Wednesday, December 30, 2015

GAO Draws Attention to Site of Service Payment Disparities and Incentives

The GAO has released a 37 page report on what it views as perverse incentives for hospitals to acquire physician practices and rebrand them as hospital-affiliated outpatient locations.   The report, "Increasing Hospital-Physician Consolidation Highlights the Need for Payment Reform," is online here.  For Medscape's coverage, here.

Tuesday, December 29, 2015

Pathologist as Movie Star: Concussion (2015)

Rare when a movie stars a pathologist.   

Concussion (2015) tells the story of recent controversies and publications in sports concussion-related encephalopathy through the perspective of Bennet Omalu, a neuropathologist who devoted considerable energies to the definition of chronic traumatic encephalopathy (CTE).

Monday, December 28, 2015

Year End Review: Books of Note & Blog Info

Books of Note

I've posted an annual book review listing, a mix of healthcare policy and books about business disasters and innovation.  Here.  

On a more personal note, I posted an essay about lessons learned in 15 years since finishing an MBA (here) and an essay on the strategy of innovation management (here).

Bloggery

Discoveries in Health Policy hit 59,000 views in December 2015, running about 5000 hits per month. There were about 17,000 hits in year 1 and 42,000 in year 2.  There were 50 blog entries in year 1, and about 150 in year 2.

The vast majority of hits come from Google, but the hits for any given keyword are limited and unpredictable.  (Cologuard seems surprisingly frequent.)  The most popular blogs include the annual CLFS fee schedule releases.  DIHP continues to host the world's longest listing of articles about Theranos (here), which has garnered about 1400 hits in a year.   

Of 20 posts in December, there were 700 hits, with 7 posts having over 40 hits.  The most active post in November, on CMS quality metrics and PSA testing, had 80 hits (here), not counting postings of CMS November fee schedules, which quickly generate over 100 hits.  

My December 23 write-up of favorite and influential books of 2015 had about 60 hits in 48 hours, which I attribute to being kindly cross-listed on my wife's Facebook account.


Thursday, December 24, 2015

Quick Links: Out of Network Problems Mount; Special Stains Increasingly Challenged.

Two quick links.

Dark Daily publishes another article in its ongoing series about the weak negotiating position and poor financials for out of network laboratories.  December 21 article here, with multiple links to their previous articles on this topic (when balance billing becomes the entire balance.)

Mick Raich, of Vachette Business Services and Stark Medical Auditing, notes that at Medicare MACs, special stains are increasingly under fire as more MACs adopt a stiffly written LCD originated by the Palmetto MolDX program.  Raich's December 22 essay here.

Wednesday, December 23, 2015

AMP Responds to the FDA's "20 Case Studies" about Bad LDTs

On November 16, 2015, the House held a hearing on regulation of LDTs, and FDA provided a sometimes poorly written review of 20 inferior or dangerous LDTs as Exhibit 1 (here).

On December 13, 2015, the Association for Molecular Pathology (AMP) released a 15-age response to the FDA's case.  Find it here.  Generally, AMP found that the FDA concerns were overstated (or worse).  In a few cases, such as the Kif6 case study and the OvaSure case study, AMP notes that a modernized CLIA that includes some clinical validity review would have caught any problems and FDA LDT review was not required.

12/21/2015: NYT Discusses New MAAA Diagnostics for Prostate Cancer

Posted online December 21, 2015, the New York Times "Well" (Health) section discusses new diagnostic tools for prostate cancer such as Oncotype DX Prostate.  The full article is here.  The author, Roni Caryn Rabin, discusses pros/cons of the introduction of new tests, with quotations from proponents as well as experts who feel more data is needed.

Update: Wide press in January 2016 on another advanced diagnostic for prostate management, the 4KScore test, see here.

Monday, December 21, 2015

MolDX Updates NGS Coverage; Comes Up With Surprising Definitions

The MolDX program released several coverage and policy updates between December 16 and 18, with some surprises.  The MolDX program uses a distinctive approach to coding, billing, and pricing, which cannot always be predicted by the use of the AMA CPT code book and CMS CLFS price tables alone.

Wednesday, December 16, 2015

1293 Comments on PAMA reform of the CLFS

On November 24, 2015, the comment period for rulemaking on PAMA Section 216 - new law for new pricing of the Clinical Laboratory Fee schedule.

1293 comments were submitted to CMS and are online.  I culled about 40 of the corporate comments - such as from ACLA, AMA, Advamed, BCBS, American Hospital Assocation, CAP, AMP, NILA, and others - and you can find them bundled in a 17MB zip file in the cloud: here.


WSJ: Employers Include Genetic Tests as a Wellness Benefit

The December 16, 2015 WSJ has a story discussing employers who are adding genetic testing as a Wellness Benefit for employees.   The full story is here.  In a brief extract, they write that:
Employers want workers to know what’s in their genes.  A handful of firms are offering employees free or subsidized tests for genetic markers associated with metabolism, weight gain and overeating, while companies such as Visa Inc., Slack Technologies Inc., Instacart Inc. recently began offering workers subsidized tests for genetic mutations linked to breast and ovarian cancer.  The programs provide employees with potentially life-saving information and offer counseling and coaching to prevent health problems down the road, benefits managers say....



Friday, December 11, 2015

Are Pharmacogenetics a "Culture Shock" Zone for Payers, FDA, and Labs?

This entry discusses why pharmacogenetic information (like recommendations for CYP gene testing) proliferate on FDA labeling but are rarely covered by payers.   At the FDA pharmacokinetics, dosing, pharmacogenetics, are fundamentals of every drug approval.  On the other hand, for doctors who are medical directors (including active physicians) pharmacokinetic data and equations may be at most a rare or incidental part of their thinking and practice.  

WSJ 12/11/2015: Are LDTs the Wild West of Medical Care?

On December 11, 2015, the Wall Street Journal ran a lengthy article on laboratory developed tests, the contrast with FDA approval procedures, the FDA's efforts to regulate LDTs, and included a range of interviews on "both sides of the issue."   See the WSJ article here.


Thursday, December 10, 2015

Next Gen Reimbursement in Germany Crazy in its Own Way

Two years ago, Genomeweb reported briefly on kerfuffles in the German health care system over whether next gen sequencing methods were reimburseable or not under their policies and procedures.

In December, 2015, Genomeweb provides its readers with a deep dive update showing there is still a tempest raging over this issue in Europe's largest economy, and it's gotten bigger, not smaller.   Julie Karow's article here (subscription).

AMA CPT: 1Q2016 Will Be Very Active!

The AMA CPT editorial process has become much more public and open over the last several years.  One key improvement is that the AMA CPT meeting agendas are now posted publicly well in advance on the AMA website.

New hot topics will include (1) quarterly special AMA CPT lab codes; (2) AMA CPT responses to CMS changes regarding drugs of abuse lab test panels; (3) several new MAAA codes, including one for "comprehensive pharmacogenetic data," and (4) potential changes to the 88361 IHC code.  And (5) AMA initiatives for telemedicine coding are also reviewed below.

Wednesday, December 9, 2015

Expanding Medicare Telehealth: S.2343, "Telehealth Innovation and Improvement Act of 2015."

Sen Gardner of Colorado has introduced the Telehealth Innovation and Improvement Act of 2015, with press releases on December 2 and, after a delay, the actual legislative text is posted at Congress.gov.

The Top Ten Health Issues of 2016: From Price Waterhouse Cooper

PWC Health Research Institute:

HRI’s top 10 health industry issues for 2016


#1-#5: Mergers, drug prices, apps, cyberscurity, deductibles.
#6-#10: Behavior, community care, big data, biosimilars, and value-based costing (not purchasing).

Details and links after the break.

The Other LDT Regulatory Battle: Genetic Testing in Europe

While news about U.S. LDT regulation pops up almost weekly - there's an FDA hearing, or a legislative proposal - lab test regulation is also on the charts in Europe.

Below, the European Society for Human Genetics (ESHG) and "a range of organisations" raise concerns about in likely changes in European diagnostic test regulation.

Larry Kricka's 20 Page Review of the History and Future of Laboratory Medicine

Approach the end of 2015, we can turn to 2016 by taking a look at a fascinating article that appeared a few months ago.

Larry Kricka, professor of pathology and laboratory medicine at Penn (here), is first author of four on the review and opinion article, "The Future of Laboratory Medicine: A 2014 Perspective," which appeared as an Invited Critical Review in Clinical Chimica Acta 438:284-303.   It is online (subscription or article purchase) here.

Kricka opens by citing a 1920 prediction that someday, there might be "as many as two lab workers" at major hospitals (here).

Tuesday, December 8, 2015

CMS Publishes Correct Coding Manual of Pathology Rules for 2016

For a number of years, CMS has published giant Excel spreadsheets of "correct coding edits" and "medically unlikely edits" which give allowable units of thousands of CPT code services or show which codes cannot be used together (e.g. "appendectomy" cannot be supplemented by a code for "wound closure.")  

There is also a text document in paragraph style with hundreds of concepts and rules that govern correct coding for Medicare.  This "provider's manual" has now been updated for 2016, and as usually, new revisions are shown in festive holiday red.   The whole kit and caboodle can be downloaded at this CMS web page, here.   Look for "NCCI Policy Manual...2016 [ZIP]."   For the chemistry and pathology section, see inside that ten document ZIP file or see just the pathology chapter in the cloud, here.


Bringing Genomics into the Clinic: Explaining Complex Issues

Genomeweb's Turna Ray has written a detailed article on the pathway from genomics discovery and genomics laboratory to the clinic.  It's mixed news, in that things seem to be getting better, but there's still much to be done.  The article is online here (subscription).

Just a couple years ago, Boehringer Ingelheim conducted a survey suggested that only 50% of lung cancer patients were getting basic genomic testing, like EGFR.  In a new survey, that number had risen to 81%.  However, due to delays in genomic test results, a significant proportion of patients are already started on non-precision chemotherapy even before their tests are back.

Friday, December 4, 2015

December 3, 2015: CMS Posts the Full CY2016 Lab Fee Schedule

On December 3, 2015, CMS published the full CY2016 clinical laboratory fee schedule.  The CMS CLFS fee schedule website (including 2016 and back years) is here.  At the CMS CLFS website, download the "16LAB" zip file for the fee schedule plus some explanatory files.

I've loaded the fee schedule itself, a 1300-line Excel spreadsheet, in the cloud here.

Wednesday, December 2, 2015

Medicare Grapples with Ashkenazi Heritage in BRCA Policies

Medicare has very few national policies for coverage that are predicated on racial background.  One is the glaucoma screening benefit, which is specialized for individuals who are African American and 50 or older, or Hispanic American and 65 and older (here).  Medicare is silent on questions like how this is defined or how mixed-background individuals are coverd.  And for example, individuals from Egypt or Dutch background South Africa are from the continent of "Africa" and now live in "America" but the coverage is silent on how their benefits would be handled.

There is no national policy that is specialized for individuals of Ashkenazi descent, but there are draft local coverage policies that would guide BRCA testing for individuals with different backgrounds.  While these have statistical bases, they also raise challenging implementation questions.

CAP TODAY on (1) Novel Cardiac Biomarkers and (2) CAP's NGS Proficiency Programs

CAP Today frequently runs excellent reviews on timely topics.  The November issue includes a detailed article on CAP's rapidly evolving efforts to ensure high consistent standards for clinical NGS testing, here.  Interesting in light of New York State and FDA efforts to do the same.

CAP Today also offers a detailed article on sorting out new waves of novel cardiac biomarkers, focused on heart failure biomarkers.  Here.

The Senate's Bipartisan Report on Sovaldi Pricing

The week of December 1, there were numerous news reports on a lengthy Senate report on the pricing of Sovaldi.   Many of the press reports don't include links to the original documents.

The Senate's own detailed press release is here.  Note that on this Senate webpage, there are links to 13 separate PDF files running down the right-hand margin.

A two page executive summary is here.   The 144-page main report (excluding numerous online appendices) is here.



Tuesday, December 1, 2015

MEDPAC Touches Telehealth

Federal government policy on telehealth has advanced slowly, even as we all read about the rapid growth of a multi billion dollar industry.   For example, in 2012, the Institute of Medicine published a workshop on telehealth (here).

On November 5, 2015, the MEDPAC held a one hour session to update on the Medicare program and telemedicine.  Its concise "issue brief" is here, the PowerPoint deck here, and the 50 page transcript of the MEDPAC discussion is here.

Wednesday, November 18, 2015

CMS Quality Measures and PSA Testing

On an obscure webpage, CMS issued a request for public comment for a physician performance metric that would financially penalize physicians who order PSA testing.  Physicians would be penalized for providing testing allowed to the patient by the Medicare statute, and even for a range of purposes that are recommended by the CMS NCD for diagnostic PSA testing.

From that lead-in, you can guess I view this as a flawed idea for multiple reasons.   These are discussed, and links are also provided to four brand new JAMA articles on PSA testing.

The JAMA articles on PSA testing policy and whither it should be going, were picked up by the New York Times and other major media (here).  The day after this blog appeared, the WSJ (here) ran an article on the new anti-PSA metric that this article discusses.

UPDATE: February 26, 2016:  CMS will not continue work on the proposed measure, according to the AUA (here).

House Hearings on FDA LDT Regulation: Key Quotes, Video, Detailed Notes

The House has posted a two hour, twenty minute video on the November 17, 2015 hearing, "Examining the Regulation of Diagnostic Tests and Laboratory Operations."  Here.


Tuesday, November 17, 2015

CMS Locks Down Final Crosswalks for New CY2016 Codes; Others in Gapfill; Drug Testing Finalized

On November 17, 2015, CMS released final decisions on how it will handle new laboratory codes for January, 2016.  As has been discussed in several public meetings and public comment periods since July, the new codes enter either a crosswalk or gapfill process.  There has been much sturm and drang all year how CMS would handle drug tox coding and pricing.  There was a kerfuffle in September when about ten MAAA tests were priced at about $692.  Increasing attention has been paid to an AMP proposal to price new codes via a "log natural" method.

Generally, simple genetic codes were crosswalked to existing genes, and complex genomic procedures (and new MAAA tests) were sent to the gap fill process for CY2016.  For drug tox results, see below.

CMS Finalizes CY2015 Gapfill Prices

CMS has released final decisions on the CY2015 gapfill process, that is, for codes that were new in January 2015.   There was a stir in September 2015, when the 5-50 tumor gene codes were priced at only around $600 and Oncotype DX was priced somewhat below its historic CMS price.

In the final gapfill pricing, both Oncotype DX and Nanostring Prosigna are priced at $3416 for CY2016.   The codes for 5-50 tumor genes (81445, solid tumor; 81450, hematolymphoid tumor) were still priced at $597 and $647 respectively.

There is *no* CMS price for the 50+ tumor gene code (81445).

At the CMS website, here, see the file for "2015 CLFS Gapfill Final Determinations."

Monday, November 16, 2015

FDA Tells World (And Hill) It Needs to Regulate LDTs

On November 16, 2015, the FDA released a detailed white paper on why LDTs need to be more stringently regulated.

The FDA Blog introduces the topic, authored by Peter Lurie (here).   The FDA's homepage for the report on LDT safety and problems is here.   The FDA's 39 page white paper is here and assesses potential risks and harms associated with twenty different LDT tests.

The report went up the day before FDA will testify at a Hill hearing on the need to regulate LDTs.

30 Slide Deck on PAMA - the New Lab Test Pricing Law

In October, BIO invited me to provide a webinar on PAMA, the law that will eventually create a new pricing system for laboratory tests in 2017 or 2018.

The deck is in the cloud, here.



Yes, Virginia, MolDX is really coming to J15 (OH/KY)

In mid August, Noridian announced that MolDX would expand to Jurisdiction F - the northwestern and mountain states (my blog here).

At that time, I found a Palmetto MolDX webpage remark that MolDX was *also* coming to the CGS MAC (my blog here).   I couldn't find any statement on CGS's own website.

A few days later, on August 17, CGS did post news of the MolDX expansion.  The CGS MolDX webpage (updated as of October 30, 2015) is here.   I've clipped it below as it stood as of November 16, 2015.



Friday, November 13, 2015

My Interview on Mendelspod

I've enjoyed the genomics podcast Mendelspod for a couple years.  It was a special treat to be interviewed by Theral Timpson for a podcast on trends in CMS diagnostics reimbursement.

Via your smartphone podcast app, under the Mendelspod channel, or here.




Wednesday, November 11, 2015

PAMA CLFS COMMENTS: DUE NOV 24; EARLY RETURNS

[UPDATE: SEE THE UPDATED DECEMBER 16 BLOG 
WRITTEN AFTER THE CLOSE OF THE COMMENT PERIOD: HERE.]

November 12, 2015:

Medicare issued proposed regulations for implementing PAMA's changes to the Clinical Laboratory Fee Schedule on September 23 (Federal Register final version, October 1, here).  The comment period runs til November 24, and comments can be typed up and entered online here.

As of November 12, 75 comments had been submitted.  About 15 are similar letters from employees of Quest Diagnostics.  Otherwise, most of the comments represent a lengthy form letter submitted from dozens of individuals.

My comment, focused only on the definition of ADLT, is here.

Tuesday, November 10, 2015

New Flurry of Letters to LDT Labs: FDA Found You!

November opens with the FDA sending letters to at least three LDT labs, DNA4Life, DNA CardioCheck, and Interleukin Genetics, in Alabama, Illinois, and Massachusetts, respectively.

The three letters are online at the FDA here, here, and here.  For November 16 coverage at Bloomberg, see here.

Sunday, November 8, 2015

Much Interest in CMS Reform of Physician Incentive Metrics ("MIPS" regulations)

Last spring, Congress repealed the longstanding SGR policy for the CMS Part B physician fee schedule.  The legislation also set in motion what could be a big overhaul of the physician performance metrics like "PQRS."   Nearly 200 comments on the topic are already on the regulations.gov website.  Meanwhile, until Tuesday, November 17, CMS is requesting additional deep dive comments through a special MIPS "request for information" process.


Thursday, November 5, 2015

Medicare Releases CY2014 Utilization of Part B Genomic Tests

Data on CMS payments for CY2014 genetic CPT codes have been released.  Total payments were about $650M in Part B; about 10% flowed through "Tier 2" codes.  The top five codes by total dollar volume including the winner - 81401Tier 2, Level 2; followed by two CYP genes and the clotting factor genes Factors 2 and 5.  Just 3 codes captured 55% of the $650M spend.

Saturday, October 31, 2015

House to Hold Hearing on DTWG in November 2015; Posts Legislative Draft

According to the trade journal Gray Sheet (subscription; here), on November 17, 2015, the House will hold a hearing on a legislative reform that would create a new body of FDA statute for diagnostic tests.  Draft legislation is offered for discussion, and tracks pretty closely to the Spring 2015 DTWG FDA Reform proposal.

Medicare OPPS Rule: Complex Handling of Protein and DNA/RNA MAAA Tests

On October 30, CMS issued its final rule for the hospital outpatient, or "OPPS," fee schedule for CY2016.  (Full listing here).

Regarding molecular pathology, CMS has finalized its plan to treat genetic tests and DNA/RNA MAAA tests differently than it treats protein-based MAAA tests.  For extra confusion, CMS treats some protein-based MAAA tests differently than others.

Medicare Publishes OPPS, PFS Final Rules (October 30, 2015)

On October 30, 2015, Medicare published "final rules with comment" for both the OPPS and PFS payment systems.   OPPS, PFS, Medicaid services adequacy, and ESRD rules after the break.

Wednesday, October 28, 2015

Sudden Change Can Happen: Legislation on Medicare's Outpatient Location Payments

Often change at Medicare - whether within the agency or from the Hill - appears to come very slowly.  This week was an example of an unexpectedly sudden change.   According to Bloomberg (here),  new budget balancing legislation will call a halt to hospital system acquisitions of physician practices which are then reclassified as hospital outpatient clinics.

The basic issue has been known for a number of years, discussed in newspapers, trade journals, and in CMS rulemaking and MedPAC publications.   For example, from February 6, 2015 in the New York Times:  "When Hospitals Buy Doctors' Offices, Patient Fees Soar."  (Clear; here.)

Tuesday, October 27, 2015

AMA and Coalition Support Enhanced CLIA

On October 27, 2015, the American College of Medical Genetics issued a press release that it had joined AMA and a broader coalition in supporting an "Enhanced CLIA" approach to LDT regulation.

While there has been some discussion of CAP and AMP producing somewhat different versions of an enhanced CLIA paradigm in recent months, the letter is signed by the AMA (including CAP), and by the AMP.  (Genomeweb, subscription, here.)

The joint letter to both House and Senate, dated October 26, 2015, is online here.  ACMG's news release, which discusses both the two page consensus letter to the Hill and provides a number of helpful ACMG-specific links, is here.

FDA and Theranos: FDA Promised Tougher Enforcement when LDTs are DTC

As is well known in the laboratory and FDA policy communities, the FDA has generally let laboratory developed tests (LDTs) operate under "enforcement discretion."  This means the FDA believes it has the legal authority to regulate LDTs (for example, through 510(k)'s and PMAs) but the FDA declines to routinely require such review - "enforcement discretion."

FDA's Updated October 2015 Documents on 23andMe: Class II Without 510(k)

In February 2015, the FDA announced not only that it would allow 23andMe's DTC carrier screening tests to begin moving forward, but that recessive hereditary genetic tests could be:

  • Categorized as Class II devices;
  • Not require separate 510(k)s;
  • Be offered direct to consumer.
Together, this was a remarkable constellation of decisions.  Links to documents from February to October 2015 are below the break.

Tuesday, October 20, 2015

Version 2 of the Diagnostic Test Working Group Proposal is Circulating

According to the subscription trade journal Inside Health Policy, the Diagnostic Test Working Group (DTWG) is circulating a revised version of its plan for FDA reform and a new paradigm for diagnostics regulation.   Inside Health Policy also suggests (here) a potential House Energy & Commerce hearing on laboratory tests for October 29, 2015, although this is not publicly calendared at the House website yet.  The hearing was held in November, my blog here.

Inside Health Policy on the revised DTWG plan, subscription, here.   On the Senate side, Inside Health Policy suggests the possibility of standalone diagnostics regulation that would not be part of 21st Century Cures or its Senate equivalent (here).

The DTWG does not maintain a website or provide easily accessible versions of its proposals.   In late September, the trade journal Genomeweb published a long article that assessed the competing approaches to LDT regulation from FDA, CAP, AMP, and DTWG (here).  See also Genetic Engineering News, 10/2015, here.

Medicare Posts Video of October 19, 2015 Diagnostics Advisory Board

CMS has posted the morning an afternoon sessions of the October 19, 2015 CLFS advisory panel online.  Links at:
Morning (3h30min):  here.
Afternoon (4h):  here.

The panel discussed Medicare's Gapfill recommendations of September 25, 2015, as well as Medicare's proposed implementation of lab fee schedule repricing aka PAMA Section 216.


Wednesday, October 14, 2015

My Talk at PMC/BIO Solution Summit for Personalized Medicine (October 14, 2015)

On October 14, 2015, I had the privilege of being invited to give the morning keynote address at the 2nd Annual Personalized Medicine Solution Summit, held in Washington.   (The meeting's agenda is here).

The deck is here as PowerPoint, and here as PDF.  Details after the break.

Wednesday, October 7, 2015

CMS Updates 2015 Gapfill Spreadsheet: Oncotype DX Now $3416 not $2900

On September 25, CMS released a spreadsheet of final CY2015 gapfill prices from its MACs, which listed Oncotype DX Breast at a price (beginning January 1, 2016) of $2900.  This was the median price of a small number of MACs reporting.

On October 7, CMS updated the spreadsheet.  The new spreadsheet lists Oncotype at $3416, and the change was caused by Noridian entries (which were previously blank) now being filled in at $3416.

Saturday, October 3, 2015

Keeping Track of CMS Comment Periods for Labs and for MACRA

CMS currently has four comment periods open, one on 2015 gapfill, one on 2016 proposed gapfill/crosswalks, one on PAMA rulemaking, and one on MACRA's physician payment reforms.

More CMS MAC Contractors Publish Next-Gen Sequencing LCDs for Lung Cancer

On Thursday, September 30, two Medicare MAC contractors issued proposed LCDs for the field on next generation sequencing in oncology.  See also a footnote discussing similar coverage at United and Aetna.

Friday, October 2, 2015

Medicare to Hold Extra Clin Lab Advisory Panel: October 19, 2015

Medicare will hold a second meeting of its new Clinical Laboratory advisory panel on October 19, 2015.  Register to attend in person before Tuesday, October 13.

Details via the Federal Register website, here.


Monday, September 28, 2015

Genomeweb posts detailed article on competing LDT regulation proposals

For those with access to the trade journal Genomweb, on September 28, 2015, that site published a detailed discussion of competing proposals and approaches to enhancing regulation of LDTs.

September 28, 2015
Amid Competing LDT Regulatory Proposals, Common Ground but Key Disagreements for Congress to Consider.
By Turna Ray.  Here.

Ray discusses plans proposed by CAP, AMP, and the Diagnostic Test Working Group in the 2,100 word article.

CMS Issues Request for Comment on New Physician Payment Incentives

Last spring, the SGR reform bill ("MACRA") included sections allowing CMS to create new, and considerably larger, penalties and incentives for physician behavior.   The new incentive systems include one system that consolidates and expands existing fragmented incentives (such as e-Prescribing, PQRS, and electronic health records) into a program called MIPS.   The other system is for doctors active in ACOs and is called APM.



Saturday, September 26, 2015

Did CMS Miscalculate the 2016 Price of the Oncotype DX Breast Test?

The Genomic Health Oncotype DX Breast test received a CPT code, 81519, that became active on January 1, 2015.   Based on decisioning making in late 2014, CMS placed the pricing of this code in the hands of its MACs under the Gapfill pricing process.   On September 25, 2015, CMS published an excel spreadsheet of the MAC prices.  The spreadsheet shows a "National Limitation Amount" of $2900 for Oncotype DX.   Based on my reading of CMS's own regulations, I believe CMS miscalculated the amount and it should be $3416.

UPDATE:  On October 7, 2015, CMS released a new Excel spreadsheet, now calculating the Oncotype DX price as $3416.  (Here).  CMS did so by adding the dozen Noridian states to the spreadsheet, so now, the median is $3416 whether calculated by "state" or by "MAC."

Friday, September 25, 2015

GAPFILL: CMS Posts September Results of the CY2015 Gapfill for Genomic Procedures and MAAAs

On September 25, 2015, CMS posted the results of MAC gapfill efforts on genomic procedure and other codes under gapfill this year.  By policy, CMS then calculates the median of MAC proposed prices, and sets this as the CY2016 price.  Details after the break.

2016 CLFS PRICING: CMS posts proposed pricing for new CY2016 tests including CY2016 Genome, MAAA, and Drug Tests

Having held the July 2015 summer CLFS comment meeting on new codes, and having held a special PAMA advisory panel on lab test in late August, on September 25, 2015 CMS released its proposed pricing for new lab tests for 1/1/2016.  Details after the break.

Genomeweb's article here. Fierce Diagnostics here.  San Francisco Business Journal here.

PAMA: CMS Posts Proposed PAMA Lab Price Rulemaking - First Thoughts

On September 25, 2015, CMS posting a 131-page document announcing its proposed rulemaking to implement PAMA Section 216.   Through the proposed policy and procedures, CMS will reset the 20-year-old Clinical Laboratory Fee Schedule to new prices based on market price surveys for clinical laboratory tests.  More after the break.

The link to PAMA rulemaking is here.

Genomeweb's article here.  ACLA's press release is here.  Coverage at Gray Sheet is here.

CMS accepts comments until November 24, 2015.  Since that will lead into the holidays, and since comments and complaints will be voluminous, final rulemaking may not appear until January or  February.


Judge rules against CMS policymaking style - too unclear for informed public comment

September 25, 2015

Several trade press articles have picked up on a judge's ruling this week in Shands Jacksonville Medical Center re Burwell (Advisory Board, here; case online at AHA, here; subscription article at Law360, Sept. 21 here ).

Because the case involves the controversial Two Midnight Rule and a potential (though small) refund to the hospital industry, the broader implications of the case haven't received much attention.   [Addendum: Law360 picked up on this on September 29: here).   I believe that many stakeholders should be interested in this slap against CMS policymaking methods.

Addendum; CMS published a court-ordered explanation of its earlier reasoning, on November 30, 2015: here.

Thursday, September 24, 2015

IOM Report: Diagnosis & Misdiagnosis are the Blind Spot in Medicine

Those of us who work intensely in diagnostics will not be surprised by a new September 22, 2015 Institute of Medicine report  on Errors in Diagnosis.  We might be surprised by some of the media response and the degree to which the pivotal role of diagnosis could be considered a "blind spot" in healthcare.

The report, called "Improving Diagnosis in Health Care," is online at the Institute of Medicine, here.  The 450-page PDF is authored by the "Committee on Diagnostic Error in Health Care" - Erin Balogh, Bryan Miller, and John R. Ball.  A four page executive summarize is available, here.

Coverage in US News here - "Countless patients harmed by wrong or delayed diagnosis."
Coverage at Advisory Board here - "IOM says patients are dying because of this 'blind spot' - and providers must fix it."
Coverage at California Healthline here - "IOM report calls for collaborative effort to reduce diagnostic errors."

According to the website on 9/24, 48 hours after release, 1,749 copies of the free PDF had been downloaded.


Tuesday, September 22, 2015

Craig Venter's Company - Human Longevity Inc - and the $250 Commercial Exome

Craig Venter's company, which has been assembling a suite of top-ranking executives, announced on September 22 it would be able to sell exomes for $250.  See press stories here, here.  According to MIT Technology Review,

Jonathan Broomberg, chief executive of Discovery Health, which insures four million people in South Africa and the United Kingdom, says the genome service will be made available as part of a wellness program and that Discovery will pay half the $250, with individual clients covering the rest. 
Gene data would be returned to doctors or genetic counselors, not directly to individuals. The data collected, called an “exome,” is about 2 percent of the genome, but includes nearly all genes, including major cancer risk factors like the BRCA genes, as well as susceptibility factors for conditions such as colon cancer and heart disease. Typically, the BRCA test on its own costs anywhere from $400 to $4,000.
Technology Review adds, "Deals with other insurers could follow."

At its home base in San Diego, the company will open a genetic and health service with $25,000 self-pay services, including genome, microbiome, and whole body MRI studies.

UnitedHealthcare Provides Limited NGS Panel Coverage in Advanced Lung Cancer

As reported in some trade journals (e.g. Genomeweb, here), United Healthcare has released a new policy, "Molecular Profiling to Guide Cancer Treatment," effective 10/1/2015.  See UHC Policy 2015T0576A, online here.

The eight-page policy states that multiple or NGS sequencing is "proven and medically necessary to guide systemic chemotherapy in patients with stage IV non small cell lung cancer" when two criteria are met.  First, molecular profiling is used ONLY to test for EGFR, HER2, RET, and ALK gene rearrangements (with a citation to current NCCN practice guidance.)   This sounds like they might expect a "don't ask, don't tell" stance on the several hundred other genes found in some commercial panels.  But although profiling is to be used "only" for the four named genes, the policy refers to 5-50 gene CPT codes, which wouldn't technically apply if only 4 genes were tested.

Second, the laboratory must be approved by the New York State Department of Health (which has explicit standards for setting up NGS assays, orthogonal control quality testing, etc).  The policy then states then indications other than the above are explicitly not covered.

The policy may face challenges in staying up to date; for example, in August 2015 a NEJM article found that NSCLC had good responses to BRAF drugs when V600E mutations were present (here, here) - an indication not yet found in the UHC policy.  In a conference report in September 2015, in a Foundation Medicine study of lung cancer patients under 40, 6% had ROS1 rearrangements, another gene not in the UnitedHealthcare list (here).  FMI reported that 76% of 68 patients under 40 had druggable mutations, 44% of the patients having ALK mutations which are vastly less common in unselected populations.  The report is part of the Genomics of Young Lung Cancer Study (GoYLC).

Saturday, September 19, 2015

Noted in Passing: Evidence Based Medicine meets Prescription Drug Coupons

Co-pay support programs for expensive drugs have been in the policy news for at least five years (here, here).  Do they simply help patients with $100 copays, or are they a way of boosting sales of overpriced drugs that have a justifiably poor position on the formulary tier?

Here's an ad for Outcomes and adherence in patient assistance support programs.


Company here.



Friday, September 18, 2015

In Medicare, Can You Appeal a Pricing Decision made by a MAC?

Periodically I am asked, "Can an ALJ making a pricing decision and enforce it on a MAC?"   The answer is a little cryptic and I always have to dig up a Federal Register publication from 2009.  Here is the short answer.

Tom Norton's Insightful Futurism: Pharma Price Escalation, Key Events, and Public Policy

Pharm Exec is an open source trade journal for the biopharma industry.  One regular author, Tom Norton of a communications consultancy, has written a set of three excellent blogs/articles on pharma pricing trends and political forces.

See the following -
September, 2015 - The Pathway to Public Price Controls (here)
May, 2015 - "Take a Breath" on the Specialty Drug Pricing Issues...? (here)
November, 2014 - How Gilead Blew Out the Lights with Sovaldi (here)

See also:
August, 2015 - 2015 Medicaid Drug Price Controls - The Past is Prologue? (here)

Anyone interested in the future of health policy - whether in drugs or other areas - would benefit from seeing how Norton writes, thinks, and assembles a forward-moving story line.

The September, 2015 article contains links to the California Drug Price Relief Act, which will be on November ballots (here).

Friday, September 11, 2015

Trade journal: Hill will not "tinker with" FDA LDT Guidance before it is Final

On September 10, 2015, GRAY SHEET (a subscription trade journal, here) reported that across both political parties and in both House and Senate, the FDA probably will be left to develop a final LDT guidance without interference.  On background, staff indicated the Hill might act after the FDA has acted, but not before.

At a Next Generation Sequencing conference in Washington in mid-August 2015, FDA speakers remarked that public comment on the FDA LDT draft guidance had been considered thoroughly, the draft guidance had been revised, and it was working its way through approval and release channels at the FDA and/or executive branch.

Thursday, September 10, 2015

Genomics and RBC Transfusion; Note on Palmetto's LCD.

This week's JAMA has an online-first article on the growth of genomic medicine in the century-old field of RBC transfusion.   The article, "Red Blood Cell Transfusion: Precision vs Imprecision Medicine," by Klein, Flegel, and Natanson, is here.


News Watch: "Medical Testing is So Hot Right Now!"

Two articles within a few days on the theme that medical testing, venture investment, and direct to consumer topics are riding a wave.

From Wired.com, here, September 4, 2015, the article "Medical Testing is So Hot Right Now. This Startup Wants In."  The journalist interviews the founders of CoFactor Genomics and writes,
Why don’t the two of you tell me how you plan to diagnose disease from little rings of RNA that most biologists considered junk three years ago? Let’s talk about your $1.5 million National Institutes of Health grant. While we’re at it, why did you decide to temporarily uproot your company—which is nearly a decade old and already pulling in millions of dollars—to join Y Combinator, the startup boot camp known more for putting nestling consumer tech companies like Instacart, Airbnb, and Dropbox into high orbit?
From Bloomberg Business, here, September 10, 2015, "Consumer Blood Test to Detect Cancer Hits Market Amid Skepticism."  The journalist writes,
Biotechnology startup Pathway Genomics Corp. is introducing the first “liquid biopsy” tests designed to detect cancer-associated mutations in the blood of healthy people who are at high risk of developing tumors....Pathway, a closely held firm backed by investors including International Business Machines Corp. and venture capital firm Founders Fund, is offering its CancerIntercept Detect test for $699, according to Chief Executive Officer Jim Plante. The price tag drops to $299 if the consumer signs up to be tested once a quarter.
“The cost is a big advantage because a liquid biopsy could be one-10th or one-20th the cost of an invasive biopsy,” Plante said. “There’s a lot of value here for the patient and consumer.”
The FDA shared the market's skepticism, asserting that the test was improper for marketing.  For trade press, here.   For the FDA's September 21, 2015 letter, here.  Pathway Genomics has received warning letters from the FDA in prior years (here, here).

The FDA seems polite enough in writing:

 [We] believe you are offering a high risk test that has not received adequate clinical validation and may harm the public health. We would like to discuss with you your offer of the CancerInterceptTM Detect and the associated blood specimen collection device, and any validation strategies you have undertaken beyond those reported in the publications cited in your white paper, including your determination of the test’s clinical sensitivity and specificity and the corresponding positive and negative predictive values for its claimed intended use. Given the importance of your claims, we request an acknowledgement of receipt of this letter and a proposed timeline for meeting with the FDA within 15 business days. 

On September 24, 2015, Pathway Genomics issued a public blog posting commenting on the most recent FDA letter (here):

Pathway Genomics greatly respects and shares the FDA’s concerns about patient safety. We have received a letter from FDA, dated September 21, 2015, requesting certain information regarding the Pathway Genomics CancerIntercept™ Detect testing service.  We are carefully considering the concerns of the FDA as stated in their letter, and we will be responding to that letter.  We assure that there is physician involvement in the ordering, review and follow-up of CancerIntercept™ testing.  We believe that CancerIntercept™ Detect is a  laboratory developed test and, as a CLIA and CAP certified clinical laboratory, we are offering it as such.  While Pathway Genomics is involved in educating and marketing the tests to physicians and consumers, we do not believe this is a direct-to-consumer model. We believe we have performed appropriate validation of the test as a laboratory developed test, and we are in the process of performing additional studies.
WSJ coverage on September 28, 2015, here.

Patient Engagement is a Wellspring of New Trends...from Venture Capital to FDA to CMS.

This blog often starts off with trends in the lab industry but includes a wide range of healthcare topics as well, reflecting the range of health policy consulting work I do.

On the laboratory side, there are many efforts to seek "closer engagement with patients," ranging from Theranos to Labcorp (from here to here).

However, the concept of patient engagement is high in other areas as well.  For background, see Marc Boutin's excellent open access article on Patient Engagement at American Journal of Managed Care earlier in 2015 (here).  Boutin is CEO of the National Health Council.  The Food and Drug Law Institute is offering a webinar on Patient Engagement and the FDA, on September 30, 2015, here.  (The webinar features Pat Furlong of the Parent Project Muscular Dystrophy, Janet Woodcock of the FDA, and is moderated by my colleague Debra Lappin of FaegreBD Consulting).


PMC and BIO host second Personalized Medicine Solutions Summit, October 14, 2015, in DC

The Personalized Medicine Coalition and BIO are holding the second annual Personalized Medicine Solution Summit on October 14, 2015 in Washington, DC.

The home page for the meeting is here.  Topics, following an opening keynote speaker, will be:

  • Evidence and integration of personalized medicine into health practice: Issues faced by CMS.
  • Education regarding the use of personalized medicine through the health care continuum.
  • Integrating a Total Health Solutions Approach.
  • Demonstrating the value of personalized medicine in clinical practice.
  • Health systems: Infrastructure and information challenges related to personalized medicine.

The first annual summit was attended by several hundred participants.  I have the privilege of being a lead speaker for this year's summit.

Registration site is here and the PDF agenda is here.  Registration is $500; $250 for PMC or BIO members.


FDA Announces NGS Public Policy Workshops on November 12,13, 2015

The FDA has announced public policy workshops on two aspects of next generation sequencing, to be held Thursday November 12 and Friday November 13.  (This was the only Friday the 13th available this year).

The November 12 session is: Standards-Based Approach to Analytical Performance Evaluation of Next Generation Sequencing In Vitro Diagnostic Tests.

The November 13 session is: Use of Databases for Establishing the Clinical Relevance of Human Genetic Variants.

UPDATE (October 22, 2015): FDA has updated the conference webpage with a Discussion Document on the use of databases for variants.  Here.

Friday, September 4, 2015

What is the AMP comment on the MolDX Next Gen Sequencing Analytic Performance Guidance?

The Medicare Palmetto MolDX program has finalized an LCD that provides next generation sequencing panels in patients with lung cancer who have met certain preconditions (here).

Along with this LCD, MolDX published guidance as to its analytical standards for comprehensive gene panel testing, typically by NGS.  The Association of Molecular Pathologists has released a public comment.  Details after the break.

Tuesday, September 1, 2015

What has AMP recommended for genomic sequencing pricing?

In summer CLFS public meetings of July 2014 and July 2015, the Association for Molecular Pathologists recommended interesting methods by which CMS could price new CPT codes for genomic sequencing procedures, such as 5-50 tumor genes.  AMP also held a webinar on this topic at early 2015 (archived here).

I believe I understand what they've recommended, and helpfully, AMP publicly posted its detailed 12-page public comments to the agency (dated August 6, 2015 (here)).

My sense is that in just a few key places, the AMP document is a bit confusingly worded so the transition from one AMP pricing method to another is not obvious to the reader.   AMP re-presented its methodology to the new CLFS public advisory board which held its first meeting on August 26, 2015 (here).  I haven't yet seen that presentation, the Gray Sheet report on the meeting was a little confusing based on what I already knew about AMP's proposals (Gray Sheet here, subscription).

What follows is, in my own words, my grasp of AMP's proposals.  For the final word, readers should work through AMP's original documentation (here).

Monday, August 31, 2015

Bringing Clear Thinking to Evidence Based Medicine and Evidence Based Policy

Two very recent articles, each discussed in a separate blog, discuss how to bring more lucid and objective insights to two common policy problems.

The question of whether the FDA is "too strict" or "too lax" is perennial for decades.  In a new open access paper, MIT authors Montazaerhodjat and Lo frame this as a "type I" and "type II" error problem, and show an analytical approach to decision-making.  The paper is here - "Is the FDA Too Conservative or Too Aggressive?  A Bayesian Decision Analysis of Clinical Trial Design."  For a summary you can read on your smartphone, see the blog at marginalrevolution.com by Alex Tabarrok (here).  [*]  Tabarrok's blog includes an active discussion chain.

Another very important and perennial question is:  "How Do You Know Which Health Care Effectiveness Research You Can Trust?"  Soumerai, Starr, and Majumdar (from Harvard, Boston University, and University of Alberta) discuss this at the CDC journal Preventing Chronic Disease, here (open access).  Soumerai and Koppel overview the study at Health Affairs Blogs, here.

[*]
Footnote.
Companion piece to Montazerhojdat and Lo.  In July 2015, BIO released a white paper called, "Life Cycle Perspective for Structured Risk Benefit Design."  Here.

Thursday, August 27, 2015

CMS Posts Youtube Video of Lab Advisory Expert Panel (August 26, 2015)

At the beginning of August, CMS announced the membership of its new Congressionally required expert panel on laboratory issues, including payment and coverage (article here).  The panel held its first meeting on site at CMS in a public hearing on August 26, 2015.



Wednesday, August 26, 2015

Highmark Announces "Coverage with Evidence Development-Like" Program

Highmark announces a program called VITAL for selected new technologies.  VITAL is described as, "a program that aims to accelerate the adoption of new technologies that have received regulatory approval but are not yet covered by most commercial insurance companies."

According to the industry website Healthcare Dive:

     “Technologies that have received regulatory approval from the FDA often lack sufficient scientific data to convince commercial insurers to pay for them,” the company says. “Without support from commercial payers, it is difficult for new innovations to influence the practice of medicine.”
     Highmark Health aims to influence this process through its position as the country’s third-largest integrated healthcare delivery and financing system. It describes the VITAL program as “the missing link between FDA approval of an innovative technology and its full reimbursement.”
For more on Highmark and this program, see Healthcare Dive, here.

Healthcare Dive's home page is here.  See also their BioPharma Dive, here.  Both are good industry news sources.

Friday, August 21, 2015

CMTP Issues Guidance for Payer Coverage of Next Gen Sequencing

CMTP Press Release:


Collaborative Issues Initial Guidelines for Health Insurance Coverage of Next Generation Sequencing (NGS) Testing in Oncology

Multi-stakeholder group recommends coverage for NGS panels of 5-50 genes (including all standard of care genes); 23 pages; online here.


Press release after the break.

IQWIG TWEETS....

Germany has a powerful and very active health technology assessment group, IQWiG.   The official English translation is:  Institute for Quality and Efficiency in Healthcare; the German original is, Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen.

Since they are viewed as powerful and ominous by some stakeholders, it's interesting to see their Twitter feed.  After the break.

Two excellent discussions of biopharma/medtech innovation, pricing, and strategy

Two excellent articles this week on biopharma/medtech innovation, pricing, industry challenges, and strategy.

At the Health Affairs blog, Jane Horvath has a broad and content-rich review of why pharma prices land where they are, giving the reader a deep view of pharma economic strategies.  Here. (2000 words.)   Horvath is an experienced industry consultant and former HHS policymaker.

At Harvard Business School's thought capital site, Working Knowledge, Michael Blanding writes: "Why Medical Devices Get to Patients Too Slowly."   Here.   Discusses and paired with a 59-page PDF white paper by Ariel Dora Stern ("Innovation under Regulatory Uncertainty: Evidence from Medical Technology.")  Here.
Stern is Assistant Professor at Harvard Business School, faculty webpage here; her impressive CV here.  See also her "Limits on the use of health economic assessments for rare diseases," Quarterly Journal of Medicine, 2014, here.

Wednesday, August 19, 2015

Structured Risk Benefit and Flibanserin

One of the most-visited articles on this blog is a 2014 article on structured risk-benefit, which makes some comparisons with how regulatory bodies are trying to cope with uncertainty and risk/benefit and how this might give insights to payer coverage decision-making (here).  The FDA's approval of Addyi (flibanserin) raises an opportunity to look at structured risk-benefit theory in the context of a drug approval that was a rapid media sensation.

"Addyi is a serotonin 1A receptor agonist and a serotonin 2A receptor antagonist, but the mechanism by which the drug improves sexual desire and related distress is not known."     [FDA press release, 8/18/2015]

More after the break.

Tuesday, August 18, 2015

Clinical Sequencing in Breadth and Scope - Conference 8/2015

We're frequently confronted by the scale of the next generation sequencing (NGS) industry, but I was uncommonly struck by the scope and scale of a conference this week in Washington DC, where I'm chairing a panel on federal payment reform in diagnostics.

We take for granted that NGS is  moving incredibly fast - see, for example, a September 2014 market report that states, "The global NGS market will be worth $2.5B in 2014 and is poised to reach $8.7B by 2020" (here).

The clinical literature is growing at a hockey-stick rate as well, as shown in the graphic below that culls PubMed for the term "clinical exome."  There were 2000 publications using this search term in the last several years, up from a near standstill in 2011.

More after the break.

Thursday, August 13, 2015

MolDX Finalizes Coverage of Nanostring Prosigna Test

On May 14, 2015, the MolDX program published a draft LCD proposing to cover the Nanostring Prosigna test for breast cancer (here).   On August 13, 2015, MolDX published a final coverage LCD which becomes effective on 10/1/2015, coincident with the new ICD-10 diagnosis codes.

The final Prosigna LCD (essentially the same as the draft) is available here - L36125.   MolDX also published a concise response to comments, primarily acknowledging letters of support of the draft policy (A54565, here).

The LCD also exists in draft form in KY/OH under the CGS MAC.  That draft LCD, L36127, does not yet state it is released-to-final (here).

The company's press release is here.


Wednesday, August 12, 2015

MolDX Updates its Frequently Asked Questions (August 5, 2015: Ver 5)

On August 5, 2015, MolDX updated its "Frequently Asked Questions," which is now in Version 5.
The new version is available on its own MolDX webpage, here.
For those interested in updates between the February 2015 version and the August 2015 version, a redline copied is here.

Noridian Announces Expansion of MOLDX to Jurisdiction F (And J E "Pt A")

On August 4, 2015, Noridian announced expansion of the MolDX program from its current Noridian footprint - Jurisdiction E "Part B" only - to Jurisdiction E "Part A" and Parts A/B in Jurisdiction F.  Their website article provided after the break.

Association for Molecular Pathologists Releases Lab Regulation Plan

As released on its website, on August 4, 2015, the Association for Molecular Pathologists (AMP) met with Senate Finance Committee staff to discuss the AMP's framework for some upgraded controls or regulation of laboratory developed tests.  The project is titled, "Modernization of CLIA Regulations
for Laboratory Developed Testing Procedures (LDPs)."
More after the break.

Thursday, August 6, 2015

Federal Court Finds DNA Fingerprint for Specimen I.D. is not a Medicare Benefit

For a couple of years, it's been possible to track the progress of a molecular pathology case through the Medicare appeals system, which works through independent review contractors, a federal administrative law judge, a Medicare board of administrative law judges, and eventual the federal courts.

The lab in question can use DNA fingerprinting to confirm that the tissue in a paraffin block is a perfect match to the patient's DNA (based on blood or saliva).   Some local MAC decisions had found that this was not a Medicare benefit but a lab quality operations procedure.

This summer, a federal judge agreed with the CMS agency that this type of DNA fingerprinting was not, in itself, a payable Medicare benefit as a laboratory service.  The case is online here.

Early parts of the Medicare case, from February 2013, online here, and September 2012, here.  A discussion of the case is also available here (page 4 forward) by Wachler, who represented the lab.


2015 White Paper: Building the Genomics Infrastructure

In late July, the Center for Data Innovation and the Health IT NOW coalition released an insightful ten page white paper, "From Evolution to Revolution: Building the 21st Century Genomic Infrastructure."

In the last few days I've heard a half-dozen different individuals or organizations raise thoughts along these lines, so the white paper must be capturing the Zeitgeist.

Links to the press release, here - and to the actual white paper, here.

Press release quoted after the break.


CMS Announces Members of Lab Advisory Panel; First Meeting 8/26/2015

CMS has announced the experts it has selected for a fifteen-member expert advisory panel on laboratory policy.   The panel will hold its first public meeting on August 26, 2015.

The panel will specifically give CMS an opportunity to reopen and revisit issues about molecular test crosswalking and issues on drugs of abuse testing that were discussed at a prior July 26, 2015 public meeting (here).  Details after the break.  Updated August 20, 2015 with additional information about each panelist.

Wednesday, July 29, 2015

The Popularity of Palmetto’s Approach to Urine Drug Tox Coding and Payment

Topline:
  • Medicare and stakeholders has sparred for years over correct coding and pricing for urine drug tests (UDTs.
  • AMA and CMS are using quite different systems in the current year, 2015 – private payers could probably pick either.
  • Palmetto GBA has come up with a “tiered” coding and pricing system that was praised by many stakeholders at the July 16, 2015 CMS CLFS meeting.

Details after the break.

Monday, July 27, 2015

Two worthwhile open access articles on Telehealth

Two interesting open access articles on Telehealth appeared in the last few months.

In March, Third Way (here and here), a public policy and communications think tank in Washington, published an excellent white paper on a dozen interesting examples of telehealth being deployed in useful ways nationwide.  The white paper is available here.  It's titled "Local Examples: Innovations in Telehealth."

In July, former Senator Frist, a physician, published a blog at Health Affairs entitled, "Telemedicine: A solution to address the problems of cost, access, and quality."  It's online here.


Monday, July 20, 2015

Bruce Quinn Joins FaegreBD Consulting as Senior Director

Health Markets & Reimbursement Policy Expert Bruce Quinn, M.D., Ph.D. Joins FaegreBD Consulting


Washington, D.C. (20-July-2015) - Bruce Quinn, M.D., Ph.D., has joined FaegreBD Consulting as a senior director with the firm’s health and biosciences team in Washington, D.C., where he leads the firm’s health markets and reimbursement strategy consulting practice. He has offices in Washington, D.C. and Palo Alto, California.
Quinn is a national leader on Medicare policy, the impact of health reform on innovation and the crafting of successful business strategies within the U.S. health care reimbursement system. In addition to his work in the health and biosciences sector, Quinn also provides significant synergies with the firm’s intellectual property, compliance, and corporate transactions groups.
Prior to joining FaegreBD Consulting, Quinn was a senior health policy advisor with Foley Hoag after serving as the medical director for the Medicare Administrative Contractor in California.  Earlier in his career, Quinn was a physician executive in the health and life sciences division of Accenture, working with the pharma, biotech and genomics industries.
“Bruce has unparalleled experience advising companies of all sizes through the enormous change occuring across the health policy landscape, particularly in bringing new technologies into a reimbursed market,” said Dave Zook, FaegreBDC chair. “We are pleased to add Bruce’s deep expertise to our regulatory and legislative capabilities as the shift from volume to value unfolds in our public and private health plans.”
“Bruce brings invaluable expertise to our expanding health and biosciences practice,” said group leader and principal Debra Lappin. “Bruce joins shortly after we’ve welcomed former CMS senior offical Mike Adelberg. Bruce brings yet another new perspective that we’re thrilled to offer our clients.”
Quinn is a board-certified pathologist with a subspecialty in neuropathology. As a physician-scientist on the faculty of Northwestern University School of Medicine, he led pathology research for Northwestern’s NIH-funded Alzheimer Research Center. Quinn has also held academic positions at New York University School of Medicine and the UCLA Center for Health Sciences — and is the author or co-author on over 30 scientific publications.
Quinn holds an M.D. and Ph.D. from Stanford University School of Medicine and an M.B.A. in health, finance and strategy from Northwestern University’s Kellogg School of Management.
LInks:
http://www.faegrebdc.com/
http://www.faegrebdc.com/bruce-quinn

Press release:
http://www.faegrebdc.com/19454
Media Contact: Meg McCormick, +1 612 766 8127, megan.mccormick@FaegreBD.com