Monday, April 5, 2010

Health Care Reform Requires Immediate and Longer Lead Time Changes Regarding CT, MRI and PET Scans

As we continue to review the recently enacted Patient Protection and Affordable Care Act, what is immediately striking is the broad range of regulatory requirements that will impact health care providers. Some of these requirements will not go into effect for a year or more. However, one requirement that became effective immediately upon the President signing the bill relates to in-office referrals for CT, MRI or PET scans. The Act requires a physician who refers an individual for CT, MRI or PET (which is being provided under the in-office ancillary services exception to the Stark Law) to “inform the individual in writing at the time of the referral that the individual may obtain the services for which the individual is being referred from a person other than” the referring physician or medical practice. In addition, any medical practice providing these diagnostic imaging services must “provide [their patient] with a written list of suppliers (as defined in section 1861(d)) who furnish such services in the area in which such individual resides.”

Again, this requirement is now in effect. Be aware that another recent change regarding CT, MRI and PET will soon impact health care providers. As required by the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA), by Jan. 1, 2012, all suppliers of the technical component of advanced diagnostic imaging procedures must be accredited by an accreditation organization designated by the Secretary of Health and Human Services. MIPPA specifically defines advanced diagnostic imaging procedures as including diagnostic CT, MRI and PET scans.

The accreditation requirement applies to physicians, non-physician practitioners, and physician and non-physician organizations that are paid for providing the technical component of advanced imaging services under the Medicare Physician Fee Schedule. The accreditation requirement will apply only to the suppliers furnishing the imaging services, and not to the physician’s interpretation of the images.

CMS has designated three national accreditation organizations – the American College of Radiology (ACR), the Intersocietal Accreditation Commission (IAC), and The Joint Commission (TJC) - to accredit suppliers furnishing the technical component of advanced diagnostic imaging procedures.

CMS has promised to issue further guidance to suppliers about meeting the accreditation requirements. CMS plans to undertake a provider education outreach program to ensure that all affected suppliers understand the requirements and are able to comply with them prior to the Jan. 1, 2012 accreditation deadline.

Thursday, February 4, 2010

As of February 22, Comply with HIPAA Breach Notification Rules or Face Sanctions

The HITECH (“Health Information Technology for Economic and Clinical Health”) Act enacted last February imposed obligations on health care providers to notify patients if their protected health information was used or disclosed in a manner not permitted by HIPAA’s Privacy Rule. The U.S. Department of Health and Human Services published regulations which took effect in September 2009 specifying when and how providers have to notify patients of HIPAA breaches as well as recordkeeping requirements regarding reported HIPAA violations. When it published these “breach notification” regulations, HHS stated it would delay imposing sanctions for failure to comply with the regulations until February 22, 2010. So now is the time to familiarize yourself with the HITECH Act’s breach notification rules to avoid the prospect of hefty sanctions, ranging from a minimum of $10,000 up to $50,000 per violation, for willful neglect of the regulatory requirements.

Basically the breach notification rules require a health care provider to notify a patient if his/her protected health information (PHI) has been acquired, accessed, used or disclosed in a manner not permitted under HIPAA’s Privacy Rule which “poses a significant risk of financial, reputational, or other harm to the individual.” The form and manner of notification required under the regulations vary depending on whether a breach involves the PHI of fewer or more than 500 patients. There are certain good faith exceptions to the requirement to notify patients of PHI breaches.

The breach notification rules also require reporting of PHI breaches to HHS under certain circumstances, and impose an obligation on health care providers to document alleged HIPAA violations as well as the provider’s determination as to whether a breach occurred for purposes of the breach notification rules.

The key to compliance with the breach notification rules is establishing a procedure for receiving information about alleged HIPAA violations, evaluating whether a purported violation constitutes a breach for purposes of the notification rules, and documenting whether and how notification was provided. All documentation related to this procedure should be maintained in one location, preferably by one individual, in your practice. With February 22 just days away, it’s time to understand the HITECH breach notification rules and establish a procedure for complying with them.

Friday, October 2, 2009

The OIG issues its 2010 Work Plan

The Office of Inspector General (“OIG”) has issued its Work Plan for fiscal year
(FY) 2010. (The effective date is October 8, 2009.) The OIG issues a Work Plan each year that describes activities that the agency plans to initiate or continue with respect federal health care programs. The full document can be located at the following link. http://oig.hhs.gov/publications/docs/workplan/2010/Work_Plan_FY_2010.pdf


However, A quick review of the Work Plan yielded the following observations.

Sleep Studies-According to the Work Plan, Medicare payments for polysomnography increased from $62 million in 2001 to $215 million in 2005. So the OIG will examine the factors contributing to the rise in Medicare payments for sleep studies, as well as the appropriateness of Medicare payments for sleep studies.

Epidural Injections-According to the Work Plan, Medicare Part B physician claims for transforaminal epidural injections increased by 130 percent between 2003 and 2007. So the OIG will review Medicare claims to determine the appropriateness of Medicare Part B transforaminal epidural injections as an interventional technique to diagnose or treat back problems.

Use of the GY modifier-We have always been under the impression that many medical practices are unaware of the GY modifier, which is to be used for coding services that are statutorily excluded or do not meet the definition of a covered service. Apparently the code is more widely used than we believed. According to the OIG, in FY 2008, Medicare received over 75.1 million claims with a modifier GY totaling approximately $820 million. The OIG plans to examine patterns and trends for physicians’ and suppliers’ use of modifier GY.

Independent Diagnostic Testing Facilities-Not surprisingly, IDTFs remain an area of concern for the OIG. A 2006 OIG review raised concerns with IDTFs, and suggested that Medicare had made improper payments of $71.5 million to IDTFs. With overutilization on everyone’s minds these days, it is not surprising that the OIG plans to review services and billing patterns in geographic areas with high concentrations of
independent diagnostic testing facilities (IDTF).

X-Rays in Hospital Emergency Departments-Yet another recurring issue involves Medicare Part B claims for diagnostic x-rays performed in hospital emergency departments. According to the Work Plan, in 2007, Medicare reimbursed physicians approximately $207 million for imaging interpretations performed in emergency departments. The OIG plans to determine the appropriateness of payments for diagnostic x rays and interpretations.

As far as the OIG’s planned activities regarding Medicaid are concerned, drugs, drugs and more drugs. Among the issues the OIG plans to review are: Timely Submission of Average Manufacturer Price Data, Calculation of Average Manufacturer Prices, Recalculation of Base Date Average Manufacturer Prices, Rebates of Brand-Name Drugs, and several others.

However, the OIG also plans to review Medicaid payments for dental care. According to the OIG, in 2007, Medicaid costs for dental services totaled more than $3 billion. So it appears that the audits of dental practices providing care to Medicaid beneficiaries will continue.

Wednesday, September 9, 2009

The Office of Inspector General sets its sights on hospice care in nursing homes

On September 8, 2009, the Office of Inspector General posted an eye-catching report on Medicare hospice care in nursing facilities. The OIG found that 82 percent of hospice claims for beneficiaries in nursing facilities did not meet at least one Medicare coverage requirement. The Medicare hospice benefit allows a beneficiary with a terminal illness to forgo curative treatment for the illness and instead receive palliative care. Medicare paid approximately $1.8 billion for these claims.

We have long subscribed to the belief that predicting where the government will focus its investigative resources is as simple as determining where the government feels it has the best chances of recovering overpayments. Based on the results of this report, we anticipate the government will be even more focused on monitoring compliance with hospice coverage requirements. According to the OIG report, studies suggest that the use of hospice care has grown most rapidly in nursing facilities. Skilled nursing homes, hospice care providers and the doctors who certify terminal illness requirements should read the report (http://www.oig.hhs.gov/oei/reports/oei-02-06-00223.pdf) and monitor their compliance with Medicare coverage requirements.

The report identifies several ways that hospice and skilled nursing providers frequently fail to meet Medicare coverage requirements. Eighty-one percent of claims did not meet at least one Medicare coverage requirement pertaining to election statements, plans of care, services, or certifications of terminal illness. In thirty-one percent of claims, hospices provided fewer services than outlined in beneficiaries' plans of care. Significant to the physicians who certify compliance, four percent of claims did not meet certification of terminal illness requirements.

Reports like the one issued by the OIG this week signal the existence of a well-stocked pond to folks who like to fish for False Claims Act cases. Government investigators and whistleblowers are likely to cast their lines in these waters. It is a good time for health care providers engaged in hospice care to carefully review their compliance with hospice coverage requirements and take the steps necessary to ensure compliance.

Thursday, July 30, 2009

New Amendments to the Delaware False Claims Act May Signal More Claims Against Health Care Providers

After more than two years of trying to pass a law amending Delaware’s False Claims and Reporting Act, the House and the Senate were finally able to pass a bill in the last days of the recent legislative session. Governor Jack Markell signed the bill into law late last week. The amendments to the Act provide the State enhanced financial incentives for pursuing False Claims Act recoveries. Accordingly, we expect the Delaware Department of Justice Medicaid Fraud Control Unit to step up its False Claims Act recovery efforts.

The changes to Delaware’s False Claims and Reporting Act were brought about by the federal Deficit Reduction Act of 2005, which contained provisions that created incentives for states to enact anti-fraud legislation modeled after the federal False Claims Act. The primary incentive offered by the federal government was an increased percentage of any False Claims Act recovery, meaning the State of Delaware would receive an additional 10% of any False Claims Act recovery if it brought its Act into compliance.

It took the General Assembly over two years (and several versions) to enact a bill.

The delay was in large part due to effective lobbying efforts of several organizations representing the interests of Delaware health care providers. As a result of their work, the current bill appears to meet the requirements of the Deficit Reduction Act of 2005, but does not contain several provisions that the Delaware Department of Justice (“DOJ”) had proposed.

Gone from the bill is the controversial provision creating a DOJ False Claims Act Litigation Fund that would have required the accused to finance the costs of the government’s investigation. Also removed from the final version of the bill was a section giving the DOJ broad investigative powers that would have permitted it to demand records without any requirement of demonstrating cause.

The new bill imposes an annual reporting obligation on the DOJ. Each year the DOJ will have to report, among other things, the number of cases filed under the Act during the previous calendar year and the total amounts recovered. We will now be able to see whether the enhanced financial incentives will generate more filings against health care providers.

Wednesday, July 1, 2009

Turning up the HEAT on health care fraud

The United States Department of Justice and the U.S. Department of Health & Human Services have created an interagency team – the Health Care Fraud Prevention and Enforcement Action Team (“HEAT”) – to increase both fraud detection and fraud prevention.

Significant to Delaware health care providers, HEAT will work with State Medicaid officials to conduct provider audits and monitor activities to detect fraudulent activities. HEAT has announced that it will use modern technology to complete in a matter of days analysis of electronic evidence that previously took months to analyze using traditional investigative tools.

Perhaps most significant among the announced HEAT initiatives is a new focus on using criminal prosecutions as a deterrent against health care fraud. Already, HEAT has announced filing criminal charges against 53 doctors for alleged fraud.

Additional HEAT initiatives include increasing compliance training for Medicare providers, improving communication between CMS and law enforcement, and focusing on suppliers of durable medical equipment. HEAT is also asking the public to get involved in the fight against fraud and has created a Web site (www.hhs.gov/stopmedicarefraud) and a tip line for reporting suspected fraud.

The joint announcement of the HEAT initiatives by Attorney General Holder and HHS Secretary Sebelius underscore the Obama administration’s commitment to health care fraud enforcement.