On May 5, 2016, CMS released the third annual set of data files on physician and laboratory behavior: comprehensive multi hundred megabyte data sets of CPT codes and who used them and where.
For the CMS press release, here. For a short article at HealthcareDive, here. For the actual data set page (where you can find 2012, 2013, 2014 in sequence), at CMS, here.
For a short blog on the data set, here.
Tuesday, May 10, 2016
Monday, May 9, 2016
Why Did CMS Hold a MedCAC on Treatment Resistant Depression? (Answer)
On April 27, 2016, CMS held a MEDCAC meeting on "Treatment Resistant Depression," covered a bit in the CMS press. The CMS webpage for the meeting, including agenda, prepared documents, and (eventually) a transcript, is here.
I noticed that two different trade journal articles, MedPageToday (here) and Modern Healthcare (here), noted that CMS had not stated "a reason for holding the meeting."
The rationale have its roots in a 2014 appeal of the one NCD that addresses treatment resistant depression, an NCD for vagal nerve [electrical] stimulation, which covers therapy for epilepsy but does not allow coverage for treatment resistant depression.
I noticed that two different trade journal articles, MedPageToday (here) and Modern Healthcare (here), noted that CMS had not stated "a reason for holding the meeting."
The rationale have its roots in a 2014 appeal of the one NCD that addresses treatment resistant depression, an NCD for vagal nerve [electrical] stimulation, which covers therapy for epilepsy but does not allow coverage for treatment resistant depression.
The Brouhaha around a DMEMAC Lower Extremity Prostheses LCD Revision
In September 2015, the WSJ ran an article on a proposed LCD revision in the DME MAC world, which would change some coverage standards for lower extremity prostheses (see WSJ, here.) The topic appears again in the May issue of the trade journal Insider CMS (subscription; here). Inside CMS describes that an Energy & Commerce legislator's effort to "slap a moratorium on the LCD until July 2017" and a House effort to "give CMS more power over local coverage policies in general." The American Orthotic and Prosthetic Association is also "shopping a bill" on the topic. The article also describes "a protest from amputees."
An April 28, 2016 letter from four House members to HHS Secretary Burwell is described. CMS posts that the LCD is on hold pending further workgroup study.
Precision Medicine IPO: NantHealth Files for IPO
NantHealth, a Culver City based company led by billionaire Patrick Soon-Shiong MD, has filed for a $92M IPO under the symbol NH. The S-1 is available here. The summary begins at page PDF p. 8; the full business plan description begins on page PDF p. 103.
[Update, an update was filed May 24 with new information including a proposed share price of $12-15; news here; document here].
Current investors include Allscripts, Verizon, Blackberry, Kuwait, and Celgene. In the past year, Nanthealth reports $58M revenue and a $72M net loss, suggesting spending at the rate of about $130M per year.
A 7-point analysis by Neil Versel at MedCity News is here. An 8-point analysis by HIT Consultant, here. Coverage at FierceMedicalDevices here.
NantHealth's home page is here. For an April, 2016 video interview between Soon-Shiong and Eric Topol, here (website includes transcript).
[Update, an update was filed May 24 with new information including a proposed share price of $12-15; news here; document here].
Current investors include Allscripts, Verizon, Blackberry, Kuwait, and Celgene. In the past year, Nanthealth reports $58M revenue and a $72M net loss, suggesting spending at the rate of about $130M per year.
A 7-point analysis by Neil Versel at MedCity News is here. An 8-point analysis by HIT Consultant, here. Coverage at FierceMedicalDevices here.
NantHealth's home page is here. For an April, 2016 video interview between Soon-Shiong and Eric Topol, here (website includes transcript).
Thursday, May 5, 2016
New Data on the Ways "PSA Screening" RCTs Can Be Very Misleading
This is the May 5, 2016, letter in NEJM from Columbia and Cornell showing that in the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial, in the "control" arm, PSA testing rates were very high, higher than generally known.
The findings mean that it was not really an RCT of the additive impact or benefit of PSA screening, since PSA was 'de facto' being screened in both arms. This shows one of the hazards of a rigorous "intention to treat" analysis when the control group actually veers to pragmatic treatment very similar to the treatment group.
The findings mean that it was not really an RCT of the additive impact or benefit of PSA screening, since PSA was 'de facto' being screened in both arms. This shows one of the hazards of a rigorous "intention to treat" analysis when the control group actually veers to pragmatic treatment very similar to the treatment group.
[M]ore than 80% of the participants in the control group without baseline screening contamination (which for PSA wasdefined as ≥2 tests within 3 years before trial entry)reported having undergone at least 1 PSA test during the trial, with more than 50% undergoing testing within the past year and 70% within the past 2 years.
Overall, including the 10% of control participants with baseline PSA screening contamination, the proportion of control participants who reported having undergone at least1 PSA test before or during the trial was close to 90%.
Wednesday, May 4, 2016
Foundation Medicine to Open Lab in North Carolina; Billing to Palmetto/MolDx Policy System
In its investor call for first quarter results, held May 3, 2016, Foundation Medicine (FMI) noted that it will be opening a laboratory center in Research Triangle Park, North Carolina. A lab in that location would bill to a different Medicare MAC for all its Medicare fee for services patients. Some of the complexities are unraveled after the break.
Tuesday, May 3, 2016
Price Transparency Deja Vu: Advertising Lab Services in the 1920s
We read something about the missing value of "transparent pricing" almost daily in American health care.
Archives of Pathology and Laboratory Medicine just published a historical review of changes in the pathology profession and industry in the 1920s (by James Wright. University of Calgary; here and here. This epublication appears to be open access, at least this week.)
One of the dramas of the 1920s was that some commercial laboratories were openly advertising their prices, and professional pathologists/physicians felt this was a violation of ethics codes "as if tests were commodities" since physicians ought not advertise prics. A screenshot below. As Wright describes, there were actually several full cycles of debate over the relative pro's and con's of advertising laboratory prices in JAMA and other medical journals (advertising might prevent the unscrupulous from overcharging [other] physicians.)
Archives of Pathology and Laboratory Medicine just published a historical review of changes in the pathology profession and industry in the 1920s (by James Wright. University of Calgary; here and here. This epublication appears to be open access, at least this week.)
One of the dramas of the 1920s was that some commercial laboratories were openly advertising their prices, and professional pathologists/physicians felt this was a violation of ethics codes "as if tests were commodities" since physicians ought not advertise prics. A screenshot below. As Wright describes, there were actually several full cycles of debate over the relative pro's and con's of advertising laboratory prices in JAMA and other medical journals (advertising might prevent the unscrupulous from overcharging [other] physicians.)
Can Pragmatic Trials and Real World Evidence be "Certified?" A Published Proposal
Can real world evidence be 'certified' for validity and lack of bias, including when sponsored by industry?
Maybe so, according to a proposal by Hopkins, Univ. Washington, and other policymakers.
Open access article here. Abstract clipped after the break. For a Washington white paper on RWE, appearing in June 2016, see here.
Maybe so, according to a proposal by Hopkins, Univ. Washington, and other policymakers.
Open access article here. Abstract clipped after the break. For a Washington white paper on RWE, appearing in June 2016, see here.
Giant Consolidations: IMS/Quintiles to follow Payers, Hospitals, and Pharmas in Consolidation Bonanza
Articles on the ongoing rollup of physicians into hospital networks, hospitals into bigger networks, pharmas into mergers, and payers into mergers...are legion. For an April 29, 2016 article at NYT, here.
The healthcare information, R&D, and value measurement industry is gaining a colossus worth about $20B with the merger of Quintiles and IMS Health, announced on May 3. For an article at MedCity News, here. Writing in part:
Two heavyweights in healthcare and biopharma Big Data, IMS Health and Quintiles Transnational Holdings, are coming together in what the companies are calling a “merger of equals.” The all-stock transaction brings together companies with a combined enterprise value of upwards of $23 billion and current market capitalization of $17.6 billion. “This combination addresses life-science companies’ most pressing needs: (1) to transform the clinical development of innovative medicines, (2) demonstrate the value of these medicines in the real world and (3) drive commercial success,” said Quintiles CEO Tom Pike.
_______
For an acquisition that brought together a lab and a CRO, recall the $6B acquisition of Covance by Labcorp in early 2015.
Aaron Bossler's 62 Slide Deck on "The Squeeze on Molecular Pathology"
Aaron Bossler MD, University of Iowa, has been highly active in the Association for Molecular Pathology and co-authored a new paper on both the lab economics and healthcare economics of molecular testing (here; open access).
His 62-slide deck, 'The Squeeze on Molecular Pathology," is online at ARUP's website, here. It has a PDF creation date of 12/2015.
His March, 2015 45-slide deck on molecular lab costs and pricing for Pathology & Laboratory Medicine Executive War College is online, here.
Extra Credit Reading:
For a 38 slide deck from 2014 by Michael Watson for ACMG, on similar themes, see here.
His 62-slide deck, 'The Squeeze on Molecular Pathology," is online at ARUP's website, here. It has a PDF creation date of 12/2015.
His March, 2015 45-slide deck on molecular lab costs and pricing for Pathology & Laboratory Medicine Executive War College is online, here.
Extra Credit Reading:
For a 38 slide deck from 2014 by Michael Watson for ACMG, on similar themes, see here.
Monday, May 2, 2016
Noridian JE Finalizes West Coast MolDX Cardiac Biomarker LCD
Over the past year, MolDX and other MACs have been bringing out more stringent LCDs on the use of cardiac biomarker testing, probably in the wake of high billing at the HDL commercial laboratory in Virgnia (here).
In April 2015, Noridian finalized its cardiac biomarker LCD with relatively few changes - but there are a few. Details after the break.
In April 2015, Noridian finalized its cardiac biomarker LCD with relatively few changes - but there are a few. Details after the break.
Comments Are In: CMS Asks Public About MAC Contracting
MACRA (the 2015 SGR Reform) Section 509 extends MAC contracting from 5-year to 10-year periods. (CMS website for these changes, here.)
In December 2015, CMS also issued a "Request for Comments" on MAC performance and the MAC contracting process. The Docket for the request (#2015-32027, CMS-1653-NC) is here. The full text of the CMS public request for information is here (html) or here (80 Fed Reg 27343-5).
In total, 23 comments were submitted (here). Details after the break.
In December 2015, CMS also issued a "Request for Comments" on MAC performance and the MAC contracting process. The Docket for the request (#2015-32027, CMS-1653-NC) is here. The full text of the CMS public request for information is here (html) or here (80 Fed Reg 27343-5).
In total, 23 comments were submitted (here). Details after the break.
CMS Happy Talk Animated Breezy Explanation of MACRA
CMS released an animated three minute explanation of the 950 page MACRA rulemaking. It's on YouTube, here.
These are boom days for explanatory animations where you either see graphics and words appearing as if hand drawn in real time, or, you may (as here) see the animators hand whizzing on and off the animation. Khan Academy was an early producer of these. Vi Hart produces particularly offbeat ones on math and other topics (here). Hart once remarked it takes two weeks or more to produce a 2 minute video of this type in her style.
This category of explanatory animation video may have (or deserve) a dedicated name, but I haven't found it.
While it lacks music, the CMS video may remind musical fans of the Dr. Pangloss description of the workings of the world in Candide, see here at the 18:00 minute mark. Of course, Pangloss was being portrayed as a happy talk idiot by Voltaire and his later theatrical partners.
These are boom days for explanatory animations where you either see graphics and words appearing as if hand drawn in real time, or, you may (as here) see the animators hand whizzing on and off the animation. Khan Academy was an early producer of these. Vi Hart produces particularly offbeat ones on math and other topics (here). Hart once remarked it takes two weeks or more to produce a 2 minute video of this type in her style.
This category of explanatory animation video may have (or deserve) a dedicated name, but I haven't found it.
While it lacks music, the CMS video may remind musical fans of the Dr. Pangloss description of the workings of the world in Candide, see here at the 18:00 minute mark. Of course, Pangloss was being portrayed as a happy talk idiot by Voltaire and his later theatrical partners.
Saturday, April 30, 2016
PAMA 216 Rulemaking Has Left HHS; Under Review in Executive Branch
PAMA Section 216 is the massive overhall of the Clinical Laboratory Fee Schedule, passed 24 months ago by Congress. The legislation told CMS to have final rulemaking in place by July 1, 2015. The proposed rulemaking was not released until last fall.
The final version of the implementation was received at the White House Budget Office on April 21, 2016, per "Inside Health Policy" (subscription, here) and Bloomberg News (here). See also McDermott Plus Consulting, here. The executive branch regulatory information site is here.
The final version of the implementation was received at the White House Budget Office on April 21, 2016, per "Inside Health Policy" (subscription, here) and Bloomberg News (here). See also McDermott Plus Consulting, here. The executive branch regulatory information site is here.
A "Hiccup" for Digital Drugs: FDA Postpones Oral Abilify/Pill/Transmitter
One of the fiercest problems in healthcare is poor compliance with medications that actually work. Industry is now on the edge of producing pills with tiny embedded transmitters in the tablet. However, it won't be as fast as Otsuka and Proteus Digital Health hoped. According to an April 26, 2016, press release, the FDA issued a complete response for their combination product with Abilify and an ingestible sensor. The FDA asked for more information about the product "under the conditions under which it is likely to be used." Press release here. The issue has implications for the coordination between CDRH and CDER, the FDA's framework for digital health, and how regulatory approach the regulatory science and risk/benefit uncertainties of new generation products. Trade press here and here.
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