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Archive for March, 2013

Nursing Home Compliance Programs – ACA Statutory Mandate

Tuesday, March 26th, 2013

Mandatory Compliance Program Requirements – Affordable Care Act Statutory Mandate

Provisions of Affordable Care Act Relating to Mandatory Compliance Programs For Nursing Facilities

 

SEC. 6102. ACCOUNTABILITY REQUIREMENTS FOR SKILLED NURSING

FACILITIES AND NURSING FACILITIES.

Part A of title XI of the Social Security Act (42 U.S.C. 1301 et seq.), as amended by sections 6002 and 6004, is amended by inserting after section 1128H the following new section:

‘‘SEC. 1128I. ACCOUNTABILITY REQUIREMENTS FOR FACILITIES.

‘‘(a) DEFINITION OF FACILITY.—In this section, the term ‘facility’ means—

‘‘(1) a skilled nursing facility (as defined in section 1819(a)); or

‘‘(2) a nursing facility (as defined in section 1919(a)).

‘‘(b) EFFECTIVE COMPLIANCE AND ETHICS PROGRAMS.—

‘‘(1) REQUIREMENT.—On or after the date that is 36 months after the date of the enactment of this section, a facility shall, with respect to the entity that operates the facility (in this subparagraph referred to as the ‘operating organization’ or ‘organization’), have in operation a compliance and ethics program that is effective in preventing and detecting criminal, civil, and administrative violations under this Act and in promoting quality of care consistent with regulations developed under paragraph (2).

‘‘(2) DEVELOPMENT OF REGULATIONS.—

‘‘(A) IN GENERAL.—Not later than the date that is 2 years after such date of the enactment, the Secretary, working jointly with the Inspector General of the Department of Health and Human Services, shall promulgate regulations for an effective compliance and ethics program for operating organizations, which may include a model compliance program.

‘‘(B) DESIGN OF REGULATIONS.—Such regulations with respect to specific elements or formality of a program shall, in the case of an organization that operates 5 or more facilities, vary with the size of the organization, such that larger organizations should have a more formal program and include established written policies defining the standards and procedures to be followed by its employees. Such requirements may specifically apply to the corporate level management of multi unit nursing home chains.

‘‘(C) EVALUATION.—Not later than 3 years after the date of the promulgation of regulations under this paragraph, the Secretary shall complete an evaluation of the compliance and ethics programs required to be established under this subsection. Such evaluation shall determine if such programs led to changes in deficiency citations, changes in quality performance, or changes in other metrics of patient quality of care. The Secretary shall submit to Congress a report on such evaluation and shall include in such report such recommendations regarding changes in the requirements for such programs as the Secretary determines appropriate.

 

‘‘(3) REQUIREMENTS FOR COMPLIANCE AND ETHICS PROGRAMS.—

In this subsection, the term ‘compliance and ethics program’ means, with respect to a facility, a program of the operating organization that—‘‘(A) has been reasonably designed, implemented, and enforced so that it generally will be effective in preventing and detecting criminal, civil, and administrative violations under this Act and in promoting quality of care; and ‘‘(B) includes at least the required components specified

in paragraph (4).

‘‘(4) REQUIRED COMPONENTS OF PROGRAM.—The required components of a compliance and ethics program of an operating organization are the following:

‘‘(A) The organization must have established compliance standards and procedures to be followed by its employees and other agents that are reasonably capable of reducing the prospect of criminal, civil, and administrative violations under this Act.

‘‘(B) Specific individuals within high-level personnel of the organization must have been assigned overall responsibility to oversee compliance with such standards and procedures and have sufficient resources and authority to assure such compliance.

‘‘(C) The organization must have used due care not to delegate substantial discretionary authority to individuals whom the organization knew, or should have known through the exercise of due diligence, had a propensity to engage in criminal, civil, and administrative violations under this Act.

‘‘(D) The organization must have taken steps to communicate effectively its standards and procedures to all employees and other agents, such as by requiring participation in training programs or by disseminating publications that explain in a practical manner what is required.

‘‘(E) The organization must have taken reasonable steps to achieve compliance with its standards, such as by utilizing monitoring and auditing systems reasonably designed to detect criminal, civil, and administrative violations under this Act by its employees and other agents and by having in place and publicizing a reporting system whereby employees and other agents could report violations by others within the organization without fear of retribution.

‘‘(F) The standards must have been consistently enforced through appropriate disciplinary mechanisms, including, as appropriate, discipline of individuals responsible for the failure to detect an offense.

‘‘(G) After an offense has been detected, the organization must have taken all reasonable steps to respond appropriately to the offense and to prevent further similar offenses, including any necessary modification to its program to prevent and detect criminal, civil, and administrative violations under this Act.

‘‘(H) The organization must periodically undertake reassessment of its compliance program to identify changes necessary to reflect changes within the organization and its facilities.

ATA Issues Telemedicine Protocols for Mental Health Services

Tuesday, March 26th, 2013

ATA Proposed Telemedicine Protocols – Mental Health Video Services

telemedicine video mental healthThe American Telemedicine Association just issues a request for public comment on a draft policy that it released relative to video-based mental health services. The proposed ATA policies are intended to “detail best-practices for online mental health providers delivering video-based services through personal computers and mobile devices” according to the ATA release.

You can access the ATA proposed practice guidelines at: www.americantelemed.org/standards

You can comment to the proposed practice protocols at the following link:
www.americantelemed.org/comments

For more information regarding legal and regulatory issues affecting telemedicine and telehealth programs, contact John H. Fisher at the Ruder Ware Health Care Focus Group through the contact information on this page.

Nursing Facility Compliance Program Deadline Is Here!

Friday, March 22nd, 2013

Nursing Facilities Must Have Effective Compliance Programs In Place by March 23, 2013

Nursing Home Compliance ProgramsThe statutory deadline requiring nursing facilities to have formal compliance programs in place is upon us.  The Patient Protection and Affordable Care Act (PPACA) requires all nursing facilities and skilled nursing facilities to have formally adopted effective compliance and ethics programs by March 23, 2013.  To date, the Centers for Medicare & Medicaid Services (CMS) has not released final regulations regarding the required elements of nursing facility compliance programs.  However, the failure of CMS to issue final regulations should not deter nursing facilities from adopting compliance programs.  Even though regulations have not been released, the statutory mandate is in place.  Additionally, there is an abundance of guidelines that define what should be included in the compliance progam of a nursing facility. 

It is unclear how the failure of CMS to issue regulations will impact enforcement in this area.  The statute requires effective compliance programs to be in place by March 23, 2013 regardless of whether regulations are released.  Compliance programs are now a “condition of participation” that can be cited in survey reports.  Directions to survery agencies on this issue is not clear, but it is possible that citations could be issued in this area.  Additionally, if a nursing facility is contemplating a transaction, it is likely that the failure to have a compliance program in place by March 23, 2013 will arise in the course of due diligance.

Remember that it is not enough to simply have the appropriate compliance documents in place.  The compliance program must be demonstrated (and certified) to be “effective.”  Documents alone cannot make a compliance program “effective.”  Compliance program effectiveness requires a specific anlysis of both the content and operation of the compliance program.  Compliance programs that do not have a track record of effective operation cannot be considered to be “effective.”  Organizations need to consider what backup they plan to create to meet the certification requirements under PPACA.  Nursing facilities that do not have compliance programs in place need to address this deficiency immediately.  Those that have compliance programs in place need to assess the effectiveness of their programs.  In either event, experienced compliance counsel should be consulted to determine hat is required in order to meet the statutory mandate.

Ruder Ware offers a full range of compliance attorney services.  Health care attorney John Fisher is certified in Health Care Compliance and Corporate Compliance and Ethics and is one of a handful of attorneys in private practice in the country to hold this dual compliance certification.  You can contact Mr. Fisher through the Ruder Ware web site or through the “Contact” section of this blog.

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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