Category: Employment Law

Obamacare is a Game-Changer for Extra Income Earned By Doctors

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Penalties, Fines and Adverse Consequences Doctors should know about before Entering into PODS, Consulting Agreements and other Arrangements with Medical Device Manufacturers and Pharmaceutical Companies

The U.S. market size for orthopedic medical device R&D is estimated to be $1.3 billion in 2011, corresponding to 8% of market revenues[1]. The aging population and expanded medical insurance coverage has resulted in a growing profitability of the orthopedic implant market.   It is not unusual for a new medical device company to realize 30% annual growth and 30% – 35% EBITDA.[2]

Prior to the implementation of the Affordable Care Act, which is commonly known as “Obamacare”,  manufacturers created a fake  research and development market using programs that had no intrinsic value to the companies or the patient population to bribe doctors with extra income gained from supposedly participating in the programs. In reality, the payments compensated the doctors for prescribing for patients the devices made by the bribing manufacturer. The bribes were disguised by:  the use of supposed consulting assignments; memberships on “medical advisory committees” set up by the manufacturers, royalties on contributions to minor, but insubstantial changes to the company’s products that were not needed except to fabricate an ostensibly legal  basis for compensating  the company’s doctor-customers; and other even more aggressive programs.

The  Hammer will be coming down on the blatantly illegal PODS

Beginning in around 2008, the entities that made and marketed orthopedic medical devices seduced doctors to become owners of their own distribution companies in an entity known as a “Physician Owned Distributor” or “POD”. This scheme put money directly into the hands of the doctors as a reward and incentive for the doctors’ efforts to boost sales of the participating manufacturer’s medical devises.

Here is how the POD’s typically work. Assume we have a manufacturer of orthopedic medical devices, known in our example as “Device-Co”; and assume also that Device-Co focused on spinal implants that were prescribed by spine surgeons. Device-Co approached a spine surgeon (whom we will call “Dr. Smith”), and offered to help Dr. Smith set up the Smith-POD – which would then be appointed as an independent sales representative to sell Device-Co’s spinal implants in the city were Dr. Smith had his surgical practice (“Practice City”). In this scenario, there would be one potential hurdle. Under existing federal conflict of interest laws and regulations on the books since the 1990’s, Dr. Smith could not be a buyer or prescriber of any medical device made by Device-Co. However, there was a ready (although highly suspect) solution:  Device-Co had made separate informal (and not written down) deals with “Competitor-Co,” one of its competitors that was similarly sponsoring spinal surgeons to set up PODS to sell products manufactured by Competitor-Co . We will assume for purposes of our example that Competitor-Co convinced Dr. Wilson, another spine surgeon in Practice City, to establish the Wilson-POD  to distribute spinal implant products made by Competitor-Co.

Under the POD business model, Dr. Smith would prescribe only spinal implants made by Competitor-Co that he purchased from the Wilson-POD . In return, Dr. Wilson would prescribe only spinal implants made by Device-Co that he purchased form the Smith-POD. Each of the spine surgeons would make a commission on the sales generated by his POD, and the two cooperating spinal implant manufacturers would insure that no other competitor selling spinal implant products could break into this market, no matter how good their products might be, or how much more reasonable their pricing. Under this scheme, Device-Co and Competitor-Co were happy to pay hefty sales commissions that otherwise would be paid to the support personnel anyway.

The Office of Inspector General says “No” to PODs

The Unites States Department of Health and Human Services Office has within its organization a body known as of the Office of Inspector General (OIG) that is charged, along with other federal and state regulators, to identify and stop conflicts of interest and schemes that potentially could entice a doctor to prescribe a product, not because it was the most effective device at the best price, but because the doctor had a collateral financial interest in the sale. Since most implant operations in hospitals have some subsidy provided by the federal government through Medicare, Medicaid, the Veterans Administration network and similar programs, schemes that inflate the cost of implant products or that deter the doctor from acting on his best medical judgment are deemed a fraud on the US government.  The OIG, has already  identified  many of the compensation arrangements are directly correlated to the surgeons’ selection of medical devices, and therefore illegal, and the chief offender are PODs.[3]

In June 2011, five US senators requested that the OIG investigate the legality of PODs.  This prompted the Affordable Care Act (‘ACA”) to vastly increase the funding for the OIG  and other federal watchdogs under the Health Care Fraud and Abuse Control program, the Medicaid Integrity Program, and the American Recovery and Reinvestment Act of 2009. The OIG investigations are not limited to device manufacturers since money has been allocated to 50 Medicaid Fraud Control Units for investigation and prosecution of criminal and civil actions against physicians and other  Medicaid providers  who may have committed patient fraud.[4] Moreover section 6002 of the ACA—the Physician Payment Sunshine Act—requires HHS to create and  operate a “sunshine” database of information disclosed by applicable manufacturers of all  financial relationships with physicians and hospitals. This means that the law requires every POD to be disclosed to HHS.

In addition, the states are now getting into the act. For example, New Hampshire has pending legislation designed to end PODs that provides,

A health care practitioner, including an immediate family member, shall not:  Enter into a contract or business arrangement with another entity where the purpose or effect of the contract or business arrangement is to accomplish prohibited self-referrals indirectly, such as through the use of a third party, or through the use of a cross-referral agreement. Such prohibited contracts or business arrangements shall include any arrangement that requires or has the purpose or effect of causing the purchase of such medical devices from a specific supplier as a condition of, or incident to the provision of medical care by the health care practitioner.[5]

Are there any legal ways for doctors to make money from device manufacturers?

The short answer is “yes”. The ACA is tough, but it has loopholes that allow medical device manufacturers to enter into arrangements that ultimately provide payments to surgeons who prescribe their products. The method of complying with the law may seem like a maze, but there are now institutions that were established to allow doctors to continue to earn income form non-clinical duties and to be in full compliance with the law.

Sidkoff, Pincus & Green P.C. has worked with many of  its physician clients as well as clients in the chain of medical device manufacturing and distribution to help create alternatives to the now infamous PODs and several other discredited schemes that were popular before passage of the HCA. If you have any interest in learning of our work in this area, feel free to contact us by visiting our web site: www.greatlawyers.com.

[1] Current 10Ks at Feb 2011: Stryker, Zimmer, Biomet indicate 8% of sales spent on R&D

[2] Globus Medical Devices is one such example, surpassing $100 million in sales within 5 years.

[3] The Department of Health and Human Services and The Department of Justice Health Care Fraud and Abuse Control Program Annual Report for Fiscal Year 2009.

[4] Medicaid Integrity Program Report, the HHS Office of Inspector General

[5] New Hampshire,  HOUSE BILL 1725-FN

 

Retaliation Claims under the Federal False Claims Act

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Section 3730(h) of the False Claims Act prohibits retaliation against an individual asserting a violation of the Act.  The statute provides: “Any employee, contractor, or agent shall be entitled to all relief necessary to make that employee, contractor, or agent whole, if that employee, contractor, or agent is discharged, demoted, suspended, threatened, harassed, or in any other manner discriminated against in the terms and conditions of employment because of lawful acts done by the employee, contractor, agent or associated others in furtherance of an action under this section or other efforts to stop one or more violations of this subchapter.” 31 U.S.C. Section 3730(h).  This is known as the anti-retaliation provision of the False Claims Act.

To establish a claim under Section 3730(h), a plaintiff must show “(1) he engaged in protected conduct, (i.e., acts done in furtherance of an action under Section 3730) and (2) that he was discriminated against because of his protected conduct.”  U.S. ex rel. Hefner v. Hackensack Univ. Med. Ctr., 495 F.3d 103, 110 (3d Cir. 2007).  “For a plaintiff to demonstrate that he was discriminated against because of conduct in furtherance of a False Claims Act suit, a plaintiff must show that (1) his employer had knowledge he was engaged in protected conduct; and (2) that his employer’s retaliation was motivated, at least in part, by the employee’s engaging in protected conduct.” Id. at 111. 

Section 3730(h) protects a wide variety of conduct, including investigation for, initiation of, testimony for, or assistance in bringing a claim under the False Claims Act.  Campion v. Ne. Utilities, 598 F. Supp. 2d 638, 648 (M.D.Pa. 2009).  Determining what activities constitute protected conduct under the statute is a fact specific inquiry.

If you think you might be a victim of retaliation for asserting a violation of the False Claims Act, please contact the experienced lawyers at Sidkoff, Pincus & Green in Philadelphia, who are licensed to practice law in all courts in Pennsylvania and New Jersey.

Protection for Employees who are Retaliated against for Refusing to Work under Unsafe Conditions

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Section 11(c) of the Occupational Safety and Health Act of 1970 (“Act”), at 29 U.S.C. § 660(c), offers protection to employees who face retaliation for refusing to work in the face of imminent danger.  Section 11(c) of the Act renders the discrimination against or discharge of an employee for exercising “any right” protected under the Act unlawful. 29 U.S.C. § 660(c)(1). The Secretary of Labor promulgated a regulation, codified at 29 C.F.R. § 1977.12, defining certain “rights” which, although not delineated by Section 11(c), are protected under the Act. One such protected right, codified at 29 C.F.R. § 1977.12(b)(2), is an employee’s right to refuse to work under conditions the employee apprehends will subject him to serious injury or death.

By virtue of this regulation, where an employee is confronted with a choice of not performing an assigned task or performing the task under apprehension of serious injury or death, Section11(c) protects from subsequent discrimination or discharge the employee who, having no reasonable alternative, refuses to perform the assigned task. The employee’s apprehension of serious injury or death is measured by the standard of a reasonable person under the circumstances. To establish a violation of Section 11(c) the employee’s engagement in protected activity need not be the sole reason for the subsequent discharge but “a substantial reason for the action” or if the discharge “would not have taken place `but for’ engagement in protected activity.” 29 C.F.R. § 1977.6(b)

An employee who is retaliated against for complaining about workplace safety or refusing to work in the face of imminent danger must file a complaint with OSHA within 30 days of the retaliation.  The attorneys at Sidkoff, Pincus & Green, located in Philadelphia, Pennsylvania, are experienced in drafting such complaints.  If you have experenced employment retaliation, please feel free to contact an attorney at Sidkoff, Pincus & Green via email ([email protected]) or by phone at (215) 574-0600.

The Qui Tam Action under the Federal False Claims Act: Brief Overview

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“Qui tam” is the process by which an individual sues or prosecutes in the name of the government and shares in the proceeds of any successful litigation or settlement.  The name “qui tam” comes from the shortened version of a Latin phrase which roughly translates to “he who prosecutes for himself as well as for the King.”

The False Claims Act provides, inter alia: “Any person who (a) knowingly presents, or causes to be presented, a false or fraudulent claim for payment or approval; [or] (b) knowingly makes, uses, or causes to be made or used, a false record or statement material to a false or fraudulent claim…is liable to the United States Government for a civil penalty of not less than $5,000 and not more than $10,000…plus 3 times the amount of damages which the Government sustains because of the act of that person[.]”  31 U.S.C. Section 3729(1)(a), (b).

Section 3730 of the False Claims Act sets forth that a private person may bring a civil action for a violation of Section 3729 for the person and for the United States Government.  31 U.S.C. Section 3730(b)(1).  The private person is known as a “Relator.”  The Government may elect to intervene and proceed with the action within 60 days after the Relator provides a copy of the Complaint and a written disclosure of substantially material evidence and information the Relator possesses.  31 U.S.C. Section 3730(b)(2).

The statute provides substantial rewards to a qui tam plaintiff.  Under Section 3730(d): “If the Government proceeds with an action brought by a person under subsection (b), such person shall…receive at least 15 percent but not more than 25 percent of the proceeds of the action or settlement of the claim, depending upon the extent to which the person substantially contributed to the prosecution of the action.”  31 U.S.C. Section 3730(d)(1).  “If the Government does not proceed with an action under this section, the person bringing the action or settling the claim shall receive an amount which the court decides is reasonable for collecting the civil penalty and damages.  The amount shall be not less than 25 percent and not more than 30 percent of the proceeds of the action or settlement and shall be paid out of such proceeds.  Such person shall also receive an amount for reasonable expenses which the court finds to have been necessarily incurred, plus reasonable attorneys’ fees and costs.  All such expenses, fees, and costs shall be awarded against the defendant.”  31 U.S.C. Section 3730(d)(2).

If you have knowledge of a violation under the False Claims Act and seek more information about bringing a qui tam action, please contact the experienced lawyers at Sidkoff, Pincus & Green in Philadelphia, who are licensed to practice law in all courts in Pennsylvania and New Jersey.

Hostile Work Environment Claims under Title VII – Brief Overview

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Title VII of the Civil Rights Act makes it “an unlawful employment practice for an employer…to discriminate against any individual with respect to his compensation, terms, conditions, or privileges of employment, because of such individual’s race, color, religion, sex or national origin.”  42 U.S.C. Section 2000e-2(a).  This provision further protects against discrimination that creates a hostile work environment.

To establish a hostile work environment claim under Title VII, a plaintiff must show: (1) he/she suffered intentional discrimination because of his/her membership in a protected class; (2) the discrimination was pervasive and regular; (3) the discrimination detrimentally affected him/her; (4) the discrimination would have detrimentally affected a reasonable person similarly situated in that protected class; and (5) there is a basis for employer liability.  Saidu-Kamara v. Parkway Corp., 155 F.Supp.2d 436 (Ed.Pa. 2001).

The discrimination complained of must be severe and/or pervasive enough to alter the conditions of the plaintiff’s employment and create an abusive working environment.  In determining whether a plaintiff has demonstrated the elements of a hostile work environment, a court will consider the frequency of the discrimination, its severity, whether it is physically threatening or a mere offensive utterance, and whether it reasonably interferes with the plaintiff’s work performance.  Id.

If you think you might be a victim of a hostile work environment, please contact the experienced lawyers at Sidkoff, Pincus & Green in Philadelphia, who are licensed to practice law in all courts in Pennsylvania and New Jersey.

Retaliation Claims under Title VII – Brief Overview

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Title VII of the Civil Rights Act provides: “It shall be an unlawful employment practice for an employer to discriminate against any of his employees…because he has opposed any practice made an unlawful employment practice by this subchapter, or because he has made a charge, testified, assisted, or participated in any manner in an investigation, proceeding, or hearing under this subchapter.”  42 U.S.C. Section 2000e-3(a).  This is known as Title VII’s “anti-retaliation” provision.

To establish a claim for retaliation under the anti-retaliation provision, a plaintiff must demonstrate: (1) she engaged in “protected activity” under Title VII; (2) the employer took an adverse employment action against her; and (3) there was a causal connection between her participation in the protected activity and the adverse employment action.  Moore v. City of Philadelphia, 461 F.3d 331 (3d Cir. 2006).

Under the “protected activity” prong, Title VII protects those who participate in certain Title VII proceedings, or those who oppose unlawful discrimination practices.  The plaintiff must have a good faith belief that the conduct that she opposes is unlawful.

Adverse employment actions can take many forms including, but not limited to, termination, demotion, suspension, or even reassignment to a less desirable job.

If you think you might be a victim of retaliation under Title VII, please contact the experienced lawyers at Sidkoff, Pincus & Green, who are licensed to practice law in all courts in Pennsylvania and New Jersey.

Whistleblower Protection for Employees under the Surface Transportation Assistance Act

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1. Employees and Employers Covered

To be an employee covered under the Surface Transportation Assistance Act (STAA), one must be a driver of a commercial motor vehicle (including independent contractors), a mechanic, a freight handler, or an individual that is not an employer who is involved in activities directly affecting commercial motor vehicle safety or security. Employees of public transportation agencies or general railroads are not covered under this Act. Commercial motor vehicles are defined as “any self-propelled or towed vehicle used on the highway in commerce principally to transport cargo or passengers.” A vehicle covered under the Act must have a gross vehicle weight of at least 10,001 pounds, be designed to transport more than 10 passengers (including the driver), or be a placarded hazardous material vehicle. To be an employer under the Act one must be a “person engaged in a business affecting commerce that owns or leases a commercial motor vehicle in connection with that business, or assigns an employee to operate the vehicle in commerce.” The STAA does not cover the Government, a State, or a political subdivision of a State.

2. Protected Activities

A person may not discharge or discriminate against an employee, because the employee (or another person at the employee’s request) has filed a complaint, or begun a proceeding related to a violation of a commercial motor vehicle safety or security regulation, standard, or order. A person may not discharge or discriminate against an employee because (s)he refuses to operate a vehicle because the operation violates a regulation, standard, or order of the U.S. related to commercial motor vehicle safety, health, or security, or the employee has a reasonable apprehension of serious injury to the employee or the public because of the vehicle’s hazardous safety or security condition. A person may not discharge or discriminate against an employee because the employee cooperates, is about to cooperate with a safety or security investigation by the Secretary of Transportation, the Secretary of Homeland Security, or the National Transportation Safety Board. A person may not discharge or discriminate against an employee for furnishing information to the Secretary of Transportation, the Secretary of Homeland Security, or the National Transportation Safety Board about facts relating to an accident or incident resulting in injury or death to an individual or damage to property in connection with commercial motor vehicle transportation.

An employee’s apprehension of serious injury is reasonable only if a reasonable individual in the circumstances then confronting the employee would conclude that the hazardous safety or security condition establishes a real danger of accident, injury or serious impairment to health. To qualify for protection, the employee must have sought correction of the hazardous condition from the employer, and have been unable to obtain such correction.

3. Proving Your Case

Any employee alleging a violation under this Act may file a complaint with the Secretary of Labort through the Occupational Safety and Health Administration (OSHA), no later than 180 days after the alleged violation occurred. An employee must establish that (s)he engaged in a protected activity, which was a contributing factor of the unfavorable action taken by the employer. If a plaintiff successfully establishes his/her claim, an employer may avoid liability by demonstrating by clear and convincing evidence that it would have taken the same unfavorable action in absence of the employee’s protected activity.

4. Available Remedies

If an employee’s whistleblower claim under the STAA is successful, an employee may be entitled to remedies that include reinstatement with previous seniority and benefits, back pay with interest, compensatory damages, including compensation for special damages, expert witness fees, and reasonable attorneys’ fees, punitive damages in certain cases, but not to exceed $250,000.

5. Time to File: 180 days

If you believe you have a whistleblower case under the STAA, please contact an attorney at Sidkoff, Pincus and Green, located in Philadelphia, Pennsylvania.

Whistleblower Protection for Employees under the Energy Reorganization Act

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1. Employees and Employers Covered

Under the Energy Reorganization Act (ERA), certain employees in the nuclear power and nuclear medicine industries may file complaints to the Department of Labor, through the Occupational Safety and Health Administration (OSHA), if they believe that they have experienced discrimination or retaliation for reporting alleged violations of nuclear safety laws or regulations. Under the ERA, the definition of an employee refers to anyone who is employed by a licensee of the Nuclear Regulatory Commission, the Department of Energy, and their contractors and subcontractors. Independent contractors may also be protected, depending on the extent of control the employer exercised over a worker. Former employees are protected where the employer’s post-employment actions arise out of his/her former employment.

These protections do not apply to any employee who acts without direction from his or her employer, and thereby deliberately causes a violation of any requirement of this chapter or of the Atomic Energy Act.

2. Protected Activity

An employee is protected from retaliation in situations where he/she is reporting internally, to regulators, or to media, issues of nuclear safety. These actions are protected only when the reported practices are that which he or she reasonably believes to implicate nuclear safety. The employee must reasonably believe the employer is engaged in the conduct, but does not need to be right in the belief as long as the belief is reasonable.

3. Proving Your Case

Any employee who believes that (s)he has been discharged or otherwise discriminated against for engaging in such protected activity may file a complaint with the Secretary of Labor, through OSHA, within 180 of the alleged incident.

The Secretary shall dismiss the complaint unless the complainant has made a prima facie showing that any of the behaviors prohibited in the Act was a contributing factor in the unfavorable personnel action alleged in the complaint. Relief may not be ordered if the employer demonstrates by clear and convincing evidence that it would have taken the same unfavorable personnel action in the absence of such behavior.

4. Available Remedies

If an employee’s whistleblower claim under the ERA is successful, he/she is entitled to reinstatement, and may be entitled to back pay and benefits, lost wages, compensatory damages for pain and suffering, and attorneys’ fees.

5. Time to File: 180 days after alleged violation.

If you believe that you have a whistleblower claim under the ERA, please contact an attorney at Sidkoff, Pincus & Green, located in Philadelphia, Pennsylvania.

Whistleblower Protection for Employees under the Solid Waste Disposal Act

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1. Employees and Employers Covered

 The purpose of the Solid Waste Disposal Act (SWDA) is to safeguard the health, welfare, and physical property of people and to protect the environment by controlling the management of solid waste. As determined by the draftors of this Act, it is in the public interest to require hazardous waste to be stored, processed, and disposed of only at permitted hazardous industrial solid waste facilities. The SWDA protects employees from retaliation for reporting abuses of funding and assistance, violations of waste management requirements, or other violations of the Act.

This Act covers employees of agencies, Federal or State, with the authority and responsibility for planning or administration of solid wastes. Whistleblower protection is not offered to any employee, who acting without discretion from his employer deliberately violates any requirement of this chapter.

2. Protected Activities

Pursuant to the SWDA, no person shall fire or discriminate against any employee or authorized representative of employee due to the employee’s actions in providing information to the state or federal government regarding violations of environmental laws, or assisting in proceedings regarding the administration or enforcement of the provisions of this chapter.

3. Proving Your Case

A successful complainant must prove the following by a preponderance of the evidence:

1. The employee engaged in protected activity;

2. The employer knew of the employee’s reporting/protected activity;

3. The employer subjected the employee to unfavorable personnel action; and

4. The employee’s protected activity was a “contributing factor” to the employer’s decision to take unfavorable personnel action against the employee. Complaints are made to the Department of Labor, through the Occupational Safety and Health Administration (OSHA), and must be made within 30 days of the adverse employment action.

In order to avoid liability, the employer must demonstrate “clear and convincing evidence” that it would have taken the same unfavorable personnel action against the employee in the absence of the employee’s protected activity.

4. Available Remedies

If an employee’s whistleblower claim is successful, he or she may be entitled to reinstatement with previous seniority and benefits, back pay with interest, and other possible relief including attorneys’ feeds, compensatory and punitive damages.

5. Time to File: 30 days from alleged violation.

If you believe that you have a whistleblower claim under the SWDA, please contact an attorney at Sidkoff, Pincus & Green, located in Philadelphia, Pennsylvania. 

A Provision in an Employee Handbook May Supplant the At-Will Rule in Pennsylvania

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A claim for wrongful discharge in Pennsylvania may only be asserted in very limited circumstances. An at-will employee who is terminated may claim wrongful discharge only when his termination is made with a specific intent to harm or is contrary to public policy. Tourville v. Inter–Ocean Ins. Co., 353 Pa.Super. 53, 55, 508 A.2d 1263, 1265 (1986); Engstrom v. John Nuveen and Company, 668 F.Supp. 953, 958 (E.D.Pa.1987); Geary v. U.S. Steel Corp., 456 Pa. 171, 178–83, 319 A.2d 174, 177–80 (1974).

In Pennsylvania, there is a very strong presumption of at-will employment relationships. The presumption may be overcome by express contract, implied in-fact contract (where the surrounding circumstances of the hiring indicate that the parties did not intend to be at-will), and additional consideration passing from the employer (if the employee bestows a legally sufficient benefit or incurs a sufficient detriment for the benefit of the employer beyond the services for which he was hired, a court may infer that the parties intended to overcome the at-will presumption).Scott v. Extracorporeal, Inc., 376 Pa.Super. 90, 95, 545 A.2d 334, 336 (1988).

Notwithstanding the level of proof required to supplant the at-will presumption, “[a] handbook is enforceable against an employer if a reasonable person in the employee’s position would interpret its provisions as evidencing the employer’s intent to supplant the at-will rule.” Scott v. Extracorporeal, Inc., supra, 376 Pa.Super. at 97, 545 A.2d at 337; DiBonaventura v. Consolidated Rail Corp., 372 Pa.Super. 420, 426, 539 A.2d 865, 868 (1988); Reilly v. Stroehmann Bros. Co., 367 Pa.Super. 411, 419–20, 532 A.2d 1212, 1215–16 (1987). In all of these cases the courts looked to the language of the handbook to determine whether a reasonable employee would understand the provisions to transform his at-will employment into a contractual employment relationship. “A handbook, to be construed as a contract, must contain unequivocal provisions that the employer intended to be bound by it and, in fact, renounced the principle of at-will employment.” Id. at 416, 532 A.2d at 1214.

It is important to keep in mind that there is no presumption that the distribution of a handbook by an employer shows that the employer intends to alter the existing employer-employee relationship.  Mudd v. Hoffman Homes for Youth, Inc., 374 Pa. Super. 522, 543 A.2d 1092 (1988); Martin v. Capital Cities Media, Inc., 354 Pa. Super. 199, 511 A.2d 830 (1986).  As shown above, however, an employee may reasonably regard a handbook as legally binding when the handbook, or an employer’s oral representation about the handbook, unequivocally states that it is to have this effect.