Thursday, October 3, 2019

Trump Signs Medicare Policy Executive Order; Highlights New Tech Access

On October 3, 2019, President Trump signed an executive order regarding a suite of Medicare policies and adaptations.  Effects including widening access to Medicare Advantage (MA) plans; improved telehealth benefits in Medicare Advantage; and additional statements about rapid access to new technologies.
  • See the Executive Order here.
  • See a favorable fact sheet about administration accomplishments here.
  • See a negative fact sheet against "Medicare for All" here.
  • See a very brief press statement by Seema Verma here.
  • See YouTube video of speech by DJT here (one hour).
  • See transcript of speech here. [9200 words]
I've put the documents above in a cloud zip file here

See early coverage at The Hill here. At NPR here.  MedTechDive here.  MedPageToday here.  MedCityNews here.  Summary by Michael Adelberg at Faegre Baker Daniels here.  And, in December 2019, see a Health Affairs blog by Kushal Kadakia on the E.O. and on CMS viewing "innovation as the next frontier," here.


Some of the Executive Order statements are reiterations of existing policy, but I include those in the list below.  For details see the full E.O. at link above.


Telehealth in MA.  MA to make more use of telehealth.  Historically this had has pro's and con's, for example, if MA plans ignore local brick and mortar providers and "compensate" by offering only telehealth visits.  Implications for network adequacy in Medicare Advantage telehealth; here.

Pricing cuts.  Several items about repricing FFS rates against "market rates" or "MA rates."

Shorten the current lag from FDA approval.  Interesting to see how they will reduce time from FDA approval to coverage.  They also want to improve Parallel Review between CMS/FDA, which has only fully been used twice in six years.

Define evidence standards (reasonable and necessary) for coverage and appeals.  Defining "R&N" is an issue that CMS has broached before in regulation, but dropped.  See a 2002 article here and 2009 here.  Article by Sean Tunis 2006 here.  FDA"s 2019 guidance on balancing uncertainty of risk/benefit, here.  For a 2016 court case on NCDs and R&N, Kort v Burwell, here.

MA covers new tech?  Look into situations where MA plans cover a new tech, but, FFS Medicare does not.  (I'm not sure this happens very often; it may happen sometimes.)

Bullet Summary of Full E.O.:
  1. Medicare is good, but Medicare For All is bad.
  2. Improve the Medicare program through value and alternative payment methods.
  3. Let MA plans and benefit structures be more diverse. Let beneficiaries share in savings for less expensive care.  Don't favor FFS Medicare over MA. Consider lowering FFS rates to MA rates where appropriate.
  4. Make network adequacy rules for MA flexible and include telehealth.
  5. Give doctors more time with patients by reducing regulation.  Appropriate reimburse allied specialties (eg nurse practitioners).
  6. Encourage Innovation by Regulatory and Sub-Regulatory Means.
    1. Minimize or eliminate time from FDA approval to CMS coverage decisions.
    2. Clarify evidence standards for coverage decisions and appeals (define "reasonable and necessary")
    3. Repair challenges to Parallel Review
    4. Examine situations where MA plans cover new tech but FFS has barriers.
  7. Continue to push for site neutrality in payments.
  8. Make Medicare better by e.g. highlighting physicians with practice patterns that pose risk to patients.  
  9. Combat fraud and abuse. Use artificial intelligence.
    1. Study ways to transition Medicare to market-based pricing, including competitive bidding for FFS providers and use of MA rates.
  10. Eliminate regulatory burdens.
  11. Improve policies for patients who choose not to be in Part A.
  12. Implementation to be consistent with existing law.


"Right to Try" Watch: In several prior healthcare speeches, such as on renal policy and on surprise billing, President Trump has included several paragraphs discussing his successful push for Right to Try experimental drug laws.  Again in today's speech: several paragraphs on the success of the administration's Right to Try drug law.


Are They Raising FFS Prices???  I've seen a few sources assert that Trump will peg FFS Medicare prices to higher MA prices and make FFS unsustainably expensive (e.g. LATimes here).  I don't read the E.O. text that way; I think they would cherry pick MA for places where MA prices are lower than FFS.  This would also help "reduce any advantages that FFS has," one of the high level goals.  I don't know if there are many examples where MA prices are lower than FFS prices, but, competitive bidding dropped DME prices and pegging to commercial rates dropped lab test prices.

Medicare tidbit: CMS doesn't control prices in MA.  There is a regulation somewhere that providers out of network in MA can appeal prices until and unless it matches FFS levels.   MA plans and providers otherwise have a free hand to voluntarily elect to contract at prices higher or lower than FFS.