Overview
The Centers for Medicare and Medicaid Services (“CMS”) has finalized another rule (“Final Rule”) implementing the President’s Executive Order 13563 calling for the removal or revision of obsolete, duplicative or unnecessary regulatory provisions for the purpose of reducing burdens and costs for a variety of providers and suppliers. The Final Rule was published in the Federal Register on May 16, 2012 and can be found here. It is effective on July 16, 2012. Highlights of the Final Rule are summarized below.
Only Certain ESRD Facilities Obligated to Comply with Life Safety Code Provisions
CMS revised the end stage renal disease (“ESRD”) conditions for coverage (“CfC”) and removed the requirement that all ESRD facilities comply with the NFPA 101 Life Safety Code (“LSC”) regulations. The LSC regulations currently require all ESRD facilities to install smoke compartments, occupancy and hazardous area separations and upgraded fire alarms – all costly renovations with very limited benefit in low fire risk locations. On the effective date of the Final Rule, only ESRD facilities located adjacent to “high hazard occupancies” (locations where flammable or combustible materials are used and stored) and those whose patient treatment areas are not located at grade level with direct access to the outside, will be required to comply with the LSC regulations. CMS also clarified that the requirement for sprinklers in ESRD facilities located in multi-story buildings only applies to buildings constructed after January 1, 2008.
Mandatory List of ASC Emergency Equipment Eliminated
The CfCs for ambulatory surgical centers (“ASCs”) currently require all ASCs to have available in the operating room a prescribed list of emergency equipment. CMS removed the standard mandatory list believing that some of the equipment requirements are outmoded and that not all equipment specified on the list is necessary for the particular emergency needs of every ASC. The revised CfC requires the ASC medical staff and governing body to specify in policies and procedures the types of emergency equipment needed for use in the ASC’s operating room. The equipment must be “immediately available” for use during an emergency, be appropriate for the ASC’s patient population and be maintained by appropriate personnel.
“Re-enrollment Bar” Removed in Certain Circumstances/New Deactivation Option
In the current Conditions for Medicare Payment, CMS provides that if any provider or supplier has its billing privileges revoked, it is barred from participating in the Medicare program from the effective date of the revocation through the end of the re-enrollment bar, which may be 1-3 years depending on the seriousness of the basis for revocation. Because the re-enrollment bar is a severe consequence in certain cases and also may result in compromised access to care, CMS has eliminated the re-enrollment bar in situations where providers/suppliers have not responded timely to CMS requests for revalidation of enrollment or other requests for information. This frequently occurs due to such mishaps as misrouted mail or clerical errors.
Related to this, CMS has added a new Condition for Payment that will allow it to deactivate, versus revoke, billing privileges if the provider/supplier fails to furnish complete and accurate information and supporting documentation within 90 days of receiving notice to submit an enrollment application or resubmit and certify accuracy of enrollment information. The deactivation action is less severe than a revocation action; thus, CMS believes the new provision will reduce the burden on providers/suppliers.
CMS Opts Not to Finalize Physician/Non-Physician Practitioner Deactivation Bar
Under a current Medicare condition for payment, CMS may deactivate the Medicare billing privileges of a provider or supplier that does not submit any Medicare claims for 12 consecutive calendar months. This deactivation authority is discretionary. In an October 24, 2011 proposed rule, CMS proposed to revise this condition for payment so that Medicare billing privileges could not be deactivated for physicians and non-physician practitioners failing to bill for 12 consecutive months. The purpose of the proposed rule was to decrease the burden on physicians and non-physician practitioners who may treat mostly non-Medicare patients or who may have multiple separately-enumerated practice locations and mainly provide services at one of them. After consideration of multiple comments, CMS opted not to finalize the proposed rule at this time. Failure to bill Medicare raises questions as to whether the provider is compliant and still operating. Further, an idle provider number potentially can lead to fraudulent billing activity/program integrity risks. CMS intends to study this issue further and may consider other approaches, including future rulemaking to address the concerns of providers/suppliers regarding deactivation for failure to bill for 12 consecutive months.
ICF/IID Provider Agreements under Medicaid to Be Open-ended
Current regulations limit Intermediate Care Facilities for Individuals with Intellectual Disabilities (“ICF/IID”) (formerly known as Intermediate Care Facilities for the Mentally Retarded or ICF-MR) Medicaid provider agreements to 12 months. CMS has removed time limited agreements for ICFs/IIDs, and these agreements will remain in effect until the Secretary of HHS or a state determines the ICF/IID no longer complies with the relevant conditions of participation. Further, CMS added a new requirement that the ICF/IID must be surveyed, on average, every 12 months with a maximum survey interval of 15 months.
Miscellaneous Revisions
- CMS has removed outdated regulations at 42 C.F.R. part 405 subparts G and H related to initial determinations, appeals and reopenings of Claims under Medicare Part A and B. These provisions, effectively, were superseded by Social Security Act (the “Act”) revisions, and implementing regulations put into effect under the Benefits Improvement and Protection Act of 2000 (“BIPA”) and the Medicare Modernization Act of 2003. CMS believes all “pre-BIPA” claims, likely, have been processed, thus its decision to eliminate the pre-BIPA regulations described above. Currently, initial determinations, appeals and reopenings of Medicare Part A and B claims are governed by Section 1869 of the Act and 42 C.F.R. part 405, subpart I.
- CMS removed a duplicative, older infection control ASC CfC at 42 C.F.R. §416.44(a)(3) rendered obsolete by a more recent, more inclusive and separate ASC CfC infection control standard at 42 C.F.R. §416.51.
- CMS has removed outdated Medicaid regulation personnel qualifications for occupational and physical therapists and has cross-referenced personnel qualifications for these therapists to 42 C.F.R. §484.4 (Medicare home health services standards-recently updated).
- CMS has adopted updated e-prescribing standards-compliant versions of e-prescribing transactions for Medicare Part D.
- CMS has eliminated duplicative organ procurement organization regulations and updated definitions.
- Medicaid “recipients” have been renamed Medicaid “beneficiaries” consistent with Medicare terminology.
- The term “mental retardation” has been replaced by the term “intellectual disability” throughout the CMS regulations.
Practical Considerations
ESRD facilities located in low fire risk locations and with grade-level evacuation capability no longer will need to comply with the LSC on the effective date of this Final Rule. ASCs may discard unnecessary emergency equipment no longer required but will need to assess, obtain and make immediately available a customized list of equipment needed for that particular ASC’s patient population. The list will need to be incorporated in new written policies and procedures. CMS has eliminated the draconian “re-enrollment bar” for select circumstances but, interestingly, has declined, at this time, to eliminate its discretionary authority to deactivate a physician’s or non physician practitioner’s billing privileges for failure to submit claims for 12 consecutive months.
If you have any questions or would like additional information about this topic, please contact:
- Adele Merenstein at (317) 752-4427 or amerenst@hallrender.com;
- Clifford A. Beyler at (317) 977-1441 or cbeyler@hallrender.com; or
- Your regular Hall Render attorney.
