President Trump References at HHS Website

This past week, I ran across several HHS/CMS press releases or quotations specifically praising President Trump's vision and leadership, and I wondered how this compared to the Obama era.

See for example:

“Hospitals would be required to post all their payer-specific negotiated rates, which are the prices actually paid by insurers,” CMS Administrator Seema Verma said on a conference call with reporters. “Hospital pricing has been a mystery, but thanks to the leadership of President Trump, those days are over.”

 At: MedCityNews, July 29, 2019, here.

Once in a while this may be OK, but if it ever becomes mandatory in each press release, it would be a little eerie (sort of like, "Thanks to Comrade Stalin's leadership, the wheat crop has increased by 2%.")

Searching CMS.gov

I used the built-in search function on the CMS website to search for citations to Trump, and there were 101 (that's 40 per year).   Searching for Obama, there are 270 (that's 33 per year).  But large numbers of the Trump citations are from public comments on rulemaking where "trump" is used as a verb (rule A trumps rule B), so at least with this simple quantitative measure, Trump occurs less at HHS than Obama, although the Trump citations are sometimes more bold and colorful, as in the Verma quote above.

"Trump" As Part of Headlines

While I haven't done a systematic review of press releases, I did notice that an October 7 press released "headlined" the Trump Administration on a policy update.  Here.  "Trump Administration Empowers Nursing Home Patients, Residents, Families, and Caregivers by Enhancing Transparency about Abuse and Neglect."  Opening sentence, "Today, the Trump Administration and the Centers for Medicare & Medicaid Services (CMS) announced a major enhancement of the information available to nursing home residents, families, and caregivers..."

FIT may be as good as colonoscopy

DARK REPORT
https://www.darkdaily.com/regenstrief-institute-finds-fecal-immunochemical-test-may-be-as-effective-as-colonoscopy-at-detecting-colorectal-cancers/

July 2019

ANNALS INTERN MED
https://annals.org/aim/article-abstract/2726664/performance-characteristics-fecal-immunochemical-tests-colorectal-cancer-advanced-adenomatous-polyps?searchresult=1

5 March 2019  Imperiale et al.

https://annals.org/aim/article-abstract/2726665/why-what-you-may-know-about-fecal-immunochemical-testing-matters

Op Ed: Allison

Some U.S. primary care physicians and many of their patients may be unaware that fecal immunochemical tests (FITs) are noninvasive, easy to prepare, and inexpensive and have effectiveness similar to that of colonoscopy when used in a consistent, programmatic fashion to screen for colorectal cancer (CRC) (1). The paucity of studies comparing FITs and colonoscopy in 2000 may have been why Podolsky advocated for insurers to cover colonoscopic screening in all average-risk persons aged 50 years or older (2). Shortly thereafter, Congress ordered Medicare to cover the procedure without requiring published evidence of its superiority over less invasive and cheaper tests. 

In 2019, although trials are under way, we still lack published results of randomized controlled trials showing that colonoscopy is superior to FITs.

Currently, only about 65% of U.S. adults aged 50 to 75 years have been screened for CRC, and most of them have been screened with colonoscopy (3). 

OIG Audits Sleep Studies

https://www.lexology.com/library/detail.aspx?g=38defdf2-9a50-40b3-ac67-640ce667f1c4


http://www.klgates.com/the-oig-audits-diagnostic-sleep-studies--how-providers-should-respond-07-19-2019/


https://oig.hhs.gov/oas/reports/region4/41707069.pdf


##
Separately, July 2018 financial blog cites DIHP

https://seekingalpha.com/instablog/47547305-the-capitolist/5188969-myriad-genetics-morgan-stanley-wrapped-short-bow

Myriad Jeter Docket Screen Shots

https://www.pacermonitor.com/case/29159740/United_States_of_America_et_al_v_Myriad_Genetics_Inc

See below.  Most are 1-p motions to seal, etc.

Friday, July 19, 2019
28		2 pgs order Order ~Util - Case Unsealed Fri 2:39 PM  ORDER unsealing case, directing the complaint be served upon the defendant by the relator, and directing the relator to serve this Order and the Government's Notice of Election to Decline Intervention after service of the Complaint. Signed by Honorable Joseph F. Anderson, Jr. on 07/19/2019. (bshr, ) (bshr, )
27		2 pgs notice Notice of Settlement Fri 9:12 AM  NOTICE of Settlement by Elaine Jeter, United States of America (Tuck, Thomas)
Thursday, July 18, 2019
26		NOTICE of ELECTION to decline intervention by United States of America (Ragsdale, Stanley)
Monday, May 20, 2019
23		EXPARTE ORDER granting 22 Ex Parte Motion to extend the seal period by 60 days from May 20, 2019 until July 19, 2019. Directed by Honorable Joseph F Anderson, Jr on 5/20/19.(mflo, )
22		EX PARTE MOTION SEALED by United States of America. Response to Motion due by 6/3/2019. Add an additional 3 days only if served by mail or otherwise allowed under Fed. R. Civ. P. 6 or Fed. R. Crim. P. 45. Proposed order is being emailed to chambers with copy to opposing counsel.(Ragsdale, Stanley)
Monday, March 18, 2019
21		EX PARTE ORDER, Granting 20 EX PARTE MOTION SEALED filed by United States of America until 5/20/19. Signed by Honorable Joseph F Anderson, Jr on 3/18/19. (mflo, )
Friday, March 15, 2019
20		EX PARTE MOTION SEALED by United States of America. Response to Motion due by 3/29/2019. Add an additional 3 days only if served by mail or otherwise allowed under Fed. R. Civ. P. 6 or Fed. R. Crim. P. 45. Proposed order is being emailed to chambers with copy to opposing counsel.(Ragsdale, Stanley)
Thursday, January 31, 2019
19		***DOCUMENT E-MAILED 18 Text Order on Ex Parte Motion to Stanley D Ragsdale, Dennis Charles Dukes, II, Robert S Wood, Thomas Christopher Tuck (mflo, )
18		TEXT ORDER granting 17 Ex Parte Motion for new intervention deadline of 3/21/19 as to the government. Directed by Honorable Joseph F Anderson, Jr on 1/31/19.(mflo, )
Monday, January 28, 2019
17		EX PARTE MOTION SEALED by United States of America. Response to Motion due by 2/11/2019. Add an additional 3 days only if served by mail or otherwise allowed under Fed. R. Civ. P. 6 or Fed. R. Crim. P. 45. No proposed order.(Ragsdale, Stanley)
Thursday, January 10, 2019
16		TEXT ORDER granting 15 Ex Parte Motion to toll the seal and intervention period in light of lapse of appropriations. Directed by Honorable Joseph F Anderson, Jr on 1/10/19.(mflo, )
		***DOCUMENT E-MAILED 16 Order on Ex Parte Motion to attorneys of record (mflo, )
Wednesday, January 09, 2019
15		EX PARTE MOTION SEALED by United States of America. Response to Motion due by 1/23/2019. Add an additional 3 days only if served by mail or otherwise allowed under Fed. R. Civ. P. 6 or Fed. R. Crim. P. 45. No proposed order.(Ragsdale, Stanley)
Friday, November 09, 2018
13		ORDER granting 12 Ex Parte Motion. The USA shall have up to and including 2/14/19 to notify the court of its decision to intervene. Signed by Honorable Joseph F Anderson, Jr on 11/9/18.(mflo, )
Wednesday, November 07, 2018
12		Third EX PARTE MOTION SEALED by United States of America. Response to Motion due by 11/21/2018. Add an additional 3 days only if served by mail or otherwise allowed under Fed. R. Civ. P. 6 or Fed. R. Crim. P. 45. No proposed order.(Ragsdale, Stanley) (Main Document 12 replaced on 11/8/2018 as provided by filing user to correct typographical error) (mflo, ).
Thursday, May 17, 2018
10		EX PARTE ORDER extending the seal period through November 14, 2018. Signed by Honorable Joseph F Anderson, Jr on 5/17/2018. (mdea )
Thursday, May 10, 2018
9		Second EX PARTE MOTION SEALED by United States of America. Response to Motion due by 5/24/2018. Add an additional 3 days only if served by mail or otherwise allowed under Fed. R. Civ. P. 6 or Fed. R. Crim. P. 45. No proposed order.(Ragsdale, Stanley)
Friday, January 05, 2018
7		EX PARTE ORDER granting in part 6 First EX PARTE MOTION SEALED filed by United States of America. The time in which the United States may elect to intervene in this matter, as provided for in 31 U.S.C § 3730(b)(3), is extended from January 8, 2018, until May 13, 2018. Signed by Honorable Joseph F Anderson, Jr on 1/5/18. (mflo, )
6		First EX PARTE MOTION SEALED by United States of America. Response to Motion due by 1/19/2018. Add an additional 3 days only if served by mail or otherwise allowed under Fed. R. Civ. P. 6 or Fed. R. Crim. P. 45. No proposed order.(Ragsdale, Stanley)
Tuesday, October 31, 2017
2		3 pgs Local Rule 26.01 Answers to Interrogatories by Elaine Jeter.(mflo, )
1		24 pgs COMPLAINT against Myriad Genetics Inc ( Filing fee $ 400 receipt number 0420-7440403.), filed by Elaine Jeter. Service due by 1/29/2018(mflo, )

How late are 2019 gapfill proposed codes (link list)

2015
  29 codes, Draft May 26, 2015.   Final, September 25, 2015.
http://www.discoveriesinhealthpolicy.com/2015/05/cms-releases-spring-gapfill-draft-clfs.html
http://www.discoveriesinhealthpolicy.com/2015/09/cms-posts-september-results-of-cy2015.html

2016
  16 codes, Draft, June 10, 2016.   Final, September 30, 2016.
http://www.discoveriesinhealthpolicy.com/2016/06/cms-posts-mac-proposed-gapfill-prices.html
http://www.discoveriesinhealthpolicy.com/2016/10/cms-posts-final-gapfill-prices-for-2016.html

2017
  No gapfill?

2018
  15 codes, Draft June 13, 2018.  Final, October 19, 2018.
http://www.discoveriesinhealthpolicy.com/2018/06/very-brief-blog-cms-posts-preliminary.html
http://www.discoveriesinhealthpolicy.com/2018/10/cms-posts-final-gapfill-codes-for.html

2019
   18 codes under Gapfill.
http://www.discoveriesinhealthpolicy.com/2018/12/very-brief-blog-cms-releases-cy2019.html

2017 Physician CPT Database

2017 Physician Supplier Database
https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Medicare-Provider-Charge-Data/Physician-and-Other-Supplier2017.html


https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Medicare-Provider-Charge-Data/Physician-and-Other-Supplier.html

CMS PHYSICIAN DATA 2018/05

https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Medicare-Provider-Charge-Data/Physician-and-Other-Supplier.html

CMS PART B CARRIERS

https://www.cms.gov/research-statistics-data-and-systems/downloadable-public-use-files/part-b-carrier-summary-data-file/overview.html

CMS NATIONAL B 2018/08

https://www.cms.gov/Research-Statistics-Data-and-Systems/Downloadable-Public-Use-Files/Part-B-National-Summary-Data-File/Overview.html

HHS Video: Reimagine HHS Innovation

HHS held a conference "Reimagine HHS: Accelerate Clinical Innovation" which is archived in three segments at Youtube.  The meeting was July 1, 2019.   ACI is the acronym, one of 10 initiatives at HHS.

ACI:

https://www.youtube.com/watch?v=mGsSuf8VoB0

https://www.youtube.com/watch?v=qIP4tEe9bqI

The above total about 3 hours.  There is a third segment for Q&A but truncates at 2 minutes.
https://www.youtube.com/watch?v=OSbEU58Fh_A


There was also apparently another meeting in this vein by HHS on June 20-21.
https://www.hoganlovells.com/en/publications/hhs-announces-public-meeting-on-ways-to-accelerate-clinical-innovation

See 84 Fed Reg 24162, 5/24/2019, here:
https://www.govinfo.gov/content/pkg/FR-2019-05-24/pdf/2019-10911.pdf


KIDNEY:

Secretary Azar also had a one hour video webinar on July 10 on the new kidney initiatives:
https://www.youtube.com/watch?v=8BbZqt8Tum4

President Trump's remarks in that session are here:
https://www.youtube.com/watch?v=NZBjTs9NqnQ

CMS Rules for Foreign National Visitors

CMS has special rules that need to be activated almost two weeks before a visit by a non-US passport holder (foreign national). 

CMS doesn't always communicate these rules clearly, but posted some instructions in the setting of a July 22-23 lab meeting agenda.  I've clipped them below.

https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/Downloads/2019-07-22to23-Agenda-CDLT-Panel-Meeting.pdf

Appendix A:  Foreign National Visitation and Federal Building 

Access

General security instructions for foreign national visitors requesting access to the CMS campus:
All foreign nationals visiting any CMS facility must request prior approval at least 12 business days before the visit date in order to obtain foreign visitation access. To initiate the approval process, the following information must be submitted to the CDLT Panel resource box (CDLTPanel@cms.hhs.gov):

[this email box will vary depending on the CMS meeting]

1. The full first and last name (s) of the visitor (as it appears on passport)
2. Gender
3. Country of origin and citizenship
4. Date of birth
5. Place of birth
6. Passport number
7. Passport issue date
8. Passport expiration date
9. Visa type
10. Date of visit
11. Company name
12. Position/Title


If visitation is approved, foreign national visitors are required to produce a valid passport issued by their country of origin on the day of the visit.

Foreign national visitors who cannot produce a valid passport will be denied access, even if the visit has been approved. Approved foreign national visitors will be assigned a “Hosting Official” who is responsible for the visitor for the duration of their facility visit.

In addition, an “Escort” may be required and is responsible for accompanying a visitor while the visitor has access to HHS facilities, maintaining visual and voice contact at all times in all non-escort free areas or areas to which the visitor is not permitted independent access.


If you are a foreign visitor and plan to attend the July 22-23, 2019, Medicare Advisory Panel Meeting on Clinical Diagnostic Laboratory Tests Meeting (CMS-1725-N; Published: April 1, 2019; Registration deadline was July 1, 2019), you must be registered as an attendee and provide the above information so your approval clearance process may be initiated. Once the process is initiated CMS will contact you directly with follow-up instructions for completing the approval request via the Foreign National Management System (FNMS).

Please submit inquiries to the CDLT Panel resource box (CDLTPanel@cms.hhs.gov) if you have
questions regarding this matter and if you have CDLT Panel-related questions.

Notepad CAP PIERIAN on Distributed Genomics Parts

https://www.pieriandx.com/cap-distributive-model?__hstc=71729676.1905608b5bb3acdc436ac1e93c865920.1561943534005.1561943534005.1561988977782.2&__hssc=71729676.1.1561988977782&__hsfp=1037774400

CLSI requests nominations for volunteers to serve as members and contributors on a document development committee for a new document.



MM25: Sequencing Bioinformatics for Human Genetics and Oncology, 1st Edition



Description

CLSI document MM25 will provide information on the primary and secondary components of a bioinformatics pipeline for handling data from massively parallel sequencing. In addition, this guideline will assist with understanding the complexity of the pipeline development process, pipeline validation, continued monitoring, and version control. Guidance on meeting regulations applicable to the bioinformatics pipeline to ensure quality and patient safety will also be included. MM25 will provide information on freeware and open-source software, data storage, databasing, and data sharing.



This group is looking for volunteers with:

Proficiency in bioinformatics
Expertise in massively parallel sequencing technology in the medical laboratory, government, or industry
Experience representing vendors that provide in silico data files


Additional information on essential job duties and skills and abilities for CLSI committee participants can be viewed here.



Timeline for this project

Week of 23-28 January 2020: First face-to-face meeting (NOTE: This will be a 2-day meeting scheduled during the January Committees Week in Tempe, Arizona.)



February 2020 to June 2021: Drafting of document (higher-intensity volunteer time period)



September 2021 to November 2021: Voting period for draft document



December 2021 to February 2022: Revision of draft based on comments received during voting



August 2022: Expected publication date



Due date for submission of required documentation

Please submit nominations and required documentation (see Requirements for Nomination Consideration) on or before 29 July 2019 to volunteer@clsi.org.





Kathy Castagna, MS, MT(ASCP)CT, MB

Director, Standards Development

Clinical and Laboratory Standards Institute (CLSI)

950 West Valley Road, Suite 2500

Wayne, PA 19087 USA

P: 484.588.5947 | E: kcastagna@clsi.org