Nursing Facilities Are The First to Require Compliance Programs

The Patient Protection and Affordable Care Act of 2010 (PPACA) mandates compliance programs for most providers and requires the Secretary of Health and Human Services to publish regulations that establish the core elements for compliance programs.

Nursing facilities are the first providers to be mandated and must comply in 2013. However, CMS missed its statutory deadline of March 23, 2012 for issuing detailed regulations for nursing facility compliance programs. It is expected that these regulations and the requirements for other providers will be forthcoming now that the Supreme Court has opened the way for enforcement.  In the meantime, nursing facilities do not have precise guidance on compliance program requirements. 

Even though final detailed regulations have not been issued, providers should not wait to step up their compliance efforts.  There are many sources for guidance on how compliance should operate.  Providers will be required to certify that their compliance programs are effective in preventing and detecting criminal, civil, and administrative violations and in promoting quality of care.  Simply having a program in place is not enough.  The program must have sufficient operating history to demonstrate that it is “effective.”  Effectiveness reviews should be periodically performed to support the required certifications.

CMS Regulations Would Eliminate Need For Staff Radiologist In ASC

Just a few days ago, CMS released a proposed regulation that contains a number of regulatory items that is considers to be unnecessary and overly burdensome on providers and in need of elimination.  One item that was proposed is the elimination of the requirement that Ambulatory Surgery Centers maintain a radiologist on staff.  This requirement makes little sense to most Ambulatory Surgery Centers because radiologic services are normally limited to services that are provided contemporaneous with a surgical service.  In these cases, the surgeon must be qualified to perform the procedure, including the use of the radiology component.

In most cases, having a Radiologist on staff at an Ambulatory Surgery Center is not necessary and in fact creates credentialing and other costs.  Arrangements with Radiologists also raise potential liability concerns for the Radiologist who has responsibility to review material that was not intended as part of a diagnosis but was rather only part of a procedure.  Many radiologists have become concerned about potential “line of site” issues that could be present and which they could be liable for by being responsible for oversight of radiology services at the Ambulatory Surgery Center.

Under the proposed regulations, ASCs would be limited to providing radiologic services that are integral to the procedures being performed at in the facility.  Surgeons would need to demonstrate competency in using radiology in the performance of the surgical procedure.  A general member of the Medical Staff could be put in charge of radiology oversight, thus reducing the expense involved with credentialing and compensating a radiologist to be on staff at the ASC.

This change was just proposed a few days ago as part of a series of rule changes aimed at cutting unnecessary regulatory burdens on providers.  There is currently no reason to believe that the change will not eventually be adopted in a final regulation.  Until final adoption of the regulation, Ambulatory Surgery Centers must continue to comply with current conditions of participation which include the necessity of having a radiologist on staff.

You can find the regulations at the following Link.  CMS ASC Radiology Rule

On November 29, 2012, the Wisconsin Division of Quality Assurance published a new memorandum (DQA Memo 12-018) that provides information to health care providers regarding Wisconsin Act 160.  Act 160 created new licensing requirements for anesthesiology assistants.  Act 160 (the “AA Licensure Act”) was signed into law by Governor Walker in March and went into effect on November 1, 2012.
The AA Licensure Act added a new category of licensed health care providers in the state known as “anesthesiologist assistants” and created an infrastructure to create requirements to promote the safe and competent practice of individuals who attain this new licensure status.

The passage of the AA Licensure Act is but the latest development in the legal dynamics between Anesthesiologists and Certified Registered Nurse Anesthetists that began when Wisconsin opted to permit CRNAs to independently bill for their services which was affirmed in 2007.  The AA Licensure Act creates a separate class of licensed professional that can only operate under supervision from a physician anesthesiologist.

For a full summary of the AA Licensure Act and the recently released DQA Memo, visit our web site.

Council On Anesthesiologist Assistants

The AA Licensure Act created a new council on anesthesiologist assistants within the Department of Safety And Professional Services by adding section 15.407(7) to the Wisconsin Statutes.  The council is created to make recommendations to the medical examining board regarding the scope of practice of anesthesiologist assistants.  The membership of the counsel is to be selected from a list of recommended appointees to be submitted by the president of the Wisconsin Society of Anesthesiologists after considering the recommendations of the Wisconsin Academy of Anesthesiologist Assistants.

The members of the council are subject to final approval by the medical examining board and hold three-year terms.  Members on the council must include a member from the medical examining board, a licensed anesthesiologist assistant, and two physician anesthesiologists.

Practice Locations and Temporary Licensure

Licensed anesthesiologist assistants may practice in Wisconsin hospitals, critical access hospitals and ambulatory surgical center in the state of Wisconsin.  Section 448.04(1)(g) that was created by the new law permits a temporary license to be issued to individuals who meet certain requirements and who are eligible for but have not yet passed the certification examination to become and anesthesiologist assistant.  The temporary license may only be issued for up to 18 months.

Supervision and Supervision Agreement

An anesthesiologist assistant is only permitted by the scope of licensure to assist an anesthesiologist and must practice under the supervision of an anesthesiologist.  The statute specifies details that must be maintained by the supervising anesthesiologist in order to meet the definition of “supervision.”  The supervising anesthesiologist must at all times be immediately available in the same location or facility and must be able to intervene in the procedure if required.  Supervision requirements should be reviewed in detail and incorporated into specific protocols that are applicable to the provision of anesthesia services in a facility.

Employment Requirement

The statute requires an anesthesiologist assistant to be employed by a hospital, ambulatory surgery center or an affiliate of a hospital.  Anesthesiologist assistants can only practice under a  supervision agreement with a physician anesthesiologist who represents the employer of the anesthesiologists assistant.  The statutes defined specific provisions that must be included within the supervision agreement between the anesthesiologist and the anesthesiologists assistant.

Limited Permitted Activities

The statute defined a limited scope of practice for an anesthesiologist assistant who is only authorized to perform the following types of tasks:

(a) Developing and implementing an anesthesia care plan for a patient;
(b) Obtaining a comprehensive patient history and performing relevant elements of a physical exam;
(c) Pretesting and calibrating anesthesia delivery systems and obtaining and interpreting information from the systems and from monitors;
(d) Implementing medically accepted monitoring techniques;
(e) stablishing basic and advanced airway interventions, including intubation of the trachea and performing ventilatory support;
(f) Administering intermittent vasoactive drugs and starting and adjusting vasoactive infusions;
(g) Administering anesthetic drugs, adjuvant drugs, and accessory drugs;
(h) Implementing spinal, epidural, and regional anesthetic procedures;
(i) Administering blood, blood products, and supportive fluids;
(j) Assisting a cardiopulmonary resuscitation team in response to a life threatening situation; and
(k) Participating in administrative, research, and clinical teaching activities specified in the supervision agreement.

The new category of provider will require hspitals and other facilities to take a look at their credentialing policies, anesthesia policies, procedures and protocols, and their compliance program risk areas.  The new supervision requirements need to be closely examined and integrated into procedure.  Credentialing implications of the temporary and permanent licensure categories should also be considered.  Facilities should also look at their applicable conditions of participation and/or accreditations agency policies to determine whether any issues are raised.

Reimbursement Issues

Medicare generally permits reimbursement to be received for the services of appropriately supervised anesthesia assistants.  However, the supervision requirementsfor anesthesiologist assistants is generally more stringent than for Certified Registered Nurse Anesthetists who, depending on state law, may be permitted to independently bill for their services without supervision.

A good place to start on reimbursement issues is the Medicare MLN Matters Article found at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/Medicare_Information_for_APNs_and_PAs_Booklet_ICN901623.pdf

You can access the DQA Memo at the following link: DQA Memo 12-018 – http://www.dhs.wisconsin.gov/rl_DSL/Publications/12-018.htm

You can directly access Act 160 that created the new category of provider at the following link: Wisconsin Act 160 –  https://docs.legis.wisconsin.gov/2011/related/acts/160.pdf

For more information on the requirements of the new anesthesiologist assistant law and its implications, please feel free to contact John H. Fisher, CHC, CCEP, a health care law and compliance attorney in our law firm.