April 2009 Archives

April 30, 2009

New OIG Advisory Opinion Published

The Office of the Inspector General (the "OIG") posted new Advisory Opinion 09-03 on April 30, 2009, which concerns an arrangement whereby three municipalities reciprocally waive the otherwise applicable cost-sharing obligations of individuals residing within each other's borders when providing backup emergency medical services transportation.

Based on the facts presented, the OIG concluded that: (i) the Proposed Arrangement would not constitute grounds for the imposition of civil monetary penalties under section 1128A(a)(5) of the Act; and (ii) while the Proposed Arrangement could potentially generate prohibited remuneration under the anti-kickback statute, if the requisite intent to induce or reward referrals of Federal health care program business were present, the OIG would not impose administrative sanctions.

Favorable factors leading to the OIG's determination that the risk of the arrangement was minimal were as follows:

• First, the arrangement does not involve the routine waiver of cost-sharing obligations.

• Second, because the arrangement does not involve the provision of routine, non-emergency transportation services, but is instead limited to backup EMS transportation, it does not increase the risk of overutilization and is unlikely to lead to increased costs to Federal health care programs. Further, neither the number of Federal health care program beneficiaries requiring EMS transportation within the geographic limits of the Requestors, nor the treatment the beneficiaries receive or require, is related to the existence of the arrangement.

• Third, because each Requestor waives cost-sharing obligations when it provides EMS transportation, there is no expectation on the part of the individuals receiving the backup EMS transportation that they would have cost-sharing obligations. Therefore, Requestor's waiver of such obligations for the isolated instances in which it provides the backup EMS transportation is unlikely to induce the use of those or any other services.

• Finally, the underlying nature of the arrangement - including but not limited to: the fact that the waivers are not routine; the Requestors are local governments engaged in a mutual aid arrangement for backup EMS transportation; and the individuals receiving the waiver are, for all intents and purposes, simply being treated the same as any other individual in the Requestors' jurisdictions who receives EMS transportation - distinguishes it from arrangements in which a municipality requires a private company to bill "insurance only" as a condition of getting the municipality's EMS transportation business, including Medicare business.

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April 29, 2009

HHS Secretary Confirmed

The new Secretary of the Department of Health and Human Services ("HHS") has been confirmed. On Tuesday, April 28, 2009, by a vote of 65-31, the Senate confirmed Kansas governor Kathleen Sebelius as the new Secretary of HHS. Just hours later, in an Oval Office ceremony, Sebelius was sworn in.

As stated by the HHS website, HHS is "the United States government's principal agency for protected the health of all Americans and providing essential human services, especially for those who are least able to help themselves." Sebelius' first responsibility as Secretary will be to attend to the public health emergency involving swine flu.

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April 28, 2009

Electronic Health Records Bill Introduced

Electronic health records could become a reality sooner than expected for more users, if a recent bill, introduced by Democratic Senator Jay Rockefeller of West Virginia on April 23, 2009, is passed. The Health Information Technology Public Utility Act of 2009 would facilitate the nationwide adoption of open source-based electronic health records ("EHR"). According to the Senator's press release, Senate Bill 890 would create a new federal Public Utility Board, housed within the Office of the National Coordinator for Health Information Technology, to direct formation and ongoing operation of the Public Utility Model.

Additionally, the bill would administer a grant program for safety-net providers to cover the costs of developing and implementing open source software for up to five years (with possible renewal for five more); facilitate communication between open source user groups to encourage improvement; ensure compatibility between different programs, as well as integration with Medicaid and CHIP billing; create a child-specific EHR to be used with federal children's health programs; and develop performance measurements for the open source software.

According to Sen. Rockefeller, the bill builds on the successful use of 'open source' electronic health records by the Department of Veterans Affairs as well as the 'open source exchange model,' expanded among federal agencies through the Nationwide Health Information Network-Connect Initiative. The primary objective of the bill is the development of an open source implementation that would be completely free to users who want an EHR solution--especially small, rural users who can't afford a commercial option.

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April 27, 2009

The In-Office Ancillary Services Exception's Continued Relevance

The current legislative initiatives to restrict (or eliminate) the In-Office Ancillary Services Exception (the "IOASE") under Stark is, by no means, a new phenomenon. Rather, over the years, CMS has received a substantial number of comments from interested groups whose economic interests are adversely affected by the IOASE. In fact, the amendments to the Anti-Markup Rule (the "AMR"), effective 1/1/09 reflect a recognition by CMS that certain minor modifications to the rule are appropriate. In formulating the revisions to the AMR, CMS noted in the commentary that it had been asked to consider, but rejected, a wholesale elimination of the IOASE. Thus, although it is appropriate to include well-designed strategies to unwind the deal if regulatory changes make the structure economically unviable, the prospect of a near-term elimination of the IOASE is considered by industry insiders to be remote. A fuller exposition of the issue will be published in the June edition of Link (the monthly journal of AHRA, the Association for Medical Imaging Management).

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April 27, 2009

The Federal Stark Law and Anti-Kickback Statute Addressed in OIG's Open Letter Refining Self-Disclosure Protocol

In an Open Letter to health care providers published March 24, 2009, the Office of Inspector General ("OIG") refined its Self-Disclosure Protocol ("SDP") to resolve matters giving rise to civil monetary penalties ("CMPs") under the federal Stark law and Anti-Kickback Statute, initially addressed by way of Open Letter dated April 24, 2006.

In order to best allocate its enforcement resources, acknowledging that kickbacks "pose a serious risk to the integrity of the health care system, and deterring kickbacks remains a high priority," the OIG narrowed the SDP's scope related to the federal Stark law. Moving forward, the OIG will only accept disclosure of matters involving violations of the Anti-kickback Statute, and will not accept disclosures only involving federal Stark law violations (if the Anti-Kickback Statute is not implicated).

Additionally, following the date of the Open Letter (March 24, 2009), the OIG will require a minimum $50,000 settlement amount to resolve SDP submissions related to the Anti-Kickback Statute.

To access a copy of the Open Letter, please click here. To access a copy of the OIG's provider self-disclosure protocol, please click here.

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April 27, 2009

Changes to COBRA Included in Stimulus Package

The American Recovery and Reinvestment Act (the "Act" or "Stimulus Package") included important changes to the Consolidated Omnibus Reconciliation Act ("COBRA"). Generally speaking, COBRA allows workers who have lost employer-sponsored health insurance to retain coverage for a period of time. The Stimulus Package includes important provisions related to the cost of health insurance premiums.

Generally speaking, when an employer provides health insurance, the cost of the health insurance premium is covered in part by the employer and in part by the worker. Prior to the Act, when a worker lost his or her job and elected to receive health insurance through COBRA, the worker paid the full cost of the insurance coverage him- or herself. However, with the passage of the Act, in most cases if a worker was terminated between September 1, 2008 and December 31, 2009, the worker will be required to pay only 35 percent of the cost of the health insurance premium. The remaining 65 percent will be subsidized by the federal government.

Employers or their health plans must notify former workers of their right to pay reduced premiums for COBRA health insurance by April 18, 2009.

For more information about COBRA, please visit The U.S. Department of Labor website.

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April 27, 2009

Recovery Audit Contractors ("RACs") Authorized to Engage in Statistical Sampling

Recovery Audit Contractors ("RACs"), as other Medicare contractors, are authorized to audit only a small sample of a providers' or suppliers' records, and if the RACs find an overpayment, they will extrapolate the overpayment finding to the providers' or suppliers' patient population. If RACs engage in statistical sampling and extrapolation, RACs are entitled to keep their contingency fee based upon the extrapolation. Particularly since the RACs are limited in the amount of medical records they can audit per 45-day period, providers and suppliers must be aware of the risk for increasing use of statistical sampling and extrapolation.

Recently, the CMS website published a Frequently Asked Question related to this topic. Please click here to view the Frequently Asked Question, which states the following:


Will the RACs receive a full contingency fee for claims in which they utilize the extrapolation procedure outlined in the SOW?


Yes RACs will receive their full contingency fee for extrapolated claims.

Significantly, Section 935 of the Medicare Prescription Drug Improvement and Modernization Act of 2003 ("MMA") sets restrictions regarding when statistical extrapolation may be used, and the Medicare Program Integrity Manual (CMS Pub. 100-08) Chapter 3, §§ 3.10.1 through establishes guidelines for CMS to follow when performing an audit based upon a statistical sample. If an extrapolation is flawed, it may be successfully challenged, bringing the total dollars at issue to the "actual" alleged overpayment, and not the extrapolated alleged overpayment.

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April 27, 2009

Federal Stark Law Frequently Asked Question Addresses Lithotripsy

Generally speaking, the Federal Stark law makes it unlawful for a physician to refer Medicare or Medicaid patients for designated health services ("DHS") to an entity with which the physician (or an immediate family member) has a financial relationship, unless an exception applies. The Federal Stark law applies only to referrals of DHS.

Questions can arise when it is unclear whether a service constitutes a DHS under the law. To address one such situation, on January 22, 2009, CMS published a Frequently Asked Question ("FAQ") regarding lithotripsy services provided "under arrangements" with hospitals. The FAQ specifically asked:

Where a physician-owned lithotripsy partnership contracts with a hospital to provide a lithotripter and skilled technician "under arrangements," may the hospital pay for such services using a per-use or percentage-based compensation formula without violating the physician self-referral law?

In its answer, CMS explained that lithotripsy is not considered a DHS. As a result, if the physician owners refer to the hospital for lithotripsy services only, the Stark law would not be implicated. If, however, the physician owners of a lithotripsy partnership refer Medicare patients to the contracting hospital for any other DHS service, such as inpatient or outpatient hospital services, the arrangement would fall within the purview of the Stark law.

To access a copy of the FAQ, please click here.

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April 27, 2009

Michigan Medical Marijuana Process Begins April 6, 2009

The Michigan Medical Marijuana Program is set to begin April 6, 2009. Beginning on this date, patients may submit an application to participate in the Michigan Medical Marijuana Program.

Applicants must have a "debilitating" illness or condition, such as cancer, glaucoma, positive status for human immunodeficiency virus (HIV), acquired immune deficiency syndrome (AIDS), hepatitis C, amyotrophic lateral sclerosis, Chron's disease, Alzheimer's disease, or other diseases or treatments that produce cachexia, severe or chronic pain, severe nausea, seizures, or severe or persistent muscle spasms.

Applications must be accompanied by an application fee and a written certification signed by the patient's attending physician, indicating that the patient has a qualifying debilitating illness or condition. Applications will be reviewed within 15 days. If approved, a registry identification card will be mailed to the patient within five days.

For more information regarding the Michigan Medical Marijuana Program, please see http://www.michigan.gov/mdch/0,1607,7-132-27417_51869---,00.html.

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April 27, 2009

Non-Random Pre-Payment Medical Review Rule Finalized

The Centers for Medicare and Medicaid Services ("CMS") recently published a final rule addressing termination of non-random prepayment complex medical review, which became effective January 1, 2009. The final rule implements Section 934 of the MMA, which required CMS to establish termination dates for non-random prepayment complex medical reviews performed by Medicare Administrative Contractors ("MACs"), or performed by intermediaries and carriers until MACs are in place. CMS will impose the same limitations on medical reviews performed by program safeguard contractors, to ensure that consistent criteria for terminating non-random prepayment review are applied to all providers and suppliers.

The final rule mandates that, in most cases and unless an exception applies, CMS will terminate a provider or supplier from non-random pre-payment complex medical review no later than one year from the initiation of the review, or when the provider's or supplier's error rate decreases by 70 percent from the initial error rate.

The provisions of the final rule can be found at 73 Fed. Reg. 55753 (September 26, 2008). See also 42 C.F.R. §421.501 et seq.

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April 27, 2009

Health Law Partner Presents to Radiology Business Management Association

On March 31, 2009, Adrienne Dresevic, Esq., one of the founding shareholders of The Health Law Partners, P.C., presented to members of the Radiology Business Management Association ("RBMA") on the topic of "Regulations Impacting Healthcare Marketing." The presentation addressed the following healthcare legal topics:

• Federal Stark Law;
• Federal Anti-Kickback Statute;
• Civil Monetary Penalties Law;
• Independent Diagnostic Testing Facility ("IDTF") Regulations; and
• The Health Insurance Portability and Accountability Act ("HIPAA").

RBMA was founded in 1968 and is a radiology-specific business organization with over 2,200 members. According to its website, the mission of RBMA is to provide its members with information, resources, education and networking to run successful radiology businesses. Ms. Dresevic presented as part of the Building Better Radiology Marketing Programs conference. For more information regarding RBMA, please click here.

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April 27, 2009

Michigan Recovery Audit Contractor ("RAC") Provider Outreach Scheduled for April 10, 2009

The Medicare Recovery Audit Contractor Program ("RAC") program has been made permanent and is expanding nationwide, pursuant to Section 302 of the Tax Relief and Health Care Act of 2006. Medicare providers and suppliers in Michigan are some of the first in the country that will experience RAC audits and potential claim denials. Pursuant to CMS's most-recently published "Phase In Schedule," the RAC program expanded to Michigan March 1, 2009.

CGI Technologies and Solutions, Inc. ("CGI Technologies") is the RAC assigned to "Region B" - an area of the nation comprised of Michigan, Indiana and Minnesota. Before CGI Technologies begins auditing, on April 10, 2009, it will conduct a webinar presented by the Michigan State Medical Society. The purpose of the webinar is to provide education regarding RAC audits and RAC processes to Medicare providers and suppliers that may be soon subject to RAC audits. The webinar will be held from 9 a.m. to 12 p.m. EST.

The goals of the RAC program are to identify and correct improper Medicare payments made to providers. RACs are compensated on a contingency-fee basis, based upon the principal amount collected from and/or returned to Medicare providers and suppliers. Thus, the RACs are highly incentivized to identify improper payments. CMS advises, on its website, that before RAC auditing begins, providers and suppliers should ensure that submitted claims meet Medicare rules. For more information on the RAC program, please click here.

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April 27, 2009

Recovery Audit Contractor ("RAC") Program Challenged by Hospital System

The Medicare Recovery Audit Contractor ("RAC") program is being challenged by the two San Diego, California-based hospitals of Palomar Pomerado Health ("Palomar"). In a complaint filed against the Department of Health and Human Services ("HHS") on March 27, 2009, Palomar alleged that PRG Schultz International, Inc. ("PRG Schultz"), the RAC operating in California during the RAC demonstration program, failed to follow appropriate procedures when reopening a certain claim, in violation of Federal regulations.

Specifically, the complaint alleges that, contrary to the provisions of 42 C.F.R. § 405.880, PRG Schultz unlawfully failed to demonstrate good cause for reopening a claim that was reopened after one year from the date of favorable initial determination. Pursuant to 42 C.F.R. § 405.980 (b): "A contractor may reopen and revise its initial determination or redetermination on its own motion - ... (2) [After one year and] [w]ithin 4 years from the date of the initial determination or redetermination for good cause..."

The complaint further alleges that a recent Medicare Appeals Council ("MAC") decision, finding that Administrative Law Judges do not have jurisdiction to consider whether claims were reopened appropriately, was wrongfully decided.

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April 27, 2009

Stark, Anesthesia and the Federal False Claims Act

A recent Federal appeals court decision paved the way for a whistleblower to proceed with a False Claims Act ("FCA") case involving allegations of Stark and Anti-kickback Statute violations regarding an exclusive anesthesia coverage agreement and pain management services arrangement. This case is important as it highlights how courts and enforcement officials may apply Stark to common anesthesia and pain management arrangements.

The whistleblower was a former partner of an anesthesiology group. The anesthesia group had entered into an exclusive anesthesia services agreement with a hospital. The written agreement provided that:
• The group would provide 24/7 exclusive anesthesia coverage for hospital's patients;
• The hospital, at no charge, would provide space, equipment, personnel and supplies necessary for the group to provide the anesthesia services to the hospital's patients;
• The group would use the personnel, space, equipment, and supplies provided by the hospital solely for the practice of anesthesiology and pain management on the hospital's patients; and
• The group would not practice anesthesia or pain management at any location other than the hospital.

Approximately six years later, the hospital built a stand-alone facility, containing a pain clinic. Upon opening of the pain clinic, the anesthesia group provided pain management services at the clinic and the hospital did not charge the group rent for the space and equipment, or a fee for the support personnel provided to the group. As with the anesthesia services, the group submitted claims for the professional pain management services and the hospital submitted claims for the facility component. There was not a separate written agreement between the parties for this pain clinic arrangement.

A Federal appeals court found that the hospital's pain management arrangement with the group failed to meet the requirements of the Stark law, as the exclusive anesthesiology agreement did not cover the pain management services provided at the pain clinic.

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April 27, 2009

OIG, Medicare Payments and Pain Management Procedures

As part of the OIG 2008 Work Plan, the OIG reviewed Medicare payments for interventional pain management procedures in connection with Section 1862(a)(1)(A) of the Social Security Act, which requires that services must be medically necessary. The OIG noted that interventional pain management was a growing specialty and that Medicare paid almost $2 billion for interventional procedures in 2005. The review was to focus on the appropriateness of payments for the procedures.

In September of 2008, the OIG issued a report on "Medicare Payments for Facet Joint Injection Services" wherein they found that 63% of facet joint injection services allowed by Medicare in 2006 did not meet Medicare program requirements, resulting in $96 million in improper payments. Based on the review, the OIG recommended that CMS should:

1. Strengthen program safeguards to prevent improper payment for facet joint injections;
2. Clarify billing instructions for bilateral services; and
3. Take appropriate action regarding the undocumented, medically unnecessary, and miscoded services identified in the sample.

Of particular note, CMS agreed with the OIG recommendation to clarify instructions and to take appropriate action on services paid in error in the sample.

This report highlights the importance of compliance in the pain management arena as pain management procedures may continue to be a focus of potential scrutiny in 2009. Given the report findings, pain management physicians may also experience Medicare auditing activity with regard to facet joint injections and/or other pain management procedures. You can obtain a copy of the OIG report by visiting www.oig.hhs.gov/oei/reports/oei-05-07-00200.pdf

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April 27, 2009

The Red Flag Rules and Health Care Providers

As the "Red Flag Rules" enforcement date of May 1, 2009 quickly-approaches, health care providers need to get prepared. The Red Flag Rules require financial institutions and "creditors" to develop and implement identity theft prevention programs that provide for identification, detection, and response to patterns, practices or specific activities (known as red flags) that could indicate identity theft. Although enforcement was initially slated for November 2008, the Federal Trade Commission suspended enforcement until May 1, 2009 to give creditors, which may include many health care providers, additional time to develop and implement their identity theft programs.

Many health care providers including physicians and hospitals were surprised to learn that they could be subject to the Red Flag Rules. The FTC regulation defines a creditor as an entity that regularly extends, renews, continues credit or arranges for the extension of credit. The FTC would include a health care provider in this definition if the provider does not regularly demand payment in full for services at the time of service, which according to the FTC would be considered extending credit. If the provider is a creditor, the next step is to determine whether the provider maintains covered accounts of its patients. This would include consumer accounts designed to accept multiple payments and other accounts that would have a reasonably foreseeable risk of identity theft. In summary, it appears that the FTC's position is that health care providers are subject to the Red Flag Rules if they extend credit to a consumer/patient by establishing an account that permits multiple payments (e.g., a payment plan). You can learn more about the Rules by visiting the Federal Trade Commission website at www.ftc.gov.

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April 27, 2009

Medicare "Incident To" Services Under Continued Scrutiny

According to the Office of Inspector General ("OIG") 2009 Work Plan, "incident to" services continue to be an area of scrutiny. The OIG is currently reviewing this billing area and expects to issue a report of its findings in 2009.

In summary, in order to bill "incident to" services, the services must be integral to the physician's service, performed by a person who is paid by the physician and who is under the direct supervision of the physician. The services must also be performed in a non-institutional setting. Direct supervision requires that the physician be on the premises in the "office suite" while the services are being performed. It is not appropriate to bill "incident to" services on a first patient visit as the physician must initiate a course of treatment during which the incident to services are performed. It is also important to keep in mind that the physician must be actively involved in the patient's treatment course and thus the physician's involvement in subsequent visits should be documented. For those physicians utilizing the "incident to" billing rules, it is important to establish careful documentation practices to support fulfillment of the requirements. Depending on the circumstances (e.g., type of ancillary provider), other billing options may be available if the practice is unable to meet the "incident to" requirements. For example, if a nurse practitioner is performing the service, this may include the submission of a claim under the provider number of the nurse practitioner.

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April 27, 2009

HITECH Act - HIPAA Privacy and Security Expanded by the Stimulus Bill

The Health Information Technology for Economic and Clinical Health Act ("HITECH Act" or the "Act") included in the "Stimulus Bill" significantly expands HIPAA privacy and security provisions. Health care organizations and providers may be interested in some of the critical aspects of the HIPAA privacy and security portions as follows:

• Required Notification for Information Breaches:

Effective 30 days after the Secretary of the Department of Health and Human Services ("HHS") publishes interim final regulations (which regulations are due within 180 days from the enactment of the legislation), covered entities and business associates will be required to follow certain notification protocols when a person's unsecured protected health information has been breached. This includes individual notification to consumers and, depending on the number of individuals whose information is involved, media notification. Notification must also be made to the Department of HHS immediately if the breach involves 500 or more individuals. If the breach involves less than 500 individuals, the provider can maintain such information on a log, which must be provided annually to HHS.

• Required Accounting of Disclosures Involving Electronic Health Records:

As many providers are aware, under the current HIPAA regulations providers need not provide individuals with an accounting of disclosures of their health information if the disclosure is related to treatment, payment activities or health care operations ("TPO") of the provider. Although the implementation date is set into the future, under the HITECH Act, providers who use or maintain electronic health records will be required to account for TPO disclosures. In such cases however, the accounting period is limited to three (3) years prior to the date on which the accounting is requested. The Act directs the Secretary of HHS to implement regulations on what information has to be collected about each disclosure. The effective dates for this new requirement are dependent upon whether the provider acquired an electronic record as of January 1, 2009 or after January 1, 2009.

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April 27, 2009

Are Mandated Compliance Programs A New Trend?

New York Medicaid Inspector General Mandates Compliance Programs

Although compliance programs have traditionally been viewed as voluntary, on January 14, 2009, the Office of Medicaid Inspector General issued proposed regulations mandating the establishment and maintenance of compliance programs for many Medicaid participating providers. In addition to applying to certain providers like hospitals and hospices, the regulations include physician practices to the extent the medical assistance program is or should be reasonably expected by a physician practice to be a substantial portion of their business operations. Substantial portion of business operations includes collections of $500,000 for a consecutive 12-month period as well as providers who claim or are expected to claim at least $500,000 in a consecutive 12-month period from the New York medical assistance program. It is not clear as to meaning of "claim"; however, an inquiry has been submitted to the regulators requesting clarification on this issue. While this particular regulation only applies to New York providers, you should continue to monitor regulatory activities in your state to determine whether the mandating of compliance programs will be a trend with regard to Medicaid programs. This new proposed regulation, along with the expected increase in Medicare auditing for 2009, continues to highlight the importance of physician groups (as well as other health care providers like hospices, DME suppliers and others) maintaining active compliance programs.

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