The next four years are going to be a battle over whether or not Uncle Sam continues to morph into Uncle Sam, MD.
Consider:
Uncle Sam as our nation’s largest payor.
Uncle Sam as funder of comparative effectiveness research.
Uncle Sam as “academic” detailer of comparative effectiveness research.
Uncle Sam as determiner of Essential Health Benefits.
Consider the continued disempowered physicians, patients -- and states (which are the true laboratories for healthcare delivery innovation).
Consider a battle royale over whether or not comparative effectiveness should become a third leg for FDA approvals (in addition to safety and efficacy).
Consider whether CMS reimbursement will move to a value-based reimbursement model, setting up the foundation for a US version of Britain's NICE. (Remember Don Berwick?)
Consider Medicare and Medicaid adopting the NHS model of "expanded access" (formerly known as "risk sharing") wherein reimbursement is granted -- but if predefined patient outcomes aren’t achieved, the pharmaceutical company reimburses CMS. Hm.
Consider FDA Commissioner Peggy Hamburg. Will she stay or will she go? (I predict she will stay.)
I predict that (regardless of who gets elected) IPAB gets revoked on the Hill. IPAB is a slippery slope to broader government price controls, so it should be good riddance to dangerous rubbish – if the President doesn’t veto this first congressional rebuke to ObamaCare.
And what of the legitimacy of Billy Tauzin’s famous ACA “deal?” Will there be legislative action to revoke the Non-Interference Clause (as mentioned by Vice President Biden -- although not by name -- during the Vice Presidential debate)? Unlikely.
Will the President continue to push for 7 years of data exclusivity for biologics (as opposed to the 12 currently allowed under the ACA?) Will he have the chutzpah to claim he is pro-innovation if he does?
Will we have to endure another foolish waste-of-time debate over drug importation?
And did somebody say “Doc Fix?”
Ladies and Gentlemen, fasten your seatbelts and start your engines.
