Health Law Blog - Healthcare Legal Issues

Archive for July, 2015

Major Revamp of Nursing Home Regulations Proposed By CMS

Friday, July 17th, 2015

Nursing Home Regulations Proposed Revision CMSThe Centers for Medicare & Medicaid Services (CMS) has release new proposed regulations that would implement the first major rewrite of the long-term care Conditions of Participation in over 25 years. The proposed regulations were published on On July 13, 2015 in proposed form and are subject to a 60 day comment period before CMS issues them in final form. It is possible that CMS would revise the proposed rules based on input from the public duringthe comment period.

By changing nursing home regulations, CMS intends to improve the quality of care and safety affecting long-term care residents. The proposed changes would implement a number of safeguards including some protections that were required under the Affordable Care Act.

Providers involved in the nursing home industry should study the proposed regulations and may wish to provide comments to CMS to be addressed prior to finalization of the proposed regulations. Some of the items addressed in the proposed regulations include:

– Regulations regarding reduction of unnecessary hospital readmissions and infections

-increased quality of resident care

– New requirements to assure training of nursing home staff

– increased focus on patients with dementia and prevention of elder abuse.

– New rules regarding staffing decisions.

– Rules that help assure that staff members have the right skill sets and competencies to provide person-centered care to residents.

– Increased emphasis on resident preferences when developing care plans.

– Improvements to the process of care planning and discharge planning

– Increased authority of dietitians and therapy providers to write orders in their areas of expertise subject to physician delegatino and state law compliance.

– Requiring greater food choice for residents.

– Updating of infection prevention and control programs and establishment of new requirements for infection prevention and control.

– Enhancement of nursing home resident rights

More details can be obtained by reviewing the proposed regulations. We will be issuing additional updates regarding topics that are covered in the proposed regulations as we review the proposal in greated depth.

Medicare Shared Savings Program Changes Under 2016 Physician Fee Schedule Regulations

Friday, July 17th, 2015

Physician Fee Schedule Regulations Propose Changes to the Medicare Shared Savings Program

physician fee schedule mssp changesThe 2016 Physician Fee Schedule proposed rule that was published on July 8, 2015 includes proposals specific to certain sections of the Shared Savings Program regulations and solicits feedback from stakeholders. Following are a few of the proposed revisions to the Shared Savings Program that were contained in the PFS Regulations.

 

  • Proposed addition of a measure of Statin Therapy for the Prevention and Treatment of Cardiovascular Disease in the Preventive Health domain of the Shared Savings Program quality measure set to align with PQRS;
  •  Preservation of flexibility to maintain or revert measures to pay for reporting if a measure owner determines the measure no longer aligns with updated clinical practice or causes patient harm;
  • Clarification of how PQRS-eligible professionals participating within an ACO meet their PQRS reporting requirements when their ACO satisfactorily reports quality measures; and
  • Proposed amendment to the definition of primary care services to include claims submitted by Electing Teaching Amendment hospitals and exclude claims submitted by Skilled Nursing Facilities.

HCQIA and Clinically Integrated Provider Networks

Tuesday, July 7th, 2015

Health Care Quality Improvement Act and Clinically Integrated Provider Networks 

Clinical Integration HCQIAClinically integrated networks present unique credentialing issues that are normally not present in hospital or facility credentialing.  These unique issues stem from the very nature of integrated networks which require providers to comply with evidence-based protocols, individualized care plans, quality metrics, efficiency standards, and other system standards.

In order to assure compliance with these standards, integrated networks need to assert much more control over the clinical practices of its provider members than has historically been exercised in the hospital setting.  Credentialing and recredentialing processes need to be put in place to assure that providers practice in conformance with evidence-based practice protocols, coordinate care with other network providers, and otherwise work well within the system.

Integrated networks face a number of choices when determining how to structure their credentialing and recredentialing processes.  A threshold decision is whether the credentialing process should be structured to take advantage of the immunities that are available under the Health Care Quality Improvement Act (“HCQIA”).

Qualifying under the HCQIA has some benefits but also carries some burdens.  In order to qualify for HCQIA immunities, the organization must implement a formal credentialing, hearing, and appeal process in order to qualify for immunities.

A CIN must also register with the HRSA and is required to make reports to the Practitioner Databank if adverse peer review determinations are made.  The CIN receives a Data Bank Identification Number and can be penalized for not reporting adverse determinations.  The reporting requirement is an issue that provider networks may wish to avoid.  The obligation to report has the practical effect of making peer review actions much more controversial and prone to litigation because a database report is a serious negative mark on a physician’s record.

On the other hand, the immunities offered by the HCQIA can be extremely valuable to a clinically integrated network.  One of the immunities that is available under the HCQIA is from the treble damage provisions under federal antitrust laws.  This immunity cannot be discounted; particularly with provider networks that make more aggressive credentialing decisions based on achievement of quality and cost issues and infirmity with system protocols.

If a choice is made to secure the HCQIA immunities, a comprehensive credentialing, peer review and fair hearing process is required as is use of the Practitioner Databank.  Furthermore, in order to qualify, adverse actions only be taken in furtherance of quality healthcare, after a reasonable effort to develop the facts, with adequate notice and hearing to the affected practitioner.  The Act and interpreting case law have created rather detailed requirements for notice and hearing.  The end result is that extensive procedural processes must be in place and consistently followed by the organization.  This of course adds another layer of complexity and cost to the organization.  At the same time, it greatly decreases the organization’s potential liability exposure which under certain circumstances could greatly exceed the cost of complying with HCQIA requirements.

John H. Fisher

Health Care Counsel
Ruder Ware, L.L.S.C.
500 First Street, Suite 8000
P.O. Box 8050
Wausau, WI 54402-8050

Tel 715.845.4336
Fax 715.845.2718

Ruder Ware is a member of Meritas Law Firms Worldwide

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