a) Selection of Regional Carriers.--
            (1) In general.--The Secretary of Health and Human Services 
        (in this section referred to as the ``Secretary'') shall--
                    (A) divide the United States into no more than 5 
                regions, and
                    (B) designate a single carrier for each such region,
        for the purpose of payment of claims under part B of title XVIII 
        of the Social Security Act with respect to clinical diagnostic 
        laboratory tests furnished on or after such date (not later than 
        July 1, 1999) as the Secretary specifies.
            (2) Designation.--In designating such carriers, the 
        Secretary shall consider, among other criteria--
                    (A) a carrier's timeliness, quality, and experience 
                in claims processing, and

[[Page 111 STAT. 461]]

                    (B) a carrier's capacity to conduct electronic data 
                interchange with laboratories and data matches with 
                other carriers.
            (3) Single data resource.--The Secretary shall select one of 
        the designated carriers to serve as a central statistical 
        resource for all claims information relating to such clinical 
        diagnostic laboratory tests handled by all the designated 
        carriers under such part.
            (4) Allocation of claims.--The allocation of claims for 
        clinical diagnostic laboratory tests to particular designated 
        carriers shall be based on whether a carrier serves the 
        geographic area where the laboratory specimen was collected or 
        other method specified by the Secretary.
            (5) Secretarial exclusion.--Paragraph (1) shall not apply 
        with respect to clinical diagnostic laboratory tests furnished 
        by physician office laboratories if the Secretary determines 
        that such offices would be unduly burdened by the application of 
        billing responsibilities with respect to more than one carrier.

    (b) Adoption of National Policies for Clinical Laboratory Tests 
Benefit.--
            (1) In general.--Not later than January 1, 1999, the 
        Secretary shall first adopt, consistent with paragraph (2), 
        national coverage and administrative policies for clinical 
        diagnostic laboratory tests under part B of title XVIII of the 
        Social Security Act, using a negotiated rulemaking process under 
        subchapter III of chapter 5 of title 5, United States Code.
            (2) Considerations in design of national policies.--The 
        policies under paragraph (1) shall be designed to promote 
        program integrity and national uniformity and simplify 
        administrative requirements with respect to clinical diagnostic 
        laboratory tests payable under such part in connection with the 
        following:
                    (A) Beneficiary information required to be submitted 
                with each claim or order for laboratory tests.
                    (B) The medical conditions for which a laboratory 
                test is reasonable and necessary (within the meaning of 
                section 1862(a)(1)(A) of the Social Security Act).
                    (C) The appropriate use of procedure codes in 
                billing for a laboratory test, including the unbundling 
                of laboratory services.
                    (D) The medical documentation that is required by a 
                medicare contractor at the time a claim is submitted for 
                a laboratory test in accordance with section 1833(e) of 
                the Social Security Act.
                    (E) Recordkeeping requirements in addition to any 
                information required to be submitted with a claim, 
                including physicians' obligations regarding such 
                requirements.
                    (F) Procedures for filing claims and for providing 
                remittances by electronic media.
                    (G) Limitation on frequency of coverage for the same 
                tests performed on the same individual.
            (3) Changes in laboratory policies pending adoption of 
        national policy.--During the period that begins on the date of 
        the enactment of this Act and ends on the date the Secretary 
        first implements national policies pursuant to regulations 
        promulgated under this subsection, a carrier under such

[[Page 111 STAT. 462]]

        part may implement changes relating to requirements for the 
        submission of a claim for clinical diagnostic laboratory tests.
            (4) Use of interim policies.--After the date the Secretary 
        first implements such national policies, the Secretary shall 
        permit any carrier to develop and implement interim policies of 
        the type described in paragraph (1), in accordance with 
        guidelines established by the Secretary, in cases in which a 
        uniform national policy has not been established under this 
        subsection and there is a demonstrated need for a policy to 
        respond to aberrant utilization or provision of unnecessary 
        tests. Except as the Secretary specifically permits, no policy 
        shall be implemented under this paragraph for a period of longer 
        than 2 years.
            (5) Interim national policies.--After the date the Secretary 
        first designates regional carriers under subsection (a), the 
        Secretary shall establish a process under which designated 
        carriers can collectively develop and implement interim national 
        policies of the type described in paragraph (1). No such policy 
        shall be implemented under this paragraph for a period of longer 
        than 2 years.
            (6) Biennial review process.--Not less often than once every 
        2 years, the Secretary shall solicit and review comments 
        regarding changes in the national policies established under 
        this subsection. As part of such biennial review process, the 
        Secretary shall specifically review and consider whether to 
        incorporate or supersede interim policies developed under 
        paragraph (4) or (5). Based upon such review, the Secretary may 
        provide for appropriate changes in the national policies 
        previously adopted under this subsection.
            (7) Requirement and notice.--The Secretary shall ensure that 
        any policies adopted under paragraph (3), (4), or (5) shall 
        apply to all laboratory claims payable under part B of title 
        XVIII of the Social Security Act, and shall provide for advance 
        notice to interested parties and a 45-day period in which such 
        parties may submit comments on the proposed change.

    (c) Inclusion of Laboratory Representative on Carrier Advisory 
Committees.--The Secretary shall direct that any advisory committee 
established by a carrier to advise such carrier with respect to coverage 
and administrative policies under part B of title XVIII of the Social 
Security Act shall include an individual to represent the independent 
clinical laboratories and such other laboratories as the Secretary deems 
appropriate. The Secretary shall consider recommendations from national 
and local organizations that represent independent clinical laboratories 
in such selection.