Thursday, October 25, 2018

Trump Drug Pricing Transcript October 25



https://www.youtube.com/watch?v=1-UfrqqdS8c



Thank you very much, thank you. It's a big day. It's a very important day. Thank you, please. Thank you very much, secretaries that are here for your tremendous leadership. This really is an important day for me. I've been talking about drug price reductions for a long time and now we're doing things that nobody was, let's say, 'cause I'm speaking on behalf of all of us bold enough to do and they're gonna have a tremendous impact.

I also want to thank FDA Commissioner, Scott Gottleib. Scott, stand up Scott, you've done such an incredible job. Really incredible job. And CMS Administrator, Seema Verma for joining us. Seema, thank you very much Seema, great job, great job.

I'm thrilled to be here at the Department of Health and Human Services and I want to thank everybody. I understand that's it's been decades since the last President came here and I'm very surprised that President Obama didn't come here for Obamacare, explain that one to me. But he didn't. But it's a great honor to be here. You do an incredible job, you really do an incredible job. So I thank you.

Since the day I took office, I have made reducing drug prices one of my highest priorities. Last year, the FDA approved more than 1000 low cost generics, the most in the history of our country. This year, we beat that record, approving even more generics. These new approvals are leading to cheaper, competitive alternatives for our life-saving drugs like the EpiPen, saving Americans almost 9 billion dollars a year last year alone.

Since releasing my drug pricing blueprint in May, 16 drug companies reduced their list prices, rolled back increases or froze their prices for the rest of the year. We called a few of those companies recently where they raised their prices and I guess maybe it was one of the times that I realized how powerful the presidency is because they immediately rolled their prices back to where they started. And those companies know who we're talking about and we appreciate it very much.

Earlier this month, I signed two bills to lower the cost of prescription drugs. The Know the Lowest Price Act, Know the Lowest Price Act, it's a big thing and the Patient Right to Know Act and by the way, put those two together and you have a complicated deal. Sounds simple, but that one's not, ending the unjust gag clauses once and for all. Where you go into a drug store and the pharmacist wouldn't even be allowed to talk about alternatives or pricing. How ridiculous is that? Think about it, how ridiculous. That's not going to take place anymore and actually the pharmacists are very happy about it.

Patients now have the right to know the lowest price and the most affordable alternative available at their pharmacy. Today, we are here to announce another bold and historic action to bring down the price of prescription drugs. With the action I am unveiling today, the United States will finally begin to confront one of the most unfair practices, almost unimaginable that it hasn't been taken care of long before this, that drives up the cost of medicine in the United States.

We're taking aim at the global freeloading that forces American consumers to subsidize lower prices in foreign countries through higher prices in our country. And I've seen it for years and I never understood. Same company, same box, same pill, made in the exact same location and you'll go to some countries and it would be 20% the cost of what we pay and in some cases, much less than that and I'd say, why is this? I never knew that I would be able to stand here before you and have a chance to fix it and that's what we're doing, we're fixing it. That's called real life experience I guess.

For decades, other countries have rigged the system so that American patients are charged much more and in some cases, much, much more, for the exact same drug. In other words, Americans pay more so that other countries can pay less, very simple. That's exactly what it is. It's wrong, it's unfair, it's not surprising. I've seen trade deals where it's far more costly to us then even this, and we're changing them also.

Foreign countries even threaten to disrespect our patents if they are not given cheaper prices on drugs. So they're not going to even look at the patents. They've been very, very disrespectful previously to our country and to all of the things we stand for. And especially they would disrespect patents when it came to American made drugs. The American middle class is effectively funding virtually all drug research and development for the entire planet. So we are paying for it. We are subsidizing it, everybody else is benefiting and they are paying nothing toward research and development.

The world reaps the benefits of American genius and innovation while American citizens and especially our great seniors who are hit the hardest, pick up the tab. But no longer. Here are just a few examples. For one, eye medication that helps prevent blindness. Medicare pays over 1 billion dollars a year. If we paid the prices other nations pay, we'd bring the 1 billion dollars down to 187 million dollars a year. It's pretty amazing isn't it? We spend more than a billion dollars a year on two drugs to treat bone disease but we could save more than 800 billion dollars, think of that, 800 billion dollar saving for our seniors by paying the prices other countries pay. [Note, more likely $800 million]  Nothing special. Just the prices that other countries pay. That's the way the United States has been disrespected for too long in too many ways.

One common cancer drug is nearly seven times as expensive for Medicare as it is for other countries. This is a highly used and very effective drug and it's seven times more expensive, not fair. This happens because the government pays whatever price the drug companies set without any negotiation whatsoever. Not anymore. Under our new plan, the Department of Health and Human Services, would allow Medicare to determine the price it pays for certain drugs based on the cheaper prices paid by other nations. Some people call it Favored Nations Clauses. We have them in business. We have them in a lot of different contracts that I've seen over the years and been part of. Favored Nations. So think of that. So we're paying a price based on the price that other nations are paying. That's what we're going to pay. No longer seven times more. No longer 10 times, 11 times, even 12 times, I've seen examples. Paying the same price. Talking about billions and billions of savings to people, to people.

We will no longer accept the inflated prices being charged to our seniors. I had a Congressman, respected Congressman come to the Oval Office and say, "Sir, for my constituents, drug pricing is more important than healthcare." And I said, "Explain that to me." But he actually said, "Drug pricing," I've never forgotten the expression, drug pricing, we know how important healthcare is. Drug pricing is even more important for my constituents.

At long last, the drug companies in foreign countries will be held accountable for how they rigged the system against American consumers. This is a revolutionary change, nobody's had the courage to do it or they just didn't want to do it. And this is a change for the people. This is not a change for industry or for companies or for pharma. This is a change for the people. It will be substantially a reduction in drug prices for our people and our senior citizens. Tremendous, tremendous difference.

Our plan will also fix a broken payment system where doctors are reimbursed more if they prescribe a much more expensive drug. Under our new proposed payment system, doctors will be paid a flat rate. Now when you think of it, it's like being a contract or anything else. If it's an expensive drug or a less expensive drug, it's the same, doesn't take anymore and I think this will be good. In terms of the pricing of the drug, it will be fantastic for that. But it'll also be much better for patients and it very well may be better for doctors.

This follows other significant actions that we've taken to protect Medicare for our great seniors. We have given the plans that serve more than 45 million seniors on Medicare Part D and 20 million seniors on Medicare Advantage, new tools to negotiate lower prices. Thanks to our actions, this year premiums for both Medicare Part D and Medicare Advantage have, and I'll give you a word that you haven't ever heard, ever heard, have gone down. You've never heard that word. True, gone down and now they're going to go substantially down.

Sadly a majority of Democrats in the House of Representatives have cosponsored a very Socialist Healthcare plan that would destroy Medicare, terminate Medicare Advantage and outlaw the employer sponsored healthcare plans of 157 million Americans. We think that they're going to actually come along with us when they see what we're doing, we think, we hope. It's something that makes no sense any other way. So we really think they can be bi-partisan. It happened to be a Democrat that told me how important drug pricing was. It wasn't a Republican in this case, it was a Democrat.

Under this administration, we will always protect Medicare for our great seniors and we will always protect Americans with preexisting conditions, always. In every action we take, we are putting America first and this is very much about putting America first. We get tired of having people go to other countries to literally fill prescriptions and you know where I'm talking about. We're fighting for lower drug prices which will now be automatic, it will be automatic and very substantial. Lower premiums, where we've done a really good job with healthcare in bringing the premiums down to a much lower level, much more acceptable level and we're going to be soon announcing somethings that will really have a tremendous and positive impact on healthcare also. And better healthcare, very importantly for every single American.

So I just want to thank everybody in this room, you're outstanding people. I know how hard you work. I know how important your work is. How brilliant you're work has to be and how complex a job you have. You have a very complex job. You have everything. You have probably every single element of life in the work you do. But I just want to let you know the American people very much appreciate, have great respect for you. I think they'll even have more. That'll go up very significantly when they see their drug prices falling. They're going to say, "What's happened? They must've made a mistake." It's true. They're gonna go up to the counter ... Did you make a mistake? Some won't say that, they'll just think it. And some might say, "Did you make a mistake?" But you're gonna see a big reduction.

I wanna thank everybody very much. It's an honor to be here, thank you very much, thank you.

Friday, October 19, 2018

10/2018: Final Gapfill Pricing, Comments View (For CY2019)

0001U  $                        720  Red blood cell antigen typing, DNA,  Contractors looked at payment rates for similar tests on the CLFS (i.e. 81403) and also payment amounts derived from outside payer of the service.
0002U  $                          25  Oncology (colorectal), quan assessment of 3 urine metabolites  Contractors used the cost per test as indicated by the company, minus the cost of shipping and sales/education and 18% discount already offer by the laboratory.  Other contractors based recommendation on similar urine assessment tests on the CLFS.
0009U  $                        107  Oncology (breast cancer), ERBB2 (HER2) copy number by FISH  Contractors used the payment amount based on HER2 FISH code 88367 as a similar test.  Some contractors adjusted the fee to reflect 2018 RVUs.
0010U  $                        427  Infectious disease (bacterial), strain typing by WGS  Some contractors used the payment amount of a similar test on the CLFS (87153) and adjusted the fee to reflect 2018 RVUs. Other contractors recommended code 87153 as a similar test but recommended a multiplier of 3.  
0012U  $                    2,516  Germline disorders, gene rearrangement detection by WGS  Some contractors used payment rates of a similar test on the CLFS, code 81445.  Others used commercially available service rates of $349.00.  Other contractors used information from a similar code being gapfilled, 81425, to estimate a payment rate recommendation.  They reasoned that since 0012U  examines the whole genome, but only detects large scale mutations, the payment rate should be estimated at 81425 x 0.5.
0013U  $                    2,516  Oncology (SO neoplasia), gene rearrangement detection by WGS  Some contractors used payment rates of a similar test on the CLFS, 81445.  Other contractors used information from a similar code being gapfilled, 81425, to estimate a payment rate recommendation.  They reasoned that since 0012U examines the whole genome, but only detects large scale mutations, the payment rate should be estimated at 81425 x 0.5. 
0014U  $                    2,516  Hematology (hematolymphoid neoplasia), gene rearrangement detection by WGS  Some contractors used payment rates of a similar test on the CLFS, 81445.  Other contractors used information from a similar code being gapfilled, 81425, to estimate a payment rate recommendation.  They reasoned that since 0012U  examines the whole genome, but only detects large scale mutations, the payment rate should be estimated at 81425 x 0.5.
81327  $                        192  SEPT9 (Septin9) methylation analysis  Contractors used the average of two similar tests on the CLFS.  Specifically, they used the payment amount provided by a laboratory for code 81287 and the commercially available payment amount provided by a laboratory for code 81288.
81471  $                        914  X-linked intellectual disability dup/del, 60 Genes  Contractors used the average of the payment amount for a similar test on the CLFS, 81433, and the payment amount recommended by the laboratory. 
81470  $                        914  X-linked intellectual disability (XLID) 60 Genes  Contractors used an average of the payment rate for a similar test on the CLFS, 81445, and a publically recommended payment amount.  
81551  $                    2,030  Oncology (prostate), profiling by real-time PCR of 3 genes  Recommended payment rate based on company information and applied a 15% discount that was being offered by the provider.
0004M  $                          79  Scoliosis dna alys  Contractors based payment rate recommendation on commercial lab charges.  Contractors further explained that resources required for this test are comparable or relevant from labs with similar tests.
0006M  $                        150  Onc hep gene risk classifier  Contractors based payment rate recommendation on commercial lab charges.  Contractors further explained that resources required for this test are comparable or relevant from labs with similar tests.
0007M  $                        375  Onc gastro 51 gene nomogram  Contractors used 50% of the publically available rate.  No data were received from the laboratory when requested.  
0009M  $                        133  Fetal aneuploidy trisom risk  Contractors used 50% of the publically available rate.  No data were received from the laboratory when requested.  
81425  $                    5,031  Genome sequence analysis  Some contractors based initial recommendations on laboratories with similar test with charges of $349.00. Upon further review, however, several contractors revised their recommendations.  Some contractors looked to similar tests on the CLFS, specifically 81415, a Whole Exome Sequencing code, and adjusted the payment rate based on input from several laboratories.  Other contractors simply followed public recommendations to use CPT 81415 as a similar test on the CLFS to recommend a payment rate.   
81426  $                    2,710  Genome sequence analysis, each comparator genome  Some contractors based initial recommendations on laboratories with similar test with charges of $349.00. Upon further review, however, several contractors revised their recommendations.  Some contractors looked to similar tests on the CLFS, specifically 81415, a Whole Exome Sequencing code, and adjusted the payment rate based on input from several laboratories.  Other contractors simply followed public recommendations to use CPT 81415 as a similar test on the CLFS to recommend a payment rate.   
81427  $                    2,338  Genome re-evaluation  Initially, several contractors felt this code represented interpretation only and thus averaged two comparable codes (G0452-26 and 88291).  Upon further review, some contractors followed public recommendations to use CPT 81417 as a similar test on the CLFS. Others did not recommend this similar payment rate and instead estimated a professional labor rates for the code.   

Friday, October 5, 2018

2019 CPT meetings

CPT Submission Due
CPT Conference Date
City
Category III Result
November 7, 2018
February 7-9, 2019
Tucson 
(Westin Paloma)
Posted next July or January, and effective the next July or January
February 12, 2019
May 9-11, 2019
Chicago 
(Loews)
June 25, 2019
September 26-28
Seattle 
(Hyatt Regency)

Wednesday, October 3, 2018

UK NHS Digital Health Tidbits, Including "Topol Report" on DHealth in the UK

An interesting website,  https://www.hsj.co.uk/
(?health services journal), has some eye catching digital health news recently.

See an article on concerns, "fragmentation,"  and potential changes about DHealth regulation in the UK, here.

See an article on evidence for adoption and implementation of DHealth and digital medicine in the UK, here
This adoption article is based on, and links to, a 48 page interim report and 16 page slide deck prepared by US expert Eric Topol for the guidance of the NHS.   Find entry points to the Topol documents here.


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Digital health funding has been very high in the U.S. through 3Q2018; trade press here.

Thursday, September 13, 2018

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


See main blog here.


From YOUTUBE auto transcript.

https://www.youtube.com/watch?v=PVfHH1KaAvs

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

 I
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.

 Medicare
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.

Specifically
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
alternatives.

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.

This
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
response.


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.

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

We
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
differences.

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.

Applying
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.

 Medicare
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:

https://www.youtube.com/watch?v=u3YismPN8AM

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





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For my regular health policy blog, see www.discoveriesinhealthpolicy.com



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