Thursday, September 13, 2018

House Speech about LCD Clarification Act (September 12, 2018)

See main blog here.

From YOUTUBE auto transcript.

Mr. Speaker, today I rise in support of
HR 3635, the local coverage
determination clarification Act.

introduced this legislation along with
Congressman [Kind] which will help ensure
the Medicare coverage decisions are made
by qualified health experts through a
transparent process that is based on
sound medical evidence.

administrative contractors or Macs play
a critical role in ensuring that
Medicare beneficiaries have access to
needed care.

However the less than transparent
process used by Mac's to make coverage
decisions can limit or deny patients
access to necessary care.

the science that guides some of these
decisions can be flawed mischaracterized
or misapplied.

The deliberations and
decisions of the Mac's which should be
based on medical science are often
conducted behind closed doors, with
little opportunity for interested
stakeholders to raise issues or offer

These decisions affect
millions of Medicare beneficiaries and
impact crucial access to innovative
technologies and services.  The
establishment of a clear process
informed by health experts will make the
local coverage determination or LCD
process, and the decisions developed by
that process, more sound more transparent
and ensure accountability among Mac's.

These requirements are necessary to
ensure that our nation's seniors receive
quality health care treatment.

Specifically HR 3635 would improve
the LCD process by requiring that
carrier advisory committee meetings of
the Mac are open public and on the
record with minutes taken and posted to
the Mac's website for public inspection.

The gravity of limiting or precluding
coverage for both beneficiaries and
practitioners heightens the need for
transparency especially when such
meetings are currently closed off.

Mac's would be required to include at
the outset of the coverage determination
process a description
of the evidence of Max considered when
considering a local coverage
determination - as well as the rationale
it applies on to deny coverage.

Additionally under current rules local
coverage determinations are essentially
unreviewable once they become final.

legislation would create a process for
stakeholders to request additional
review of a max local coverage decision
from the  Centers for Medicare and
Medicaid Services.

It would also require
the secretaries to submit a report to
Congress regarding the number of
requests filed with fiscal
intermediaries and carriers and the
number of appeals filed with the
Secretary as well as the actions in

Additionally the report would recommend
ways to improve the usefulness and
effective efficiency of the process as
well as the communication from Medicare
beneficiaries and providers.

pleased that the legislation we have
here today take steps to improve the
process and bring transparency to
protect access for Medicare patients.

must continue to work to ensure that
Mac's independently evaluate the
evidence of other max coverage decisions
local coverage determinations should be
thoroughly evaluated by experts in each
local jurisdiction.

Currently loopholes
in the process allow contractors to
adopt another macs coverage determination
without the necessary scientific rigor
and meaningful engagement with
stakeholders that is vital to informing
the most appropriate policy, due to
regional Geographic and population-based

These carbon copy LCDs may
not reflect the specific geographic
region they are intended to serve local
coverage determinations should be just
that local but simply what works best
for one location dan does not always
work best for another location.

local coverage determinations across
jurisdictions has the practical effect
of establishing national coverage
policies - without having followed the
more rigorous national coverage
determination process.

As such I look
forward to working with my colleagues on
this issue moving forward.

beneficiaries deserve transparency and
accountability for these decisions that
directly impact their access to care.

These reforms are necessary to ensure
that local coverage determinations do
not impede a physician's medical
judgment and deny patients access to
medically necessary care.

By changing the
LCD process Congress can ensure that
medical and scientific evidence is not
used selectively to deny appropriate
coverage to seniors.

 I want to thank Mr.
Kyne who joined me in introducing this
legislation, I want to ask my colleagues
for their bipartisan support of this
bill as we work to improve access and
care for every American.

 Mr Speaker I
reserve the balance of my time.

Tuesday, September 11, 2018

Summer 2018 Public Comment Gapfill Comments re 81425 Reimbursement

In Summer 2018, CMS published and accepted stakeholder comment on about twenty codes going through the gapfill process. 

These comments are publicly available from CMS.  Public comments on whole genome sequencing (81425 81426 81427) are in the cloud here.  Click "down arrow" to download (about 25 documents, about 6 mb).

Monday, September 10, 2018

Ben Sasse: NBC Interview September 9, 2018 (Meet The Press, 9 min)

I've Met One Sitting Senator

I have only met one sitting Senator for an extended one-on-one meeting - Sen. Ben Sasse, from whom I wrote a report on genomics reimbursement in 2008.   He read the report with care and we had a half-hour discussion on the topic in his office at HHS when he was an assistant secretary in the Bush administration.*  Recently trained as a PhD political scientist at Yale, I was impressed that Sasse had absorbed the white paper and had come to the meeting with a complete, detailed and insightful view of reimbursement issues in genomics -- an incredibly arcane area.

NBC's Ben Sasse Interview: September 2018

On September 9, 2018, NBC featured a nine-minute detailed interview with Sen. Sasse about current events and trends in Washington, including relationships between the Hill and the White House.  See the Youtube video here:

I've also put a PDF transcript of the interview in the cloud, here.  Sasse is interviewed by NBC's Chuck Todd.


For my regular health policy blog, see


* As of September 2018, the 2008 Quinn report was still online at, here.  It is also stored in a separate cloud location here.

Wednesday, September 5, 2018

CMMI's Chief, Adam Boehler: His 2017 Youtube Remarks about Landmark and Outcomes

Adam Boehler became (1) head of CMS CMMI in Spring 2018, and holds additional titles such as (2) Deputy Administrator of CMS and (3) Advisor to HHS Alex Azar on Innovation.

As of September 5, 2018, there are just a few recent August speeches where he talks about his vision for CMMI and healthcare innovation.   See for example:

Earlier 2017 Speech by Boehler as CEO of Landmark Health

In his prior role as head of LANDMARK HEALTH, there’s a Youtube speech from 2017 archived by the National Institute for Healthcare Management, NIHCM.   An unofficial transcript is below.
The section including Boehler begins on page 13 with Boehler’s main remarks beginning on page 15.

  • Cloud transcript here.   
  • Youtube video (with powerpoints) here.