BREAKING: CMS Proposes Regulation Changes & Updates to Data Collection Tool

www.regulations.gov – refer to file code CMS-1770-P.

Proposed Changes to Nonemergency, Scheduled, Repetitive Ambulance Services Regulation

Currently, the regulation concerning medical necessity for nonemergency, repetitive scheduled transports states plainly that: “The presence of the signed physician certification statement does not alone demonstrate that the ambulance transport was medically necessary.”  CMS also says that the existing regulation has been “interpreted too narrowly,” and often transports where beneficiaries simply need monitoring by EMS personnel are excluded from coverage.  The proposed regulation will expound significantly on the existing regulation by stating:

While a signed physician certification statement (PCS), does not alone demonstrate that transportation by ground ambulance was medically necessary, the PCS and additional documentation from the beneficiary’s medical record may be used to support a claim that transportation by ground ambulance is medically necessary. The PCS and additional documentation must provide detailed explanations, that are consistent with the beneficiary’s current medical condition, that explains the beneficiary’s need for transport by an ambulance, as described at § 410.41(a), that includes observation or other services rendered by qualified ambulance personnel, as described in § 410.41(b).

4 Important Implications of the Proposed Changes:

1. Change to Regulation NOT RSNAT Program.  These are proposed changes to the regulations, not the RSNAT guidelines for the Prior Authorization program.  These changes would carry global weight for all scheduled, repetitive transports.
2. Observation of Patient.  These changes would expressly add “observation” – i.e., monitoring by an EMS provider even if the patient doesn’t need “tangible services” – as a condition for which medical necessity can be established. CMS says that the existing regulation has been “interpreted too narrowly” by some.  That means that CMS believes the current regulation includes coverage of repetitive, nonemergency transports where the patient simply needs monitoring.  If this new regulation is passed, it can serve as great evidence in an appeal or reconsideration even of past claims that fall under the current regulation, since CMS is saying this “clarifies the intent of existing regulatory language.”
3. Additional Documentation. We believe it is a good thing that CMS is proposing that “additional documentation from the beneficiary’s medical record” can be used to support medical necessity.  This essentially means that Medicare reviewers must consider facility and physician records when reviewing medical necessity (provided they meet the “detailed” and “consistent” criteria in the proposed regulation).
4. PCS Language Pitfall.  CMS’s proposed language states that: “the PCS and additional documentation must provide detailed explanations…”  This language seems to imply a new requirement for a PCS to include a “detailed explanation” – which sounds a lot like a “thorough narrative.”  It’s possible that under the proposed changes PCS forms that only use check boxes and signatures would not satisfy Medicare to establish medical necessity for repetitive, scheduled non-emergency trips because they do not include a space for detailed explanations.  CMS has always maintained that it does not dictate requirements for the design of a PCS form, other than the form must certify that the medical necessity provisions of the regulations are met.  This proposed change seems to change that stance, at least for repetitive/scheduled non-emergencies.

Proposed Changes to Ground Ambulance Data Collection Instrument

CMS also proposed some changes to the ground ambulance data collection tool and instructions.  Most of them are for clarity and consistency and to correct typos and technical issues.  A draft of the updated instrument that includes all of the CY 2023 proposed changes to review and provide comments on is posted on the CMS Ambulance Services Website.  CMS is also proposing an automated process for requesting a hardship exemption and informal review request and this is supposed to happen in late 2022.

What’s Next?

Stay tuned as PWW monitors these proposals and considers its own comments to the proposed rule, which we will share with the industry.  We will have information as soon as a final rule is announced.  We’ll dive into what this means for the industry this Fall at our abc360 Hershey conference!