According to a newly unveiled White Paper from Informatics Corporation of America, you had better not.

Nashville, Tennessee-based provider of technology services to healthcare providers and health information exchanges, Informatics Corporation of America (ICA) has made available an informative white paper, “Health Care IT Investment Heightens Need For Effective Implementation: Introducing five key elements for successful roll-out of clinical information systems (CIS).”

Co-authored by John Tempesco, vice president of client services and marketing at ICA, and Larry T. Mercer, eCare training director for Sentara Information Technology, the paper is available for download at
http://www.icainformatics.com/news-and-events/white-papers. It is available at no charge but requires registration.
Tempesco explains that the paper outlines the critical steps for successful implementation of clinical information systems (CIS) in order to ensure the value of past, current, and future IT investments.

“Given the high cost of health care IT investments, it is devastating when the implementation process fails at some point in the process,” added Mercer. “This white paper draws on ICA and Sentara’s combined experience in successfully putting clinical information systems into practice, offering a road map that identifies the strategic components for achieving an optimal roll-out. As a result, health care systems can look forward to maximizing their investments while improving the quality of data and patient care across the board.”

The five elements featured in the white paper provide guidelines for avoiding clinician frustration, lack of adoption and — at the extreme — de-installation of these systems. The paper demonstrates how to enhance the implementation process by:

• Developing a comprehensive business plan
• Demanding executive commitment and leadership
• Setting realistic expectations
• Securing operational ownership of the project
• Piloting and nurturing the implementation

Sentara is a nationally awarded Integrated Delivery System in Southeastern Virginia with a fully integrated electronic medical record (EMR) across the continuum of care. The EMR includes multiple inpatient and ambulatory clinical and administrative IT applications, from scheduling to order entry.

http://www.icainformatics.com

www.Sentara.com

Though the RAC program itself is new and though no contractor has yet received permission from CMS to audit a home care agency, most providers accept the fact that the day will eventually arrive. When it does, CMS has declared, the appeals process for reconsideration of a payment recoupment resulting from a RAC audit will be exactly the same as the current process for appealing a payment denial by a Regional Home Health Intermediary.

Editor’s note: We have decided to continue using the terms “Regional Home Health Intermediary” and “fiscal intermediary” for clarity. When the new name, explained below,* enters into common usage, we will begin to switch our usage as well.

CMS has made quite clear the rules under which RACs must play, including during the appeals process. The CMS Program Integrity Manual (PIM) is the guide for all contractors. Readers are invited to examine previous articles in this series for detailed descriptions of the appeals process.

From the CMS Program Integrity Manual
1.1- Overview of Program Integrity and Provider Compliance
(Rev. 313; Issued: 11-20-09; Effective/Implementation Date: 12-21-09)
Affiliated contractors (ACs) shall follow all sections of the PIM unless otherwise indicated.
Medicare administrative contractors (MACs), comprehensive error rate testing (CERT) contractors, recovery audit contractors (RACs), program safeguard contractor (PSCs) and zone program integrity contractors (ZPICs) shall follow the PIM as required by their applicable Statement of Work (SOW).

*Background on Medicare Contractors
The Centers for Medicare & Medicaid Services (CMS) contracts with private insurance companies to perform many functions on behalf of the Medicare program, including processing claims for Medicare payment and carrying out the first level of the Medicare claims appeals process. Historically, these companies have been known as fiscal intermediaries (FIs) for Part A services and carriers for Part B services; however, as directed by section 911 of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003, both Part A and B work is being integrated under new entities called Medicare Administrative Contractors (MACs). For more information on MAC implementation, see: http://www.cms.hhs.gov/MedicareContractingReform/.

Here are some considerations for assessing your risk level:

1. Who will do the assessment?
   1. Do you have adequate internal resources with appropriate tools to review a sample of your hospice’s clinical records to ensure forms are valid, signed and timely and that documentation supports the eligibility of each patient for each day on service and for every level of care provided?
   2. Do you need to retain outside clinical consultants to provide expert and objective clinical record reviews to help identify risk exposure and opportunities for improvement?
2. Do you need to retain counsel to protect findings under attorney-client privilege?
   1. This is usually a good idea if you retain outside consultants and have concerns about what might be discovered during an assessment.
3. How far back in time should you review?
   1. It is usually best to start with where you are currently – with active patients and preferably for time frames for which claims have not yet been submitted. If problematic issues are discovered you can then determine (perhaps with the advice of counsel) how much farther back in time you might need to go.
4. What do you do with the results of the audit?
   1. If your findings indicate the possibility that your hospice has been overpaid for claims it has submitted (for example, if documentation does not support patient eligibility) there is the possibility you might be in a voluntary disclosure situation. If that is the case, retain counsel and get legal advice before you do anything else.
   2. If the findings are of concern but do not clearly indicate an overpayment situation, use the findings to identify opportunities for improvement. For example, what needs to be done to ensure members of the IDG have the tools, resources and training they need to accurately and thoroughly document patient eligibility?

Once an assessment of risk is conducted, you will have a better idea of how much you should be worrying about the RACs. More importantly, you will be able to develop a concrete action plan to strengthen staff assessment and documentation skills and ongoing auditing and monitoring activities to ensure your level of risk is minimized.

The Medicare fraud strike forces are multiagency teams of federal, state and local investigators designed to detect and prosecute fraud. In addition to DOJ and HHS, these strike forces involve the Federal Bureau of Investigation (FBI) and the Drug Enforcement Agency (DEA).  The strike forces use real time data analysis to stop fraud as it occurs.

According to Attorney General Eric Holder, Medicare and Medicaid fraud cost the government billions of dollars each year. In an effort to combat these problems, DOJ and HHS have established a new taskforce, the Health Care Fraud Prevention and Enforcement Action Team (HEAT).

An FBI agent caries a computer seized from Courtesy Medical Group, Tuesday, Dec. 15, 2009 in Miami. Federal agents arrested several suspects and expected to roundup about 30 in three states Tuesday on charges related to Medicare fraud totaling $61 million as the government cracks down on waste under health care overhaul plans. (AP Photo/Wilfredo Lee)

On December 16, the Department of Health and Human Services announced the new strike force offices in Baton Rouge, Tampa and Brooklyn. The strike forces have focused on states that spend the most money on Medicare per person. According to HHS, Louisiana spent $8,659 per enrollee in 2004, the highest in the country. Previously, the Houston strike force office handled all of Louisiana.

Types of Medicare Fraud
Medicare fraud can involve a variety of activities. Most commonly, this fraud involves the billing and coding for services, for example:
-Billing for services not provided
-Billing for equipment not provided
-Billing for services that are not medically necessary
-Improperly coding for services
-Double billing

However, fraud may also involve some type of improper financial relationship between a physician and an entity providing health care. For example, an anti-kickback law prohibits any type of payment in return for referring a patient. A physician self-referral law prohibits a doctor from having a financial relationship with an entity to which he or she refers a Medicare patient.

Civil and Criminal Liability
Last year the DOJ filed 502 criminal health care fraud cases with charges against 707 defendants, ultimately resulting in 588 convictions. The average prison sentence was more than three years (37.4 months).

Many federal statutes deal with health care fraud. Some specifically apply to health care fraud, like the anti-kickback law and the law against self-referral. Others are general laws that can be applied to health care fraud, such as the False Claims Act, Racketeer Influenced and Corrupt Organizations Act (RICO) and money laundering laws.

New State-Based Medicaid Strike Force Teams
In addition to the Medicare strike force teams, DOJ and HHS are encouraging the states to establish their own Medicaid strike forces using some of the same tools used by the Medicare strike forces, such as real time data analysis. These strike forces are working together to help eliminate fraud and investigating fraudulent operators who are cheating the system and costing taxpayers money.

Recommendations
These investigations are very serious and anyone convicted of Medicare of Medicaid fraud charges faces severe consequences. Owners of home care agencies and hospices who discover they are under investigation should treat the situation with utmost seriousness and speak to a criminal defense attorney immediately.

“With this announcement, we raise the stakes on health care fraud by launching a new effort with increased tools, resources and a sustained focus by senior-level leadership,” said Attorney General Holder. “Every year we lose tens of billions of dollars in Medicare and Medicaid funds to fraud. Those billions represent health care dollars that could be spent on medicine, elder care or emergency room visits, but instead are wasted on greed. This is unacceptable, and the Justice Department is committed to working with the Department of Health and Human Services to eradicate it.”

“Today, we are turning up the heat on perpetrators who steal from the taxpayers and threaten the future of Medicare and Medicaid,” said Secretary Sebelius. “Most providers are doing the right thing and providing care with integrity. But we cannot and will not allow billions of dollars to be stolen from Medicare and Medicaid through fraud, waste and serious abuse of the system. It’s time to bring the fight against fraud into the 21st century and put the resources on the streets and out into the community to protect the American taxpayers and lower the cost of health care.”

The HEAT team will include senior officials from DOJ and HHS who will build upon and strengthen existing programs to combat fraud while also investing new resources and technology to prevent fraud, waste and abuse before it happens. Efforts will include the expansion of joint DOJ-HHS Medicare Fraud Strike Force teams that have been successfully fighting fraud in South Florida and Los Angeles. Established in 2007, these teams have a proven record of success using a “data-driven” approach to identify unexplainable billing patterns and investigating these providers for possible fraudulent activity. The Medicare Fraud Strike Force team operating in South Florida has already convicted 146 defendants and secured $186 million in criminal fines and civil recoveries. After the success of operations in South Florida, the Medicare Fraud Strike Force expanded in May 2008 to phase two in Los Angeles, where 37 defendants have been charged with criminal health care fraud offenses. To date in the Los Angeles cases, more than $55 million has been ordered in restitution to the Medicare program.

“We know these strike forces work. I believe a targeted civil and criminal enforcement strategy in these locations will have a substantial impact on deterring fraud and abuse, protecting patients and the elderly from scams, and ensuring that taxpayer funds are not stolen,” said Attorney General Holder.

Prevention is critical to reforming the system and the HEAT team will also focus critical resources on preventing fraud from occurring in the first place. The team will build on demonstration projects by the HHS Inspector General and the Centers for Medicare & Medicaid Services that focus on suppliers of durable medical equipment (DME). These projects increase site visits to potential suppliers to prevent imposters from posing as legitimate DME providers. Other initiatives include:

Increasing training for providers on Medicare compliance, offering providers the resources and the knowledge they need to help identify and prevent fraud.

Improving data sharing between the Centers for Medicare & Medicaid Services and law enforcement so we can identify patterns that lead to fraud.

Strengthening program integrity activities to monitor and ensure Medicare Parts C (Medicare Advantage plans) and D (prescription drug programs) compliance and enforcement.

The Attorney General and the HHS Secretary also called on the American people to visit a new Web site www.hhs.gov/stopmedicarefraud or call 1-800-HHS-TIPS (1-800-447-8477) to report suspected Medicare fraud.

“The American people are some of our best weapons in the fight against Medicare fraud,” added Sebelius. “Fraud is happening in communities across the country right now and we need the American people to blow the whistle on thieves and criminals who are stealing from all of us.”

Fraud prevention efforts are also strengthened in President Obama’s proposed Fiscal Year 2010 budget. The President’s budget invests $311 million – a 50 percent increase from 2009 funding – to strengthen program integrity activities within the Medicare and Medicaid programs. Combined, the anti-fraud efforts in the President’s budget could save $2.7 billion over five years by improving oversight and stopping fraud in the Medicare and Medicaid programs, including the Medicare Advantage and Medicare prescription drug programs.

“CRIMINAL PROSECUTION AS A DETERRENT TO HEALTH CARE FRAUD”
PRESENTED MAY 20, 2009

Health care fraud enforcement has restored funds to the trust funds and protected our citizens from health care fraud schemes. The Department is committed to the ongoing success of the HCFAC program and will continue to marshal its resources, including those provided by the HCFAC program and its own discretionary funds, to ensure that federal health care dollars are properly expended. We are committed to prosecuting fraud and abuse in the Medicare and Medicaid programs and restoring the recovered proceeds to these programs. We look forward to working with Congress and this Committee in particular, through these efforts, to make health care available to those who have no such safety net.

Introduction

Mr. Chairman, Ranking Member Graham and distinguished Members of the Subcommittee, I appreciate the opportunity to appear before you to discuss the Department of Justice’s efforts to combat health care fraud and abuse. We are grateful for the leadership of your Subcommittee on this important topic and to you, Mr. Chairman, for inviting me to discuss the Department of Justice’s enforcement efforts.

Crimes involving fraud – whether they involve mortgage, securities or commodities fraud, bribery of government officials in violation of the Foreign Corrupt Practices Act or health care fraud – can jeopardize our economy, threaten the integrity of our financial system and cost taxpayers billions of dollars. The Department has been, and will continue to be, committed to the vigorous investigation and prosecution of these crimes. Health care fraud, in particular, is one of the Department’s top enforcement priorities given the vital role Medicaid and Medicare play in supporting our most vulnerable citizens, the rising cost of funding these programs, and the huge amounts of waste, fraud, and abuse.

HEALTH CARE FRAUD ENFORCEMENT

The Medicare and Medicaid programs serve essential roles in our nation’s health care system. They serve vulnerable populations of seniors, people with disabilities, and various low-income Americans. Last week, the trustees who monitor the Medicare Trust Fund issued a report that said that hospital expenses will pay out more in benefits than Medicare will collect this year, and that the . It is therefore vitally important that the Departments of Justice and Health and Human Services do everything possible to prevent, detect, and prosecute health care fraud and abuse in order to return stolen Medicare dollars to the Trust Fund.

The Department, along with our partners from the Department of Health and Human Services and state law enforcement agencies is committed to this effort. Last year, the Department of Justice filed 502 criminal health care fraud cases involving charges against 797 defendants and obtained 588 convictions for health care fraud offenses – record high numbers of criminal health care fraud prosecutions since Congress established the Health Care Fraud and Abuse Control (HCFAC) program in 1996. Moreover, the Department, working with our colleagues in the Department of Health and Human Services, has obtained more than $14 billion in total recoveries, including criminal fines and civil settlements, since 1997.

The Department’s prosecutions have a clear deterrent effect. Our inter-agency Departments of Justice and Health and Human Services enforcement efforts in South Florida, spearheaded by the Department’s Criminal Division and U.S. Attorney’s Office for the Southern District of Florida through the Medicare Fraud Strike Force, contributed to estimated reductions of $1.75 billion in durable medical equipment (DME) claim submissions and $334 million in DME claims paid by Medicare over the 12 months following the Strike Force’s inception, compared to the preceding 12-month period. The average prison sentence in Miami Strike Force cases was 48.8 months, which exceeded by nearly one year the overall national average health care fraud prison sentence of 37.4 months.

Our criminal and civil enforcement efforts have taught us some important lessons. In the criminal arena, we have learned to identify criminal claim trends and track systemic weaknesses so we can stop false claims before they occur. We have also learned that quick apprehension and punishment of these criminals is critical to deterring others. But we have also learned that we cannot prosecute our way out of this problem. Instead, we must prevent criminals from accessing Medicare, Medicaid and other health care programs in the first place. Medicare and Medicaid are extremely large programs — federal and state spending on both programs collectively exceeds $800 billion per year. In FY 2008, the federal government devoted $1.13 billion for program integrity activities and health care fraud enforcement. The Administration is requesting in the FY 2010 Budget that Congress provide an additional $311 million in two-year funding to enhance federal program integrity and anti-fraud enforcement work of which $29.8 million is designated for the Department of Justice. We ask for your support for this and future anti-fraud funding enhancements.

HEALTH CARE FRAUD ENFORCEMENT IS A TOP DEPARTMENT PRIORITY

National health care spending in the United States exceeded $2.2 trillion and represented 16 percent of the Nation’s Gross Domestic Product (GDP) in 2007. The Federal government financed more than one-third of the Nation’s health care that year; federal and state governments collectively financed 46 percent of U.S. health care costs. The National Health Care Anti-Fraud Association estimates that 3 percent of the nation’s health care spending-or more than $60 billion each year-is lost to fraud. The GAO has estimated that up to 10% of health care spending may be wasted on fraudulent claims. Over the next ten years, U.S. health care spending is projected to double to $4.4 trillion and to comprise more than 20 percent of national GDP. In short, health care fraud is an enormous problem that we cannot allow to continue.

The Department is committed to prosecuting all who commit health care fraud – providers and practitioners, equipments suppliers and corporate wrongdoers. In criminal enforcement actions during 2008, Department prosecutors:

• Opened 957 new criminal health care fraud investigations involving 1,641 defendants, and had 1,600 criminal health care fraud investigations involving 2,580 potential defendants pending at the end of the fiscal year; and
• Filed criminal charges in 502 health care fraud cases involving charges against 797 defendants and obtained 588 convictions for the year. Each of these figures represents an “all time high” count of federal criminal cases, defendants, and convictions.

Another 773 criminal health care fraud cases involving 1,335 defendants were pending at the end of FY 2008.

Despite the staggering volume of cases, the Department has succeeded because of strategic thinking about how best to address this problem. The Medicare Fraud Strike Force in Miami is one example. The Strike Force’s mission is to supplement the criminal health care fraud enforcement activities of the United States Attorneys’ Offices by targeting emerging or migrating schemes along with chronic fraud by criminals operating as health care providers or suppliers. The Miami Strike Force was structured in five teams with criminal prosecutors, a licensed nurse, federal HHS and FBI agents, and state and local police investigators.
In March 2008, the Department’s Criminal Division expanded the Strike Force to a second site, partnering with the United States Attorney’s Office for the Central District of California. That Strike Force includes four teams of prosecutors and federal and state agents to combat DME fraud in the Los Angeles metropolitan area. In Phase

Two of the Strike Force, Fraud Section attorneys, working with federal prosecutors from the U.S. Attorney’s Office, and FBI and HHS-OIG agents, charged 37 defendants in 21 indictments involving more than $55 million in fraudulent Medicare claims.

The Strike Force model for criminal health care fraud prosecutions has now become a permanent component of the United States Attorneys’ Office in both the Southern District of Florida and the Central District of California.

In March 2009, the Department Criminal Division initiated a third Strike Force phase, in partnership with the United States Attorney’s Office for the Southern District of Texas in the Houston area. The Department’s Criminal Division is currently planning to launch a fourth Strike Force phase, using its allocation of the supplemental funding Congress provided to the Department in the Omnibus Appropriations Act of 2009.

The Strike Force model or approach is similar in some ways to “problem-oriented policing” because it is based on obtaining an understanding of local or regional fraud schemes and focusing on the geographic areas which have the greatest rates of crime in a concentrated effort to deter fraudulent claims. Since its inception two years ago, the Strike Force, with a limited number of investigators and prosecutors, has:

• filed 108 cases charging 196 defendants who collectively billed the Medicare program more than half a billion dollars;
• taken 129 guilty pleas;
• handled 14 jury trials resulting in convictions of 18 defendants; and
• obtained 109 sentences of imprisonment, ranging from 30 years to 4 months of home confinement, with an average term of imprisonment of 48 months.

Here are several examples of the Strike Force successes

• After a two-week criminal trial, a Miami jury convicted a physician and the court sentenced her to serve 30 years in prison for her role in an $11 million HIV infusion fraud scheme. The physician, with the assistance of a nurse who also was convicted and sentenced to seven years in prison, ordered and then provided hundreds of unnecessary HIV infusion treatments to patients who were paid cash kickbacks of $150 per visit to accept the services so the co-conspirators could steal from Medicare.
• DME company owners were sentenced for conspiring to defraud the Medicare program by submitting false claims for medically unnecessary DME items and supplies, including aerosol medications and oxygen concentrators. The companies paid kickbacks to a physician previously investigated by the Department of Health and Human Services’ Office of the Inspector General, and to several Medicare beneficiaries in order to use their Medicare numbers to submit the fraudulent claims. The 13 convicted DME company owners involved in the scheme were ordered to pay a total of more than $6.4 million in restitution. The 13 subjects were also sentenced to various terms of imprisonment, probation, and/or home detention, the longest prison sentence for the case being 6 years and 6 months.
• After a five-week trial, a Federal jury in Miami convicted three owners of two DME companies, a home health agency and an assisted living facility which conspired to defraud Medicare of more than $14 million for unnecessary medicine, DME, and home health care services. Two defendants were sentenced to 51-month terms of imprisonment, and the third was sentenced to a 31-month prison term. Patients testified at trial that they took kickbacks, were falsely diagnosed with chronic obstructive pulmonary disease and prescribed unnecessary aerosol medications, including commercially unavailable compounds. A fourth co-defendant, a dermatologist, was also convicted in a separate jury trial and was sentenced to prison for 41 months.

As proud as we are of our Strike Force initiative, it is but one element of our comprehensive health care fraud efforts. Indeed, the Criminal Division and the U.S. Attorney’s Offices bring many other significant health care fraud cases.

For example, in the Western District of Wisconsin, Thomas Arthur Lutz (Lutz), the former President and CEO of Health Visions Corporation (Health Visions), pleaded guilty to conspiracy to defraud TRICARE, the Department of Defense’s worldwide health care program for active duty and retired uniformed services members and their families, and was sentenced to 5 years in prison. On behalf of Health Visions, Lutz entered into a kickback agreement with a medical provider in the Philippines, in which the provider paid 50 percent of the amount of the bills for medical services rendered to TRICARE patients referred by Health Visions, back to Health Visions. The court ordered Lutz and the corporation to pay $99,915,131 in restitution. The court further ordered the corporation to liquidate its assets, pay a $500,000 fine and forfeit $910,910.60.

CIVIL ENFORCEMENT

The Department’s Civil Division, using the False Claims Act, 31 U.S.C. §§ 3729-3733, plays an enormous role in the Department’s efforts to protect public funds from fraudsters. In addition, lawsuits are often brought by private plaintiffs, known as “relators” or “whistleblowers,” under the qui tam provisions of the FCA, and the government will intervene in appropriate cases to pursue the litigation and recovery against the provider or company.

Since the False Claims Act was substantially amended in 1986, the Civil Division, working with United States Attorney’s Offices, has recovered $21.6 billion on behalf of the various victim federal agencies. Of that amount, $14.3 billion was the result of fraud against federal health care programs – primarily the Medicare program. Cases involving fraud committed by pharmaceutical and device manufacturers have resulted in total criminal and civil recoveries of more than $9.2 billion since 1999.

The Civil Division, through its Office of Consumer Litigation, also pursues many of these cases as criminal violations of the Federal Food, Drug, and Cosmetic Act (FDCA). For example, in January of this year, OCL and the U.S. Attorney’s Office in the Eastern District of Pennsylvania prosecuted Eli Lilly and Co., which pled guilty to violating the FDCA for its illegal marketing of the anti-psychotic drug Zyprexa. Zyprexa was approved by the FDA for use in treating schizophrenia and certain aspects of bipolar disorder. Eli Lilly promoted Zyprexa for unapproved uses, including the treatment of, among other conditions, dementia, Alzheimer’s dementia, agitation, and aggression, and specifically directed this effort through its long-term care sales force. That sales force targeted nursing homes and assisted living facilities, even though schizophrenia rarely occurs in the elderly.

Eli Lilly sought to convince doctors to use Zyprexa to treat older patients for disorders which are prevalent in this population, despite the fact that the FDA had not approved Zyprexa for those conditions. Because the unapproved uses promoted by Eli Lilly were not medically accepted indications and, therefore, were not covered by State Medicaid programs, the company’s conduct caused false claims to be submitted to Medicaid. The global settlement with Eli Lilly totaled $1.415 billion, which included a $515 million criminal fine, $100 million in forfeiture, and up to $800 million in civil recoveries under the federal and state False Claims Acts.
In addition to these accomplishments, the Department’s Elder Justice and Nursing Home Initiative, coordinated by the Civil Division, supports enhanced prosecution and coordination at federal, state, and local levels to fight abuse, neglect, and financial exploitation of the Nation’s senior and infirm population. Through this Initiative, the Department also makes grants to promote prevention, detection, intervention, investigation, and prosecution of elder abuse and neglect, and to improve the scarce forensic knowledge in the field. The Department additionally pursues cases

under the False Claims Act against skilled nursing homes and other long term care providers that provide services so substandard as to constitute worthless services and constitute a complete “failures of care.”

CIVIL RIGHTS DIVISION

he Civil Rights Division plays a critical role in the HCFAC Program. The Special Litigation Section of the Civil Rights Division is the sole Department component responsible for the Civil Rights of Institutionalized Persons Act. CRIPA authorizes the investigation of conditions of confinement at state and local residential institutions (including facilities for persons with developmental disabilities or mental illness, and nursing homes) and initiation of civil action for injunctive relief to remedy a pattern or practice of violations of the Constitution or federal statutory rights. The review of conditions in facilities for persons who have mental illness, facilities for persons with developmental disabilities, and nursing homes comprises a significant portion of the program.
In the context of persons residing in health care institutions operated by or on behalf of a government, the Division evaluates residential placements in each of its investigations under CRIPA, in light of the requirement in the Americans with Disabilities Act that services be provided to residents in the most integrated setting appropriate to their needs. Through its CRIPA work, the Division seeks to eliminate the unjustified institutional isolation of persons with disabilities. The Division recognizes that unnecessary institutionalization is discrimination that diminishes individuals’ ability to lead full and independent lives. The Civil Rights Division’s CRIPA enforcement activities have enabled thousands of unnecessarily institutionalized individuals to live safely in the community with adequate supports and services.

As part of the Department’s Institutional Health Care Abuse and Neglect Initiative, the Civil Rights Division conducts reviews of conditions in health care facilities. It has found that conditions and practices at eight state facilities for persons with mental illness, two state facilities for persons with intellectual and developmental disabilities, and three nursing homes violated the residents’ federal constitutional and statutory rights. The Section entered settlement agreements to resolve its investigations of one state-operated facility for persons with intellectual and developmental disabilities, and one state-operated nursing home.

INTER-AGENCY COOPERATION

The Department is not alone in the fight to combat fraud and preserve the integrity of the country’s health care system. Because HHS directly administers the Medicare Program, maintains all the payment records and data submitted by providers, and oversees the Medicaid program in partnership with the states, the close cooperation between the Departments is critical to our success. Within the framework of HCFAC, we work closely with the Inspector General of the Department of Health and Human Services, as well as our colleagues at the Centers for Medicare and Medicaid Services (CMS). As a result of this cooperation:

• Our Strike Force model focuses interagency resources on those regions with the highest levels of Medicare program fraud.

• Interagency health care fraud task forces and working groups exist in a majority of federal judicial districts that consist of Assistant U.S. Attorneys, HHS and FBI investigative agents, CMS program agency personnel and Medicare Program Safeguard Contractors, Medicaid Fraud Control Units, state Attorney General staff, and some private insurer investigators.

We also work closely with the Food and Drug Administration, including its Office of Criminal Investigations (FDAOCI), the Federal Employees Health Benefits Program (FEHBP) at the Office of Personnel Management and its Office of Inspector General, and our State law enforcement partners in their Offices of Attorneys General and Medicaid Fraud Control Units. Because health care fraud schemes frequently impact private health insurance plans, we also work with private sector health care insurance providers. These partnerships are a key to our success in stemming health care fraud and protecting the federal fisc.

MORE THAN $14 BILLION IN TOTAL RECOVERIES SINCE 1997

Working with our colleagues, during Fiscal Year 2008 alone, the Department’s health care fraud litigation resulted in deposits of $1.48 billion to the U.S. Treasury, which was reimbursed to the Centers for Medicare and Medicaid Services, other Federal agencies administering health care programs, or paid to private “whistleblowers” who filed health care fraud litigation completed by the Department. The Medicare Trust Fund received transfers of nearly $1.28 billion during this period as a result of these efforts, as well as those of preceding years, in addition to $344 million representing the federal share of Medicaid money similarly transferred to the Treasury as a result of these efforts.

Since the inception of the HCFAC program in 1997, the Department has obtained, according to our preliminary estimates, more than $14.4 billion in total recoveries, which include criminal fines and Federal and State civil settlements in health care fraud matters, predominantly involving losses to the Medicare program. Of this total, $12.5 billion has been transferred or deposited back into the Medicare Trust Fund and $1.2 billion, representing the federal share of Medicaid fraud recoveries, has been transferred to the Treasury. The monetary recoveries we achieve go right back into the Medicare and Medicaid programs to help fund the health care costs of the Americans who are enrolled in these programs.

These recoveries were made possible by the dedicated funding stream provided by the HCFAC Program, which was established by the Health Insurance Portability and Accountability Act of 1996. The HCFAC program is the principal source of annual funding for Department of Justice efforts to combat Medicare and Medicaid fraud.

FUNDING

Earlier this year, the Omnibus Appropriations Act of 2009 provided $198 million for joint HHS and Department health care anti-fraud programs through an allocation adjustment for new program integrity work, predominantly for the Medicare Advantage, Medicare Part D, Medicaid and Children’s Health Insurance (CHIP) programs. Nearly $19 million of this new amount is designated for the Department. The Administration’s FY 2010 budget seeks an additional $311 million in two-year funding to continue and enhance this new program integrity and anti-fraud enforcement work of which $29.8 million is designated for the Department of Justice.
In addition to our partners in the HHS Office of Inspector General, and Centers for Medicare and Medicaid Services, the Department combats the Nation’s health care fraud with a total of fewer than 400 full-time equivalent (FTE) positions, and roughly 750 FBI agents and support staff. With $12.5 billion returned to the Medicare Trust Fund since the inception of the HCFAC program, the average “return on investment” for funding provided by HIPAA to all “law enforcement agencies,” the figures are as follows: total transfers to Medicare Trust Fund ($3.82 to $1) and all victims ($4.41 to $1). Further, we believe that the deterrent effects from our efforts may produce far greater “returns on investment” through dramatic reductions in fraudulent billings to and payments from Medicare.

As successful as our Strike Force and other anti-fraud efforts have been, our prosecutors believe that we may be only scratching the surface. The Administration has requested additional resources for FY 2010 to support the Department’s efforts to bolster its health care fraud enforcement activities and protection of the Medicare Trust Fund. This additional time to use these enhanced resources would permit the Department to recruit, hire, and fully train the best and brightest attorneys and investigators to conduct and enhance this very important work, especially as the Administration and Congress seek to make health care coverage available to the millions of citizens who currently lack health insurance.

CONCLUSION

Health care fraud enforcement has restored funds to the trust funds and protected our citizens from health care fraud schemes. The Department is committed to the ongoing success of the HCFAC program and will continue to marshal its resources, including those provided by the HCFAC program and its own discretionary funds, to ensure that federal health care dollars are properly expended. We are committed to prosecuting fraud and abuse in the Medicare and Medicaid programs and restoring the recovered proceeds to these programs. We look forward to working with Congress and this Committee in particular, through these efforts, to make health care available to those who have no such safety net.

Thank you for the opportunity to testify. I would be please to take any of your questions.

TRISH TULLOCH

In the summer of 2008, we at RBC Limited were privileged to work with two home health demonstration agencies participating with the Centers for Medicare and Medicaid Services (CMS) and Abt Associates to field test the revised OASIS-C. Since that time we have supported dozens of agencies in their transition planning to OASIS-C through leadership, staff education and competencies. To help you plan and refine your agency’s transition processes to ensure success in 2010, this column shares some “Lessons Learned” from those experiences.

What are the Most Challenging OASIS-C Items?

M2400, a new process measure that is to be completed on transfer or discharge, surfaced as the most challenging item during the demonstration period. M2400 requires the clinician performing the assessment to “look back” at the care provided during this specific episode of care to determine if six specific care practices were included in the Plan of Care (POC, still called by some the 485) and if included, determine if these practices were implemented during this episode of care. You can find M2400 on page 24 of the final OASIS-C at http://www.cms.hhs.gov/HomeHealthQualityInits/Downloads/HHQIOASISCAllTimePoint.pdf

Things to remember about M2400

• The actual “look back” audit period includes a review of only the current episode in which the patient is receiving care and services.
• Subsequent OASIS-C field use indicates M2400 presents many challenges based on the documentation and/or software system used by the agency. Many agencies have developed a simple paper “look back” tool to be used during the episode of care that helps the clinician with accurate and timely completion of this item on transfer or discharge. Software vendors are challenged to consolidate this information during the episode of care on one screen, as a reference guide to clinicians completing this item as indicated.
• Agencies have also reviewed their transfer/discharge processes relative to completing OASIS-C and are considering a revised review/audit process focused on these six items to ensure accuracy prior to locking this final OASIS-C document.
• Since these items may be used in the revised Home Care Compare Report for agency Quality Outcomes and may ultimately impact agency reimbursement under a future Pay for Performance model, it is important to accurately and efficiently monitor the collection and analysis of these data elements.

M2100, the Care Management grid, directs clinicians to assess the types and sources of caregiver assistance for multiple activities, including medication administration, Activities of Daily Living (ADLs) and Instrumental Activities of Daily Living (IADLs) as well as medical treatments and advocacy for medical care. The level of caregiver ability and willingness is assessed and documented in the M2100 grid. You can find M2100 on page 21 of the final OASIS-C at
http://www.cms.hhs.gov/HomeHealthQualityInits/Downloads/HHQIOASISCAllTimePoint.pdf

Things to remember about M2100

• CMS defines caregiver abilities or willingness with grid columns for “needs training and/or support,” “not likely to provide assistance” and or “unclear if they will provide assistance.” It is critical that assessing clinicians have a comprehensive, working knowledge of these definitions.
• Agencies have found that a detailed item review with multiple realistic case scenarios provides and supports the clinician’s understanding and application of this new OASIS-C item in designating the assistance the patient needs.
• Assessing clinicians from the demonstration indicated frustration with the definitions of each level of assistance needed, as well as an inability within the restricted admission timeframe to accurately assess this item.
• Additionally, experienced home care clinicians know that caregiver availability and abilities is very difficult to fully determine during the initial start of care assessment. Agencies should develop policies and processes that support clinicians with the flexibility needed to comprehensively build a realistic POC. If this requires two admission visits to complete the POC, then clinicians should not fear recrimination or penalties if they can justify the need.

Tools to Support Accuracy on the Optional Best Practices

While CMS indicates that the newly integrated process items are optional practices, regulators and industry experts agree that identified clinical Best Practices are critical to providing quality clinical outcomes that save agencies and payers money. Furthermore, the decision to continue the optional approach with your staff may adversely impact your future patient and agency outcomes, community marketing initiatives and eventually reimbursement in a pay-for-performance payment structure.

Proactive agencies have reviewed and identified optional best practices they intend to perform when using the revised OASIS-C. A recent poll by Home Care Outcomes indicates that agencies are currently performing many of the identified best practices. In fact, current transition training by RBC indicates many agencies are already performing 70-80% of these Best Practices and that clinician training revolved around the revised documentation of these practices on specified OASIS-C assessment items.

What Best Practices has your agency selected, and what tools support clinician completion of these items?

• Software vendors have integrated a variety of Best Practice tools into their system to support clinician completion of these items.
• Demonstration and transition agencies have indicated that easy tool access for use by clinicians in the home is vital.
• Consider using available Best Practice tools to simplify assessment and documentation of these practices. CMS includes links to several Best Practices in Chapter 5 of the OASIS-C Guidance Manual, which can be found at http://www.cms.hhs.gov/HomeHealthQualityInits/14_HHQIOASISUserManual.asp#TopOfPage

Training and Leadership Processes to Support the Transition

Administrative and management leadership understands that any change in clinical practice needs ongoing support and close monitoring to ensure accurate and consistent implementation. Recognize that a learning curve will exist in the transition to the revised OASIS-C that will take a considerable amount of time. Hopefully you are in the middle of considering how your agency will support field clinicians during transition to OASIS-C. Consider the following questions when developing and revising your plans.

• How will your agency ensure consistent understanding of the revised and new OASIS-C elements?
• What have you done to provide the support to reinforce implementing the revised and new items in 2010?
• How will you support your clinicians to ensure optimal practices that enhance and refine care in the delivery of your home health services?
• Will you provide the incremental training and review time to discuss these new items to ensure accuracy and consistency throughout 2010?
• How will your clinicians learn common errors to avoid with the revised OASIS-C tool?

Consider these options:

• Mini staff meetings or regular in-service sessions to update staff on revised OASIS-C items. One demonstration agency has already initiated a weekly morning mini OASIS-C training session that provides a quick review and tool for each revised or new item in an incremental process throughout October, November and December.
• Bi-weekly team meetings that integrate the application of OASIS-C items into current case review. One agency indicates that the additional time for discussion and application supports clinician understanding of score variations beginning in 2010.
• Share your strategies with your colleagues. (see editor’s note, below)

Consider these options:

• Provide each clinician with the Final OASIS-C Guidance (Chapter 3)
• Provide each clinician with your updated Best Practice tools to complete the new OASIS-C items
• Ensure clinicians easy access to agency OASIS-C experts who can readily answer their questions when completing these documents in the New Year

From Editor Carolyn Humphrey: Look for articles in upcoming issues of The Informed Home Care Clinician detailing strategies and approaches we have learned from you and your colleagues to help you address these questions. We are here to provide you with the best and easiest-to-apply information for all the issues you face each day. Our commitment is to have a minimum of one OASIS-C column in every issue and other need-to-know OASIS-C material in each issue’s “News You Can Use” segment. Let us know what you think and what you want us to cover on the critically important topic of transitioning to OASIS-C.

Trisha Tulloch is a Senior Consultant with RBC Limited of Staatsburg, New York. A seasoned clinician with more than 30 years in health care practice, Trisha’s diverse experience includes leadership roles in both Home Health and Hospice.  A Registered Nurse with code credentials from the Board of Advanced Medical Coding, she is a nationally recognized speaker who provides both clinical and administrative expertise to agencies across the country.  Responsible for oversight of RBC Limited’s Health Care Division, she collaborates with industry experts and attorneys for Corporate Compliance, Fact Finding, Fraud and Abuse and Regulatory Standards.  Her specialty in coding and OASIS education and training, utilizing RBC Limited’s Integrated Oasis Solutions methodology, reflects her unique skill set to promote industry best practices. Contact the author through RBC Limited: www.rbclimited.com

This Clear as M.U.D. saga is titled, “I’m OK. You’re OK. Your Patient, We’re Not So Sure About.”

Prologue

This newsletter is collecting stories like the one below, in an effort to explore the validity of recent informal accusations suggesting the organizations charged with making sure Medicare home health care providers obey the rules may be breaking their own rules in the process. If, after reading this short narrative, you are reminded of any similar incident within your experience, please share it with us, anonymously if you wish. Your story may be our next “Medically Unbelievable Denial.”

The Medicare-certified home health care agency we will call “As Honest As the Day Is Long Care” (AHADLC) has been serving elderly patients in a metropolitan area for nearly 15 years. Joint Commission accredited, AHADLC enforces strict company policies with every member of its staff. Never once has any government body or competitor accused agency owners of any intentional violation of the rules under which Medicare providers operate.

Unfortunately, AHADLC operates in a region that is known to have more than its share of home health operators that were not formed to serve patients but solely to generate Medicare claims, using any method that works. There are stories throughout the area of physician kickbacks, cash payments to beneficiaries for use of their Medicare number and even lists of beneficiary names and numbers available for sale. There is a well-known pattern of sham agencies opening and closing and opening again under different names in rapid succession.

Frequently in such communities, a Medicare beneficiary who once accepted cash under the table in exchange for his or her Medicare number eventually develops a need for actual home health care services by a real nurse or therapist. They usually wind up with a legitimate provider since they know their previous “agency” did not actually employ any nurses and, even if it did, it is no longer in business, at least not under the same name.

The Payment Denial

This is the environment in which AHADLC conducts its legitimate home health care business, which is why it is not surprising that the following events occurred. In fact, they happen regularly.

At the end of one typical, 60-day Medicare PPS episode, AHADLC submitted a claim in good faith to its RHHI for services that included both nursing and physical therapy and amounted to approximately $4,000. The RHHI, in this case Cahaba Government Benefit Administrators, immediately denied payment.

The key word is “immediately.” When a denial arrives this soon after claim submission, it can only be the result of a computer edit. No person can examine and adjudicate millions of claims this quickly. In fact, Cahaba’s initial denial letter admitted as much, explaining that the denial was the result of a “5HCBA computer-generated code.” The denial letter explained 5HCBA thus:

“The Medicare health insurance number (HIICN) has been identified as being utilized in questionable billing practices. Based upon this, it appears services were not provided as billed. The beneficiary is not responsible for payment of this claim.

Only one interpretation is possible. Cahaba computers are set to presume guilt by association, coded to assume that a tainted beneficiary — whether or not that beneficiary knew her Medicare number had been abused — will never again in her life require legitimate health care. Think of it as a teenager ticketed for speeding while driving your car. If Cahaba were in traffic enforcement, you would get a speeding ticket every time you started up that car. Of course, you would also receive a polite letter explaining your right to contest the tickets in court.

Because this patient’s number had been flagged as having been used by a criminal in the past, Cahaba’s computer determined that the current services were not legitimate, probably not even provided. Naturally, AHADLC exercised its right to demand a redetermination.

Note: NGS uses the same edit to deny payments but refers to it as “5DHOB.“ We have not yet come across first-hand experience of Palmetto using the practice.

The Appeal

In its response to the 5HCBA denial, AHADLC argued that its RHHI is presuming fraud and denying payment without requesting and analyzing pertinent medical records, conducting interviews with beneficiaries or performing other standard program safeguard contractor activities. For good measure, the agency requested copies of any and all information Cahaba used to reach its conclusion, reminding the RHHI that CMS PUB 100 -4, 310.4 (D.) requires the contractor making the payment denial (RHHI) to make such evidence available for inspection by an appellant upon request.

In one carefully worded paragraph, the agency made its demands clear:

“Pursuant to CMS publication 100 -4, section 310.4 and under the Freedom of Information Act, we request the information utilized in determining that fraudulent or questionable billing practices have taken place. Denial of payment, without first addressing the accusations made by the fiscal intermediary, is fully inappropriate and can only be considered to be capricious and arbitrary in nature.”

The Unlawful Redetermination

Not only did Cahaba’s reply, bearing the signature of one Betsy Lulf, break the law by ignoring AHADLC’s documentation request, it also appeared to have forgotten all about computer edit 5HCBA, the original reason payment was denied. Now the reason for denial had suddenly morphed into “missing physician certification” for eight PT visits.

The agency’s CFO and owners were understandably left scratching their heads. “Of course there was no medical documentation submitted,” they told each other. “The initial denial was not for a medical reason. We were accused of nothing more than providing services to someone who had fallen in with a criminal in the past. Why would we have provided medical charts with our request to review a 5HCBA denial?” Follow-up calls and letters requesting the documentation, reminding Cahaba that CMS rules require it to do so, receive no reply.

Stay Tuned

This story has not yet ended. The next legal step for the agency is to demand a reconsideration from Cahaba’s contract partner, Maximus Federal Services, a Qualified Independent Contractor (QIC). As we have reported in the past, QIC reconsiderations agree with the initial RHHI determination slightly more than 99% of the time, calling into question their purpose for existing.

After receiving its inevitable QIC denial, which, as frequently occurs, may introduce new denial reasons unrelated to the first two, the agency will be able to present its case to a judge, where the evidence is fully explored and 80% to 90% of denials are overturned.

More than a $4,000 payment for one episode is at stake for this agency. The denial described in this story is the tip of the iceberg. It was one of six 5HCBA denials in a batch of 11 claims submitted together in the same transmission. In the last two years, this agency’s 5HCBA denials average an astounding 16% of all claims submitted. Every one is eventually overturned at the ALJ, and yet they keep coming.

We will continue to follow this “Clear as M.U.D.” case as it develops. AHADLC is currently preparing to deliver its request for reconsideration to Maximus.

Post Script

Everyone is familiar with a standard insurance industry practice. Deny payment for a service, even if the claim is legitimate, and reverse the decision if the covered customer takes the trouble to challenge it. Customers will avoid the agony of fighting an insurance company often enough to make the cost of the extra personnel needed to conduct the practice worthwhile.

When working with your staff or an outside appeals consultant to understand an illogical payment denial, remember that Medicare is essentially an insurance plan and it is insurance companies that win contracts to serve as RHHIs. Do they issue spurious denials in the hopes that many will go unchallenged? Getting an answer to that question is the reason RAC Assistance for Home Care wishes to hear your stories.

There are many ways to prepare your agency to withstand illogical attacks such as the one described in this story. One of them is to learn the rules under which your RHHI is required to operate. At times, it can be useful to cite one of their rules in order to demonstrate your familiarity.

One place to acquire that information is Chapter 3 of the Medicare Program Integrity Manual, titled “Verifying Potential Errors and Taking Corrective Actions.” It is available as a PDF document but it is 112 pages. Here is one excerpt you may find useful someday. We will print other selections from time to time.

3.11.1.10 – Track Appeals

(Rev. 71, 04-09-04) Track and consider the results of appeals in your medical review activities. It is not an efficient use of medical review resources to deny claims that are routinely appealed and reversed. When such outcomes are identified, take steps to (1) understand why hearing or appeals officers viewed the case differently than you did; and (2) discuss appropriate changes in policy, procedure, outreach or review strategies with your regional office. (emphasis added)

With all identifying data removed, here is one representative case in which a home care provider’s Regional Home Health Intermediary initiated a payment denial for services provided to one patient. The agency challenged the initial determination and learned what happens when doing battle with multiple government contractors. This example may or may not be typical of the payment denials you will see in your mailbox. Each RHHI operates slightly differently.

Timeline

• Home Health PPS Episode, 40 days from admission to discharge, fall of 2008. Skilled nursing services for patient with hypertensive heart disease with complicating factors such as lumbago and unspecified hyperlipidemia.
• Claim submitted to RHHI, January 2009.
• Payment denial letter received from RHHI, 3/12/09.
• Agency submitted request for redetermination, 4/23/09, with plan of care and certification, physician orders, nursing notes, OASIS and other records, including medication list.
• RHHI reconfirmed its “unfavorable decision” on 5/21/09
• Agency requested reconsideration, which the RHHI forwarded to its Qualified Independent Contractor (QIC) on 6/15/09.
• QIC rendered a “partially favorable” decision on 8/12/09, including advice that the provider is entitled to further appeal to the Administrative Law Judge (ALJ).

Rationale

The RHHI and QIC did not question whether services were provided by agency nurses. Denial was based on lack of documentary evidence that the skilled nursing visits were “reasonable and medically necessary.” The QIC authorized payment of the first two visits but denied payment for all remaining service, saying the patient had “identified educational needs related to prescribed medication regimen.”

The remaining visits, the QIC document reasoned, “consisted only of assessment and observation of the patient’s chronic conditions with no significant change documented in condition or treatment regimen. Teaching beyond the above two visits was repetitive.” Consultants, attorneys and other experts who live in this world report that QICs rarely if ever overturn an RHHI’s denial. They often create new arguments unrelated to the RHHI’s original denial reason but they do not change the outcome.

Consequences

Nine months after this agency initiated services for this patient, the agency received the decision that it would be paid for two visits, a LUPA episode. Costs had long since been posted, nurses and supervisors and office staff were long since paid. The agency was compensated approximately $200 instead of $2,000 and has to absorb the remaining costs or go through the expense of a court appeal before the ALJ. The QIC, on the other hand, can notch a “partially favorable” decision on its belt. When CMS evaluates this QIC’s overall contract performance, only a detailed examination would reveal that “partially favorable,” in this case as in most such reconsiderations, means “10% favorable.”

Betting against the house

Sooner or later, most Medicare providers will find themselves in the same situation. This agency now faces the decision whether to hire an attorney, or an appeals consultant with attorney-like skills and experience in the Medicare court system, or walk away from an $1,800 payment. It is a gamble many do not have the will to take, even if they believe they are likely to win.

“The RHHI/QIC system counts on that lack of will,” opines one of those above mentioned appeals consultants. Michael McGowan, senior consultant with “Medicare Appeals Development,” a Las Vegas consulting firm, wonders to what extent denial decisions based on weak arguments effectively dare providers to pursue their appeal while betting that they will not.

“If they do carry it to the next level,” McGowan explained, “they usually win. I spend half my life in front of the ALJ and I watch while they reverse the QIC decision about 90% of the time. It is sad that so many providers give up before getting there.”

Motivation, created by the federal contractor payment system, could explain the discrepancy, McGowan believes. RHHIs and QICs are contractors that are paid and scored based on performance, which is measured by how well they protect Medicare funds, and therefore the taxpayer, from inaccurate or fraudulent claims. Their decisions to release or withhold payments are made within that context. Administrative Law Judges, however, are federal employees, who receive a salary unrelated to the decisions they render.

“It is not surprising that the results are what they are, is it?” McGowan concludes. “Contractors paid a bounty make decisions that increase both their commissions and their standing with CMS. Independent judges who make decisions based on the evidence routinely come to completely different conclusions.”

1-Newborn Pediatric CPT Codes Billed for Patients Exceeding Age Limit

Certain service codes are specific to patients of a specific age and should not be applied/billed for patients which exceed the age limit defined by the CPT Code.

2-Once in a Lifetime Event

Certain procedures are only performed once in a persons lifetime. Query identifies claims paid for those procedures for more than one service date.

Reference: CMS Pub 100-08, Ch. 3, § 3.6.

3-Excessive Units-Untimed Codes

When reporting service units for untimed codes (excluding Modifiers -KX, and -59) where the procedure is not defined by a specific timeframe, the provider should enter a 1 in the units bill column per date of service.
Reference: CMS Pub 100-04, Transmittal 1019, dated 8.3.06, pages 7-11 CMS Pub 100-04, Ch. 5, § 20.2

4-Excessive Units-Blood Transfusions

Blood Transfusions should be billed with a maximum of (1) unit per patient per date of service.
Reference: Federal Register, Volume 67, No.212, (11/01/02) page 66868. Program Memorandum Intermediaries, Transmittal A-01-50, April 12, 2001, page 1 CMS Pub 100-04, Ch. 4, § 231.8

5-Excessive Units-Bronchoscopy

Bronchoscopy services should be billed with a maximum number of units (1) per patient per date of service.
Reference: Federal Register, Volume 67, No. 251, (12/31/02) page 80072. American Medical Association (AMA), Current Procedural Terminology (CPT) American Thoracic Society Coding 2005 Update

6-Excessive Units- IV Hydration

IV Hydration should be billed with a maximum number of units (1) per patient per date of service.
Reference: CMS Pub 100-4 Ch. 12, pages 31-32 CMS Pub100-20, Transmittal 419, page 7. MLN Matters, MM6349 R/T CR Release Date 12.19.08, page 4

7-Neulasta

Neulasta (HCPCS code J2505) Claims submitted with the total number of milligrams instead 1 unit per 6mg. Claims for J2505 should be submitted so that the units billed represent the number of multiples of 6mg administered, not the total number of mgs.
Reference: CMS Manual System, Publication 100-04 Medicare Processing Manual, Transmittal 949 (dated May 12, 2006) MLN Matters Number MM5912, Release Date, January 18, 2008 HCPCS Level II 2007, 2008, 2009

8-Urological bundling

A potential vulnerability may exist if certain urological procedure codes are billed in conjunction with other urological procedure codes for the same date of service and same beneficiary.
Reference: CMS Pub.100-3, Ch1, § 230.17 Noridian LCD Policy Article A25377

9-Wheelchair Bundling

Bundling guidelines for wheelchair bases and options/accessories indicate certain procedure codes are part of other procedure codes and, as a result, are not separately payable.
Reference: CMS Pub 100-03, Ch 1, § 280.1 & 280.3 Noridian LCD Policy A19846

10-Knee Orthotic Bundling

There are Knee orthotic addition codes that cannot be billed separately due to the fact that they are bundled with the base knee orthotic code or that the addition code is not medically necessary when billed in conjunction with a specific knee orthotic base code.

11-PEN supplies more than 1 time a day

The description or the billing guidelines state parenteral/enteral nutrition codes are allowed once a day.
Reference: CMS Pub. 100-3 (National Coverage Determinations Manual), Chapter 1, Section 180.2. LCD L11576 Parenteral Nutrition, LCD L11568 Enteral Nutrition, LCD Policy Article A37077 Parenteral Nutrition