30 SEP-1 Titles from PubMed (June 2021)

 This is based on a crude search for SEP-1 titles only, in PubMed.

##

Allison, M. G. and S. M. Schenkel (2018). "SEP-1: A Sepsis Measure in Need of Resuscitation?" Ann Emerg Med 71(1): 18-20.

Baghdadi, J. D., et al. (2020). "SEP-1 Septic Shock Bundle Guidelines Not Applicable to Inpatients-Reply." JAMA Intern Med 180(12): 1713-1714.

Baghdadi, J. D., et al. (2020). "Adherence to the SEP-1 Sepsis Bundle in Hospital-Onset v. Community-Onset Sepsis: a Multicenter Retrospective Cohort Study." J Gen Intern Med 35(4): 1153-1160.

Barbash, I. J., et al. (2019). "National Performance on the Medicare SEP-1 Sepsis Quality Measure." Crit Care Med 47(8): 1026-1032.

Barbash, I. J., et al. (2021). "Treatment Patterns and Clinical Outcomes After the Introduction of the Medicare Sepsis Performance Measure (SEP-1)." Ann Intern Med.

Barbash, I. J. and J. M. Kahn (2019). "Sepsis quality in safety-net hospitals: An analysis of Medicare's SEP-1 performance measure." J Crit Care 54: 88-93.

Bauer, S. R., et al. (2019). "Inter-rater Agreement for Abstraction of the Early Management Bundle, Severe Sepsis/Septic Shock (SEP-1) Quality Measure in a Multi-Hospital Health System." Jt Comm J Qual Patient Saf 45(2): 108-111.

Bauer, S. R., et al. (2020). "Association Between Compliance With the Sepsis Quality Measure (SEP-1) and Hospital Readmission." Chest 158(2): 608-611.

Faust, J. S. and S. D. Weingart (2017). "The Past, Present, and Future of the Centers for Medicare and Medicaid Services Quality Measure SEP-1: The Early Management Bundle for Severe Sepsis/Septic Shock." Emerg Med Clin North Am 35(1): 219-231.

Heil, E. L., et al. (2020). "Recommended Revisions to the National SEP-1 Sepsis Quality Measure: A commentary by the Society of Infectious Diseases Pharmacists on the Infectious Diseases Society of America Position Paper." Pharmacotherapy 40(4): 368-371.

Jorgensen, A. L. (2019). "Nurse Influence in Meeting Compliance With the Centers for Medicare and Medicaid Services Quality Measure: Early Management Bundle, Severe Sepsis/Septic Shock (SEP-1)." Dimens Crit Care Nurs 38(2): 70-82.

Klompas, M. and C. Rhee (2021). "Has the Medicare Sepsis Performance Measure (SEP-1) Catalyzed Better Outcomes for Patients With Sepsis?" Ann Intern Med.

Liao, J., et al. (2020). "Association of Hospital Characteristics With Early SEP-1 Performance." Am J Med Qual 35(2): 110-116.

Marik, P. E. (2018). "SEP-1: The Lactate Myth and Other Fairytales." Crit Care Med 46(10): 1689-1690.

Marik, P. E. and M. Malbrain (2017). "The SEP-1 quality mandate may be harmful: How to drown a patient with 30 mL per kg fluid!" Anaesthesiol Intensive Ther 49(5): 323-328.

Miller, J., et al. (2020). "Impact of SEP-1 on broad-spectrum combination antibiotic therapy in the emergency department." Am J Emerg Med 38(12): 2570-2573.

Motzkus, C. A. and C. M. Lilly (2017). "Accountability for Sepsis Treatment: The SEP-1 Core Measure." Chest 151(5): 955-957.

Peled, H., et al. (2021). "Modify Centers for Medicare & Medicaid Services' Sepsis Core Measure (SEP-1) Now to Optimize Care for COVID-19." Ann Intern Med 174(6): 860-861.

Pepper, D. J., et al. (2018). "Evidence Underpinning the Centers for Medicare & Medicaid Services' Severe Sepsis and Septic Shock Management Bundle (SEP-1): A Systematic Review." Ann Intern Med 168(8): 558-568.

Pepper, D. J., et al. (2018). "Evidence Underpinning the Centers for Medicare & Medicaid Services' Severe Sepsis and Septic Shock Management Bundle (SEP-1)." Ann Intern Med 168(8): 610-612.

Pepper, D. J., et al. (2019). "Antibiotic- and Fluid-Focused Bundles Potentially Improve Sepsis Management, but High-Quality Evidence Is Lacking for the Specificity Required in the Centers for Medicare and Medicaid Service's Sepsis Bundle (SEP-1)." Crit Care Med 47(10): 1290-1300.

Rhee, C., et al. (2018). "Variability in determining sepsis time zero and bundle compliance rates for the centers for medicare and medicaid services SEP-1 measure." Infect Control Hosp Epidemiol 39(8): 994-996.

Rhee, C., et al. (2021). "Infectious Diseases Society of America Position Paper: Recommended Revisions to the National Severe Sepsis and Septic Shock Early Management Bundle (SEP-1) Sepsis Quality Measure." Clin Infect Dis 72(4): 541-552.

Rhee, C., et al. (2018). "Compliance With the National SEP-1 Quality Measure and Association With Sepsis Outcomes: A Multicenter Retrospective Cohort Study." Crit Care Med 46(10): 1585-1591.

Rhee, C., et al. (2020). "SEP-1 Has Brought Much Needed Attention to Improving Sepsis Care...But Now Is the Time to Improve SEP-1." Crit Care Med 48(6): 779-782.

Sanghvi, S., et al. (2019). "Does the Severe Sepsis and Septic Shock Early Management Bundle (SEP-1) Improve Survival in Septic Adults?" Ann Emerg Med 73(4): 363-365.

Septimus, E. J., et al. (2017). "Sepsis National Hospital Inpatient Quality Measure (SEP-1): Multistakeholder Work Group Recommendations for Appropriate Antibiotics for the Treatment of Sepsis." Clin Infect Dis 65(9): 1565-1569.

Sonis, J. D., et al. (2020). "Utilization of a multidisciplinary emergency department sepsis huddle to reduce time to antibiotics and improve SEP-1 compliance." Am J Emerg Med 38(11): 2400-2404.

Stankiewicz, J., et al. (2020). "SEP-1 Septic Shock Bundle Guidelines Not Applicable to Inpatients." JAMA Intern Med 180(12): 1712-1713.

Sterk, E., et al. (2020). "Comparison of an ED triage sepsis screening tool and qSOFA in identifying CMS SEP-1 patients." Am J Emerg Med 38(10): 1995-1999.

Townsend, S. R., et al. (2021). "Centers for Medicare and Medicaid Services Measure Stewards' Assessment of the Infectious Diseases Society of America's Position Paper on SEP-1." Clin Infect Dis 72(4): 553-555.

Townsend, S. R., et al. (2018). "Evidence Underpinning the Centers for Medicare & Medicaid Services' Severe Sepsis and Septic Shock Management Bundle (SEP-1)." Ann Intern Med 168(8): 609-610.

Wang, J., et al. (2020). "Driving blind: instituting SEP-1 without high quality outcomes data." J Thorac Dis 12(Suppl 1): S22-S36.

Whitfield, P. L., et al. (2020). "Implementation of an adult code sepsis protocol and its impact on SEP-1 core measure perfect score attainment in the ED." Am J Emerg Med 38(5): 879-882.

Placeholder ADU

https://www.healthcaredive.com/news/health-data-giants-ciox-datavant-merge-in-7b-deal/601595/

https://www.healthcaredive.com/news/hhs-warns-providers-insurers-covid-19-testing-must-be-free-for-patients/601617/

##### 

https://endpts.com/with-its-controversial-aducanumab-approval-in-hand-biogen-gears-up-for-a-quick-us-rollout/

https://endpts.com/a-second-adcomm-member-abandons-his-post-in-aftermath-of-controversial-aducanumab-decision/

Weekly Genomics HEOR Website

 https://healtheconomicsandgenomics.com/

zgenomics

zheor

ApoE at CGS MAC (Nix)

 https://www.cgsmedicare.com/partb/topic/mopath/apoe_coding.html

 ApoE Genotype: Coding and Claim Submission Guidelines

ApoE Genotype: Coding and Claim Submission Guidelines

Apolipoprotein (Apo) E genotype testing was developed to assess the risk of cardiovascular disease. Risk assessment for developing a disease or condition in the absence of signs and symptoms of an illness or injury is not defined as a Medicare benefit. CGS has determined that there is insufficient evidence to support the required clinical utility for ApoE genotype testing as a Medicare benefit category. Accordingly, ApoE Genotype tests are statutorily excluded tests.

The following ApoE tests have been identified as non-covered:

Test
ADmark ApoE Genotype Analysis
ApoE
ApoE Genotyping
Apolipoprotein E (APOE) 2 Mutations, Cardiovascular Risk
Apolipoprotein E Genotyping, Blood
ApoE Genotyping
Apolipoprotein E Genotype Analysis
Apolipoprotein E Genotyping
Apolipoprotein E Genotyping

Health care providers are not required to submit claims to Medicare for statutorily non-covered services; however, you may choose to submit claims (e.g., at the patient's request). Claims for ApoE must include:

• Appropriate CPT code for the test
• HCPCS modifier GY (statutorily non-covered service)
• The appropriate ICD-9-CM code(s)
• The name of the test:
  • Electronic claims: Loop 2400, NTE02, or SV101-7 field
  • Paper claims: Block 19

Reference:

• Definition of "reasonable and medically necessary": Social Security Act, section 1862(a)(1)(A)
• Exception to mandatory claim submission for "categorically excluded services": CMS MLN Matters article SE0908, "Mandatory Claims Submission and Its Enforcement"
• Guidance on issuing Advance Beneficiary Notices of Noncoverage (ABNs) on a voluntary basis for statutorily excluded services: CMS Beneficiary Notices Initiative Web page – Fee-For-Service (FFS) ABN

Very Brief Blog; Verily and Parkinson's App: When a Clinical Standard of Care Test Flops with FDA

 To me, there's a tidbit hiding inside today's news item that a Google/Verily app to diagnose Parkinson's disease flopped with the FDA.  Here.

It's not surprising that Verily can measure finger tap speed on a smartwatch or other device.  And this is one of the most common tests in a Parkinson's disease evaluation.  However, it appears that in FDA's rejection of the device, the FDA is actually rejecting the finger tap test itself.  FDA notes that the finger tap speed "is limited in its capacity to evaluate meaningful aspects of concepts of interest that are relevant to patients' ability to funciton in day to day life."  Ouch.

Interesting and perhaps unexpected basis for rejecting something as well-known as a neurologic finger tap test.

Aduhelm Links

July 19

Harrowing reality and stress of Alzeimer's (long, Vox)

https://www.vox.com/policy-and-politics/22577776/alzheimers-disease-dementia-symptoms-aduhelm-drug

Endpoints on "Slick disease awareness campaign"

https://endpts.com/biogen-wasted-no-time-in-rolling-out-a-disease-awareness-campaign-for-alzheimers-as-an-rd-marathon-turns-into-a-sprint-a-top-analyst-awards-gold-silver-and-bronze/

July 15

ADU Debated at ICER

https://www.managedhealthcareexecutive.com/view/aduhelm-pros-and-cons-debated-at-icer-meeting

https://www.fiercepharma.com/pharma/despite-biogen-s-sharp-rebuke-cost-watchdog-experts-unanimously-refute-aduhelm-s-benefits

https://endpts.com/as-investigations-mount-and-controversy-swirls-biogen-fights-back-against-icer-and-then-faces-another-unanimous-slapdown/

Radhakrishnan vilified the ICER report as “inappropriate” and “fundamentally flawed.” Radhakrishnan particularly objected to ICER’s “blending” of the two Phase III trials in its analysis, leading to its flaws.

ADU, AMY PET, META-ANALYSIS

Ackley et al, ...Glymour....Reductions in amyloid [and] cognitive change...

https://www.bmj.com/content/bmj/372/bmj.n156.full.pdf

July 14

Private insurers nix ADU coverage

https://endpts.com/private-insurers-decline-to-cover-biogens-new-alzheimers-drug-in-escalating-standoff-report/

(subsc) https://www.bostonglobe.com/2021/07/13/business/this-is-unprecedented-several-private-insurers-wont-cover-biogens-alzheimers-drug/

Kaiser: We may never know if ADU works

https://khn.org/news/article/commentary-aduhelm-alzheimers-drug-effectiveness/

JAMA

https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2782120

https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2782118

https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2782122

https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2782119

July 7

Rep. Porter, OIG to investigate FDA-Biogen close ties

https://endpts.com/rep-porter-calls-on-hhs-inspector-general-to-investigate-fda-biogen-ties-ahead-of-aduhelm-approval/

July 6

Endpoints on Disapproval of Off-Label Use

https://endpts.com/if-you-thought-the-fdas-approval-of-aduhelm-for-alzheimers-was-controversial-you-should-hear-the-experts-thoughts-on-off-label-use/

Underlying Lancet Article to Endpoints Article (open access)

https://www.thelancet.com/journals/laneur/article/PIIS1474-4422(21)00213-1/fulltext#%20

July 5

ADU approval, questions about AMY Hypothesis

https://www.washingtonpost.com/health/2021/07/05/aduhelm-new-alzheimers-drug-amyloid/

Off-Label ADU _ Amyloid Angiopathy

https://endpts.com/if-you-thought-the-fdas-approval-of-aduhelm-for-alzheimers-was-controversial-you-should-hear-the-experts-thoughts-on-off-label-use/

Acumen Raises $160M for AMY Drugs

https://medcitynews.com/2021/07/all-in-on-amyloid-acumen-pharmas-ipo-raises-160m-for-alzheimers-drug-rd/

Is Alz Assoc serious about ADU pricing?

https://www.statnews.com/2021/07/06/alzheimers-association-pushing-biogen-or-lip-service/

July 2

Class of Molecules, ADU, New Lease on Life

https://endpts.com/the-class-of-molecules-behind-one-of-biotechs-biggest-alzheimers-failures-get-a-new-lease-on-life/

Duke, FDA, Private Meeting with Payers and Stakeholders

https://endpts.com/duke-to-host-private-meeting-with-payers-and-biopharma-on-how-to-pay-for-alzheimers-drugs/

June 30

Medicare "CED" for ADU?

https://www.healthaffairs.org/do/10.1377/hblog20210625.284997/full/

Poll, Most Docs Doubtful re ADU Data

https://www.statnews.com/pharmalot/2021/06/30/biogen-alzheimers-fda-neurologists-primary-care/

ICER on ADU Pricing

At BiopharmaDive

https://www.biopharmadive.com/news/icer-aduhelm-cost-label-revise-biogen/602641/

At Endpoints

https://endpts.com/icer-finds-biogens-new-exorbitantly-priced-alzheimers-drug-doesnt-match-even-an-optimistic-view-of-potential-clinical-benefits/

June 29

Aduhelm Back Channels at FDA; Stat Plus

https://www.statnews.com/2021/06/29/biogen-fda-alzheimers-drug-approval-aduhelm-project-onyx/

June 28

WSJ Dubious on High ADU Costs; Quoting Tunis, Bach

https://www.wsj.com/articles/costly-new-alzheimers-drug-could-force-medicare-to-restrict-access-11624872601

Update at Biopharma Dive

https://www.biopharmadive.com/news/congress-pressure-alzheimers-aduhelm-biogen-fda/602502/

June 27

Summary to date; FDA "hornet's nest," House hearing

https://endpts.com/the-fda-has-now-poked-a-hornets-nest-of-controversy-in-the-house-and-that-could-sting-biogens-mega-blockbuster-quest-in-alzheimers/

June 22

New Drug Costs Equal NASA (NYT)

https://www.nytimes.com/2021/06/22/upshot/alzheimers-aduhelm-medicare-cost.html?referringSource=articleShare

Many Experts Say Limit ADU (NYT)

https://www.nytimes.com/2021/06/21/health/aduhelm-alzheimers-drug.html?searchResultPosition=2

ADU Triggers Cry for Price Reform (Endpoints)

https://endpts.com/biogens-new-alzheimers-drug-serves-as-a-rallying-cry-for-drug-pricing-reforms/

Janet Woodcock Defends ADU Accel Approval

https://endpts.com/woodcock-defends-biogens-new-alzheimers-drug-says-it-has-more-supportive-data-than-many-past-accelerated-approvals/

FDA Releases Approval Meeting Documents

https://www.statnews.com/2021/06/22/documents-reveal-fda-unprecedented-aduhelm-decision/

FDA web page (see "Application Review Files")

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/761178_Orig1s000TOC.cfm

Detailed Footnoted Articles at ALZFORUM (Madolyn Bowman Rogers)

https://www.alzforum.org/news/research-news/aducanumab-approval-sparks-backlash

https://www.alzforum.org/news/research-news/new-era-alzheimers-treatment

June 21

Harvard's Kesselheim Slams ADU decision

https://www.cbsnews.com/news/fda-adviser-alzheimers-drug-aduhelm/?ftag=CNM-00-10aac3a

June 20

Leroy Hood; Wife with Alzheimer's; Son with ApoE4/E4; Exercise FINGERS trial

https://www.latimes.com/opinion/story/2021-06-20/alzheimers-treatment-research-genetics-health

June 17

WaPo: Furor Rages over FDA approval

https://www.washingtonpost.com/health/2021/06/17/alzheimers-drug-controversy/

"Another complication is that the PET scans used to detect amyloid clumps — critical to diagnosing Alzheimer’s — can cost thousands of dollars and are not covered by Medicare. Nor are the multiple follow-up scans needed to check for tiny brain bleeds sometimes caused by the drug."

LATimes: Alzheimer approval looks bad (Hitzik)

https://www.latimes.com/business/story/2021-06-17/fda-alzheimers-drug-looks-worse-than-ever

  Links to report by ALTARUM consultants "raise national health spending 1%" (dateline June 16)

  https://altarum.org/news/new-alzheimer-s-drug-projected-increase-national-health-expenditures-more-one-percent 

June 16

CMS Needs to do FDA job, Limit population

https://endpts.com/opinion-cms-needs-to-do-fdas-job-and-limit-the-use-of-biogens-pricy-new-alzheimers-drug/

Alz Assoc: Stop Discussing the Decision

https://www.statnews.com/2021/06/16/qa-ceo-alzheimers-association-on-aduhelm/

Public Citizen calls on Officials to Resign

https://www.citizen.org/article/letter-to-the-hhs-secretary-calling-for-the-resignations-of-acting-fda-commissioner-other-top-officials-responsible-for-indefensible-approval-of-the-alzheimers-disease-drug-aducanumab/

June 15

Politico:  "Devastating costs," review, incl. PET issues

https://www.politico.com/news/2021/06/15/fda-alzheimers-drug-aduhelm-costs-494546

NYT: Op Ed: "Worst Decision, New Low"

https://www.nytimes.com/2021/06/15/opinion/alzheimers-drug-aducanumab-fda.html?searchResultPosition=2

Woodcock defends at BioCentury (subsc)

https://www.biocentury.com/article/637248/acting-fda-commissioner-woodcock-defends-aducanumab-approval

June 12

Stat Plus: Alz Assoc Condemns Price

https://www.statnews.com/pharmalot/2021/06/12/alzheimers-association-biogen-fda-aduhelm-price/

Stat Plus: Is Woodcock in line of ADU fire?

https://www.statnews.com/pharmalot/2021/06/11/covid19-vaccine-g7-biogen-fda-alzheimers-lilly/

June 10

Biogen hopes quick rollout.

https://endpts.com/with-its-controversial-aducanumab-approval-in-hand-biogen-gears-up-for-a-quick-us-rollout/

Drug Could Break US Healthcare / Bagley

https://www.theatlantic.com/ideas/archive/2021/06/aduhelm-drug-alzheimers-cost-medicare/619169/

Harvard Kesselheim Quits FDA Board

https://www.fiercebiotech.com/biotech/harvard-s-kesselheim-quits-adcomm-over-fda-s-aduhelm-approval

Separately, STAT quotes Kesselheim letter to FDA, "Worst drug decision in recent US history." See his June 15 NYT op ed. 

https://www.statnews.com/2021/06/10/third-member-of-fda-expert-committee-resigns-over-controversial-alzheimers-therapy-decision/

Three Quit FDA, NYT

https://www.nytimes.com/2021/06/10/health/aduhelm-fda-resign-alzheimers.html

In an ASCO video, apparently oncologist Richard Pazdur at FDA says he advised ADU team.

https://www.statnews.com/2021/06/09/virtual-event-the-asco-recap-live-2021/

"Thorny issues ahead for ADU" - Stat Plus

https://www.statnews.com/2021/06/10/biogen-aducanumab-aduhelm-payment-infusions/

Implications across stakeholders; Rachel Sachs JD

https://www.healthaffairs.org/do/10.1377/hblog20210609.921363/full/

June 9

FDA Panelist Resigns (Joel Perlmutter)

https://www.statnews.com/2021/06/08/fda-expert-panel-resigns-alzheimers-approval/

Two Doctors Resign (Business Insider) (Subsc.)

https://www.businessinsider.com/doctors-resign-from-fda-panel-after-aducanumab-biogen-approval-2021-6

   (It's David Knopman, Mayo)

    https://news.yahoo.com/two-members-u-fda-advisory-214345113.html

"Second ad comm members abandons his point." (June 10)

https://endpts.com/a-second-adcomm-member-abandons-his-post-in-aftermath-of-controversial-aducanumab-decision/

Majority Say ADU Disaster

https://endpts.com/what-does-a-clear-majority-of-the-biopharma-industry-think-of-the-fda-approval-of-aducanumab-horrifying-dangerous-confusing-disaster/

Will Biogen Ever Publish ADU??

https://endpts.com/will-biogen-will-ever-publish-the-trial-results-for-its-new-alzheimers-drug/

Bad Drug at High Price

https://www.statnews.com/2021/06/08/aducanumab-lackluster-drug-high-price/

A Drag on Innovation for Years to Come (Op Ed)

https://www.fiercebiotech.com/biotech/editors-corner-fda-s-decision-aducanumab-will-drag-down-innovation-for-years-to-come

June 8

NYT - Bonanza at taxpayer expense; Peter Bach quotes

https://www.nytimes.com/2021/06/08/business/aducanumab-alzheimers-cost.html?action=click&module=Top%20Stories&pgtype=Homepage

LAT - Debated drugs; Benefit 0.39/18, Other AMY lowering drugs didn't work in the past.

https://www.latimes.com/science/story/2021-06-07/us-regulators-ok-alzheimers-drug-against-advice-of-experts

Endpoints - ADU Price, Reactions in Global markets

https://endpts.com/analysts-hound-biogen-with-questions-over-aduhelms-56k-price-point-as-news-of-alzheimers-ok-ripples-through-global-markets/

ADU is $50,000 too much

https://qz.com/2018322/fda-approved-alzheimers-drug-aduhelm-is-50000-too-expensive/#:~:text=According%20to%20ICER%2C%20this%20is,%242%2C500%20to%20%248%2C300%20per%20year.

"A Disgraceful Decision"

https://arstechnica.com/science/2021/06/a-disgraceful-decision-researchers-blast-fda-for-approving-alzheimers-drug/

USA Today; Reagan's daughter; QOL?

https://www.usatoday.com/story/opinion/voices/2021/06/10/alzheimers-disease-new-drug-aduhelm-reagan-daughter/7621335002/

Biogen, FDA at odds over trial timing

https://www.statnews.com/2021/06/08/biogen-fda-at-odds-over-timing-of-crucial-confirmatory-trial-of-alzheimers-drug/

June 7, 2021

Mathew Herper, Stat, Biogen, FDA "Shifts the rules."

https://www.statnews.com/2021/06/07/by-approving-biogen-alzheimers-drug-fda-is-shifting-its-rules-that-is-a-giant-risk/

Adam Feuerstein, Historic approval.

https://www.statnews.com/2021/06/07/fda-grants-historic-approval-to-alzheimers-drug-designed-to-slow-cognitive-decline/

Andrew Joseph, "No limits" on patient pool.

         FDA said on phone call, it might work later patients.

https://www.statnews.com/2021/06/07/twist-fda-alzheimers-decision-no-limits-on-patients/

Damian Garde, The most lucrative drug in pharma history?

https://www.statnews.com/2021/06/07/why-biogen-may-be-sitting-on-the-most-lucrative-product-in-pharmaceutical-history/

Ed Silverman, "The price is bewildering."  "Payers may erect roadblocks." (See Joshua Cohen, below.)

https://www.statnews.com/pharmalot/2021/06/07/biogen-fda-alzheimers-medicare-cms/

 

Endpoints, "Sadly Misguided"

https://endpts.com/just-how-sadly-misguided-is-the-fda-on-aducanumab/

FDA Bent the rules, and that's bad.  Zachary Brennan.

https://endpts.com/opinion-how-the-fda-bent-its-rules-for-biogens-alzheimers-drug-and-why-thats-bad-for-the-entire-biopharma-industry/

FDA approval "sets stage for Medicare coverage battle."  Joshua Cohen, Forbes.

https://www.forbes.com/sites/joshuacohen/2021/06/07/controversial-fda-approval-of-alzheimers-drug-aducanumab-sets-stage-for-possible-medicare-coverage-battle/?sh=4b318da919dc

FDA Phase IV Trial Letter (9pp)

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761178Orig1s000ltr.pdf

Health Affairs - Limit Coverage (CED)

https://www.healthaffairs.org/do/10.1377/hblog20210604.489197/full/

AND:

Fierce Healthcare - CMS Should Act Quickly on NCD; Minemyer

https://www.fiercehealthcare.com/payer/experts-cms-should-act-quickly-a-national-coverage-decision-for-biogen-s-newly-approved

>> Discussion of Dickson, Killelea, RG Frank in HA.

ICER First Day Formal Statement

https://icer.org/news-insights/press-releases/icer-issues-statement-on-the-fdas-approval-of-aducanumab-for-alzheimers-disease/

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#####

Other News

One Medical, Iora, another huge merger in the mixed provider/payor space

https://www.statnews.com/2021/06/07/one-medical-iora-health-acquisition/

Same Day Testing Dot Com

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