On August 16, 2012, the U.S. Court of Appeals for the Fifth Circuit dismissed an appeal challenging the Patient Protection and Affordable Care Act’s (PPACA’s) restriction on expansion by physician-owned hospitals.  The lawsuit was initially filed in the Eastern District of Texas by the physician-owned hospital trade group (Physicians Hospitals of America) and a physician-owned

A client recently asked me to review its fall policies and procedures as they relate to the standard of care.   Because that project was on my mind, the new training modules for nurse aides in long term care that were recently published by the Agency for Healthcare Research and Quality (AHRQ) caught my eye.  The three published modules are:

  1. Module 1: Detecting Change in a Resident’s Condition
  2. Module 2: Communicating Change in a Resident’s Condition; and
  3. Module 3: Falls Prevention and Management

Each module has an instructor’s guide and a student workbook that includes training materials, summaries and “Pearls and Pitfalls” to help staff become more aware of residents’ needs.   For example, the module on falls includes a mnemonic checklist “HEAR ME” to help prevent falls in the facility:

  • Hazards in the environment.
  • Educate residents.
  • Anticipate residents’ needs.
  • Round frequently.
  • Materials and equipment.
  • Exercises and ambulation.

Module 1 notes that the elderly do not exhibit the same signs and symptoms of illness that are seen in younger persons.  Therefore, identification of subtle changes can alert staff to a serious illness.  The AHRQ notes the top 12 changes in residents are:

A.  Physical Changes: Walking; Urination and bowel patterns; Skin; Level of weakness; Falls; and Vital signs.

B.   Non- Physical Signs: Demeanor, Appetite, Sleeping, Speech, Confusion or agitation, complaints of pain.

Our Insight. Your Advantage.   Much of the material will not be new to many providers.  However, use of the training modules developed, and following the steps advocated, by the AHRQ will provide strong evidence that the provider’s care was within the standard of care.   Long term care facilities that incorporate the AHRQ’s training standards into their care will be ahead of the game in number of areas such as:

  1. Regulatory compliance;
  2. Limiting exposure to civil malpractice;
  3. Reimbursement matters.

With the passage of the ACA, the voluntary nature of compliance programs is about to change. Smaller healthcare organizations and other ancillary providers who have previously not established compliance programs will now be required to adopt formal programs.  The ACA mandates providers and suppliers participating in federal health care programs to implement compliance programs with “core elements” as a condition of enrollment.

The HHS Secretary is responsible for setting a timeline to implement the new “core elements” for each health care sector and then setting a timeline for providers to adopt compliance programs.  Details regarding the extent of the program have not yet been described or published.  Skilled nursing facilities are the first providers required to implement an effective compliance program by March 23, 2013.

Our Insight.  Your Advantage.  By doing the work now, healthcare organizations can get ahead and avoid surprises when HHS eventually publishes the mandatory compliance program rules for other healthcare sectors. Many in the healthcare industry anticipate the OIG’s voluntary compliance program guidance will serve as an example to HHS as it determines which compliance program elements shall be required.  As you prepare your compliance programs, 

The Missouri Supreme Court has ended the debate over the constitutionality of statutory caps on non-economic damages in common law causes of action, including medical malpractice claims for personal injury. In a 4-3 decision returned on July 31, 2012, the court in Watts v. Lester E. Cox Medical Centers found that the right to a

The Department of Health and Human Services Office for Civil Rights (OCR) recently released the protocol it developed as a guideline for conducting the HIPAA privacy, security and breach notification audits mandated by the Health Information Technology for Economic and Clinical Health (HITECH) Act enacted in 2009. The OCR launched the audit program in 2011 and developed the protocol based on the first 20 audits completed under the program. Three of the initial audits were performed on group health plans, highlighting that employer-sponsored group health plans are subject to the Health Insurance Portability and Accountability Act (HIPAA) as covered entities and are subject to audit under the protocol. The audit program represents a significant shift in HIPAA enforcement from the largely reactive, complaint-based enforcement of the past to proactive compliance monitoring.

The pilot phase of the audit program began in November 2011 and is expected to include audits of 115 covered entities by December 2012. HITECH extended HIPAA compliance requirements to business associates and, therefore, business associates are expected to be included in the audit program following publication of the final HITECH regulations. The OCR indicated that funds have already been appropriated to carry out the audit program in 2013 and 2014.

In a 2-1 decision in Sodexo America LLC, the National Labor Relations Board (NLRB) held recently that the University of Southern California hospital violated Section 8(a)(1) of the National Labor Relations Act by maintaining and enforcing a rule that limited off-duty employee access to the workplace, except for specific purposes.

The policy at issue provided that:

  1. Off-duty employees are not allowed to enter or re-enter the interior of the hospital or any other work area outside the hospital except to visit a patient, receive medical treatment or to conduct hospital-related business.
  2. An off-duty employee is defined as an employee who has completed his/her assigned shift.
  3. Hospital-related business is defined as the pursuit of the employee’s normal duties or duties as specifically directed by management.
  4. Any employee who violates this policy will be subject to disciplinary action.

HHS and DOJ today announced that Federal law enforcement is teaming up with private insurance organizations in the fight against health care fraud.  While the details of how this partnership will work are unclear, the press releases issued by both DOJ and HHS indicate that the private and public sectors will share information with each other

On June 25, 2012, the U.S. Supreme Court granted the Federal Trade Commission’s request for certiorari review in FTC v. Phoebe Putney Health System, Inc., a hospital merger case on appeal from the U.S. Eleventh Circuit Court of Appeals and the U.S. District Court for the Middle District of Georgia.

At issue in the case is the FTC’s challenge to a hospital merger that would give the acquiring health system 100% market share in its county and more than 90% market share of the multi-county region in rural southern Georgia.  Applying the state action doctrine, both the trial court and the Eleventh Circuit held that the merger of two private hospitals, Phoebe Putney Memorial Hospital and Palmyra Park Hospital, was immune from antitrust laws even though all parties agreed that the merger created a monopoly.  State action immunity applies when a policy that displaces competition is “clearly articulated” and “actively supervised” by the state.  The doctrine can extend to private actors when they act pursuant to a clearly articulated state policy to displace competition, and they are actively supervised by the state.  Clear articulation is found when a restraint of trade is a “foreseeable” consequence of the action taken by the state.   

In the wake of the U.S. Supreme Court’s June 28, 2012, decision upholding the constitutionality of the 2010 Patient Protection and Affordable Care Act, employers who had been awaiting the decision should now focus on compliance. We expect additional guidance will be released to implement several pending provisions, including those related to the 2014 employer

On June 18, 2012, the Office of Inspector General for the Department of Health and Human Services (OIG) published a notice in the Federal Register seeking comments and recommendations on how best to revise its self-disclosure protocol to make it more useful in today’s health care regulatory environment. This should come as welcome news to the healthcare provider community because OIG’s protocol was first established in 1998, when the healthcare fraud enforcement landscape was much different. Specifically, the government’s investigation and pursuit of health care fraud has substantially increased over the last 14 years. 1998’s total recoveries from health care fraud of under $500 million compared to last year’s total recoveries of $4.1 billion are good evidence of that change.

The Federal Register notice mentions that since 1998, OIG has resolved over 800 disclosures and recovered over $280 million to the Federal health care programs. These high numbers are likely due in large part to the benefits health care providers and practitioners derive from self-disclosing, namely a lower multiplier on damages (approximately 1.5) and no requirement for a Corporate Integrity Agreement (CIA) in exchange for OIG’s highly sought after exclusion release. For cases settled after an affirmative investigation by the government – rather than a voluntary disclosure – healthcare providers should expect OIG, usually in conjunction with the Department of Justice (DOJ), to demand at least a 2.0 multiplier on the single damages (overpayment) amount. As an example, if the government determines that you received $500,000 in reimbursement that you were not entitled to, OIG would likely settle the self-disclosed matter for a 1.5 multiplier, or $750,000.  However, if the settlement is pursuant to an affirmative investigation and not a voluntary disclosure, OIG and DOJ would likely demand at least “double damages,” or $1 million.