Machine learning fails in real life (retina)

https://techcrunch.com/2020/04/27/google-medical-researchers-humbled-when-ai-screening-tool-falls-short-in-real-life-testing/

Emerging Data on COVID Sequencing

https://www.biorxiv.org/content/10.1101/2020.04.21.050633v1.full.pdf

Rapid SARS CoV 2 WGS for informed public health decision-making in the Netherlands.  Munnink et al. 

The timely generation of whole genome sequences combined with epidemiological investigations facilitated early decision making in an attempt to control local transmission of SARS-CoV-2 in the Netherlands.

###

https://www.biorxiv.org/content/10.1101/2020.04.25.061499v1.full.pdf

A rapid, low cost and highly sensitive SARS CoV 2 diagnostic based on  whole genome sequencing.  St Hilaire et al. [Baylor, Rice, Stanford, Shanghai]

 Using POLAR, a single person can process 192 samples over the course of an 8-hour experiment, at a cost of ~$30/patient, enabling a 24-hour turnaround with sequencing and data analysis time included. Further testing and refinement will likely enable greater enhancements in the sensitivity of the above approach.

95% sensitive at 84 genomes/ml, better than other Dx methods.

Some COVID Treatment Guidelines

NIH expert panel

https://www.nih.gov/news-events/news-releases/expert-us-panel-develops-nih-treatment-guidelines-covid-19

https://covid19treatmentguidelines.nih.gov/
https://covid19treatmentguidelines.nih.gov/introduction/

##
Online guide via PUBMED
https://www.ncbi.nlm.nih.gov/books/NBK554776/ 

###
MedScape (March 13)
https://www.medscape.com/viewarticle/926794

"We recommend obtaining baseline CBC with differential, basic metabolic panel, liver function tests, and procalcitonin. Clues for COVID-19 include leukopenia, seen in 30% to 45% of patients, and lymphocytopenia, seen in 85% of the patients in the case series from China," Tirupathi said.


##
California Dept Public Health priority testing guideline
(received 4 22)

CDPH released guidance to help health care providers and laboratories determine prioritization of specific groups for COVID-19 testing.

The guidance sets forth the following list of priorities:

Priority 1:

·         Hospitalized patients

·         Symptomatic healthcare workers

·         Persons identified for testing by public health contact investigations and disease control activities in high risk settings, including both residents and staff

o    E.g., congregate living facilities, correctional facilities

Priority 2:

·         Screening of asymptomatic residents of congregate living facilities prior to admission or re-admission to congregate living facility

o    E.g., a hospitalized patient will be screened for COVID-19 prior to discharge to a congregate living facility

·         Screening of asymptomatic healthcare workers

o    E.g., skilled nursing facility workers, hospital workers

·         Symptomatic persons in essential health and public safety occupations

o    E.g., first responders, law enforcement, congregate living facility workers

·         Symptomatic persons >65 years of age or with chronic medical conditions

Priority 3:

·         Symptomatic persons in essential infrastructure occupations

o    E.g., utility workers, food supply workers, other public employees

Priority 4:

·         Community-based testing of all low-risk symptomatic persons

·         Surveillance testing of asymptomatic persons

From NIH guidelines quoting CDC

CDC has established a priority system for diagnostic testing for SARS-CoV-2 infection based on the availability of tests;14 the CDC testing guidance is updated periodically.

• Priority 1: Hospitalized patients and symptomatic health care workers (to reduce the risk of nosocomial infections and maintain the health care system).
• Priority 2: Individuals with symptoms who live in long-term care facilities, who are aged ≥65 years, or who have underlying conditions, and symptomatic first responders (to ensure those at highest risk of complications of infection are rapidly identified and triaged).
• Priority 3: In communities experiencing high COVID-19 hospitalizations, critical infrastructure workers and other individuals with symptoms, health care workers and first responders, and individuals with mild symptoms (to decrease community spread and ensure the health of essential workers).

Of note, false-negative test results can occur. In people with a high likelihood of infection based on exposure history and/or clinical presentation, a single negative test does not completely exclude SARS-CoV-2 infection, and testing should be repeated.

April 21, 2020: COVID 4 Act, $25B for Labs; Raw Text Here

https://www.cnn.com/2020/04/21/politics/read-congressional-bill-to-help-small-businesses/index.html

Not pretty but copied from CNN online website.  Lab sections mostly pp. 10-19.

SECTION 1. SHORT TITLE.

This Act may be cited as the ‘‘Paycheck Protection

5 Program and Health Care Enhancement Act’’.
6
7

SEC. 2. TABLE OF CONTENTS.

>>>>>>>>

For an additional amount for ‘‘Public Health and So-

10 cial Services Emergency Fund’’, $25,000,000,000, to re11 main available until expended, to prevent, prepare for, and
12 respond to coronavirus, domestically or internationally, for
13 necessary expenses to research, develop, validate, manu14 facture, purchase, administer, and expand capacity for
15 COVID–19 tests to effectively monitor and suppress
16 COVID–19, including tests for both active infection and
17 prior exposure, including molecular, antigen, and sero18 logical tests, the manufacturing, procurement and dis19 tribution of tests, testing equipment and testing supplies,
20 including personal protective equipment needed for admin21 istering tests, the development and validation of rapid,
22 molecular point-of-care tests, and other tests, support for
23 workforce, epidemiology, to scale up academic, commer24 cial, public health, and hospital laboratories, to conduct
25 surveillance and contact tracing, support development of

1 COVID–19 testing plans, and other related activities re2 lated to COVID–19 testing: 



Provided, That of the amount
3 appropriated under this paragraph in this Act, not less
4 than $11,000,000,000 shall be for States, localities, terri5 tories, tribes, tribal organizations, urban Indian health or6 ganizations, or health service providers to tribes for nec7 essary expenses to develop, purchase, administer, process,
8 and analyze COVID–19 tests, including support for work9 force, epidemiology, use by employers or in other settings,
10 scale up of testing by public health, academic, commercial,
11 and hospital laboratories, and community-based testing
12 sites, health care facilities, and other entities engaged in
13 COVID-19 testing, conduct surveillance, trace contacts,
14 and other related activities related to COVID–19 testing:
15 Provided further, That of the amount identified in the pre16 ceding proviso, not less than $2,000,000,000 shall be allo17 cated to States, localities, and territories according to the
18 formula that applied to the Public Health Emergency Pre19 paredness cooperative agreement in fiscal year 2019, not
20 less than $4,250,000,000 shall be allocated to States, lo21 calities, and territories according to a formula method22 ology that is based on relative number of cases of COVID–
23 19, and not less than $750,000,000 shall be allocated in
24 coordination with the Director of the Indian Health Serv25 ice, to tribes, tribal organizations, urban Indian health or-

12
1 ganizations, or health service providers to tribes: Provided
2 further, That the Secretary of Health and Human Services
3 (referred to in this paragraph as the ‘‘Secretary’’) may
4 satisfy the funding thresholds outlined in the first and sec5 ond provisos under this paragraph in this Act by making
6 awards through other grant or cooperative agreement
7 mechanisms: Provided further, That not later than 30 days
8 after the date of enactment of this Act, the Governor or
9 designee of each State, locality, territory, tribe, or tribal
10 organization receiving funds pursuant to this Act shall
11 submit to the Secretary its plan for COVID–19 testing,
12 including goals for the remainder of calendar year 2020,
13 to include: (1) the number of tests needed, month-by14 month, to include diagnostic, serological, and other tests,
15 as appropriate; (2) month-by-month estimates of labora16 tory and testing capacity, including related to workforce,
17 equipment and supplies, and available tests; and (3) a de18 scription of how the State, locality, territory, tribe, or trib19 al organization will use its resources for testing, including
20 as it relates to easing any COVID–19 community mitiga21 tion policies: Provided further, That the Secretary shall
22 submit such formula methodology identified in the first
23 proviso under this paragraph in this Act to the Commit24 tees on Appropriations of the House of Representatives
25 and the Senate one day prior to awarding such funds: Pro-



13
1 vided further, That such funds identified in the first and
2 second provisos under this paragraph in this Act shall be
3 allocated within 30 days of the date of enactment of this
4 Act: Provided further, That of the amount appropriated
5 under this paragraph in this Act, not less than
6 $1,000,000,000 shall be transferred to the ‘‘Centers for
7 Disease Control and Prevention—CDC-Wide Activities
8 and Program Support’’ for surveillance, epidemiology, lab9 oratory capacity expansion, contact tracing, public health
10 data surveillance and analytics infrastructure moderniza11 tion, disseminating information about testing, and work12 force support necessary to expand and improve COVID–
13 19 testing: Provided further, That of the amount appro14 priated under this paragraph in this Act, not less than
15 $306,000,000 shall be transferred to the ‘‘National Insti16 tutes of Health—National Cancer Institute’’ to develop,
17 validate, improve, and implement serological testing and
18 associated technologies for the purposes specified under
19 this paragraph in this Act: Provided further, That of the
20 amount appropriated under this paragraph in this Act, not
21 less than $500,000,000 shall be transferred to the ‘‘Na22 tional Institutes of Health—National Institute of Bio23 medical Imaging and Bioengineering’’ to accelerate re24 search, development, and implementation of point of care
25 and other rapid testing related to coronavirus: Provided




14
1 further, That of the amount appropriated under this para2 graph in this Act, not less than $1,000,000,000 shall be
3 transferred to the ‘‘National Institutes of Health—Office
4 of the Director’’ to develop, validate, improve, and imple5 ment testing and associated technologies; to accelerate re6 search, development, and implementation of point of care
7 and other rapid testing; and for partnerships with govern8 mental and non-governmental entities to research, develop,
9 and implement the activities outlined in this proviso: Pro10 vided further, That funds in the preceding proviso may be
11 transferred to the accounts of the Institutes and Centers
12 of the National Institutes of Health (referred to in this
13 paragraph as the ‘‘NIH’’) for the purposes specified in
14 the preceding proviso: Provided further, That the transfer
15 authority provided in the preceding proviso is in addition
16 to all other transfer authority available to the NIH: Pro17 vided further, That of the amount appropriated under this
18 paragraph in this Act, not less than $1,000,000,000 shall
19 be available to the Biomedical Advanced Research and De20 velopment Authority for necessary expenses of advanced
21 research, development, manufacturing, production, and
22 purchase of diagnostic, serologic, or other COVID–19
23 tests or related supplies, and other activities related to
24 COVID–19 testing at the discretion of the Secretary: Pro25 vided further, That of the amount appropriated under this







15
1 paragraph in this Act, $22,000,000, shall be transferred
2 to the ‘‘Department of Health and Human Services—
3 Food and Drug Administration—Salaries and Expenses’’
4 to support activities associated with diagnostic, sero5 logical, antigen, and other tests, and related administra6 tive activities: Provided further, That the amount appro7 priated under this paragraph in this Act may be used for
8 grants for the rent, lease, purchase, acquisition, construc9 tion, alteration, renovation, or equipping of non-federally
10 owned facilities to improve preparedness and response ca11 pability at the State and local level for diagnostic, sero12 logic, or other COVID–19 tests, or related supplies: Pro13 vided further, That the amount appropriated under this
14 paragraph in this Act may be used for construction, alter15 ation, renovation, or equipping of non-federally owned fa16 cilities for the production of diagnostic, serologic, or other
17 COVID–19 tests, or related supplies, where the Secretary
18 determines that such a contract is necessary to secure, or
19 for the production of, sufficient amounts of such tests or
20 related supplies: Provided further, That funds appro21 priated under this paragraph in this Act may be used for
22 purchase of medical supplies and equipment, including
23 personal protective equipment and testing supplies to be
24 used for administering tests, increased workforce and
25 trainings, emergency operation centers, and surge capacity




16
1 for diagnostic, serologic, or other COVID–19 tests, or re2 lated supplies: Provided further, That products purchased
3 with funds appropriated under this paragraph in this Act
4 may, at the discretion of the Secretary, be deposited in
5 the Strategic National Stockpile under section 319F–2 of
6 the Public Health Service Act: Provided further, That of
7 the amount appropriated under this paragraph in this Act,
8 $600,000,000 shall be transferred to ‘‘Health Resources
9 and Services Administration—Primary Health Care’’ for
10 grants under the Health Centers program, as defined by
11 section 330 of the Public Health Service Act, and for
12 grants to federally qualified health centers, as defined in
13 section 1861(aa)(4)(B) of the Social Security Act: Pro14 vided

further,

That

sections

330(e)(6)(A)(iii),

15 330(e)(6)(B)(iii), and 330(r)(2)(B) of the Public Health
16 Service Act shall not apply to funds provided under the
17 previous proviso: Provided further, That of the amount ap18 propriated under this paragraph in this Act, $225,000,000
19 shall be used to provide additional funding for COVID–
20 19 testing and related expenses, through grants or other
21 mechanisms, to rural health clinics as defined in section
22 1861(aa)(2) of the Social Security Act, with such funds
23 also available to such entities for building or construction
24 of temporary structures, leasing of properties, and retro25 fitting facilities as necessary to support COVID–19 test-


17
1 ing: Provided further, That such funds shall be distributed
2 using the procedures developed for the Provider Relief
3 Fund authorized under the third paragraph under this
4 heading in division B of the Coronavirus Aid, Relief, and
5 Economic Security Act (Public Law 116–136); may be
6 distributed using contracts or agreements established for
7 such program; and shall be subject to the process require8 ments applicable to such program: Provided further, That
9 the Secretary may specify a minimum amount for each
10 eligible entity accepting assistance under the two previous
11 provisos: Provided further, That up to $1,000,000,000 of
12 funds provided under this paragraph in this Act may be
13 used to cover the cost of testing for the uninsured, using
14 the definitions applicable to funds provided under this
15 heading in Public Law 116–127: Provided further, That
16 not later than 21 days after the date of enactment of this
17 Act, the Secretary, in coordination with other appropriate
18 departments and agencies, shall issue a report on COVID–
19 19 testing: Provided further, That such report shall in20 clude data on demographic characteristics, including, in
21 a de-identified and disaggregated manner, race, ethnicity,
22 age, sex, geographic region and other relevant factors of
23 individuals tested for or diagnosed with COVID–19, to the
24 extent such information is available: Provided further,
25 That such report shall include information on the number



18
1 and rates of cases, hospitalizations, and deaths as a result
2 of COVID–19: Provided further, That such report shall be
3 submitted to the Committees on Appropriations of the
4 House and Senate, and the Committee on Energy and
5 Commerce of the House of Representatives and the Com6 mittee on Health, Education, Labor, and Pensions of the
7 Senate, and updated and resubmitted to such Committees,
8 as necessary, every 30 days until the end of the COVID–
9 19 public health emergency first declared by the Secretary
10 on January 31, 2020: Provided further, That not later
11 than 180 days after the date of enactment of this Act,
12 the Secretary shall issue a report on the number of posi13 tive diagnoses, hospitalizations, and deaths as a result of
14 COVID–19, disaggregated nationally by race, ethnicity,
15 age, sex, geographic region, and other relevant factors:
16 Provided further, That such report shall include epidemio17 logical analysis of such data: Provided further, That not
18 later than 30 days after the date of the enactment of this
19 Act, the Secretary, in coordination with other departments
20 and agencies, as appropriate, shall report to the Commit21 tees on Appropriations of the House and Senate, the Com22 mittee on Energy and Commerce of the House of Rep23 resentatives, and the Committee on Health, Education,
24 Labor, and Pensions of the Senate on a COVID–19 stra25 tegic testing plan: Provided further, That such plan shall




19
1 assist States, localities, territories, tribes, tribal organiza2 tions, and urban Indian health organizations, in under3 standing COVID-19 testing for both active infection and
4 prior exposure, including hospital-based testing, high-com5 plexity laboratory testing, point-of-care testing, mobile6 testing units, testing for employers and other settings, and
7 other tests as necessary: Provided further, That such plan
8 shall include estimates of testing production that account
9 for new and emerging technologies, as well as guidelines
10 for testing: Provided further, That such plan shall address
11 how the Secretary will increase domestic testing capacity,
12 including testing supplies; and address disparities in all
13 communities: Provided further, That such plan shall out14 line Federal resources that are available to support the
15 testing plans of each State, locality, territory, tribe, tribal
16 organization, and urban Indian health organization: Pro17 vided further, That such plan shall be updated every 90
18 days until funds are expended: Provided further, That such
19 amount is designated by the Congress as being for an
20 emergency

requirement

pursuant

to

section

21 251(b)(2)(A)(i) of the Balanced Budget and Emergency
22 Deficit Control Act of 1985.

20
1

GENERAL PROVISIONS—THIS TITLE

2

(INCLUDING TRANSFER OF FUNDS)

3

SEC. 101. The requirements, authorities, and condi-

4 tions described in sections 18108, 18109, and 18112 of
5 division B of the Coronavirus Aid, Relief, and Economic
6 Security Act (Public Law 116–136) shall apply to funds
7 appropriated in this Act to the Department of Health and
8 Human Services.
9

SEC. 102. Funds appropriated by this Act under the

10 heading ‘‘Department of Health and Human Services’’,
11 except for the amounts specified in the first and second
12 provisos in the second paragraph under the heading ‘‘Pub13 lic Health and Social Services Emergency Fund’’, may be
14 transferred to, and merged with, other appropriation ac15 counts under the headings ‘‘Centers for Disease Control
16 and Prevention’’, ‘‘Public Health and Social Services
17 Emergency Fund’’, ‘‘Food and Drug Administration’’, and
18 ‘‘National Institutes of Health’’ to prevent, prepare for,
19 and respond to coronavirus following consultation with the
20 Office of Management and Budget: Provided, That the
21 Committees on Appropriations of the House of Represent22 atives and the Senate shall be notified 10 days in advance
23 of any such transfer: Provided further, That, upon a deter24 mination that all or part of the funds transferred from
25 an appropriation by this Act are not necessary, such


BAI20328

S.L.C.

21
1 amounts may be transferred back to that appropriation:
2 Provided further, That none of the funds made available
3 by this Act may be transferred pursuant to the authority
4 in section 205 of division A of Public Law 116–94 or sec5 tion 241(a) of the Public Health Service Act.
6

SEC. 103. Of the funds appropriated by this Act

7 under the heading ‘‘Public Health and Social Services
8 Emergency Fund’’, up to $6,000,000 shall be transferred
9 to, and merged with, funds made available under the head10 ing ‘‘Office of the Secretary, Office of Inspector General’’,
11 and shall remain available until expended, for oversight
12 of activities supported with funds appropriated to the De13 partment of Health and Human Services to prevent, pre14 pare for, and respond to coronavirus, domestically or
15 internationally: Provided, That the Inspector General of
16 the Department of Health and Human Services shall con17 sult with the Committees on Appropriations of the House
18 of Representatives and the Senate prior to obligating such
19 funds: Provided further, That the transfer authority pro20 vided by this section is in addition to any other transfer
21 authority provided by law.

Digital Health During Pandemic (FDA), Emergency Order Umbrella Order

2020 FDA 0415 Enforcement Digital Health Pandemic 12pp.pdf

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-digital-health-devices-treating-psychiatric-disorders-during-coronavirus-disease


Source Document for Urgent Orders
2020 FDA 0325 Process for Emergency Guidances and Rules 85FR16949 2p.pdf

https://www.govinfo.gov/content/pkg/FR-2020-03-25/pdf/2020-06222.pdf


Text

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2020–D–1136, FDA– 2020–D–1137, FDA–2020–D–1138, FDA– 2020–D–1139, FDA–2020–D–1140, FDA– 2020–D–1141, FDA–2020–D–1142, and FDA– 2020–D–1143] Process for Making Available Guidance Documents Related to Coronavirus Disease 2019 AGENCY: Food and Drug Administration, HHS. ACTION: Notice.


 I. Background
On January 31, 2020, as a result of
confirmed cases of COVID–19, and after
consultation with public health officials
as necessary, Alex M. Azar II, Secretary
of Health and Human Services, pursuant
to the authority under section 319 of the
Public Health Service Act (42 U.S.C.
247), determined that a public health
emergency exists and has existed since
January 27, 2020, nationwide.fn1

On March 13, 2020, President Donald J.
Trump declared that the COVID–19
outbreak in the United States constitutes
a national emergency, beginning March 
1, 2020.fn2

FDA is committed to providing 
timely recommendations, regulatory 
advice, guidance, and technical 
assistance on an Agency-wide basis on 
issues related to COVID–19, including 
to clarify our expectations regarding 
regulatory requirements to support 
response efforts to this emergency. To
this end, FDA is announcing procedures 
for making available FDA guidance 
documents related to the COVID–19 
public health emergency. FDA believes
that these procedures, which operate
within FDA’s established good guidance
practices regulations, will allow the
Agency to rapidly disseminate Agency 
recommendations and policies related 
to COVID–19 to industry, FDA staff, and 
other stakeholders.


II. Procedures for Making COVID–19-
Related Guidance Documents Available


To facilitate issuance of guidance on
topics related to the COVID–19 public
health emergency, the Agency intends
to use the following procedures:
• In light of the need to act quickly
and efficiently to respond to the
COVID–19 public health emergency,
FDA anticipates that prior public 
participation will not be feasible or 
appropriate before FDA implements 
COVID–19-related guidance documents. 
FDA anticipates it will issue COVID–19-
related guidance documents for
immediate implementation without
prior public comment (see section
701(h)(1)(C) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C.
371(h)(1)(C)) and 21 CFR 10.115(g)(2)
(§ 10.115(g)(2)).

• Although FDA expects that COVID–
19-related guidances will be
implemented without prior comment,
FDA will solicit comment, review all
comments received, and revise the
guidance documents as appropriate (see
§ 10.115(g)(2)). Each guidance will
specify the docket number(s) to which
comments can be submitted.

• Guidance documents related to
COVID–19 will be accessible on the 
internet from the FDA web page entitled 
‘‘Coronavirus Disease 2019 (COVID– 
19),’’ available at https://www.fda.gov/ 
emergency-preparedness-and-response/ 
mcm-issues/coronavirus-disease-2019-
covid-19.

• Guidance documents related to
COVID–19 may also be accessed from
the FDA web page entitled ‘‘Search for
FDA Guidance Documents’’ available at
https://www.fda.gov/regulatory-
information/search-fda-guidance-
documents.

• Rather than publishing a separate
Notice of Availability (NOA) for each
COVID–19-related guidance document,
FDA intends to publish periodically a 
consolidated NOA. This periodic NOA
will announce the availability of all the
COVID–19-related guidance documents
that issued during the relevant period.
The consolidated NOA will provide
instructions to the public on submitting
comments on COVID–19-related
guidance documents, including the
docket number(s) associated with each
guidance document, information on
how to view the dockets, and
instructions for persons interested in
obtaining a copy of a COVID–19-related
guidance document. In addition, the
guidance document will provide
information to the public on submitting
comments on the guidance document,
including the docket number(s)
associated with the guidance document
and instructions for persons interested
in obtaining a copy of a COVID–19-
related guidance document.

• FDA intends to establish one docket
for each Center or Office that may issue
COVID–19-related guidance documents.
All COVID–19-related guidance
documents issued by that Center or
Office will be available in the docket

associated with the Center or Office that
issues the guidance document. The
docket numbers associated with each
Center or Office that may issue COVID–
19-related guidance documents are as
follows:

( ^ Centers of FDA, plus Docket Numbers)


Dated: March 20, 2020. 
Lowell J. Schiller, 
Principal Associate Commissioner for Policy. 
[FR Doc. 2020–06222 Filed 3–20–20; 11:15 am]
BILLING CODE 4164–01–P

Medicare Enrollment, Finger printing

In some press around the March 30 "Interim final rulemaking" loosening a wide range of Medicare regulations in the name of COVID response, I read that enrollment procedures, like fingerprinting, had been expedited.

This wasn't in the actual IFR (here).

Some links that include "fingerprinting" from March 2020.

Main CMS PDF here:
https://www.cms.gov/files/document/provider-enrollment-relief-faqs-covid-19.pdf

It's difficult to be sure but I think the enrollment waivers date to March 13:
https://www.cms.gov/newsroom/press-releases/cms-takes-action-nationwide-aggressively-respond-coronavirus-national-emergency

MWE law firm has a full summary here:
https://www.mwe.com/insights/cms-dramatically-modifies-and-expedites-the-medicare-enrollment-process-to-combat-covid-19/

Per MWE, the rapid enrollment special track is focused on MD and non-physician providers (physician assistants, etc). 

There's a Medlearn Matters, updated March 20, but it doesn't say much about Enrollment:
https://www.cms.gov/files/document/se20011.pdf

There's a March 16 summary at APTA:
https://www.apta.org/PTinMotion/News/2020/03/16/CMSWaivers1135/