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
Monday, July 22, 2019
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.
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, ) |
Wednesday, July 17, 2019
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
Monday, July 15, 2019
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
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
CMS PART B CARRIERS
CMS NATIONAL B 2018/08
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
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
Wednesday, July 10, 2019
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
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.
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.
Monday, July 1, 2019
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
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
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