https://www.statista.com/topics/1167/medicare/#:~:text=In%202019%2C%20over%2061%20million,beneficiaries%20due%20to%20various%20disabilities.
Monday, December 14, 2020
Palmetto DEX License Splash Screen, 12/2020
License Splash Screen (12/2020)
Notice--DEX™
Diagnostics Exchange
General Terms: Palmetto GBA LLC and/or one of its subsidiaries
(“Palmetto GBA”) is the owner/licensor of the DEX™ Diagnostics Exchange
software product (“Software”) including its clinical content (“Clinical
Content”, and together with the Software, the “Work”). The Work contains
proprietary, confidential and trade secret information of Palmetto GBA and may
only be used by licensees who have an existing license agreement in force only
under the time-limited license as provided under that license agreement
(“Licensee”). Palmetto GBA is also the owner of DEX Z-Codes and the catalog of
Z-Codes. Licensee and any recipient thereunder shall use the Work and the
Z-Codes in accordance with the terms and conditions of the license agreement.
Any other use of the Work or the Z-Codes is unauthorized and prohibited by law.
In the event of a conflict between these Terms and a written and signed
agreement between Palmetto GBA and Licensee, such written and signed agreement
shall control.
If You Have Been
Provided Access for Evaluation Purposes: Palmetto GBA is the owner/licensor of the Work. Palmetto GBA
has prepared this Work for use solely by its licensees. This Work contains
proprietary, confidential and trade secret information of Palmetto GBA. If you
have been provided access to the Work for evaluation purposes only, such access
is provided to you only under a nontransferable, nonexclusive license whose
term is limited to the time frame set forth in the e-mail notification sent to
you containing your access password and any other terms or conditions of use
provided by Palmetto GBA from time to time. You and any recipient hereunder
shall use the Work in accordance with the terms and conditions of this license
and the e-mail notification. You are granted this license solely for the purpose
of your internal evaluation of the Work as part of your decision whether to
license the Work, and for no other purpose. You expressly agree to keep the
Work confidential and not to release or disclose the Work to any other third
person without Palmetto GBA's express written permission. Publication of the
Work or unauthorized reproduction of the Work, including but not limited to the
printing or distribution of any portion of the Work or results obtained as part
of the permitted evaluation, adaptation, incorporation into other media, and
release of this Work by you, is strictly prohibited except upon prior written
permission of Palmetto GBA. Any copies or reproductions of the Work, whether
electronic or physical, made by you during the limited evaluation term shall be
destroyed and shall not be used for any purpose upon the expiration of the
term. The permissions granted herein are terminable at will by either party.
Proprietary
Notice: The Work is protected
under United States and international copyright law, federal and state trade
secret law and/or other intellectual property laws. If this Work is delivered
pursuant to a federal government contract that requires the conveyance of
rights in data to the government, it is understood that the Work, including commercial
software, clinical content, third-party software, documentation and/or other
technical data, was developed exclusively at Palmetto GBA's private expense,
and that Palmetto GBA will convey only limited or restricted rights in the Work
to the government consistent with the guidance set forth in the Federal
Acquisition Regulation (“FAR”) and/or FAR Supplements. Conveyance of any
additional rights beyond limited or restricted rights in the Work requires
Palmetto GBA's express consent contained in a separate written agreement.
Acknowledgments and
Disclaimer:
The
Clinical Content as provided reflects clinical interpretations and analyses and
cannot alone either resolve medical ambiguities of particular situations or
provide the sole basis for definitive decisions. The Clinical Content is
intended solely for use as screening guidelines with respect to the medical
appropriateness of healthcare services and not for final clinical or payment
determinations concerning the type or level of medical care provided, or
proposed to be provided, to a patient.
THE WORK IS PROVIDED
"AS IS." PALMETTO GBA DISCLAIMS ANY OTHER WARRANTY, EXPRESS OR
IMPLIED, INCLUDING AS TO MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE
OR SERVICE OF THE WORK, OR THE COMPATIBILITY OF OUTPUT USING THE WORK WITH ANY
LAW, REGULATION, OR ORDER. IN NO EVENT SHALL PALMETTO GBA BE LIABLE FOR
SPECIAL, INCIDENTAL, CONSEQUENTIAL, OR EXEMPLARY DAMAGES IN CONNECTION WITH, OR
ARISING OUT OF, ANY USE OF THE WORK.
Trademarks: DEX
Diagnostics Exchange™ and Z-Codes™ are trademarks of Palmetto GBA LLC and/or
Blue Cross and Blue Shield of South Carolina.
© 2020 Palmetto GBA LLC.
All rights reserved.
No
portion of this publication or the Work may be copied, reproduced, or
incorporated into any other media without Palmetto GBA's prior written consent.
Third Party Notices:
AMA CPT® Codes: The Work
may incorporate the CPT® terminology developed and copyrighted by the American
Medical Association ("AMA"). The CPT codes and terminology are
provided pursuant to a license agreement between Palmetto GBA and the AMA.
CPT copyright 2019
American Medical Association. All rights reserved. Fee schedules, relative
value units, conversion factors and/or related components are not assigned by
the AMA, are not part of CPT, and the AMA is not recommending their use. The
AMA does not directly or indirectly practice medicine or dispense medical
services. The AMA assumes no liability for data contained or not contained
herein. CPT is a registered trademark of the American Medical Association.
Applicable
FARS/DFARS Restrictions Apply to Government Use.
U.S. Government Rights
This
product includes CPT which is commercial technical data and/or computer data
bases and/or commercial computer software and/or commercial computer software
documentation, as applicable, which was developed exclusively at private
expense by the American Medical Association, 515 North State Street, Chicago,
Illinois, 60654. U.S. Government rights to use, modify, reproduce, release,
perform, display, or disclose these technical data and/or computer data bases
and/or computer software and/or computer software documentation are subject to
the limited rights restrictions of DFARS 252.227-7015(b)(2) (November 1995)
and/or subject to the restrictions of DFARS 227.7202-1(a) (June 1995) and DFARS
227.7202-3(a) (June 1995), as applicable, for U.S. Department of Defense
procurements and the limited rights restrictions of FAR 52.227-14 (December
2007) and/or subject to the restricted rights provisions of FAR 52.227-14
(December 2007) and FAR 52.227-19 (December 2007), as applicable, and any
applicable agency FAR Supplements, for non-Department of Defense Federal
procurements.
HGNC: HUGO Gene Nomenclature Committee at the
European Bioinformatics Institute http://www.genenames.org/
Sunday, December 13, 2020
CMS Part B Drug Pricing Proposal Dynamites Existing Law; PhRMA Protests in Court; Hidden Backstory
On November 20, 2020, CMS released a blockbuster proposal to national reprice Part B drugs according to international price metrics (aka Most Favored Nation Status, or MFN). Response from the biopharma industry was swift and resulted in a major legal filing by December 4. The Medicare policy facts are pretty bizarre and I'll both lay out the key facts and provide some fascinating backstory in this blog.
What CMS Did on November 20
CMS used its authority (from SSA 1115A, part of the Affordable Care Act) to create new demonstration products. It's used this authority dozens or hundreds of times. In this case, CMS asserts it can rapidly create a nationwide demonstration program that will last for years, and totally reconfigure drug pricing policy under Part B (e.g. intravenous drugs, chemotherapy, etc). In fact, SSA 1115A does create the Center for Innovation (aka CMMI) and allows it waive any part of Medicare law for the purpose of demonstration projects. The law is brief and doesn't state any limits on the duration of a demo (e.g. 6 months versus 999 years) or the scope (3 metropolitan areas versus all 50 states) or the project content (e.g. tweaking a small rule as a pilot versus raising the Medicare age to 75).
- See the CMS fact sheet here.
- CMS calls this the PDPM, Prescription Drug Payment Model, which doesn't capture the fact it is Part B drugs only.
- However, the CMMI webpage it titled Most Favored Nation - here.
- See the CMS press release here.
- The proposal was released in tandem with an HHS report on drug price inflation here.
- See the November 27 Federal Register web page here.
- See the 80 page PDF here. 85 Fed Reg 76180-259, November 27, 2020.
- Yes, somebody was working the day after Thanksgiving.
- My understanding the rule doesn't change what manufacturers charge, just what CMS pays in compensation to hospitals or doctors for those patients who are fee for service Medicare patients.
- It doesn't affect Medicare Advantage except in that overall per-patient capitation for MA will slip downward as FFS payments are reduced.
A number of major stakeholders, including the Pharmaceutical Research and Manufacturers of America (PhRMA), the Association of Community Cancer Centers (ACCC), the Global Colon Cancer Association (GCCA) and National Infusion Center Association (NICA), filed a law suite against the CMS pilot on December 4.
- See ACCC press release here.
- See PhRMA here.
- You can download a legal one pager or the full case from the prior link.
- Full complaint PDF here.
- There are collateral motions like injunctions and restraining orders.
- See trade press:
Demo 3113, Complex Tests, Date of Service
As of 12/2020, HHS still has a guidance webpage for Pilot 3113, one dated January 28, 2011, one dated March 10, 2011. It refers to transmittal CR7278, Publication 100-19, Demonstrations, Transmittal 70. Here. CMS excluded tests that didn't have specific CPT codes, which left the advocates for this demo in the lurch, since proprietary codes (MAAA codes) or PLA codes...hadn't been invented yet.
Admittedly, the projects are supposed to be expected to not reduce health quality and not raise costs, which produces some scope limitations, but those are just guidelines for what the agency says it hopes to achieve in a demo.
However, there's a quirk in that the law says CMS may suspend or change (waive) any aspect of Medicare law "solely for purposes of carrying out this section with respect to testing models described in subsection (b)" where (b) refers to Pilots, not Extensions. I've seen CMS argue, somewhere in the Federal Register, that the law giving ability to waive law for pilot projects (b) implies it can also waive law for resulting permanent programs. However, as a non attorney, I find that reading hard to believe, see the law specifically says waivers can be SOLELY for the purpose of the section on pilot models "b." Expansion of models is law section "c". To me, a law that is "solely for [b] " is a law that does not include the adjacent "c." Of course, CMS could escape this problem by making the demo "b" phase 99 years long instead of a year or two, so the demo never faces finalization as expansion phase "c."
This proposed rule discusses the implementation of a new Medicare payment model under section 1115A of the Social Security Act (the Act). We propose the Part B Drug Payment Model as a two-phase model that would test whether alternative drug payment designs will lead to a reduction in Medicare expenditures, while preserving or enhancing the quality of care provided to Medicare beneficiaries. The first phase would involve changing the 6 percent add-on to Average Sales Price (ASP) that we use to make drug payments under Part B to 2.5 percent plus a flat fee (in a budget neutral manner). The second phase would implement value-based purchasing tools similar to those employed by commercial health plans, pharmacy benefit managers, hospitals, and other entities that manage health benefits and drug utilization. We believe this model will further our goals of smarter, that is, more efficient spending on quality care for Medicare beneficiaries.
CMS's COVID Test Table Pertains to Physician Ordering PHE Rules, Not To Coverage
UPDATE.
A colleague pointed out that CMS says its ;lengthy table of COVID-containing tests is a comprehensive listing of all tests that contain COVID, and any of them may qualify for special emergency rules regarding a physician's order. However, CMS adds the table ONLY concerns tests that fall under its physician-order-policy, and this is not a table regarding COVERAGE. For example, a 22-pathogen test containing COVID would fall under the special ordering rules, BUT it is not necessarily covered by various MACs. Check with the MAC.
See the CMS clarification at its (currently 165 page) guidance of COVID special rules, here:
https://www.cms.gov/files/document/03092020-covid-19-faqs-508.pdf
I'm quoted from the 12/8 update, but the particular question in the FAQ is dated back to 6/19.
11. Question: Does the CMS table “COVID-19, Influenza, and RSV Clinical Diagnostic Laboratory
Tests for which Medicare Does Not Require a Practitioner Order during the PHE” list Clinical Diagnostic Laboratory Test codes that Medicare will cover during the PHE? Answer: This table lists codes that, if otherwise covered by Medicare, do not require a treating practitioner’s order as a condition of Medicare payment. The table should not be interpreted as a statement of coverage for the listed codes. There may be some codes for which there are local coverage determinations that non-cover or limit coverage of certain tests. Practitioners and laboratories should check with their local Medicare Administrative Contractor regarding specific questions of coverage. New 6/19/20
Friday, December 11, 2020
A Third Party Description of the MOLDX System
- I can't vouch if I think every word of this is correct, but it's a pretty good review of the MOLDX system written by a third party in 2017, looking at the JJ transition in 2018.##
The Molecular Diagnostic Services (MolDX) Program
on Tuesday, 07 November 2017. All News Items | Outpatient Services | Medicare Coverage
ATTENTION JURISDICTION J PROVIDERS – ACTION NEEDED
Over the past several weeks, our newsletter has focused attention on the transition of the Jurisdiction J (Alabama, Georgia, and Tennessee) Medicare Administrative Contractor (MAC) from Cahaba to Palmetto GBA. For those providers affected by this transition, please pay special attention to this article as you will be required to participate in this program under the Palmetto contract. Special information affecting Jurisdiction J is included at the end of this article.
If you are a regular reader of our Wednesday@One newsletter, you may already know that my original role in healthcare was as a clinical laboratory scientist (CLS) or Medical Technologist (MT). I loved working in the clinical laboratory, but my detail oriented brain also loves my current work with Medicare regulations. In the realm of healthcare compliance, I keep up with the rapid and never-ending changes of Medicare healthcare regulations. Unfortunately, since Compliance is now my focus, I no longer keep up with the also rapid and never-ending changes to laboratory medicine.
Molecular diagnostic testing (MDT) is one area of laboratory advancements that is having a tremendous impact on the practice of medicine overall. Human genomics is reshaping the medical approach to therapy and diagnosis in areas such as inherited genetic diseases, infectious disease, oncology, human leucocyte antigen typing to predict immune function, coagulation, and pharmacogenomics—the genetic prediction of which drugs will work best. As this testing has become more common, healthcare payers have struggled with determining the appropriate coverage and payment for these tests.
Some of the challenges for Medicare related to molecular diagnostic testing were:
- HCPCS and CPT descriptions for these codes describe the pathology and laboratory categories but do not identify a specific test.
- The Clinical Laboratory Fee Schedule pricing methodology does not account for the unique characteristics of these tests.
- Who determines if the tests fall within a Medicare benefit category?
- Some tests have not been assessed for clinical and analytical validity and clinical utility.
Medicare’s solution was the Molecular Diagnostic Services (MolDX) Program, which was developed by Palmetto GBA in 2011 to identify and establish coverage and reimbursement for molecular diagnostic tests. Palmetto GBA currently administers the MolDX Program and all its information.
The program applies to all private, reference, and hospital laboratories that perform molecular diagnostic testing and submit claims to Medicare Part A or Part B. The following molecular diagnostic assays/tests are included in MolDX.
Code Category/Description 2017 MolDX CPT Code Range Tier 1 81161-81383 Tier 2 81400-81408 Genomic Sequencing and other MAA 81410-81471 Molecular Multianalyte Assays (MAA) 81490-81595 MAA Proprietary Codes 0001M-0009M Immunology 86152-86153 Microbiology 87149, 87150, 87505-87507 PLA *All Codes NOC 81479, 81599, 84999, 85999, 86849, 87999, 88199, 88299, 88399, 89398 How does the MolDX Program address the above challenges?
The MolDX program performs the following functions, which solve the challenges noted above concerning molecular diagnostic tests:
- Facilitates detailed and unique identification through registration of molecular diagnostics tests to facilitate claims processing and to track utilization.
- Establishes clinical utility expectations
- Completes technical assessments of published test data to determine clinical utility and coverage
- Establishes reimbursement
How does the MolDX Program work?
Obtain a DEX Z-Code
Laboratories must apply for and obtain a unique test identifier for each MDT or LDT (lab developed test) they perform.
Attention Hospitals - You are NOT expected to submit tests to obtain Z-Codes for tests sent to another laboratory to perform. You submit tests to obtain a Z-code only for those tests you perform in-house. However, the MolDX FAQs state it is the responsibility of the billing provider to obtain a DEX Z-Code™ identifier, such as in cases where the performing lab is not in a jurisdiction under the MolDX program. Since reference labs performing genetic testing generally offer services across the nation, most will have already obtained the necessary Z-codes.
These are the steps required for participation in the MolDX program:
- You are required to register your organization in the DEX Diagnostics Exchange if you plan to submit claims for the MolDX codes to MACs participating in the MolDX program (see list of Participating MACs below).
- Providers billing Part A for molecular tests performed by a proprietary or reference laboratory will “Request Sharing” in DEX, from your reference lab, to get access to the Z-Code for billing purposes. You must obtain the DEX Z-CodeTM for the molecular test(s) from the performing laboratory, either directly or through the DEX system.
- Hospital providers billing for molecular services performed by their hospital-based laboratory must register and obtain a unique DEX Z-CodeTM for each molecular test in the MolDX code ranges designated above.
Obtain a Technical Assessment Approval (Coverage Determination)
Once a Z-code is assigned, coverage is determined through a technical assessment (TA). Established FDA-approved tests with proven utility that are performed within labeling indications may not require a technical assessment. A TA is required for molecular assays that are laboratory developed tests (LDT), employ new or novel technology, or have undefined or unproven clinical utility. For these tests, labs/developers must submit a detailed dossier of clinical data to substantiate the test meets Medicare’s requirements for coverage. The Technical Assessment Submission Instructions (M00115) provides the steps to submit a dossier.
All new test services will be denied as noncovered until the test completes the TA process and reasonable and necessary criteria is established. Claims submission for tests in the TA process should be suspended until a final coverage determination is made. Labs should not provide lab tests pending a TA approval until coverage is approved and appropriate billing and coding guidelines are published.
Once a coverage determination has been established, the results will be published to the provider community. A Local Coverage Determination (LCD) or Coverage Article may be developed if the test requires administration of reasonable and necessary limitations.
Report Z-Code on Claim
When the unique test identifier (DEX Z-Code™) is reported in conjunction with the appropriate CPT/HCPCS code on the claim, it allows Medicare to determine the exact test that has been performed, facilitating the process of making pricing and/or coverage determinations. The MolDX Manual provides instructions on the claim line detail fields for reporting the Z-codes.
- Part B providers – Paper claim - Block 19 of the CMS 1500 claim form; electronic claims (837P) - SV101-7 field adjacent to the applicable CPT code.
- Part A providers – Paper claim - block 80 of the UB04 claim form; electronic claims (837I) - line SV202-7.
- Part A providers will need to specify which lines are billed for MolDX and the appropriate DEX Z-Code per line within the remarks section of the claim.
Adjudication
The molecular test is adjudicated in accordance with the MAC’s LCDs and coverage articles.
Palmetto GBA’s “Molecular Diagnostic Tests (MDT)” LCD provides coverage for MDTs and LDTs that are identified as covered in the LCD. Palmetto has also developed and published specific LCDs, and/or coverage articles for some MolDX tests. MDTs and LDTs not identified as covered in an NCD, LCD, or coverage article are not covered. Palmetto GBA will continue to accept and consider requests on excluded genetic tests. You can find a link to Palmetto’s LCDs, as well as list of covered and excluded tests, on Palmetto’s MolDX website.
Participating MACs
Although Palmetto “owns” the MolDX program, several other MACs also participate in the program. These include Noridian JE and JF, CGS J15, and WPS J5 and J8. Each of these MACs have coverage policies and websites dedicated to the MolDX program. If you are a provider in one of these jurisdictions, please check you MACs website for more information. At this time CMS has not determined how MolDX will be expanded.
Jurisdiction J Transition
Medicare Part A and Part B providers in the Palmetto GBA Jurisdiction J will be required to register all molecular tests with the Diagnostics ExchangeTM (DEX), an online test registry. There will be a phase in for Jurisdiction J to allow time for test providers to obtain their Z-codes. We strongly suggest labs and other test providers begin the process now to avoid any claim processing delays once the Z-code is required on the claim, which is currently projected to be no later than claims submitted on or after June 1, 2018 (note this is not Date of Service driven).
Refer to the Steps for Participating in the MolDX Program listed above to determine exactly what actions are needed for JJ providers billing for molecular diagnostic testing. JJ providers should carefully study all the information on the MolDX website and become familiar with Palmetto’s MolDX LCDs. This is a necessary piece of the JJ transition.
Tuesday, December 8, 2020
Jan 2020: FDA Draft Clinical Effectiveness Rules (for Drugs)
Quinn file as:
2019 FDA 1201 Clin Effectiveness of Drugs (Draft) 21pp.pdf
Monday, December 7, 2020
Excel Match, VLookup, Index Functions
See an earlier column in 7/2020 here.
___
Let's say I've got two different Excel tables. One gives NPI numbers in Column A, and Test Names in Column B, and Test Prices in Column C.
The other gives NPI numbers in Column A and Lab Name in Column B.
Easy to see where this is going. I want ONE table that gives:
- NPI Number, and Lab Name, and Test Name, and Test Price, in four columns on one page.
Basically, you start with the longer table - let's say its NPI + Name + Price. You insert a new column between NPI and Name. Now, on a separate sheet, you place the two columns of NPI and Lab Name.
You go down the empty column, and take the NPI number at its left, and look through the other table from top to bottom until you find a matching NPI. Then, you insert the Lab Name next to that NPI (in the second table) into the empty column in the first table.
Here are some instructions.
How to use INDEX and MATCH
https://exceljet.net/index-and-match
VIDEO: How to use INDEX and MATCH
https://www.youtube.com/watch?v=yH_ArqoB0no
How to use INDEX and MATCH
https://www.excel-easy.com/examples/index-match.html
How to use VLOOKUP
VIDO: How to use VLOOKUP
How to use VLOOKUP
https://www.excel-easy.com/examples/vlookup.html
___
zexcel

