Tuesday, September 10, 2019

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.






Thursday, September 5, 2019

Medicare's General Authority to Implement the Act: SSA 1102 and 1871

As noted in new fraud regulations released 9/5/2019. 

These same two sections of Medicare law were also used in a 2018 proposal, finalized in 2019 but delayed in court, to require TV ads to display prices. 

S. 1871 was also used in June 2019 to delay the expiration of a proposed rule about antibiotic stewardship programs.

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Fraud law inspection copy: https://s3.amazonaws.com/public-inspection.federalregister.gov/2019-19208.pdf

"Sections 1102 and 1871 of the Act, which provide general authority for the
Secretary to prescribe regulations for the efficient administration of the Medicare
program."

1102 grants a general authority to create regulations and places some rules regarding impact on rural hospitals.

1871 also grants a general authority, while providing a timeline (3 years), and other factors.  Comment periods must be 60 days.  A final regulation must be a natural evolution ("logical outgrowth") of a proposed regulation; if not, it itself should be a proposed regulation.  Rules shall not be retroactive.  Clipped below. 

At bottom, see some legal links on the concept "logical outgrowth," a legal term of art.

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https://www.ssa.gov/OP_Home/ssact/title11/1102.htm

Sec. 1102. [42 U.S.C. 1302] (a) The Secretary of the Treasury, the Secretary of Labor, and the Secretary of Health and Human Services, respectively, shall make and publish such rules and regulations, not inconsistent with this Act, as may be necessary to the efficient administration of the functions with which each is charged under this Act.

Sections 1102(b) (1,2,3) deal with impact of any rule on small rural hospitals.

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https://www.ssa.gov/OP_Home/ssact/title18/1871.htm

Sec1871. [42 U.S.C. 1395hh] (a)(1) The Secretary shall prescribe such regulations as may be necessary to carry out the administration of the insurance programs under this title. When used in this title, the term “regulations” means, unless the context otherwise requires, regulations prescribed by the Secretary.
(2) No rule, requirement, or other statement of policy (other than a national coverage determination) that establishes or changes a substantive legal standard governing the scope of benefits, the payment for services, or the eligibility of individuals, entities, or organizations to furnish or receive services or benefits under this title shall take effect unless it is promulgated by the Secretary by regulation under paragraph (1).
(3)(A) The Secretary, in consultation with the Director of the Office of Management and Budget, shall establish and publish a regular timeline for the publication of final regulations based on the previous publication of a proposed regulation or an interim final regulation.
(B) Such timeline may vary among different regulations based on differences in the complexity of the regulation, the number and scope of comments received, and other relevant factors, but shall not be longer than 3 years except under exceptional circumstances. If the Secretary intends to vary such timeline with respect to the publication of a final regulation, the Secretary shall cause to have published in the Federal Register notice of the different timeline by not later than the timeline previously established with respect to such regulation. Such notice shall include a brief explanation of the justification for such variation.
(C) In the case of interim final regulations, upon the expiration of the regular timeline established under this paragraph for the publication of a final regulation after opportunity for public comment, the interim final regulation shall not continue in effect unless the Secretary publishes (at the end of the regular timeline and, if applicable, at the end of each succeeding 1-year period) a notice of continuation of the regulation that includes an explanation of why the regular timeline (and any subsequent 1-year extension) was not complied with. If such a notice is published, the regular timeline (or such timeline as previously extended under this paragraph) for publication of the final regulation shall be treated as having been extended for 1 additional year.
(D) The Secretary shall annually submit to Congress a report that describes the instances in which the Secretary failed to publish a final regulation within the applicable regular timeline under this paragraph and that provides an explanation for such failures.
(4) If the Secretary publishes a final regulation that includes a provision that is not a logical outgrowth* of a previously published notice of proposed rulemaking or interim final rule, such provision shall be treated as a proposed regulation and shall not take effect until there is the further opportunity for public comment and a publication of the provision again as a final regulation.
(b)(1) Except as provided in paragraph (2), before issuing in final form any regulation under subsection (a), the Secretary shall provide for notice of the proposed regulation in the Federal Register and a period of not less than 60 days for public comment thereon.
(2) Paragraph (1) shall not apply where—
(A) a statute specifically permits a regulation to be issued in interim final form or otherwise with a shorter period for public comment,
(B) a statute establishes a specific deadline for the implementation of a provision and the deadline is less than 150 days after the date of the enactment of the statute in which the deadline is contained, or
(C) subsection (b) of section 553 of title 5, United States Code[502], does not apply pursuant to subparagraph (B) of such subsection.
(c)(1) The Secretary shall publish in the Federal Register, not less frequently than every 3 months, a list of all manual instructions, interpretative rules, statements of policy, and guidelines of general applicability which—
(A) are promulgated to carry out this title, but
(B) are not published pursuant to subsection (a)(1) and have not been previously published in a list under this subsection.
(2) Effective June 1, 1988, each fiscal intermediary and carrier administering claims for extended care, post-hospital extended care, home health care, and durable medical equipment benefits under this title shall make available to the public all interpretative materials, guidelines, and clarifications of policies which relate to payments for such benefits.
(3) The Secretary shall to the extent feasible make such changes in automated data collection and retrieval by the Secretary and fiscal intermediaries with agreements under section 1816 as are necessary to make easily accessible for the Secretary and other appropriate parties a data base which fairly and accurately reflects the provision of extended care, post-hospital extended care and home health care benefits pursuant to this title, including such categories as benefit denials, results of appeals, and other relevant factors, and selectable by such categories and by fiscal intermediary, service provider, and region.
(e)[503](1)(A) A substantive change in regulations, manual instructions, interpretative rules, statements of policy, or guidelines of general applicability under this title shall not be applied (by extrapolation or otherwise) retroactively to items and services furnished before the effective date of the change, unless the Secretary determines that—
(i) such retroactive application is necessary to comply with statutory requirements; or
(ii) failure to apply the change retroactively would be contrary to the public interest.
(B)(i) Except as provided in clause (ii), a substantive change referred to in subparagraph (A) shall not become effective before the end of the 30-day period that begins on the date that the Secretary has issued or published, as the case may be, the substantive change.
(ii) The Secretary may provide for such a substantive change to take effect on a date that precedes the end of the 30-day period under clause (i) if the Secretary finds that waiver of such 30-day period is necessary to comply with statutory requirements or that the application of such 30-day period is contrary to the public interest. If the Secretary provides for an earlier effective date pursuant to this clause, the Secretary shall include in the issuance or publication of the substantive change a finding described in the first sentence, and a brief statement of the reasons for such finding.
(C) No action shall be taken against a provider of services or supplier with respect to noncompliance with such a substantive change for items and services furnished before the effective date of such a change.
(2)(A) If—
(i) a provider of services or supplier follows the written guidance (which may be transmitted electronically) provided by the Secretary or by a medicare contractor (as defined in section 1889(g)) acting within the scope of the contractor’s contract authority, with respect to the furnishing of items or services and submission of a claim for benefits for such items or services with respect to such provider or supplier;
(ii) the Secretary determines that the provider of services or supplier has accurately presented the circumstances relating to such items, services, and claim to the contractor in writing; and
(iii) the guidance was in error;
the provider of services or supplier shall not be subject to any penalty or interest under this title or the provisions of title XI insofar as they relate to this title (including interest under a repayment plan under section 1893 or otherwise) relating to the provision of such items or service or such claim if the provider of services or supplier reasonably relied on such guidance.
(B) Subparagraph (A) shall not be construed as preventing the recoupment or repayment (without any additional penalty) relating to an overpayment insofar as the overpayment was solely the result of a clerical or technical operational error.
(f)(1) Not later than 2 years after the date of the enactment of this subsection, and every 3 years thereafter, the Secretary shall submit to Congress a report with respect to the administration of this title and areas of inconsistency or conflict among the various provisions under law and regulation.
(2) In preparing a report under paragraph (1), the Secretary shall collect—
(A) information from individuals entitled to benefits under part A or enrolled under part B, or both, providers of services, and suppliers and from the Medicare Beneficiary Ombudsman with respect to such areas of inconsistency and conflict; and
(B) information from medicare contractors that tracks the nature of written and telephone inquiries.
(3) A report under paragraph (1) shall include a description of efforts by the Secretary to reduce such inconsistency or conflicts, and recommendations for legislation or administrative action that the Secretary determines appropriate to further reduce such inconsistency or conflicts.

[502]  See Vol. II, 5 U. S.C. 553.
[503]  As in original. No subsection (d) has been enacted.


##
* Logical Outgrowth.   

Google search results here.

https://law.lclark.edu/live/files/10039-administrative-law-outline-funk-fall-2010

https://www.foreffectivegov.org/node/2585  (logical outgrowth test)

https://scholarship.law.nd.edu/cgi/viewcontent.cgi?article=4697&context=ndlr   Law article by Lifton, 2017.







Jorge Conde and Logistics/Strategy of KNOME (Bioinformatics for Whole Genome)

A17Z Podcast
Software Company in Healthcare

(Extracted)


https://en.wikipedia.org/wiki/Knome  






JORGE CONDE - KNOME
                             So in our experience and know me, it was interesting because here, this is a company with the sole purpose of the company was to provide software capability to analyze genomic information. And so, you know, when you launched that, your assumption is, well this could be used to power all kinds of applications. It could be used for research, either in academia and industry. It can be used for, you know, clinical diagnostics, flexible. We thought it was very flexible and so challenge one is, you know, a solution looking for a problem is always a very, very dangerous thing. I think that's universally true. It's especially true in the healthcare space. And challenge two was understanding exactly where in the case of the clinical setting where this technology would be used in the workflow. So here we want it to go after the clinical labs.
Speaker 2:          That was your initial hypothesis.

Our initial hypothesis for an application in a clinical setting, you have technicians and docs that are inside of the laboratory setting, receiving samples, running a test, analyzing the results of that test, generating a report that gets signed off by lab director, that goes back to a physician.

Usually it's in the form of a diagnosis, right? And it gets signed off and it goes to the physician. The physician now takes that report and basically decides what to do based on that information. So our assumption was, well, if you have the ability to sequence DNA now in a way that you couldn't before, before you'd have to do all of these specific tests, you have to know what the test, and then you'd test it and then you'd get a report. You have to know what street lamp the keys were under, right?
Speaker 2:          Like they're in that case. Whereas once you had the full genome, you would just sequence everything and just run a bunch of software [careers.] So our thought going into this was, well, that's an incredibly powerful tool for clinical labs because first of all, you can sequence just once and analyze over time, right? You can again get like a totally legitimate, right. And it turns out that there was a lot of challenges with that assumption. The first one is every lab is different.
A lot of them didn't have the budget or the willingness to basically pay the upfront piece to buy the capability to use this technology, or they didn't have the ability to sequence everything upfront, even of all of the subsequent queries would be technically free later the way they're reimbursed. Oh, how fascinating. Too expensive. Basically it's too expense. So even the, theoretically there's an ROI, a return on the investment of sequencing up front, just the way the industry is structured, the way reimbursement flows, the way payments flow.
Speaker 2:          It just didn't make sense for a lot of labs to do this.

So how is that not just a complete roadblock at that point it was a big roadblock. So that would, that required us to do was to then focus on clinical labs that had the ability to make certain investments in up front cost and those tended to be very sophisticated labs that do a lot of research work in addition to patient care. Then they tended to be on this sort of on the bleeding edge and they wanted to incorporate new technology and they were great partners and all of that. But then it goes back to your N of one problem.

So you sell something into that lab and you go next door and next door. It has a totally different set of capabilities, a totally different set of constraints, a totally different set of expectations.
Speaker 2:          And so therefore all of a sudden the solution you created for lab a is not relevant or unattainable for lab B.

 Now to just add to the stepping in it, you know, when you're analyzing genomic data, there's a massive amount of computation required. And so we went in there assuming, well this is easy, we're just gonna shoot all of this up to the cloud, we'll run the analysis, we'll send the data back to the lab to the lab, could verify it, generate a report, and off we go. It turns out labs weren't comfortable sending data up into the cloud full stop at that time, at that time, arguably even today, arguably even today in 2019 but definitely at that time we probably should have known that earlier. That would have changed how we thought about going into the clinical lab space. How would you have done your homework?
Speaker 2:          I mean, what would that have actually looked like? It was frankly, I think just defining the specs of what would be required to bring in our technology because I think people intuitively know that genomic data is massive. But you know, I don't think they know sort of the level of computation required to run the interpretation. Right? So like really running the numbers, running the numbers for them. And by the way, we tried everything. I mean we brought representatives from AWS that could show them that they had a HIPAA compliant cloud, that they had received all the certifications and it came back to risk aversion. So someone in the lab director saying like, look, I'm sure all of that's true, but I'm not going to risk sending all of this data up into the cloud. So that was a big, big challenge for us. And it ended up being a major limitation for our ability to expand into the clinical setting because of all of those barriers.
Speaker 2:          So what did you do? We have to do a plan a and a plan B. And so the plan a was we assumed that there would be a couple of forward looking labs or forward thinking labs that would be willing to work in a cloud environment much easier to deploy there. The plan B was we had to create a box, we had a grid of box and the box had to have essentially the competition. Yeah, we had a normal plan. Remember that? Oh my God. Because they didn't want the data to go outside and it's for the reasons that we'd expect, you know, there, there's regulatory, there's risk associated with that today in 2019 in fact, the companies that have managed to use this technology have taken the sort of full stack service approach. So that sort of high, low strategy became the approach is get folks to deploy into the cloud when they were willing to, and in the case where folks needed an appliance, we basically had to go to labs that had enough of a sample volume that an appliance made sense for them and make basically the case there from an investment stand.
Speaker 1:          So again, multiple choice variety and like addressing in different ways. Okay.
Speaker 2:          Pure software company in healthcare is a really hard thing to do because on the one side you have this challenge that it's hard to create a sort of a solution that's going to fit everyone and therefore you need to have some level of services around that software that's on one extreme. So when you need to have humans in the process or in the loop, and in the other extreme of it, if it is pure software, then it's considered the, it should be free. So it's very hard to abstract value.
Speaker 1:          That's so interesting. Do you think that's shifting at all with the kind of understanding of the importance of data and some other,
Speaker 2:          yeah, look, I would argue with shifting on a couple of of axes. The first one is, is data is becoming more and more valuable. Historically data was viewed as being either too small in terms of its impact, too narrow, too dirty, et Cetera, et cetera. Too difficult. Yeah, to unstructured, you know, so that historically had been the case. So if you have ways to ingest data and clean it and make it meaningful, then I think that is valued. Probably the most public one is would flat iron was able to do and ultimately getting acquired by Roche for $2 billion. And that's viewed as using an electronic medical record to capture patient experiences, take that information and give researchers the ability to drive valuable insights from that. That's a relatively new thing. So I think there is the ability to create value there. So I think that's one axis. I think there's a general shift in the model that having a tech enabled service can be a valuable thing and if done well can be a scalable business. In other words, if you know what you're trying to build and if the software layer reduces sufficient friction in the system and allows you to add people not linearly as you scale, right, but in a leverageable way, then all of a sudden you can have tech enabled services that can grow and become large businesses.
Speaker 1:          So leaning into what it is that makes it difficult almost. And then scaling that, leveraging that. Exactly. Finding ways to make that scalable. Yeah, no, that's not easy to do, but

Medicare New Fraud Regulations: Locking the Revolving Door re Provider Enrollment of Fraudsters

Updates regulations in April 2006 and February 2011.
Includes minor updates based on general authorities 1102 and 1871 (here).
The proposed rule (Obama administration, 3/1/2016) received only 87 comments.

Trade journal Health Care Dive, here.
Dark Report covered in its October 14, 2019 issue.
Arent Fox at JD Supra, here.

CMS final rule at Federal Register here.  84 FR 47794-857 (64 pp), September 10, 2019.

CMS NEWS / FOR IMMEDIATE RELEASE
September 5, 2019
Contact: CMS Media Relations
(202) 690-6145 | CMS Media Inquiries



Inspection Copy:


CMS Announces New Enforcement Authorities to 
Reduce Criminal Behavior in Medicare, Medicaid, and CHIP
The Centers for Medicare & Medicaid Services (CMS) today issued a final rule that strengthens the agency’s ability to stop fraud before it happens by keeping unscrupulous providers out of our federal health insurance programs. This first-of-its-kind action – stopping fraudsters before they get paid – marks a critical step forward in CMS’ longstanding fight to end “pay and chase” in federal healthcare fraud efforts and replace it with smart, effective and proactive measures. Today’s action is part of the Trump Administration’s ongoing effort to safeguard taxpayer dollars and protect the core integrity of the critical Medicare and Medicaid programs that millions rely on. 

The final rule, Program Integrity Enhancements to the Provider Enrollment Process (CMS-6058-FC), creates several new revocation and denial authorities to bolster CMS’ efforts to stop waste, fraud and abuse. Importantly, a new “affiliations” authority in the rule allows CMS to identify individuals and organizations that pose an undue risk of fraud, waste or abuse based on their relationships with other previously sanctioned entities. For example, a currently enrolled or newly enrolling organization that has an owner/managing employee who is “affiliated” with another previously revoked organization can be denied enrollment in Medicare, Medicaid, and CHIP or, if already enrolled, can have its enrollment revoked because of the problematic affiliation.   

“For too many years, we have played an expensive and inefficient game of ‘whack-a-mole’ with criminals – going after them one at a time -- as they steal from our programs. These fraudsters temporarily disappear into complex, hard-to-track webs of criminal entities, and then re-emerge under different corporate names. These criminals engage in the same behaviors again and again,” said CMS Administrator Seema Verma.  “Now, for the first time, we have tools to stop criminals before they can steal from taxpayers. This is CMS hardening the target for criminals and locking the door to the vault. If you’re a bad actor you can never get into the program, and you can’t steal from it.” 
The rule also includes other authorities that will effectively improve CMS’ fraud-fighting capabilities. Similar to the affiliations component, these authorities provide a basis for administrative action to revoke or deny, as applicable, Medicare enrollment if:
  • A provider or supplier circumvents program rules by coming back into the program, or attempting to come back in, under a different name (e.g. the provider attempts to “reinvent” itself);
  • A provider or supplier bills for services/items from non-compliant locations;
  • A provider or supplier exhibits a pattern or practice of abusive ordering or certifying of Medicare Part A or Part B items, services or drugs; or
  • A provider or supplier has an outstanding debt to CMS from an overpayment that was referred to the Treasury Department.
The new rule also gives CMS the ability to prevent applicants from enrolling in the program for up to 3 years if a provider or supplier is found to have submitted false or misleading information in its initial enrollment application. Furthermore, the new rule expands the reenrollment bar that prevents fraudulent or otherwise problematic providers from re-entering the Medicare program. CMS can now block providers and suppliers who are revoked from re-entering the Medicare program for up to 10 years. Previously, revoked providers could only be prevented from re-enrolling for up to 3 years. Additionally, if a provider or supplier is revoked from Medicare for a second time, CMS can now block that provider or supplier from re-entering the program for up to 20 years.

These important new authorities and restrictions, effective November 4, 2019, ensure that the only providers and suppliers that will face additional burdens are “bad actors” — those who have real and demonstrable histories of conduct and relationships that pose undue risk to taxpayers, patients and program beneficiaries. This new rule ushers in an important new era of smart, effective, proactive and risk-based tools designed to protect the integrity of these vitally important federal healthcare programs we rely on every day to care for millions of Americans. 

This new rule builds on CMS’ previous successful efforts to protect beneficiaries and taxpayer dollars while limiting burden on our provider partners without whom we could not deliver high quality care to the millions of people we are honored to serve. “Every dollar that is stolen from federal programs is a dollar that will never contribute to paying for an item or service for seniors and eligible people who need them,” said Administrator Verma. 

The Trump Administration’s program integrity activities saved Medicare an estimated $15.5 billion in Fiscal Year (FY) 2017, for an annual return on investment of $10.8 to $1. The 2018 Medicare fee-for-service (FFS) improper payment rate was 8.12%, the lowest since 2010. This translates to about $4.5 billion less in estimated improper payments from 2017. For Medicaid, in FY 2018 CMS recovered $10.5 billion in FFS improper payments. An improper payment is any payment that should not have been made or that was made in an incorrect amount under statutory, contractual, administrative or other legally applicable requirements.

In addition to today’s rule, CMS has implemented several new initiatives to increase provider and supplier transparency and accountability while reducing burden in the Medicare and Medicaid programs. To learn more, click here.



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Get CMS news at cms.gov/newsroom

Tuesday, September 3, 2019

Imran Haque - LInked In, Interviews.

Imran Haque has had a series of top-tier bioinformatics jobs in Silicon Valley.  He holds an EE/CS degree from Berkeley and a PhD in CS from Stanford (2011).

LINKED IN
https://www.linkedin.com/in/imranshaque/

Positions have included Counsyl, Freenome, Recursion Bio.

TECH TONICS PODCAST (2019/07)
https://connectedsocialmedia.com/17582/tech-tonics-imran-haque-grounded-data-scientist/?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+ConnectedSocialMedia-TechTonics+%28Tech+Tonics%29

FORBES 201905
https://www.forbes.com/sites/davidshaywitz/2019/05/23/pharmas-desperate-struggle-to-teach-old-data-new-tricks/#726472f93434

FORBES 201901
https://www.forbes.com/sites/davidshaywitz/2019/01/03/data-scientist-explains-how-ais-seductive-power-can-mislead-biomarker-researchers/#294187d59594

JAMA 2016: 350,000 Genetic Profiles for Carrier Risk
https://jamanetwork.com/journals/jama/fullarticle/2544641


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Recursion Pharmaceuticals (SLC), CEO Chris Gibson PhD
https://www.recursionpharma.com/
$121M 201907
https://www.biospace.com/article/releases/recursion-pharmaceuticals-secures-121-million-in-series-c-financing/
201905 Fast Company
https://www.fastcompany.com/90345960/most-creative-people-2019-recursion-pharmaceuticals-chris-gibson

For another company focused on AI-driven drugs,
https://endpts.com/ai-study-led-by-insilicos-zhavoronkov-bolsters-case-for-faster-cheaper-drug-discovery/



Monday, August 26, 2019

ACA FAQ #12 re BRCA Testing Free of Copay

https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/aca_implementation_faqs12.html


Affordable Care Act Implementation FAQs - Set 12

Set out below are additional Frequently Asked Questions (FAQs) regarding implementation of various provisions of the Affordable Care Act. These FAQs have been prepared jointly by the Departments of Labor, Health and Human Services (HHS), and the Treasury (collectively, the Departments). Like previously issued FAQs, these FAQs answers questions from stakeholders to help people understand the new law and benefit from it, as intended.

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Q6: Does the recommendation for genetic counseling and evaluation for routine breast cancer susceptibility gene (BRCA) testing include the BRCA test itself?
Yes. HHS believes that the scope of the recommendation includes both genetic counseling and BRCA testing, if appropriate, for a woman as determined by her health care provider.
PHS Act section 2713 addresses coverage for evidence-based items or services with a rating of “A” or “B” in the current recommendations of the USPSTF, as well as coverage for preventive care and screenings as provided for in comprehensive guidelines released by HRSA. The USPSTF recommends with a “B” rating that “women whose family history is associated with an increased risk for deleterious mutations in the BRCA1 or BRCA2 genes be referred for genetic counseling and evaluation for BRCA testing.”
The HRSA Guidelines, released by HHS in August 2011, incorporate by reference relevant portions of an Institute of Medicine (IOM) Report, released on July 19, 2011. In some instances, the IOM Committee Report provides additional interpretation of USPSTF recommendations. For the USPSTF BRCA recommendation, the IOM Committee interpreted the recommendation to include “referral for genetic counseling and BRCA testing, if appropriate.” Thus, genetic counseling and BRCA testing, if appropriate, must be made available as a preventive service without cost-sharing.

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