CMS had two major announcements this week - one, a national rule on price transparency in healthcare payments, and second, a "fourth interim final rulemaking" on COVID regulations, which includes a section on COVID test pricing.
Healthcare Price Transparency
For two years, a major push of the Trump administration has been healthcare price transparency. Proposed rules have already entered court battles. Nonetheless, CMS has released final rulemaking on price transparency.
> MACs avoid price transparency. The irony wasn't lost on me, since in the interests of price transparency, I obtained some locally priced code values from the Palmetto MAC (a type of information that some MACs say explicitly is released under FOIA). After I reported several clear-cut pricing errors to the MAC, resulting in clear-cut overpayments of Medicare funds, the Palmetto MAC responded with a cease and desist attorney's letter (here) that the overpayment rates to a few favored parties were "business secrets," which was covered in the trade press (at Genomeweb here.)
> Medicare Part B avoids payment transparency. In addition, CMS itself has declined to release its own Medicare 2018 physician and lab payment data, which under clear-cut federal policy is normally released in May./ I believe the May data has been withheld from release because it would show the level of egregious fraudulent payments (almost exclusively in Red states) under the Trump CMS administration in 2018 (here).
Here's the CMS Fact Sheet on the fourth interim rulemaking for COVID policy - link.
See the Fed Reg official publication (85 FR 71142), November 6, 2020 - here.
I haven't reviewed in full but a key section on COVID test pricing is described in the CMS fact sheet as follows. It appears to implement in regulation some text that Congress had already provided in prior COVID law. (Section 6001 of FFCRA, March 18, 2020).
[CMS fact sheet...] Price Transparency for COVID-19 Diagnostic Tests
Section 3202(b) of the CARES Act establishes a requirement for providers to publicize cash prices for COVID-19 diagnostic tests during the PHE. For purposes of implementing section 3202(b) of the CARES Act, this IFC adds a new 45 CFR part 182 to our regulations. This new requirement applies to every “provider of a COVID-19 diagnostic test” (or “provider”), which is defined as any facility that performs one or more COVID-19 diagnostic tests. Additionally, it requires that each provider of a COVID-19 diagnostic test make public the cash price, defined as the charge that applies to an individual who pays cash (or cash equivalent) for a COVID-19 diagnostic test, for such tests on the internet. If the provider does not have its own website, the provider must make the cash price available in writing within two business days upon request and through signage (if applicable). Additionally, this IFC gives CMS discretion to take any of the following actions, which generally, but not necessarily, will occur in the following order if CMS determines the provider is noncompliant with these requirements:
- Provide a written warning notice to the provider of the specific violation(s).
- Request that a provider submit and comply with a corrective action plan (CAP) if its noncompliance is not corrected after a warning notice.
- Impose a civil monetary penalty (CMP) on the provider if the provider fails to respond to CMS’ request to submit a CAP or to comply with the requirements of a CAP approved by CMS.