Wednesday, September 18, 2019

The Statutory Requirements for Explanation in an NCD; SSA 1862

https://www.ssa.gov/OP_Home/ssact/title18/1862.htm


This text is not clearly numbered but appears just prior to 1862(b).  Congress writes:

"In making a national coverage determination (as defined in paragraph (1)(B) of section 1869(f)) the Secretary shall ensure consistent with subsection (l) that the public is afforded


  • notice and opportunity to comment prior to implementation by the Secretary of the determination; 
  • meetings of advisory committees with respect to the determination are made on the record; 
  • in making the determination, the Secretary has considered applicable information (including clinical experience and medical, technical, and scientific evidence) with respect to the subject matter of the determination; 
  • and in the determination, provide a clear statement of the basis for the determination (including responses to comments received from the public), the assumptions underlying that basis, and make available to the public the data (other than proprietary data) considered in making the determination."

Subsection 1862(l) [ el ] defines LCD and NCD processes, while section 1869(f) simple defines LCD and NCD.


Link Collection: Scott Gottlieb Joins Board of AETION: RWE

Scott Gottlieb has been joining boards both large and small.  (Joins Pfizer board; here.)

In a Linked In blog, he announced he has joined the board of startup AETION, which is created to help pharma and others build and manage RWE.

in February 2019, AETION raised $27M from Sanofi, McKesson, and others.    Total funding > $70M.

See a 2019 Aetion funding announcement here:


Trade press on funding, here.

See Aetion website here: https://www.aetion.com/

Some trade press this summer on Aetion here.  Partnership with Horizon, here.  FDA, Brigham, and Aetion, here.  (Syapse also announced a link with FDA; here.).


Gottlieb blog at Linked In:



Tuesday, September 17, 2019

Prior Authorization Notepad

There have been a number of intersections of CMS and prior authorization over the years.  I noted a number of them (many I wouldn't have remembered) right on my own blog. 

In July 2019, Medicare proposed preauthorization in the annual Medicare outpatient rulemaking, although for targeted surgeries like blepharoplasty and liposuction. 

In parallel this summer, on the Hill, legislation was proposed for controlling prior authorization inside Medicare Advantage (links below). 

Also on the Hill, in September 2019, a House hearing on the burdens of preauthorization on small providers.

A note pad of some relevant links below. 

2015 Budget (released March 2014) flags pre auth ideas for CMS.
http://www.discoveriesinhealthpolicy.com/2014/03/the-presidents-fy2015-budget-medicare.html

2017, United Healthcare boosts pre authorization for genetics. (This is a pop-up headline that comes and goes for various payers year by year.)
http://www.discoveriesinhealthpolicy.com/2017/06/united-healthcare-may-be-widening-pre.html

2018-2019:
AMA has a dedicated website for prior authorization & burden issues.

https://www.ama-assn.org/amaone/prior-authorization

News: AMA Says Payers Dragging Their Feet (March 2019)
https://healthpayerintelligence.com/news/ama-payers-moving-too-slowly-on-prior-authorization-fixes

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2018 OIG Report on Medicare Advantage Denial Rates Etc.

OIG Report 9/2018

Medicare Advantage Appeal Outcomes and Audit Findings Raise Concerns About Service and Payment Denials
https://oig.hhs.gov/oei/reports/oei-09-16-00410.asp

Trade articles on the above

https://healthpayerintelligence.com/news/oig-finds-profits-to-blame-for-denied-medicare-advantage-claims
https://revcycleintelligence.com/news/medicare-advantage-plans-overturn-75-of-their-own-claim-denials
https://www.kff.org/medicare/issue-brief/prior-authorization-in-medicare-advantage-plans-how-often-is-it-used/


February 2019 AAFP/AMA letter to Seema Verma on Prior Auth
https://www.aafp.org/dam/AAFP/documents/advocacy/legal/administrative/LT-CMS-PriorAuthMedicareAdvantage-021919.pdf
https://www.aafp.org/news/government-medicine/20190308mapriorauth.html


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April 2019:  Prior Auth Bill Coming
https://www.medpagetoday.com/practicemanagement/reimbursement/79314

June 2019:  Prior Auth Bill Imminent
https://www.medpagetoday.com/practicemanagement/reimbursement/80194

June 2019: HR 3107, DelBene et al.  Prior Auth should be less burdensome... in Medicare Advantage.
https://www.congress.gov/bill/116th-congress/house-bill/3107/text

August 2019: Hospitals burdened by prior auth, want overhaul
https://www.modernhealthcare.com/payment/hospitals-call-overhauling-medicare-advantage-prior-authorization-rules

August 2019:  Myriad says it's lost $50M due to tighter edits, especially on CYP genes, meaning Genesight; due to lab benefit managers (LBMs); similar to prior auth...
http://www.discoveriesinhealthpolicy.com/2019/08/very-brief-blog-myriad-genetics-unusual.html

August 2019:  Medicare Outpatient/OPPS Policy Introduces Prior Auth Procedures
http://www.discoveriesinhealthpolicy.com/2019/07/july-20-2019-cms-releases-cy2020-pfs.html


House Hearing September 2019

September 2019, House Committee on Small Business: Pre Auth burdens physicians.  Hearings and testimony.
https://smallbusiness.house.gov/calendar/eventsingle.aspx?EventID=2794

For the Hearing, testimony from Dr. Harari, Oncology, University of Wisconsin; from Dr. Walega, Anethesiology & Pain Management, Northwestern; Dr. Cullen, family practice, Arkansas; Dr. Rogers, dermatologist, Amer Acad Dermatology.

   House Committee Info as ZIP File
   I've put all the House Hearing testimony PDF files, agenda, and an "only here" transcript in one cloud Zip file here.

Follow up press generally about the House hearing:
Modern Healthcare, September 2019:
https://www.modernhealthcare.com/politics-policy/house-committee-throws-spotlight-prior-authorization-burden
Medpage, September 2019:
https://www.medpagetoday.com/practicemanagement/reimbursement/82104
Health Payer Intelligence (playing defense!), September 2019
https://healthpayerintelligence.com/news/payers-providers-spar-over-proposed-prior-authorization-regulation
Becker Hospital Review, September 2019
https://www.beckershospitalreview.com/supply-chain/prior-authorizations-making-it-as-difficult-as-possible-for-patients-to-get-necessary-medical-supplies.html

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In other payer-provider news, Anthem rolled out steep cuts to anatomic pathology payments, see Dark Report, July 2019, here.


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This is a brief link posting. For my regular blog see Discoveries in Health Policy.


Cedars Sinai vs Quest - Trade Journal; Original Court Docs; Patent and Secrets and NDA

MedTechDive on the Cedars v Quest court case.  September 17, 2019.
https://www.medtechdive.com/news/quest-didnt-steal-cedars-sinai-blood-test-in-trade-secrets-row-jury-says/562909/

Original Complaint 11//2017, 24pp
https://www.documentcloud.org/documents/6407574-CedarsSinaicomplaint2017.html

Quest says no: 09/2019, 31pp

https://assets.documentcloud.org/documents/6407575/Questmemoranduminsupportofjudgmentasamatteroflaw.pdf

Sound bite from MedTechDive:

As to the trade secrets claims, Quest said Cedars-Sinai not only failed to prove it had any ownership interest in the claimed trade secrets but also had failed to prove any of the trade secrets were actually secret. Quest said the information was never actually secret because the hospital had been actively shopping its test to multiple companies at the same time it was in discussions with Quest.

The jury ultimately rejected Cedars-Sinai's trade secret claims.

Quest Diagnostics' senior director of external engagement Dennis Moynihan told MedTech Dive the company was pleased with the verdict.

Meanwhile, Cedars-Sinai is still committed to protecting Pimentel's innovations, Laura Coverson, senior communications specialist at the hospital, told MedTech Dive.

Tuesday, September 10, 2019

Lab Fees and Payments on a Doctor's Bill

Got an explanation of benefits from BCBS today for a doctor's visit (routine GYN).

_______

Office visit, Well Care (annual), 99396, Charge $250, payment $97.41.

Pap smear, obtaining, and transmitting to lab, Q0091, Charge $100, payment $0.

Lab test, bacteruria, other than culture or dipstick (?), 81007, Charge $50, payment $1.07.
   (Medicare CLFS, 81007, $29.98).
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This is an in-network physician so BCBS charges/copays represent payment in full.


The Unimpressive FDA Clinical Labeling for Sublingual Buprenorphine

Update: For a later blog that adds depot injection and adds the context of Medicare OTP rulemaking, here.
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It is a truism today that medication-assisted management is best for opioid disorders.  One common form is sublingual, once-a-day buprenorphine (Subutex).  What does the FDA labeling say regarding clinical trials? See the current, online FDA labeling -  Here.

The initial US approval is stated as 2002, labeling updated in 2017 and 2018.   SUBUTEX buprenorphine sublingual tablets is "indicated for the treatment of opioid dependence."   Also, use "should be part of a complete treatment plan that includes counseling and psychosocial support."

I'm used to seeing fairly complete clinical trial descriptions on drug labeling (or device labeling) including graphs, outcomes, etc.  Not here.   Three studies are briefly and incompletely described.
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It looks like in total, across three studies, 575 patients got Suboxone (buprenorphine/naloxone), and 2450 got Subotex (sublingual buprenorphine).  All trials used comprehensive therapy with psychosocial counseling.

In a double blind placebo and active-control study, 326 heroin addicts got Subotex or placebo or Suboxone.  Clinic dosing was provided M-F and home dosing on weekends.  Both drugs had "statistically higher" negative urine tests than placebo.   The degree of difference and the time course don't appear to be stated.

A second study provides time course information.  162 patients were randomized to (a) ethanolic sublingual buprenorphine, or (b) low dose active control, with a 16 week maintenance phase and a 7 week detox (withdrawal) phase.   Doses were tapered 20-30% per week during the taper phase.  " buprenorphine was  more effective than the low dose of the control, in keeping heroin addicts in treatment and in reducing their use  of opioids while in  treatment."  The degree of difference isn't stated.

A third study also provides time course information.  731 subjects were randomized to one of four doses of "ethanolic buprenorphine solution," at 1, 4, 8, 16 mg.  Maintenance for 16 weeks.   Based on "retention in treatment and percentage of negative urine samples," they found that "the three highest tested doses were superior to the 1 mg dose."   No degree of difference is stated.   Doses used here should be crosswalked to slightly higher sublingual-tablet dosing (e.g. 16 mg ethanolic = 24 mg sublingual tablet).

Analysis

The on-label FDA data, usually considered a gold standard for drug approvals, is very weak.
  • In some studies, patients had daily attendance at a clinic, something that wouldn't happen with real-world buprenorphine scrips.   
  • All patients were in controlled clinical counseling environments that were funded and tracked as part of the drug study. 
  • None of the labeled clinical studies reported the scale of outcome at all. 
    • (Were there 50% more clean urine samples ... or 5% pr 1%?)  
  • The largest of the three studies involved 16 week therapy and then a 7 week taper down to zero; nearly all popular press I read emphasizes long-term use of buprenorphine.   

There may be other data on the effectiveness of long term buprenorphine, and on modern real-world outcomes in clinical use, but it's completely absent from the FDA labeling.  The lack of any meaningful outcome data, including scale-of-impact, in the drug labeling was surprising.




Friday, September 6, 2019

Medicare's Listed Preventive Services at SSA 1861 and Open-Ended UPSTF Option

Medicare has enumerated benefits (health benefits defined; preventive benefits defined) at SSA 1861.

For example, the Act covers "medical and other health services," of which 1861(s)(1) are "physician services," 1861(s)(1)(2)(B) are "hospital services incident to a physician" (e.g. hospital surgicenters and ERs).  1861(s)(2)(J) covered prescription services for transplants before there was a Medicare Part D benefit. 

Then you get a handful of screening services, like mammography, PSA testing, colonoscopy, PAP smears, and some others.  For example, 1861(s)(2)(P) covers "prostate screening services" as defined at "subsection (oo)" and so on.  It goes on for pages.

Some Preventive Services Are Easier to Add Than Others

One take home lesson from reading 1861 carefully is that new modalities for prostate and colorectal screening can be added by CMS (probably via an NCD), whereas outside that, any kind of other preventive services can be added IF and AFTER the service is approved by USPSTF. 

For example, liver cancer screening or ovarian cancer screening would have to be approved first by USPSTF. 

(One other pathway, hypothetically, would be a demo program to screen for something under the Innovation Center (CMMI).)

Examples of Statutory Definitions of Some Preventive Benefits

Prostate Screening
Defined at subsection (oo) as a test for early detection of prostate cancer in a man over 50, to include DRE, and PSA, and "such other procedures as the Secretary finds appropriate" including for effectiveness, costs, and other factors the Secretary finds appropriate.  (Note: cost effectiveness clause here at (oo).)

Colorectal Screening
Defined at (pp) to include fecal occult blood test, sigmoidoscopy, colonoscopy, and "such other tests or procedures as the Secretary determines appropriate, in consultation with appropriate organizations."    (Note: no cost effectiveness clause here at (pp).)

Bone Mass Measurement
Defined at (rr) as "radiologic or radioisotopic procedure or other procedure" approved by FDA for the purpose of identifying bone mass or detecting bone loss or determining bone quality.   There are exactly five indications, estrogen-deficient woman, vertebral anomalies, steroid therapy, hyperparathyroidism, and osteoporosis drug therapy.

Cardiovascular Blood Test
Defined at (xx) as cholesterol and other lipid/triglyceride levels, May include other indications and blood tests if approved by USPSTF.

Additional Services Added by NCD After USPSTF Approves

After the enumerated services (above just a sample), additional services at (ddd) can be added IF:
  • Reasonable and necessary to prevent or early detect an illness or disability AND
  • Recommended A/B by USPSTF, AND
  • Appropriate for persons in Part A or B, AND
  • Determination made by NCD process.
If CMS does look at a USPSTF benefit, and consider converting it via an NCD to a Medicare benefit, CMS can consider cost effectiveness.  We read under the USPSTF clause, "The Secretary may conduct an assessment of the relation between predicted outcomes and the expenditures for such service and may take into account the results of such assessment in making such determination."
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The Colorectal NCD.   The Colorectal NCD has been revisited three times under 1861(pp):


  1. To add the FIT test, 
  2. To non-cover virtual CT colonography, and 
  3. To cover the Exact Science Cologuard test.  
    1. These are each under NCD 210.3, here.


Claims and Codes for Preventive Services

Medicare has a special Claims Processing Manual (rulebook) for preventive services, Claims Processing Manual, Chapter 13, here.   For CRC, codes include 82270 (Guaiac), G0328 (FIT), Cologuard 81528 (temp code had been G0464).. 

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Gray Areas.

There are some gray areas.  For example, Medicare has a smoking cessation benefit, and USPSTF has a preventive service Smoking Cessation that it approved.  However, these two things do not interact.   Medicare approved the Smoking Cessation Benefit in 2005 via an NCD, ruling that for smokers, smoking cessation was simply part of necessary medical care.   USPSTF also has a preventive category benefit called Smoking Cessation.  Today it could be the basis of the NCD, but in 2005 the NCD stood by itself as a "necessary medical benefit"  and was not linked to USPSTF or prevention.

I believe when CMS created the Smoking Cessation benefit in 2005, it was classed as "medical care" and therefore had a 20% copay, but a later law said that USPSTF-covered services have no copay at Medicare, so I suspect today it is also classified as a no-copay service since it is also endorsed by USPSTF.

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All this may add up to a more complex system for preventive services in Medicare than in private healthcare or in some other countries.  E.g. an OncImmune test for high risk lung cancer screening might have a faster path in the UK than USA; see here.