Blackberry, Nokia: Two Business Books

We are well aware of many colossal collapses in the business world, and they can occur in an accelerated way in the digital age - Netscape booms, then loses to IE and Firefox; Myspace is rapidly replaced by Facebook; Yahoo search loses to the Google monolith; Blockbuster caves in with the rise of web-based Netflix.   In the phone world, Motorola and Nokia dominated everything until they abruptly didn't.  Two new books profile the decline of Blackberry and Nokia.

In Losing the Signal: The Untold Story Behind the Extraordinary Rise and Spectacular Fall of BlackBerry (2015), Jacquie McNish and Sean Silcoff tell the story of a small hardscrabble Canadian tech company called RIM that rose to the top of the mobile world.  Blackberries were conceived in the digital stone age when we had (A) PalmPilots that you sync'd in the morning with your PC and there were (B) two-way pagers with very limited text capabilities.  

RIM recognized there could be a huge untapped market for providing full and seamless high security email services on mobile devices.   The early BlackBerries didn't have phones at all.  Management was appalled when iPhones were introduced in 2007: because there wasn't enough bandwidth at carriers for all that internet access (there wasn't), because people wouldn't type on glass, and because the battery was pathetic - 10 hours not 2 days.

BlackBerry avoided the internet like the plague for a while longer.  The company, despite its reputation and success, had always had a head-just-above-water approach to its global servers, and these collapsed a few times, damaging its reputation.  RIM then bungled several attempts at more modern smartphones and had delayed and sank R&D into misguided efforts like its Play tablet.  The "spectacular fall" ensured.  Some of RIM's most tightly held assumptions...that internet and corporate email access on iPhones would be difficult or impossible... proved completely wrong as the bring-your-own-device business world emerged a few years ago.

In The Decline and Fall of Nokia (2015), David J. Cord tells a similar story.  Nokia dominated the global phone market as a miracle Finnish company that could do no wrong - $50B in sales and $7B profit in 2007, the year the iPhone was introduced.  It provided a massive range of devices, for the low, mid and high markets, all rapidly remodeled, and customized to each carrier.  The endless varities of phones ran on a diversely versioned operating system called Symbian.  Android grew rapidly with a completely different model - a one fits all open access operating system.

As Cord points out, iPhone had one phone, one operating system, and was riding on top of Apple's booming success with iPods and iTunes.   Nokia declined rapidly, entering a death spiral by 2011/2012.  Just like RIM, trying to follow the iPhone, it began producing more sophisticated devices that didn't work well.  Attempts to break off Symbian with a proprietary new system, with MS-Windows, and with a Linux-like system all stumbled in turn.  

Lack of a common software platform for Nokia's phones made an iOS like "app and entertainment" ecosystem impossible, and the option of iPads using the same ecosystem made iOS even more attractive, as iPads and iPhones boomed together.

Eventually Nokia was (essentially) acquired by Microsoft, a transaction that soon generated a $7B writeoff.   After a share price peak of $230 around the time the iPhone was introduced, RIM fel to $50 in 2010/2011 and is at $8 today, where it has sat since 2012.

The stories, while different, reproduce at least three of the seven "Billion Dollar Lessons" cataloged by Carroll and Mui in their 2007 book  Billion Dollar Lessons: "Staying the Course [Threat? What Threat?]," "Fumbling Technology: Riding the Wrong Technology," and "Consolidation Blues: Doubling Down on a Bad Hand."

Lessons for healthcare and digital health?  I'm going to think about that....

Decline and Fall of Nokia is paper book only.  Losing the Signal is available in book, eBook and Audible versions, as is Billion Dollar Lessons.

My November, 2015 comment on PAMA regarding the definition of ADLTs.

My November, 2015 comment on PAMA regarding the definition of ADLTs.
=====================
I disagree with CMS's interpretation of the PAMA definition of ADLT to necessarily include "DNA or RNA."

While the PAMA rule does not give a clear explanation how this was reached, at a CMS advisory board in October, CMS staff explained that the definition of ADLT - "DNA, RNA, or protein" - was read in context of the overarching term "Advanced diagnostic laboratory test" to exclude proteomics-only tests.

This does not make enough sense to hold as a reasonable interpretation of PAMA's ADLT definition, which in contrast should be virtually self implementing.

First, we look to context of a bill when the paragraphs in question are unclear. "A, B, or C" is simple English grammar, and does not require canons of interpretation. If I tell my daughter, "Come home on the bus, subway, or taxi" it does not require her to come home only on the bus or subway. The grammar of ADLTs is the same simple English. There is nothing unclear that requires context and labored interpretation in the concept: "Use A, B, or C."

Second, even though it is inappropriate in the first place, the conceptual outreach to the mere heading, "Advanced diagnostic laboratory test" to define the tests are requiring DNA, RNA, or both, at a minimum, does not pass the sense test either.

(A) The term ADLT has not existed before, therefore it has no pre established meaning.
(B) To the extent the ADLT category close resembles either the IVDMIA (FDA) or the MAAA (AMA CPT) categories, those include RNA, DNA, or protein tests, including protein only MAAAs. The differences between the IVDMIA, MAAA, and ADLT terms are hairsplitting, in reference to multi analyte algorithm tests with single results, AND that group has included MAAAs such as the Crescendo VECTRA test.
(C) There is no bias against proteomics being one of the fundamental modern "Omics" along with DNA and RNA. Proteomics is referred to as the next frontier of molecular medicine, not a backwater.

Thus, the outreach to the  four word category "advanced diagnostic laboratory test", cannot be used to support use of DNA or RNA, as required components.

Third, CMS has built nearly a house of cards (as shown above) in its logic and assertions that ADLT, viewed as a whole, almost magically excludes protein only ADLT tests. It defies belief that such a tortured logical path of assumptions and semantic inferences - not even very well justfied ones, and unexplained in the proposed rule itself - was the main and simple intent of Congress in writing and signing the definition as we have it.

My PSA Metric Comment

For the main article, here

https://jira.oncprojectracking.org/browse/PCQM-342


"Non recommended PSA screening," as proposed, is a faulty metric for CMS.  First, there is a statutory benefit for PSA screening.  It is unfair to doctors to be placed between legal patient benefits Congress has voted for, and the position of the metric.   Second, there is substantial difference of opinion among major policy bodies on PSA testing, particularly, if a patient and doctor do it appropriately, even if USPSTF does not endorse it.  Third, the text of the metric is confusing and contradicts a CMS National Coverage Determination.  The metric text blocks screening for example "except with history of cancer" and of course that is NOT screening at all.  The text also has rare exceptions like "known dysplasia" but the CMS NCD for PSA  is much broader and endorses PSA for workup of nocturia, hesitancy, and other conditions. Arguably, that is "not screening" but most of the exceptions listed by the metric are not screening either. Hence, it is very confusing.

Instructions for JIRA commenting

For the main article, here

This is the text of the PDF in a zip file for how to comment on a currently proposed CMS performance metric.

You comment via the Office of the National Coordinator (for HHS), Project Tracking Webpage, via a section called "JIRA".  I initially suspected the "IR" stood for Issue Resolution; a management and/or developer based bug tracking system (here) seems to be retrofitted for public policy comments.  Possibly JIRA is simply a shortening of GOJIRA, the Japanese term for Godzilla (here).
_____

INSTRUCTIONS FOR COMMENTING ON JIRA [At the ONC]

If you are a current JIRA user with an active account:
http://jira.oncprojectracking.org (Select “Log In” at the top right corner.)
If you are new to JIRA and do NOT have an account:
http://jira.oncprojectracking.org/login.jsp (Select “Sign up” to set up a new account and log in to the JIRA tool.)
Once logged in, enter your comments by following these instructions:
1.
Select “Projects” at the top middle of the home screen.
2.
Select “View all Projects.”
3.
Under Quality-Measures, select “Comments on eCQMs under development” project.
4.
To enter comments, select “Create issue” (orange button) at the top middle of the screen.
5.
Select the type of issue from the “Issue type” drop-down menu.
6.
Fill out the fields labeled “Summary,” “Contact name,” “Contact email,” and “Contact phone.”
7.
In the “Summary” field, type in one of the following titles, based on the measure you are commenting on:
-
“Comment—FSA CHF” for the “Functional Status Assessment and Target Setting for Patients with Congestive Heart Failure” measure
-
“Comment—PSA Screening” for the “Non-Recommended PSA-Based Screening” measure
8.
Enter your comments in the “Description” field.
9.
Select the measure you are commenting on from the “Draft measures” drop-down box:
-
For the “Functional Status Assessment and Target Setting for Patients with Congestive Heart Failure” measure, select “FSA_CHF”
-
For the “Non-Recommended PSA-Based Screening” measure, select “PSA_Screening”
10.
Select ‘Create’ at the bottom left to submit your comments. If you would like to enter more comments, select “Create another” and then “Create.”
To be considered, comments must be submitted by November 20, 2015, via the JIRA comment tool.

2015-10-27: House Legislation re Outpatient Center Definition and Payment

As of October 27, 2015 (pending vote in House).

110  SEC.   603.   TREATMENT  OF   OFF-CAMPUS  OUTPATIENT  DE-

11                       PARTMENTS OF A PROVIDER.

12          Section 1833(t) of the Social Security Act (42 U.S.C.

13  1395l(t)) is amended—

14                 (1) in paragraph  (1)(B)—

15                         (A) in clause (iii), by striking ‘‘but’’ at the

16                 end;

17                         (B) in clause (iv), by striking the period at

18                 the end and inserting ‘‘; and’’; and

19                         (C) by adding at the end the following new

20                 clause:

21                                ‘‘(v) does not include applicable items

22                         and  services (as  defined in  subparagraph

23                         (A) of paragraph  (21))  that  are  furnished

24                         on  or  after  January   1,  2017,  by an  off-

25                         campus  outpatient   department   of  a  pro-

3                 (2)  by  adding  at  the  end  the  following new

4          paragraph:

5                 ‘‘(21) SERVICES  FURNISHED   BY  AN   OFF-CAM-

6          PUS  OUTPATIENT DEPARTMENT OF  A PROVIDER.—

7                         ‘‘(A) APPLICABLE  ITEMS AND  SERVICES.—

8                 For  purposes  of paragraph  (1)(B)(v)  and  this

9                 paragraph,  the term ‘applicable items and serv-

10                 ices’ means items and services other than emer-

11                 gency   department   services  (identified,   as   of

12                 January   1,  2015,  by  HCPCS   codes  99281–

13                 99285  (and  as  subsequently  modified  by  the

14                 Secretary)).

15                         ‘‘(B)  OFF-CAMPUS  OUTPATIENT   DEPART-

16                 MENT  OF  A PROVIDER.—

17                                ‘‘(i)  IN   GENERAL.—For  purposes  of

18                         paragraph   (1)(B)(v)  and  this  paragraph,

19                         subject to clause (ii), the term ‘off-campus

20                         outpatient    department    of    a     provider’

21                         means a department  of a provider (as  de-

22                         fined in section 413.65(a)(2)  of title 42 of

23                         the Code of Federal  Regulations, as in ef-

24                         fect as of the date of the enactment of this

25                         paragraph)  that  is not located—

2                                such   section  413.65(a)(2))   of   such

3                                provider; or

4                                        ‘‘(II)    within  the    distance   (de-

5                                scribed in such definition of campus)

6                                from a  remote  location of a  hospital

7                                facility  (as   defined  in  such  section

8                                413.65(a)(2)).

9                                ‘‘(ii)   EXCEPTION.—For     purposes of

10                         paragraph   (1)(B)(v)  and  this  paragraph,

11                         the   term   ‘off-campus  outpatient depart-

12                         ment of a provider’ shall not include a de-

13                         partment  of a provider (as so defined) that

14                         was billing under  this  subsection with re-

15                         spect  to  covered OPD  services  furnished

16                         prior  to the date  of the enactment  of this

17                         paragraph.

18                         ‘‘(C) AVAILABILITY   OF   PAYMENT  UNDER

19                 OTHER  PAYMENT  SYSTEMS.—Payments for ap-

20                 plicable items and services furnished by an off-

21                 campus  outpatient   department   of  a  provider

22                 that  are described in paragraph  (1)(B)(v)  shall

23                 be made under  the  applicable payment  system

24                 under  this  part   (other  than   under  this  sub-

1                 section)  if the  requirements  for  such  payment

2                 are otherwise met.

3                         ‘‘(D) INFORMATION NEEDED   FOR   IMPLE-

4                 MENTATION.—Each     hospital   shall  provide to

5                 the Secretary such information as the Secretary

6                 determines appropriate  to implement this para-

7                 graph  and paragraph  (1)(B)(v)  (which may in-

8                 clude  reporting   of  information  on  a  hospital

9                 claim using a code or modifier and reporting in-

10                 formation  about  off-campus outpatient  depart-

11                 ments of a provider on the enrollment form de-

12                 scribed in section 1866(j)).

13                         ‘‘(E) LIMITATIONS.—There shall be no ad-

14                 ministrative   or  judicial  review  under   section

15                 1869,  section  1878,  or  otherwise  of  the  fol-

16                 lowing:

17                                ‘‘(i) The determination of the applica-

18                         ble items and services under subparagraph

19                         (A) and applicable payment systems under

20                         subparagraph  (C).

21                                ‘‘(ii) The  determination  of whether a

22                         department  of a  provider meets  the  term

23                         described in subparagraph  (B).

1                                ‘‘(iii) Any information  that  hospitals

2                         are  required  to  report  pursuant   to  sub-

3                         paragraph  (D).’’.

Example of FDA redline of its February & October letters to 23andMe

How CMS defines MACs and Carriers for CLFS Policymaking

In a recent blog, I suggested that CMS rules should lead it to use "MACs" (Novitas, Noridian, etc) to calculate gapfill pricing medians, rather than using "states."   The relevant regulation is 42 CFR 414.508).   I stated in the simplest reading, the regulation leads to the unit of analysis as "carriers" not "states."  I also stated that "carriers are MACs."   CMS states similarly, in October 1, 2015 PAMA rulemaking.  At 80 Fed Reg 59410, CMS writes,

[W]e use
gapfilling when no comparable existing
test is available. We instruct each MAC
to determine a contractor-specific
amount for use in the first year the new
code is effective.

(We note that we are
proposing to replace ‘‘carrier’’ with
contractor to reflect that Medicare has
replaced fiscal intermediaries and
carriers with MACs.)

...contractors are required to establish
contractor-specific amounts on or before
March 31. Contractors may revise their
payment amounts, if necessary, on or
before September 1, based on additional
information. After the first year, the
contractor-specific amounts are used to
calculate the NLA, which is the median
of the contractor-specific amounts,


The unit of function is "each MAC" which, where the text refers to MAC as singular, established "an amount," singular.  So unless, for example, CMS thinks New England has five or six MACs, it is instructing the New England "MAC" to set "a[n] amount."   To me the simplest reading is that each MAC (such as Palmetto, FCSO, etc) is a rate setting entity, so that there are about ten of them, not 57.  CMS does not routinely and ordinarily refer to having 57 MACs today, although there are 57 CLFS zones.

When the Gapfill regulation was originally promulgated, on December 1, 2006 (here), CMS discussed the process in the preamble (page 69703).  CMS states, "manual instructions are
provided to each Medicare carrier to determine a payment amount for its geographic area(s) for use in the first year, and the carrier-specific amounts are used to establish an NLA for following years."   Adding, "[T]here is also a specific time frame to perform this revision so that we have adequate
time to receive and use the carrier specific amounts for the calculation of the next year’s clinical laboratory fee schedule...we proposed to pay for a new gapfilled laboratory test under our existing methodology for the first year (the carrier would establish a gapfill amount.) Beginning in the second year, the test would be paid at the national limitation amount. This would result in consistent payment in geographic areas for a new test using the median of the carriers’ gapfilled amounts."  There is no specific definition of "median of the carriers" and the most natural definition would be an understanding of "carriers" as contractors or MACs, not as states or subsections of states under the old CLFS zones.