CMS Updates State Operations Manual

By A.J. Plunkett

Just in time for the holidays, CMS is offering the gift of a newly revised State Operations Manual (SOM), one of the first significant overhauls in more than a year, especially for hospitals. Expect updated standards from accrediting organizations (AO) to follow.

The updated Interpretive Guidelines for CMS surveyors includes most—but not all—of the new or revised Conditions of Participation (CoP) for discharge planning and burden reduction outlined in two final rules published in September.

There are revisions for the SOM appendices to the CoP Interpretive Guidelines for hospitals, psychiatric hospitals, home health agencies,  portable x-ray units, rural health clinics and federally qualified health centers (RHC/FQHC), end stage renal disease facilities (ERSD), comprehensive outpatient rehabilitation facilities, ambulatory surgical centers, hospice care,  religious nonmedical healthcare institutions, critical access hospitals (CAH), organ transplant programs, and emergency preparedness.

The updates were published December 20 in a 608-page memo from CMS Quality, Safety & Oversight Group to CMS’ state regional offices and state survey agencies, as well as AOs. The memo can be found here.

While the two final rules were for the most part effective on November 29, 2019, the memo does note that changes regarding antibiotic stewardship programs for hospitals and CAHs, are not effective until March 30, 2020, and regulations quality assessment and performance improvement programs (QAPI) are not effective until March 30, 2021.

The revised Interpretive Guidelines for antibiotic stewardship and QAPI are expected in the spring, says CMS.

The final rules were “Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction” (CMS 3346-F) and “Revisions to Requirements for Discharge Planning for Hospitals, Critical Access Hospitals, and Home Health Agencies” (CMS 3317-F).

Other changes in this SOM release, as outlined in the Dec. 20 memo, include:

• “CAH- Revisions to Appendix W also include renumbering the C-Tags; inserting regulations §485.601, §485.603, §485.604, and §485.606; and inserting the CAH Distinct

Part Unit and Emergency Medical Treatment and Labor Act (EMTALA) C-Tags for reference. The changes also include updates to the Life Safety Code® (LSC).

• Hospital/CAH/RHC/FQHC- Detailed requirements of United States Pharmacopeia (USP) have been removed from Appendices A, G, and W accordingly, as CMS requires compliance with applicable Federal and State law and adherence to accepted general standards of practice or guidelines for pharmaceutical services and medication administration issued by nationally recognized professional organizations.
• Psych Hospitals- The Special Conditions of Participation (CoPs) for the regulations §482.60 through §482.62(g)(2) psychiatric hospitals have been moved from the SOM Appendix AA to the SOM Appendix A. Appendix AA is being deleted as surveyors will now refer to Appendix A.
• Transplant Programs – Requirements at §482.82 that state that transplant centers must meet all data submission, clinical experience, and outcome requirements for Medicare reapproval have been removed. In addition, the special procedures for re-approval at §488.61 (f) through (h) is revised to remove the requirements with respect to the reapproval process for transplant centers. The change corresponds to the remove of the provisions at §482.82.
• ESRD Facilities: Appendix H updates the regulatory text based on requirements set forth in the 2008 Conditions for Coverage for ESRD Facilities and also includes revisions based on recent Federal regulation changes set forth in “Fire Safety Requirements for Certain Dialysis Facilities (CMS–3334–P).
• RHC/FQHC – Revisions to Appendix G include updates to regulatory text and interpretative guidance for both §491.9(b)(4) and §491.11(a) changing the requirement for an annual review to a biennial review.”

CMS officials say they are also developing online training for its surveyors on the revisions.

Sections of the main SOM have been revised over the last months and years, as have the individual appendices for each organization type that must adhere to the CoPs. The appendix for hospitals, for instance, was last updated online in October 2018. However, the appendix for ambulatory surgical centers has not been updated online since 2014.

Other sections have been added, such as Appendix Z on emergency preparedness, while the appendix for swing beds was deleted and folded into requirements for hospitals and CAHs.

The opening sections of the manual can be found online here.

The appendices can be found here.

A.J. Plunkett is editor of the Simplify Compliance newsletter Inside Accreditation & Quality.