tag:blogger.com,1999:blog-83343212718272177592024-03-19T01:47:50.635-07:00Discoveries in Health PolicyIdeas for or from an evolving healthcare systemBrucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comBlogger2542125http://www.discoveriesinhealthpolicy.com/2024/03/cms-one-adlt-application-in-three-fails.htmltag:blogger.com,1999:blog-8334321271827217759.post-244884152860367342024-03-18T11:06:00.000-07:002024-03-18T11:06:30.257-07:00CMS, One ADLT Application in Three Fails
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Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.com"ADLT" is a narrow, special class of lab test with special pricing. About 15 of 23 applicaitons for this status have succeeded.##What are ADLTs?Created by the 2014 PAMA legislation, ADLT means advanced diagnostic laboratory test. However, it's not "advanced" in a general sense. It's a very specifically defined category. Applicable tests skip the crosswalk-gapfill
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http://www.discoveriesinhealthpolicy.com/2024/03/fda-publishes-position-and-plans-on-ai.htmltag:blogger.com,1999:blog-8334321271827217759.post-65022522590377867742024-03-16T18:16:00.000-07:002024-03-17T09:56:17.407-07:00FDA Publishes Position and Plans on AI Regulation. And Plans for Internal AI, Too.
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Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comOn March 15, 2024, FDA publishes a 7-page position paper on its plans for regulating AI, including a discussion of how different parts of the agency will work together. ALSO includes a vision for internal use of AI at FDA (Califf blog).##See the agency's cross-departmental home page for AI, including the new 7p white paper and a blog by the Comimissioner - here. The blog includes
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http://www.discoveriesinhealthpolicy.com/2024/03/house-holds-hearing-on-ldt-regiulation.htmltag:blogger.com,1999:blog-8334321271827217759.post-64486372110812761022024-03-15T09:07:00.000-07:002024-03-18T09:26:11.413-07:00FDA LDT ON HILL: House Holds Hearing on LDT Regulation: March 21, 2024
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Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comHeader: House E&C committee holds hearing on FDA LDT on March 21, 2024. Pair with Sen. Cassidy's request for input on FDA LDT, open til April 3.##The House Energy & Commerce committee will hold a hearing on FDA LDT issues, on March 21, 2024 at 10 am ET. See details in press release. Expect to hear from ACLA, CAP, AdvaMed, Friends of Cancer Research.https://
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http://www.discoveriesinhealthpolicy.com/2024/03/senate-requests-information-asap-on-lab.htmltag:blogger.com,1999:blog-8334321271827217759.post-53358596849876543722024-03-14T10:45:00.000-07:002024-03-17T09:46:10.435-07:00FDA LDT ON HILL: Senate Requests Information ASAP on Lab Regulation
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Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.com Senator Cassidy has requested public input on regulation of laboratory tests. The deadline for written documents is April 3, but I've also heard there may be a hearing as early as March 21. Stay tuned.###Update; House holds hearing on March 21 - here.###See the Senate HELP RFI press release here:https://www.help.senate.gov/ranking/newsroom/press/
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http://www.discoveriesinhealthpolicy.com/2024/03/nejm-quartet-of-papers-about-non.htmltag:blogger.com,1999:blog-8334321271827217759.post-34267787888394316592024-03-13T15:47:00.000-07:002024-03-15T12:38:14.399-07:00NEJM: A Quartet of Papers about Non Invasive CRC Screening
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Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.com NEJM offers a quartet of papers on new tests for non invasive Colorectal Cancer screening.Chung et al. report a 10,000 patient study with specificity of about 90% and cancer sensitivity of about 83%-87% depending on definition. Imperiale et al. report a next-generation of a stool test, 20,000 patients, with sensitivity and specificity both in the 90% range.Carethers of UCSD
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http://www.discoveriesinhealthpolicy.com/2024/03/fda-guidance-for-early-alzheimers.htmltag:blogger.com,1999:blog-8334321271827217759.post-51052995872809544192024-03-11T14:07:00.000-07:002024-03-16T15:36:21.914-07:00FDA Guidance for Early Alzheimer's Disease: Key Roles of Biomarkers
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Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comRecently, both LA Times (February 14) and NY Times (March 4) have had articles on the debates about how to define the use of biomarkers in early Alzheimer's disease, and at what point the term "Alzheimer's Disease" comes into play for early cases. FDA releases for comment a new 11-page draft guidance on early diagnosis of Alzheimer's by biomarkers and subtle cognitive testing.
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http://www.discoveriesinhealthpolicy.com/2024/03/in-writing-my-prediction-for-fda-ldt.htmltag:blogger.com,1999:blog-8334321271827217759.post-17570584644086994302024-03-08T11:17:00.000-08:002024-03-11T16:48:13.666-07:00In Writing: My Prediction for FDA LDT, 2024-2031
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Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.com It was big news in the past week that FDA has sents its final LDT rule to the White House for final sign-off and publication. https://www.discoveriesinhealthpolicy.com/2024/03/very-brief-blog-fda-sends-final-ldt.htmlI'm putting my official multi year policy forecast in writing. Here. Click to enlarge.click to enlargeDiscussion.First, for simplicity, I'm leaving the
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http://www.discoveriesinhealthpolicy.com/2024/03/white-house-arpa-h-launch-new-cancer.htmltag:blogger.com,1999:blog-8334321271827217759.post-15845957727046028452024-03-08T10:27:00.000-08:002024-03-15T13:31:34.224-07:00White House, ARPA-H Launch New Cancer Program "ADAPT"
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Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comHeader: In a press release March 7, 2024, the Biden administration announces its "ADAPT" program, via ARPA-H, which is new programs in precision oncology and adaptive oncology. The total budget is $400M.##See the press release here.See the ADAPT home page at ARPA, here.Here's a solicitation for a "Proposer's Day," here. And a solicitation website here. See a 25 page PDF
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http://www.discoveriesinhealthpolicy.com/2024/03/journal-club-tsimberidou-et-al-practice.htmltag:blogger.com,1999:blog-8334321271827217759.post-66126108837865405912024-03-07T08:49:00.000-08:002024-03-15T15:41:58.152-07:00Journal Club: Tsimberidou et al, Practice Gaps for Genomics in Cancer Care
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Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.com A new paper on March 5, 2024, from Tsimberidou, Sireci, Dumanois, and Pritchard: "Strategies to Address the Clinical Practice Gaps Affecting the Implementation of Personalized Medicine in Cancer Care." Find it open access at J Clin Oncol / Practice.https://ascopubs.org/doi/pdf/10.1200/OP.23.00601Issues discussed include:Biopsy referralBiospecimen collection (
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http://www.discoveriesinhealthpolicy.com/2024/03/timeline-ncd-request-to-final-change-25.htmltag:blogger.com,1999:blog-8334321271827217759.post-76720282930259254112024-03-06T14:31:00.000-08:002024-03-06T14:31:09.780-08:00Timeline: NCD Request to Final Change, 2.5 Years (!)
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Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comHeader: How long did it take to get an NCD changed? 2.5 years.##In October 2021, the American Society of Hematology and other major groups requested CMS to expand coverage of stem cell transplantation in myelodysplastic syndrome (MDS), and remove a CED requirement dating back to 2010. https://www.cms.gov/Medicare/Coverage/DeterminationProcess/downloads/id312.pdfThe 9-page letter
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http://www.discoveriesinhealthpolicy.com/2024/03/ai-corner-can-ai-read-focr-poster-on.htmltag:blogger.com,1999:blog-8334321271827217759.post-13926553502612237452024-03-06T11:07:00.000-08:002024-03-07T10:53:52.194-08:00AI Corner: Can AI Read the FOCR Poster on HRD Harmonization?
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Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comHeader: FOCR summarized interim results of its HRD harmonization workstream as a poster. I found the poster hard to get my head around. Can AI read the poster better than me?###For a couple years, Friends of Cancer Research FOCR has been running a major project on HRD harmonization - homologous recombination deficiency testing. Today I got a long email from
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http://www.discoveriesinhealthpolicy.com/2024/03/friends-of-cancer-research-note-on.htmltag:blogger.com,1999:blog-8334321271827217759.post-76665327136967056492024-03-06T10:45:00.000-08:002024-03-06T11:43:46.218-08:00Friends of Cancer Research - Note on "External Control Studies" ]]>
Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.com I was using the Friends of Cancer Research website today and ran across an article, though from 2019, that's still a good reference. It discusses "external control arm" studies, such as when contemporary external controls are used as a reference, or when administrative controls (based on computer records) are used as a reference.I am sure this can be good sometimes, but experts
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http://www.discoveriesinhealthpolicy.com/2024/03/chai-coalition-for-health-ai-launches.htmltag:blogger.com,1999:blog-8334321271827217759.post-77761596799568401092024-03-05T09:39:00.000-08:002024-03-05T10:13:08.072-08:00CHAI: Coalition for Health AI Accelerates, Names Leadership
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Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comSee a March 4, 2024, press release that the COALITION FOR HEALTH AI or CHAI has launched and has named its board of directors and CEO. Brian Anderson MD will be the first CEO, and the Board will be chaired by John Halamka MD. See press release:https://www.coalitionforhealthai.org/updates/march-4th-2024They also held a webinar kick off event on March 5, led by FDA Commissioner Dr
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http://www.discoveriesinhealthpolicy.com/2024/03/very-brief-blog-ama-confirms-new.htmltag:blogger.com,1999:blog-8334321271827217759.post-8823809641148063932024-03-05T09:33:00.000-08:002024-03-05T17:31:16.035-08:00Very Brief Blog: AMA Confirms New Alzheimer CPT Codes
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Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comAt the February 2024 CPT meeting, AMA considered several CPT codes for neurologic disease. Three out of four passed. These are CPT codes for Amyloid (40,42) and CPT code for Phospho-Tau and for Tau-Total. A fourth ALZ code, for neurofilament, was withdrawn but has appeared already on the May 2024 agenda.The new Neuro codes (including the May neurofilament one) will
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http://www.discoveriesinhealthpolicy.com/2024/03/nerd-note-position-of-national-quality.htmltag:blogger.com,1999:blog-8334321271827217759.post-68392500535940070452024-03-04T09:19:00.000-08:002024-03-05T17:19:41.849-08:00Nerd Note: Medicare Law Remarks on Costs of Quality Measures, CPT Codes
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Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comHeader. Congress renews funding for a quality measures institute. From that springboard, we discuss pricing and cost policy for both quality measures and the CPT.##As discussed in this blog in August 2023, HHS transferred the longstanding quality measures contract from National Qualify Forum (NQF) to Battelle, where it is now titled, the PQP Partnership for Quality Measurement.https:/
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http://www.discoveriesinhealthpolicy.com/2024/03/literary-note-dr-abraham-verghese.htmltag:blogger.com,1999:blog-8334321271827217759.post-76310095370790036612024-03-03T15:50:00.000-08:002024-03-04T09:34:26.935-08:00Literary Note: Dr Abraham Verghese Discusses Life, Career
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Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comHEADER: I rarely mention literatry events but here is one. Dr. Abraham Verghese, clinician and novelist, in a 45 minute interview on C-Span.##Dr Abraham Verghese was raised in Ethiopia, where he started medical school until a revolution closed it. (One of his classmates become a guerrila and eventually prime minister).Verghese finished medical school in India and has had most of his career
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http://www.discoveriesinhealthpolicy.com/2024/03/very-brief-blog-fda-sends-final-ldt.htmltag:blogger.com,1999:blog-8334321271827217759.post-20699007434678799552024-03-02T10:48:00.000-08:002024-03-18T14:28:08.451-07:00NOTEWORTHY: FDA Sends Final LDT Rule to White House
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Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comHeader: FDA Sends Finalized LDT Rule to White House OMB/OIRA##Moving at a fast pace, FDA has finalized its review of comments on the LDT regulation, and the final regulation was logged at the White House on March 1, 2024. Specifically, the rule is at the Office of Management and Budget (OMB) in the Office of Information and Regulatory Affairs (OIRA).https://www.reginfo.gov/public/do/
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http://www.discoveriesinhealthpolicy.com/2024/03/scispace-tool-for-biomedical-paper.htmltag:blogger.com,1999:blog-8334321271827217759.post-5079696052026485572024-03-01T13:11:00.000-08:002024-03-02T10:37:04.362-08:00SCISPACE: An AI tool for biomedical paper research
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Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comLike SCITE, "SCISPACE" is a sort of PubMed on AI steroids. You'll get AI-driven bells and whistles, compared to a plain-jane PubMed search.## On February 22, 2024, I highlighted SCITE, a tool for studying who's cited a key biomedical paper, how they've cited it, and seeing related papers. Here, a few words about another tool in this space, SCISPACE. Find it here: https:
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http://www.discoveriesinhealthpolicy.com/2024/03/webinar-march-7-telehealth-genetics.htmltag:blogger.com,1999:blog-8334321271827217759.post-50127089146063475302024-03-01T12:42:00.000-08:002024-03-08T12:47:11.563-08:00Webinar March 7; Telehealth, Genetics, Precision Medicine. Now with e-Summary of Deck.
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Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.com See a webinar on March 7, 2024, sponsored by the California Telehealth Resource Center:"Success and Sustainability: Digitally-provided Genetic Services Overcome Obstacles to Patient Access to Precision Medicine."Find more info here:https://caltrc.org/events/success-and-sustainability-digitally-provided-genetic-services-overcome-obstacles-to-patient-access-to-precision-medicine/See 49 slide
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http://www.discoveriesinhealthpolicy.com/2024/02/cms-update-notice-cms-updatets.htmltag:blogger.com,1999:blog-8334321271827217759.post-86607259622087320122024-02-29T08:00:00.000-08:002024-03-04T09:27:52.507-08:00CMS Update Notice - MolDx Updates a Major Transplant Article, CMS Highlights in New Press Release ]]>
Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.com I've had a number of questions about the February 22 WSJ Op Ed about Medicare and CareDx, and I've been putting together notes for an essay.##UPDATE - On February 29, 2024, see updated press release from CMS and updated billing article A58019 from MolDx.##For some CareDx news from the day before, Feb 28, see my blog here.See also coverage of
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Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comI've had a number of questions about the February 22 WSJ Op Ed about Medicare and CareDx, and I've been putting together notes for an essay.##UPDATE - On February 29, seeupdated press release from CMS and updated billing article A58019 from MolDx.##But meanwhile, on February 28, CareDx held its 4Q-2023 investor call, and issued its updated SEC 10-K form.Hint: The 10-K report uses
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http://www.discoveriesinhealthpolicy.com/2024/02/nerd-note-ama-explains-image-bundling.htmltag:blogger.com,1999:blog-8334321271827217759.post-46635896498421739052024-02-28T14:33:00.000-08:002024-02-28T21:30:06.416-08:00Nerd Note: AMA Explains "Image Bundling"
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Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comCoding in AMA CPT may include optional language, such as "Sequencing, including duplication-deletion analysis if performed."One area of healthcare where separate coding, add-on coding, and bundled coding may fly together is imaging plus procedures. The term of art is "image bundling" and it is an area of advanced policy at AMA CPT.See their entertaining flow chart and instructions:https://
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http://www.discoveriesinhealthpolicy.com/2024/02/very-brief-blog-natera-wins-moldx.htmltag:blogger.com,1999:blog-8334321271827217759.post-43422773851437643452024-02-26T11:06:00.000-08:002024-02-26T12:00:31.814-08:00Very Brief Blog: Natera Wins MolDx Coverage for MRD in Neoadjuvant Breast Cancer and in Ovarian Cancer
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Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comHeader: Natera, which provides the bespoke (patient-tailored) Signtera test for minimal residual disease, wins MolDx coverage for breast and ovarian cancer.##Natera's Signatera test, which screens for minimal residual disease with a bespoke test that is custom-tuned to each patient's prior tumor exome or large panel, adds more Medicare coverage from MolDx.Coverage is for use in neoadjuvant
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http://www.discoveriesinhealthpolicy.com/2024/02/journal-club-peabodys-2021-paper-on.htmltag:blogger.com,1999:blog-8334321271827217759.post-17968956337210280642024-02-23T13:25:00.000-08:002024-02-25T09:14:57.239-08:00Journal Club: Peabody's 2021 Paper on Success and Failure in Diagnostic Startups
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Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comHeader: John Peabody founded the medical consultancy QURE. In 2021, they published a paper on diagnostic startups, successes and failures, in "BMJ Innovations."##John Peabody MD founded the consultancy QURE (later acquired, still active). I stumbled across an interesting 2021 paper of his - find the article online here. (Firewall). For the BMJ Innovations
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http://www.discoveriesinhealthpolicy.com/2024/02/ama-posts-lab-test-agenda-for-may-2024.htmltag:blogger.com,1999:blog-8334321271827217759.post-21339385835351384512024-02-22T22:24:00.000-08:002024-03-08T10:09:23.416-08:00AMA Posts Lab Test Agenda for May 2024 CPT Meeting
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Brucehttp://www.blogger.com/profile/05149672650241065616noreply@blogger.comHeader: Months ahead of each CPT meeting, AMA publishes for comment the lab test agenda.##Months ahead of each CPT meeting, and before other codes, AMA publishes for comment the lab test agenda. Find it here:https://www.ama-assn.org/about/events/cpt-editorial-panel-meeting#agendahttps://www.ama-assn.org/system/files/may-2024-lab-mopath-agenda.pdfIf you want to comment:Read the PDF.&