The CMS homepage with lots of tables and addenda is here. CMS press release here, fact sheet here. See also a fairly detailed discussion at Lexology, November 17, here.
Diabetes Prevention Program begins on page 53254 and runs through page 53357, about 100pp or 25% of the annual rule. This is the first major program that began as an Innovation Center demo and is being expanded by rulemaking into a nationwide benefit. It's for brick and mortar DPP only. Questions on future offerings of "virtual DPP" or how MA plans will handle DPP/VDPP are to be clarified in "future guidance." (p. 53235, bottom right.)
Biosimilar guidance has been under discussion again, as CMS proposed to categorize biosimilars in one "bucket" HCPCS code which the biosimilars industry opposed. CMS will begin categorizing each biosimilar under its own HCPCS code (page 53348ff).
- Under "bucket" coding for biosimilars, CMS would likely have had lower prices, due to drug-on-drug competition to create a profit margin for physicians, by one-upping each other to give the physician more margin under the CMS payment price for the quarter.
- However, a sufficiently adverse marketplace would mean biosimilars would stand down and not enter the US marketplace at all, a genuine concern. See RAPS, October 30, here.
- CMS acknowledges that its change to biosimilar-specific coding will "address concerns about a stronger marketplace...encourage innovation to bring more products in the market."
- Note that while CMS sets payment policies only for itself, it also controls all HCPCS codes. So long as CMS staff had refused to even create unique HCPCS codes, any efforts to get a better market in other payer venues was a non-starter.
- Two other notes:
- It's unusual that a change this large could be accomplished without a regulatory change. The requisite regulation, 42 CFR 414.904(j), said that all biosimilars coded together would get an average price. It did not say whether CMS must, or must not, issue codes that group more than 1 biosimilar together.
- It's unusual in that the proposed policy change was quite short and the final policy change and discussion was very long. CMS revealed intentions and rationales in the final policy that couldn't be guessed from the July proposal.
- See July proposal, November final, and Regulation in one PDF here.
- For a fascinating article on the early impact of the existing "bucket" pricing rules for biosimilars, see Adam Fein at Drug Channels, 9/2017, here. See also various links from within that article. (Like here and here and here.)
Added 1/2018: Novartis says "US desperately needs biosimilars [at lower prices] to create fiscal space for new drug products," here.
CMS discussed comments about the PAMA data collection program for labs at 53581ff. 40 comments were received. CMS notes drily that "most comments received were out of scope."
The complex but interesting area of Appropriate Use Criteria requirements, applied to advanced imaging test orders, begins at 53187ff. This is an invention of PAMA that is still being implemented. I have always wondered if the same idea could show up some year in context of molecular tests. Except for PET scans, which are around $1000, most advanced imaging (PET, CT) is $300-600 at CMS prices. This is easily in the range of many genetic tests and below the range of many proprietary MAAA tests.
Tidbits
For an article on some revisions to Telemedicine services, here. Also remote monitoring cardiology testing, 53063. Flow cytometry RVUs, discussed at 53059; pathology consultation 53060; tumor immunohistochemistry, 53061. Discussion of using PAMA Section 220 authority to collect data on real world pricing, using independent contractors, 52998 (bottom right).
