The government's website is here. The following speakers testified (PDFs online) and there was spirited debate.
- Chairman Price
- Mark Hadley, Deputy Director, OMB
- Joseph Antos PhD, American Enterprise Institute
- Ted Okon, Community Oncology Alliance
- Mark Madden MD, OrthoVirginia
- Topher Spiro, VP, Center for American Progress
Video streams online at the House website. The House website provides no transcript, but I provide one for you on this blog: here.
For one zip file containing the various PDFs, some additional letters from stakeholders, and the transcript, click here. (To download look for "down" arrow.)
Legal Status of CMMI Questioned by Some
Two arguments have been raised about the legal status of CMMI.
One is that it has authorities that exceed the constitutional separation of powers. That is an issue that could be answered only a roomful of constitutional law experts and a panel of appellate federal judges. (See here and here).
One is that it has authorities that exceed the constitutional separation of powers. That is an issue that could be answered only a roomful of constitutional law experts and a panel of appellate federal judges. (See here and here).
But a second issue has also been raised, that CMMI can waive existing law solely within demo programs, and not in permanent policies. This argument is articulated similarly in BIO's comment on the July 2016 PFS proposed rulemaking for CY2017 (see BIO's letter, here; PHRMA, Lilly, GSK, and others make the same statutory argument.) The argument is made also for the House hearing, on pages 18-19 of Okon's Community Oncology Alliance testimony at the House CMMI hearing, but did not appear to get much verbal discussion.
CMMI is created by section 1115A of the SSA. Section (a) is definitions, section (b) allows the creation of pilot programs, and section (c) allows the permanent implementation of pilot programs if they do not raise costs and do not lower quality (hopefully, they would lower costs and raise quality). Sections (a), (b), (c) do not give CMMI any authority to waive existing law.
Then comes section (d), which allows CMMI to waive existing Medicare law but SOLELY for the purpose of demonstration projects.
CMMI is created by section 1115A of the SSA. Section (a) is definitions, section (b) allows the creation of pilot programs, and section (c) allows the permanent implementation of pilot programs if they do not raise costs and do not lower quality (hopefully, they would lower costs and raise quality). Sections (a), (b), (c) do not give CMMI any authority to waive existing law.
Then comes section (d), which allows CMMI to waive existing Medicare law but SOLELY for the purpose of demonstration projects.
In PFS rulemaking issued last summer, CMS created policy as if had authority to waive existing law both for demo projects and for the following permanent implementation. (81 Fed Reg 46414, seeming to cite 1115(A)(d) improperly and outside a pilot project).
Taking 1115A(d) as written - allowing waivers of law within a pilot project - CMMI could do a small local one year demo project (waiving laws it wants to change), and then make the next-larger activity a nationwide and 100-year-long demo project -- but that doesn't seem in spirit with the spirit of the creation of CMMI.
Interestingly, you don't hear that much about the 1115A(d) problem. Fans of CMMI don't want to bring it up, and CMS seems to even violate it (81 Fed Reg 46414, cited above), in the eyes of attorneys at BIO, PHRMA, et al. Opponents of CMMI prefer to concentrate on whether CMMI is unconstitutional - a drum that can be banged on forever, or until resolved by SCOTUS - and for them, highlighting the restrictions at 1115A(d) downsizes CMMI in a way that doesn't help its opponents' scary rhetoric.
Taking 1115A(d) as written - allowing waivers of law within a pilot project - CMMI could do a small local one year demo project (waiving laws it wants to change), and then make the next-larger activity a nationwide and 100-year-long demo project -- but that doesn't seem in spirit with the spirit of the creation of CMMI.
Interestingly, you don't hear that much about the 1115A(d) problem. Fans of CMMI don't want to bring it up, and CMS seems to even violate it (81 Fed Reg 46414, cited above), in the eyes of attorneys at BIO, PHRMA, et al. Opponents of CMMI prefer to concentrate on whether CMMI is unconstitutional - a drum that can be banged on forever, or until resolved by SCOTUS - and for them, highlighting the restrictions at 1115A(d) downsizes CMMI in a way that doesn't help its opponents' scary rhetoric.
