Susan A. Turner

Medication Chart Orders and the DEA: Long–Term Care Facility Residents Caught in the Middle

In 2009, several field offices of the Drug Enforcement Agency (DEA) began enforcement actions against a number of pharmacies serving long-term care facilities (LTCFs) in Ohio, Michigan, Wisconsin, and Virginia, alleging that the practice of using ‘‘chart orders’’—LTCF nurses calling or faxing prescriptions for Class II–V drugs to the pharmacies—violated certain DEA regulations. Long-term care pharmacies in these states have already been targeted by the DEA for inspection, and many now face huge fines. For example, 1 independent pharmacy was cited with more than 3,000 violations and faces fines of more than

Arbitration Clauses in Nursing Facility Contracts: Down, But Not Necessarily Out

32 million. Other pharmacies have changed their policies to reflect DEA regulations, resulting in significant delays in the delivery of pain medication to nursing facility residents. The DEA’s interpretation of the law prohibits pharmacies from dispensing Class II through Class V medications to LTCFs and their residents, where the prescription/medication order was obtained from the nursing facility by facsimile and where the pharmacy has not received the prescription by the prescriber (physician) with all the required elements. The critical ‘‘missing’’ element in the case of chart orders sent to the pharmacy via fax is usually the physician’s original signature. Although a pharmacy is permitted to fill a medication order transmitted via fax, the regulation requires the fax to be transmitted either by the prescribing physician or the

Battle of the experts: Providers – 1, Government – 0!

On June 1, 2009, the U.S. Supreme Court put an end to a long-standing dispute between a nursing facility in Illinois and a resident over whether the mandatory arbitration clause in the resident’s admission contract was enforceable under state and federal law. The Supreme Court refused to review a decision by the Illinois Court of Appeals that invalidated an arbitration clause used by an Illinois nursing home. The Supreme Court’s action makes it more difficult for nursing homes to enforce arbitration agreements in states with laws that expressly prohibit arbitration clauses in these settings. However, this action by the nation’s highest court should not necessarily be interpreted as a death knell to these contract clauses across the country. The facts and circumstances of the Illinois nursing home case made victory for the nursing facility very difficult. At all times during the resident’s admission to the nursing facility, Illinois had a law on its books that specifically made a nursing home resident’s waiver of the right to a trial by a jury—whether entered into voluntarily or not—‘‘null and void, and without legal force or effect.’’ Despite this law, the nursing facility admission contract included a mandatory binding arbitration clause. Following a resident’s death, family members filed a malpractice lawsuit against the nursing facility in state court. The nursing facility filed a motion to compel arbitration under the admission contract and under the Federal Arbitration Act. The trial court ruled against the nursing facility and in favor of the resident, finding that the arbitration clause was void and violated Illinois state public policy designed to protect nursing facility residents. Further, the trial court rejected the nursing facility’s arguments that the Illinois state law prohibiting nursing home arbitration

CMS overhauls nursing facility regulations

The court made clear that the opinion of one government medical expert alone cannot prove that a claim is false. Significantly, the court explained that the government’s case “boils down to conflicting views of physicians about whether the medical records support [the hospice provider’s] certifications that the patients at issue were eligible for hospice care.” The court held that to win a case against a health care provider under the False Claims Act, DOJ (or a private whistleblower) must “direct the court to admissible, objective evidence . other than [a medical expert’s] testimony, that would prove falsity and show that the Government presented more evidence than merely a difference of opinion to which reasonable minds could differ.” The court admonished DOJ’s past litigation tactics, saying “If the court were to find that all the Government needed to prove falsity in hospice provider cases was one medical expert who reviewed the medical records and disagreed with the certifying physician, hospice providers would be subject to potential FCA liability any time the Government could find a medical expert who disagreed with the certifying physician’s clinical judgment. The court refuses to go down that road.” Providers should be relieved by this recent federal court ruling on a pivotal component of the False Claims Act e the falsity of the claim. However, providers should also be forewarned e in order to effectively combat allegations of inadequate documentation to support their claims, providers need to ensure that medical records clearly demonstrate all the elements of eligibility and entitlement to the payment requested on their claims.

Medical director and other physician compensation arrangements under scrutiny

On October 4, 2016, the Centers for Medicare & Medicaid Services (CMS) will issue a regulation that makes major changes intended, in the words of CMS, “to improve the care and safety of the nearly 1.5 million residents in the more than 15,000 long-term care facilities that participate in the Medicare and Medicaid programs.” CMS explained that “the policies in this final rule are targeted at reducing unnecessary hospital readmissions and infections, improving the quality of care, and strengthening safety measures for residents in these facilities. These changes are an integral part of CMS’s commitment to transform our health system to deliver better quality care and spend our health care dollars in a smarter way, setting high standards for quality and safety in longterm care facilities.” This is the first comprehensive update of the Medicare and Medicaid requirements of participation for skilled nursing facilities (SNFs) in 25 years. Indeed, the final rule comprises over 700 pages of changes to the existing regulation. Many of the changes are simply organizational, eliminating duplicative or unnecessary provisions, or reorganizing the regulations as CMS deemed appropriate. However, there are many substantive changes to the regulations as well. In the words of CMS, some of the changes to the existing regulation finalized in this rule include:

Update on independent informal dispute resolution process

On June 9, 2015, the Office of Inspector General (OIG) of the Department of Health and Human Services issued a new Fraud Alert, focusing on the possible anti-kickback implications of certain compensation arrangements between physicians and health care providers, such as long term care facilities and hospitals. By way of brief background, federal law prohibits the offering, solicitation, payment or receipt of any remuneration in order to induce the referral of a patient whose care is payable under Medicare, Medicaid or other federal health insurance programs. This prohibition is known as the Anti-Kickback Statute, and violations of this law are subject to sanctions, such as hefty money penalties or possible criminal penalties. The Anti-Kickback Statute has been interpreted very broadly by the OIG and by federal and state courts. Because the language of the law is so broad, the OIG has issued a number of regulations known as “safe harbors” e carefully described situations where providers can conduct their business without running afoul of the broad reaches of the law. One such safe harbor is known as the “personal services exception” to the Anti-Kickback Statute. So long as a provider crafts its contracts to comply with the guidance in the safe harbor regulations, the personal services safe harbor permits a provider, such as a nursing home, to lawfully make payments to a medical director. The personal services safe harbor protects payments between providers, such as long term care facilities, and physicians who could or do refer patients to the provider, so long as, among other things, (1) the payment negotiated between the physician and the facility represents “fair market value” for the services

CMS broadens concept of hospital "medical staff" to provide greater opportunities for nurses and other nonphysician practitioners.

In the July 2011 issue of this Journal, we advised you about a number of changes made by one section of the Patient Protection and Affordable Care Act (the ACA)whichwas passed by Congress on March 23, 2010. Our column last year discussed a final regulation, published by the Centers for Medicare & Medicaid Services (CMS) on March 18, 2011, which amended the Social Security Act (the Act) by adding specific provisions related to the imposition and collection of civil money penalties (CMPs) when nursing facilities are found, following a survey, to be out of compliance with Medicare and Medicaid participation requirements. Those changes were effective as of January 1, 2012. One of the changes to the nursing facility enforcement process was the creation of a new independent informal dispute resolution (IIDR) process to be completed within 60 days of the imposition of a civil money penalty, so long as the IIDR is timely requested by the facility. Clearly, the IIDR process is new and many states have yet to receive requests from nursing facilities to conduct a review of survey deficiencies using this new option. This author recently worked with a nursing facility that decided to dispute survey findings using the IIDR process, and we are providing an overview of our experience with the process in this column, as well as take away points learned from the experience. A nursing facility underwent its annual recertification survey. At the conclusion of the inspection, the survey team advised the administrator that there were a few instances of noncompliance, but nothing was identified as being of any concern to the survey team. About a week after the exit conference, the survey team leader called the administrator to advise her that the survey agency supervisor had reviewed the inspection notes and determined that

New Regulation Modifies Civil Money Penalties Process for Nursing Facilities

On May 18, 2012, the Centers for Medicare and Medicaid Services (CMS) issued a final regulation intended to “reduce outmoded and unnecessarily burdensome rules, and thereby increase the ability of hospitals to devote resources to providing high quality patient care.” These new regulations made numerous changes to the previous conditions of participation for hospitals, a number of which stand to significantly increase the role of nurses and other nonphysician practitioners providing patient care in the hospital setting. A brief discussion of some of these changes follows.

Legislative/Legal Update—What's New in Washington for Geriatric Nursing Care

One section of the Patient Protection and Affordable Care Act (the ACA) that was passed by the U.S. Congress on March 23, 2010, amended the Social Security Act (the Act) by adding specific provisions related to the imposition and collection of civil money penalties (CMPs) when nursing facilities are found, following a survey, to be out of compliance with Medicare and Medicaid participation requirements. The Centers for Medicare and Medicaid Services (CMS) published a final rule implementing the new CMP provisions on March 18, 2011. CMS explained in the final rule that the agency interpreted the provisions of this section of the new health reform law as an expression of Congress’s intent that CMS improve the efficiency and effectiveness of the nursing home enforcement process, particularly as it relates to CMPs imposed by CMS as a remedy for regulatory noncompliance. Towards that goal, the final rule makes a number of changes to the rights of providers when a CMP is imposed by CMS, to the process by which CMPs may be challenged as well as collected, and to the uses to which CMS and the states may put collected CMPs. These changes will be effective as of January 1, 2012.

Update on blood glucose monitoring in long-term care facilities.

Ask anyone what the most important issue on their minds is these days, and you will get 1 of 2 answers—the economy or health care. So, it is no surprise that legislators and regulators in Washington, D.C., have been intensely focused over the past 9 months to a year on drafting new laws, proposing new policies, and enforcing old laws and policies—all with the goal of increasing patient access to quality health care, while decreasing the ‘‘out-of-pocket’’ expenditures for that care from patients and from the federal government. Since September 2009, the House of Representatives has authored a health care reform bill, and the Senate has just recently come out with its version of a bill. In addition to the 2 draft pieces of health care reform legislation, the Centers for Medicare and Medicaid Services (CMS) has recently published a regulation that sets out the payment rates for physicians and nonphysician practitioners (such as nurse practitioners) for 2010, and the Office of Inspector General (OIG) has published its 2010 Work Plan, a document that provides a road map to that body’s issues and concerns in the health care field. The following is a summary of the provisions of these recent legislative and legal issuances, recognizing that the House and Senate health care reform bills are still in draft and likely subject to significant modifications before they are presented to the President for his signature and enactment into law.