Monday, June 10, 2019

Brief Blog: CMS Extends Expiration Date for Antibiotic Stewardship Rule

In June 2016, CMS proposed that all hospitals have Antibiotic Stewardship Committees meeting certain regulatory standards, as a Condition of Participation.   Like all CMS proposed rules, the rule would expire in 3 years (June 2019) if not finalized.   See contemporary 2016 coverage here.   See proposed rule here.

Some stakeholders in the antibiotics and public health committee have become increasingly concerned that the rule would expire without being finalized, the equivalent of a "pocket veto."  See press here and here.   The Presidential Advisory Council on antibiotics resistance held a special, rapid, off-cycle meeting on April 8, 2019, and all the experts voted unanimously to urge HHS to finalize the rule.  For my meeting report, links, and a transcript here.


Inside Health Policy reports today that CMS will extend the deadline for consideration of this rulemaking by one year, until June 2020, because of its "complexity."   (Subscription; see headline here.)    CMS also noted that at least some stakeholders had originally (in 2016) asked CMS to delay implementation of the new policy.

Rulemaking was published in Federal Register, 84 FR 27069-70, on June 11, 2019.  Web page here, PDF rule here.

The announcement that the antibiotic stewardship rulemaking is deferred, not dumped, comes as the United Nations and others are working to raise awareness of the global antibiotics crisis.  Last week, as I was traveling through airports, I noticed that the cover story of Newsweek is the antibiotics crisis.


For a comparison of proposed 2016 CMS and Joint Committee standards, see:

Sunday, June 9, 2019

GRAIL Hires Amgen SVP Josh Ofman MD as Head of Strategy

On June 6, 2019, GRAIL announced it has hired Amgen SVP for Global Value, Access, Policy, Josh Ofman MD, as GRAIL's Chief of Corporate Strategy and External Affairs.  See the press release here.

Ofman spent 16 years at Amgen.  An internist, he holds an MD from UCI, his residency training at UCLA, and a master's from the School of Public Health at UCLA.  See his Linked In here.   See an 2018 interview with Ofman on the healthcare value of drugs here.

GRAIL also announced its current CEO has had to step down for family reasons and the new CEO will be board member Hans Bishop.  Bishop was CEO of Juno Therapeutics, which Celgene acquired for $9B in 2018.   See Stat here,  Fierce Biotech here.

A Fierce Biotech article re GRAIL data from ASCO 2019 is here. A StatPlus article on GRAIL from ASCO is here.

Friday, June 7, 2019

MolDx to Hold National Workshop on Pharmacogenomics for Medicare; June 26, 1-4 ET

Under new 2019 rules, MACs are encouraged to hold Contractor Advisory Committee or CAC panels on topics of upcoming policy interest, and featuring guest expert speakers.   The meetings are available for webinar viewing by the public, and will be archived along with transcripts. 

(If anyone thinks these sound more like CMS MEDCAC meetings, you're right.)

The MolDX MACs will hold a national CAC webinar meeting on Wednesday, June 26, 2019, from 1-4 pm ET, on the topic of pharmacogenomics.   Potentially, if I understand the rules, non-MolDx MACs would have the opportunity to co-sponsor the meeting if they want to.

A more complete agenda will be posted by June 12, and registration must be completed by June 19.

It's unclear from the announcement if the focus will be on psychiatric PGx gene panels or PGx clinical utility in general.

Find the webpage here:

I've also cut and pasted the Palmetto below the break but you need to see the live link above for the most current information and updates.


See another web page with more info here:

See a draft question list for panelists, here:$File/Tentative_Questions_for_the_Multijurisdictional_CAC_Meeting_Regarding_Pharmacogenomics.pdf

Tuesday, June 4, 2019

Very Brief Blog: Entry Points to Patent Law Reform and Genomics

In the wake of several Supreme Court cases on diagnostic test patents five years ago or longer, there is now a flurry of Hill interest in patent law reform. 

This appears to be a highly polarizing topic, with (A) proponents saying some patents are necessary to support investment and commercialization (without instant copycats), while (B) others say gene patenting is fundamentally wrong and also inhibits innovation. 

See a 2019 blog on investments and patents in diagnostics here and the underlying original article here (which is 94pp; Taylor; Cardozo law review journal).

The Hill is considering draft legislation and will hold hearings in early June.  The legal changes wouldn't be specific to genetics, but would have a significant impact on genomics patent law.  The draft bill just adds a few sentences to existing patent law, but they impact on a large number of stacked and intersecting court cases and case law.

I'll provide some entry points to this complex area.  Senate hearings are June 4, June 5, June 11 in the intellectual property subcommittee of the judiciary committee.
  • Genomeweb overview on June 4; I believe open access, here.
  • At Patent Docs, the frequently quoted patent attorney Kevin Noonan is pro-change, he has two recent open blogs with many hyperlinks,
    • Overview, May 23, here.
    • Positioning vis-a-vis ACLU, June 3, here.
  • Washington Post, June 3, (suspicious of reform; probably firewall), here.
  • Science, June 4, here.
  • ACLU, June 3, here.