Fundamentals of Law for Health Informatics Ch 15 Corporate Compliance

Unbundling

Billing practice in which providers use multiple procedure codes for a group of procedures instead of the appropriate comprehensive code in order to inappropriately maximize reimbursement

Corporate integrity agreement (CIA)

Compliance program imposed by the government on a healthcare provider

The HIPAA allowed CMP's to be assessed for:

Incorrect coding, medically unnecessary services, and persons offering remuneration to induce a beneficiary to order from a particular provider or supplier receiving Medicare or state healthcare funds. A new CMP was established for the false certification of eligibility for Medicare-covered home health services

Remuneration covered by the Anti-Kickback Statute includes, but is not limited to:

Kickbacks, bribes, and rebates

The coding and billing must be based on the provider's documentation, and a claim that was submitted correctly should:

Never be resubmitted as a result of a patient's complaint about owing money

Local Coverage Determinations

New format for LMRPs: Coverage rules, at a fiscal intermediary (FI) or carrier level, that provide information on what diagnosis justify the medical necessity of a test; LCDs vary from state to state

Qui tam

The "whistleblower" provisions of the False Claims Act, which provide that private persons, known as relators, may enforce the act by filing a complaint, under seal, alleging fraud committed against the government

The FCE empowers both the attorney general and private persons to:

institute civil actions to enforce the FCA

Safe harbor

Congress authorized HHS to establish additional ones by regulation: Activities that are not subject to prosecution and protect the organization from civil or criminal penalties

Most, but not all cases reject the theory that claims can be:

Tainted or implicitly false based on noncompliance with a minor regulatory rule, requiring instead that the falsity appear on the face of the claim or statement

With passage of the Fraud Enforcement and Recovery Act of 2009 (FERA), the FCA penalties apply to:

"any person who knowingly presents, or causes to be presented, a false or fraudulent claim for payment or approval," regardless of to whom the claim was made

To establish liability under the FCA, the government or whistleblower must:

Establish that the claim was false or fraudulent. Since the FCA does not specifically define what constitutes a false claim, the standard has been developed through case law

Corporate code of conduct

Expresses the organization's commitment to ethical behavior. Helps to define the organization's culture.

Nonfederal HC fraud laws:

Many states also have enacted laws that address hc fraud and abuse -These state laws apply to all payers, not just federal hc programs -Some states have enacted laws that prohibit self-referral, which is the referral of patients for hc svcs by a dr or hc professional to hc facilities in which that hc pro has an investment or other financial interest -Some state laws are similar to the Stark Law, while other states only require the referring physician or other hc pro to disclose their financial interests in a hc facility prior to the referral

Overcoding

Practice of using a billing code that provides a higher reimbursement rate than the code applicable to the service actually furnished to the patient

Most providers question how they can know when it may be liable for:

Submitting false information by omission. Providers are concerned that noncompliance with a minor requirement unrelated to billing may create FCA exposure

Revenue cycle management

Supervision of all administrative and clinical functions that contribute to the capture, management, and collection of patient service revenues.

Special fraud alerts are issued periodically by OIG to provide insight into:

The OIG's views on the application of Federal Anti-Kickback statute to various types of arrangements. The Special Fraud Alerts often contain descriptions of specific features that the OIG considers suspect Arrangements that contain such features are more likely to be subject to further govt scrutiny

Yet another exception to the Stark Law was created to address the unique financial arrangements between academic institutions and their affiliated hospitals and physicians. A crucial element of this exception is that:

The compensation paid by all medical center components to the referring dr is set in advance, does not exceed fair market value, is not determined in a manner that takes into account the volume or value of any referrals or other business generated by the dr, and does not violate the Federal Anti-Kickback Statute or any federal or state law or regulation governing billing or claims submission

Coding is based on the original intent of:

The encounter as documented in the health record. A claim that is resubmitted incorrectly to appease a disgruntled patient who does not want to pay is a false claim

The PPACA clarified "retention of overpayments"

This further clarified both FCA and FERA amendments to FCA by requiring reporting and return of overpayments w/in 60 days of discovery

The OIG also issues Advisory Opinions regarding:

Whether specific arrangements violate the Federal Anti-Kickback Statute Advisory Opinions may address what constitutes prohibited remuneration, whether an arrangment fits an exception or safe harbor, what constitutes inducement to reduce or limit services, and whether the activity described would constitute grounds for the imposition of sanctions

The FCA empowers both the:

attorney general and private persons to institute civil actions to enforce the FCA

"Material" is defined as:

"Having a natural tendency to influence, or be capable of influencing, the payment or receipt of money or property." These revisions allow the govt and whistleblowers to pursue violations of regulatory statutes with penalty provisions as FCA cases and to pursue false documents that are "material to an obligation to pay or to transmit money...to the govt," regardles of whether a false claim has been submitted For example: a dr who creates backdated health records to support a claim already submitted could be liable under this provision Also, since the definition of "obligation" expressly includes retention of overpayments, the FERA makes it clear that providers have an affirmative duty to notify the applicable entity and repay the overpayment

The FERA established that FCA penalties apply to:

"any person who knowingly makes, uses, or causes to be made or used, a false record or statement material to a false or fraudulent claim" A violation of the FCA also occurs when any person "knowingly makes, uses, or causes to be made or used, a false record or statement material to an obligation to pay or transmit money or property to the government, or knowingly conceals or knowingly and improperly avoids or decreases an obligation in pay or transmit money or property to the government

In a civil FCA action, the standard is a:

"preponderance of the evidence," whereas in a criminal FCA case, the govt must prove beyond a reasonable doubt that the defendant knew the claim was false

December, 2006, Jackson Memorial Hospital, Florida's largest Medicaid provider, agreed to pay:

$14.2 million to the fed govt to settle a whistleblower lawsuit accusing the Miami hospital of keeping millions of dollars in Medicare and Medicaid overpayments that it knew should be returned

The Federal Anti-Kickback Statute is expansive in scope and clearly prohibits payments for patient referrals. However, application of the statute becomes less clear when applied to:

-Arrangements that do not simply involve a payment for patient referral, but instead embody business or investment relationships between two or more individuals or organizations. -The courts have broadly interpreted the prohibition to encompass many business arrangements. -In addition, the PPACA provides that claims submitted in violation of the Fed Anti-Kickback Statute are automatically false claims under the FCA

Many states have enacted laws that prohibit:

-Certain financial arrangements between hc practitioners that constitute illegal remuneration in return for the referral of patients, such as kickbacks or bribes. -States also may have laws prohibiting fee-splitting among hc pros and others in return for patient referrals -Private insurers also have taken measures to control hc fraud and may work with state or federal agencies to report or detect hc fraud

There are two general types of healthcare claims that the government considers false:

1) furnishing inaccurate or misleading info to the govt to obtain payment or approval of a claim, such as up-coding or submitting claims for services not rendered and 2) omission of info from a claim or implicitly certifying compliance with rules, w/out actually complying with the rules

Specifically, the Stark Law excludes from the term "referral":

1. A request by a pathologist for clinical diagnostic lab tests and pathological examination services 2. A request by a radiologist for diagnostic radiology services 3. A request by a radiation oncologist for radiation therapy, if such services are furnished by or under the supervision of the pathologist, radiologist, or radiation oncologist

Designated health services as defined by the Stark Law:

1. Clinical lab services 2. PT, occupational therapy, and speech language / pathology services 3. Radiology and certain other imaging services 4. Radiation therapy services and supplies 5. Durable medical equipment and supplies 6. Parenteral and enteral nutrients, equipment, and supplies 7. Prosthetics, orthotics, and prosthetic devices 8. Home health services and supplies 9. Outpatient prescription drugs 10. Inpatient and outpatient hospital service

Statutory exceptions: Bc of the broad sweep of the Federal Anti-Kickback Statute, exceptions were created to protect legitimate business arrangements. There are many exceptions, including the following:

1. Discounts that are properly disclosed and reflected in the costs claimed or charges made by the provider 2. Payments by an employer to an employee for provision of covered items and services 3. Amounts paid by providers to a group purchasing organization where there is a written agreement that discloses the amount of the administrative fee to providers purchasing from the group purchasing organization 4. Waivers of coinsurance amounts in connection with certain federally qualified hc centers 5. Certain risk-sharing arrangements 6. The waiver or reduction by pharmacies of cost-sharing obligations under Medicare Part D 7. Remuneration between a federally qulified hc and any individual or entity providing goods, services, items, donations, or loans to the federally qualified health center 8. Exceptions related to hardware, software, IT, and training svcs used to receive and transmit e-prescription information

Some reasons why incorrect claims are submitted include (1):

1. Dr's may graduate from medical school w/out an understanding of the Medicare rules, including the evaluation and management (e/m) coding and documentation guidelines, and limited knowledge of CPT and ICD-9-Cm coding Many dr's are unaware that they are coding and billing inappropriately and that their documentation in the health record does not adequately justify the diagnosis and/or treatment

The FCA defines "knowing" and "knowingly" to mean that a person:

1. Has actual knowledge of the falsity of the info 2. Acts in deliberate ignorance of the truth or falsity of the info, or 3. Acts in reckless disregard of the truth or falsity of the info -No proof of specific intent to defend is required, therefore, submission of claims in a sloppy, unsupervised fashion w/out due care regarding the accuracy of the claim can constitute reckless disregard and create and FCA violation

The OIG has created a number of regulatory safe harbors covering such arrangements as:

1. Investments in certain large or small entities 2. Investments in entities in underserved areas 3. Space and equipment rentals 4. Sales of physician practices in health professional shortage areas to hospitals or other entities 5. Sales of practices by one practitioner or another 6. Bona fide employment arrangements 7. Group purchasing orgs 8. Coinsurance and deductible waivers 9. Practitioner recruitment activities in underserved areas 10. Investments in group practices 11. Referral arrangements for speciality services 12. Investments in ambulatory surgical centers 13. Electronic prescribing and e-health records arrangements

The Stark Law does though, provide a number of exceptions to the general prohibition. The exceptions are complex and beyond the scope of the brief examples provided. Some protect only compensation arrangements. One example is the physician services exception, which provides an exception for physician services provided:

1. Personally by or under the personal supervision of another physician in the same group practice as the referring physician, or 2. Under the supervision of another physician who is a member of the referring physician's group practice or is a physician in the same group practice

Misrepresentation of Facts on Claim Forms, examples:

1. a new dr partner joins a practice and the cred process has not been completed for his Medicare claim submission. The biller submits all his claims using the Medicare number of another partner to circumvent the credentialing process and obtain speedy reimbursement 2. A patient presents for an annual exam, but the dr knows her health plan does not cover annual exams. Since the patient happens to have hypertension, the dr bills for an office visit for that, even though that was not the purpose of the visit 3. The hospital svcs of a nurse practitioner are intentionally billed under the Medicare number of the supervising dr as "incident to" in order to receive 100% reimbursement. The NP is billing subsequent hospital visit E/M svcs under the dr's Medicare number when the notes contain only the NP's documentation not supplemented by the supervising dr. This is a false claim, bc Medicare does not allow for "incident to" billing in the hospital setting

Some reasons why incorrect claims are submitted include (2):

2. HC facilities, esp those with outpatient centers, may not have invested enough time and resources in training staff, including dr's, on proper coding, documentation, and billing requirements

Some reasons why incorrect claims are submitted include (3):

3. Medicare rules are vast and changing, as are payment system changes such as Medicare severity diagnosis related groups

Some reasons why incorrect claims are submitted include (4):

4. Information may be missing from the record during code assignment

Some reasons why incorrect claims are submitted include (5):

5. Electronic records may include info that was pasted incorrectly from another health record

Fraud

A false representation of fact. A failure to disclose a fact that is material (relevant) to healthcare transaction. Damage to another party that reasonably relies on the misrepresentation or failure to disclose.

Violation of the Anti-kickback statute constitutes:

A felony punishable by a fine of up to $25,000, imprisonment for up to five years, or both Criminal conviction constitutes automatic exclusion from fed hc programs, although the Secretary of HHS may seek exclusion from fed hc programs through an administrative proceeding whether or not a criminal conviction is obtained

Another example is the In-Office Ancillary Services Exception:

A highly technical and complicated exception that protects designated health services furnished by a dr in the dr's office setting except for parenteral and enteral nutrients, equipment, and supplies and some durable medical equipment This exception is intended to protect only services that are ancillary to physician services and contains specific reqs regarding the location, supervision, and billing of the services

Fraud Enforcement and Recovery Act of 2009 (FERA)

Amended the FCA Expands both the potential for liability under the False Claims Act (FCA) and the government's investigative powers, and it eliminates the requirement that a person has to present false claim to a US government officer or employee, or a member of the US armed services, in order to be liable under the FCA

Duplicate billing may be the result of:

An unintentional billing error, but systematic or repeated duplicate billing generally may be viewed as a false claim, esp if any overpayments are not refunded promptly The OIG has identified dupe billing as a significant risk area for providers

"Financial Relationship" is defined in the Stark Law to include:

Both compensation arrangements and investments and ownership interests "Referral" under the Stark Law is defined more broadly than merely recommending a vendor of designated health services to a patient Instead, "referral" means, for Medicare Part B services, " the request by a physician for the item or service" and, for all other Medicare and Medicaid services, "the request or establishment of a plan of care by a physician which includes the provision of the designated health service" Under the Stark Law, certain referral relationships are deemed not to constitute a referral if the services are furnished by (or under the supervision of) a specialist pursuant to consultation.

Office of Inspector General (OIG)

Branch of the Department of Health and Human Services (HHS) with responsibility for audits, investigations, inspections, and other activities to protect the integrity of HHS programs and their beneficiaries

Evaluation and management (E/M) coding

CPT codes that describe patient encounters with healthcare professionals for assessment and counseling and other routine healthcare services

Stark Law I, II

Commonly referred to as "Stark Law" after Congressman Pete Stark, who introduced and supported the statute. The original statute, referred to as "Stark 1," only prohibited physicians from ordering clinical laboratory services for Medicare patients from an entity with which the physician had a financial relationship. The expansion of the Stark Law to the other designated health services is typically referred to as Stark II The application of the Stark Law to traditional fee for service Medicaid and other issues are included in Phase III of the Stark Regulations

Compliance

Conforming or acquiescing. In healthcare it generally refers to adherence to federal statues and regulations designed to prevent unjust financial enrichment and patient privacy breaches by healthcare providers or organizations.

Civil Monetary Penalties (CMP) law

Congress enacted this law under section 1128A of the Social Security Act in 1981 to combat an increase in healthcare fraud and abuse As one of several administrative remedies, this law authorized the Secretary and Inspector General of HHS to impose CMP's, assessment, and program exclusions on individuals and entities whose wrongdoing caused injury to HHS programs or their beneficiaries The statutory penalty and assessment amounts under section 1128A generally provided for a penalty of no more than $2000 for each item or service at issue and an assessment in lieu of damages of not more than twice the amount claimed Since 1981, Congress has expanded the CMP provisions to apply to numerous types of fraudulent and abusive activities to Medicare and state healthcare programs

Penalties for violating the Stark Law include:

Denial of payment, refunds of amounts collected in violation of the statute, a civil monetary penalty of up to $15,000 for each bill or claim a person knew or should have known was for a service for which payment may not be made, three times the amount of the improper payment the designated health service agency received from the Medicare program, and a civil monetary penalty of up to $100,000 for each arrangement or scheme that the dr or entity knew or should have known had a principal purpose of ensuring referrals that, if directly made, were in violation of the Stark Law

Contending with dupe billing for Medicare is not only labor-intensive, it is also one of the leading reasons for:

Denied claims

The FCA provides protection to qui tam relators who are:

Discharged, demoted, suspended, threatened, harassed, or in any other way discriminated against in the terms or conditions of their employment as a result of their furtherance of any action under the FCA Remedies include reinstatement with seniority comparable to what the qui tam relator would have had if not for discrimination, two times the amount of any back pay, interest on any back pay, and compensation for any special damages sustained as a result of the discrimination, including litigation costs and reasonable attorney's fees

Deficit Reduction Act of 2005 (DRA)

Enacted in 2006, and significant to compliance bc it has transformed the nature of compliance programs from voluntary to mandatory; this act contains the Employee Education about False Claims Recovery provision, which requires any entity that annually receives or makes at least $5 million in Medicaid payments to establish written policies for all employees of the entity (including management) and for any contractor or agent of the entity. -This written policy must provide detailed information about the FCA, administrative remedies for false claims and statements, any state lawas pertaining to civil or criminal penalties for false claims and statements, and whistleblower protections under such laws, with respect to the role of such laws in preventing and detecting fraud, waste, and abuse in federal hc programs -The entity's written handbook must include a specific discussion of the federal and state laws pertaining to false claims and statements, the rights of employees to be protected as whistleblowers, and the entity's policies and procedures for detecting and preventing fraud, waste, and abuse. failure to comply may result in the affected entity being ineligible to receive Medicaid payments Any affected entity that knowingly violates these reqs may be penalized for submitting false claims under the FCA

Federal Anti-Kickback Statute

Establishes criminal penalties for individuals and entities that knowingly and willfully offer, pay, solicit, or receive remuneration in order to induce business for which payment may be made under any federal healthcare program

Designated health services

Excluded from the definition of "designated health services" are services that are reimbursed by Medicare as part of a composite rate (such as services performed in an ambulatory surgery center), except for the services listed in figure 15.2 that are themselves payable through a composite rate (such as home health and outpatient hospital services)

Healthcare fraud

Intentional deception or misrepresentation that the individual or entity makes knowing that the misrepresentation could result in some unauthorized benefit to the individual, the entity, or some other party.

Correct Coding Initiative (CCI)

Lists pairs of CPT codes that should not be billed together because Medicare will only pay for one of the codes in the pair and considers the other bundled into it

It is legitimate to bill for non-covered services, as Medicare understands that there are times when a hc provider, or patient, wants a test or procedure performed that Medicare does not cover. The services that are statutorily non-covered by Medicare are listed on:

Medicare's Notice of Exclusions from Medicare Benefits (NEMB) form. Medicare does not require that this form be presented to a patient who is to receive a non-covered service, but it is highly recommended bc it is important that patients know when Medicare will not reimburse for the service, since the patient will then be held responsible for the bill

The best in-depth resource for learning how Medicare and other payers monitor and deal with fraudulent billing practices is the:

OIG website; it includes "compliance guidance" for various hc entities (HHS OIG n.d.b). These guidance docs contain specific risk areas pertinent to each entity Three of these risk areas are vitally important to the accuracy of the claims submission process: coding and billing, documentation, and medical necessity for tests and procedures.

Whistleblower

Or qui tam provisions of the FCA, private persons known as relators may enforced the FCAA by filing a complaint, under seal, alleging fraud committed against the government. The government investigates the allegations while maintaining the complaint under seal. If they determine it has merit, the DOJ intervenes in the action, unseals the complaint, and assumes responsibility for prosecuting the claim. When the govt intervenes, the relator generally received 15-25 percent of the government's recovery plus reimbursement of reasonable legal fees and expenses

Advisory Opinions have been issued on a variety of topics including:

Percentage compensation arrangements, joint ventures, beneficiary inducement, discounts, and waivers of deductibles and copayments

Duplicate billing

Practice of submitting more than one claim for the same item or service. Occurs when a claim for an item or service is submitted more than once to a payer, either by the same or different providers

Upcoding

Practice of using a billing code that provides a higher reimbursement rate than the code applicable to the service actually furnished to the patient.

Federal Physician Self-Referral Statute Stark Law

Prohibits physicians from ordering designated health services for Medicare (and to some extend Medicaid) patients from entities with which the physician, or immediate family member, has a financial relationship Commonly referred to as "Stark Law" after Congressman Pete Stark, who introduced and supported the statute. The original statute, referred to as "Stark 1," only prohibited physicians from ordering clinical laboratory services for Medicare patients from an entity with which the physician had a financial relationship.

Abuse

Provider, supplier, and practitioner practices that are inconsistent with accepted sound fiscal, business, or medical practices, which directly or indirectly may result in unnecessary costs to the program, improper payment, services that fail to meet professionally recognized standards of care or are medically unnecessary, services that directly or indirectly result in adverse patient outcomes or delays in appropriate diagnosis or treatment.

Corporate compliance program

Reduce fines and penalties to organizations found guilty of healthcare fraud if the organization has a fraud prevention and detection program in place.

Recovery Audit Contractor (RAC)

Reduce improper Medicare payments through efficient detection and collection of over payments, identification of underpayments, and implementation of actions to prevent future improper payments.

Self-referral

Referral of patients for healthcare services by a physician or other healthcare professional to healthcare facilities in which that healthcare professional has an investment or other financial interest.

Knowing standard

Refers to the fact that the provider must have knowingly submitted the false claim. Falsity is not enough to impose FCA liability

Compliance officer

Responsible for overseeing the processes that promote an organization's ethical business practices and its conformity to federal, state, and private payer program requirements.

There are three categories of services to be considered when billing to Medicare:

Services Medicare considers medically necessary, services that are statutorily non-covered, and services that are covered under certain conditions - for example, only for certain diagnoses or at a certain frequency

Medical necesity

Services or supplies that are needed for the diagnosis or treatment of your medical condition, meet the standards of good medical practice in the local area, and aren't mainly for the convenience of you or your doctor

National Coverage Determinations

Sets forth the extent to which Medicare will cover specific services, procedures, or technologies on a national basis. Medicare contractors are required to follow NCDs.

Interpreting the law of knowing is sometimes difficult for providers. When a provider acts in accordance with one interpretation of the law, even if the govmt has another interpretation:

The FCA action should not succeed. If a provider's actions are based on the advice of legal counsel, it may also be difficult to prove intent to violate the FCA. However, as a practical matter, many providers settle such cases rather than proceeding to trial to defend the action, which makes the fCA a powerful government enforcement tool

HIPAA significantly expanded the OIG's sanction authorities by extending:

The application of CMP provision beyond those funded by HHS to include all federal healthcare programs (such as Tricare, Veterans Affairs, and Public Health Service). Also significantly revised and strengthened the OIG's CMP authorities pertaining to violations under Medicare and state healthcare programs The maximum penalty amount per false claim was increased from $2000 to $10,000, and the amount of authorized assessments was raised from doable to triple the amounts claimed

False cost reports

The government's primary litigation tool for combating fraud, which provides that anyone who "knowingly" submits false claims to the government is liable for damages up to three times the amount of the erroneous payment plus mandatory penalties between $5,500 and $11,000 for each false claim submitted.

False Claims Act (FCA)

The govt's primary litigation tool for combating fraud. It provides that anyone who "knowingly" submits false claims to the government is liable for penalties. This includes not only those with actual knowledge of the false claim, but also those who act in deliberate ignorance of the truth or falsity of the info and those who act in reckless disregard of the truth or falsity of the information. This Act contains both criminal and civil provisions.

A common theme that runs through the safe harbors is:

The intent to protect certain arrangements in which commercially reasonable items or services are exchanged for fair market value compensation The statute does not define the term "fair market value" but makes it clear that fmv's cannot vary based on referrals or the additional value that one party would attribute to property as a result of its proximity or convenience to sources of Medicare or Medicaid business or referrals

Who is ultimately responsible for filing accurate claims?

The provider

Further, the PPACA broadened the definition of "original source" to allow

The public disclosure defense to overcome if the individual bringing suit possesses knowledge that adds to publicly disclosed information Prior to the PPACA, knowledge had to be independent of publicly disclosed inforamtion

Remuneration is defined broadly to include:

The transfer of anything of value, directly or indirectly, overtly or covertly, in case or in kind Prohibited conduct includes not only remuneration intended to induce referrals, but also remuneration intended to induce the purchasing, leasing, ordering, or arranging for any good, facility, service, or item paid for by a federal hc program

The FCA differentiates between what kinds of errors?

Those that are made intentionally and those that are an honest mistake, for example, if the OIG or a Medicare auditor had identified what appeared to be a pattern of false claims, their full investigation would determine whether the mistakes were innocent ones or whether there was intent to commit fraud. The difference might be return of overpayments vs. jail time

Violations of the FCA result in damages up to:

Three times the amount of the erroneous payment plus mandatory penalties between $5500 and $11,000 for each false claim submitted. In addition to bringing civil penalties, submitting false claims is a criminal offense. An org can be fined either $500,000 or twice the false claim amount, whichever is greater, and an individual can be fined either $250,000 or twice the false claim amount, whichever is the larger sum, and can be imprisoned for up to five years

The interaction among the laws can be convoluted, for example, neither the Federal Anti-Kickback Statute nor the Stark Law contains a private right of action allowing a private plaintiff to file a lawsuit. Nevertheless, the govt and qui tam plaintiffs have successfully argued that:

Violations of the Fed Anti-Kickback Statute and Stark Law can serve as the basis for a claim under the FCA. According to this theory, a claim to the govt is rendered "false" for the purposes of the FCA if the medical services or items were furnished in violation of the Fed Anti-Kickback Statue or Stark Law, even though the services or items provided were themselves appropriate and proper. Despite vigorous opposition by the hc industry and defense attorneys, a number of courts have accepted these theories. It is important that competent legal counsel be consulted on these matters as the laws, regs, and case law change frequently

Patient Protection and Affordable Care Act (PPACA)

Widely known as the health reform bill, signed by President Obama in 2010. Purpose was to further amend the FCA by allowing private individuals to be more successful in filing false claims lawsuits Previously, cases based on information the individual had obtained from other legal proceedings or the news media ("public disclosure") were grounds for dismissal by the court. Now, the fed govt ultimately determines whether dismissal is appropriate

The FCA has been extended to cover quality of care cases. In the US v NHC Healthcare Corp., the govt alleged that two residents

at the defendant nursing home did not receive care that satisfied Medicare and Medicaid program standards bc the residents developed pressure sores, incurred unusual weight loss, were in what was deemed to be unnecessary, pain, and ultimately died Court ruled that as a condition of receiving reimbursement from fed hc programs, the facility agrees in principle to provide care in such a manner and in such an envmt as will promote the maintenance or enhancement of patient's quality of life

The statutory definition of a "claim" has been expanded to include:

claims submitted "to a contractor, grantee, or other recipient, if the money or property is to be spent or used on the Government's behalf, or to advance a Government program or interest" This revision broadens the types of payments that fall witin the scope of the FCA, such as claims submitted to Medicare and Medicaid managed care plans and other federally funded hc payers. These amendments to the FCA are intended to ensure that those who submit false or fraudulent claims or make false statement related to a claim - to any contractor, subcontractor, or entity to which payment is made by the gvmt - are liable to the same extent that they would be if they made such claims or provided such info to the government itself

In addition, the FERA expanded the US Attorney General's authority to :

issue civil investigative demands and broadened the govt's authority to share docs obtained through subpoena with qui tam relators and other parties

Sherman Antitrust Act

passed in 1890, is one of the several anti-trust laws, including the Clayton Act of 1914. They collectively make it illegal to restrain trade through contracts or conspiracies, and they prohibit price fixing and mergers that lessen competition -There are civil and criminal sanctions -The Federal Trade Commission (FTC) and the Department of Justice enforce these laws -Their respective websites contain info about healthcare issues -Healthcare mergers and joint ventures among providers for the purchase of equipment are examples of arrangement that must be carefully reviewed to ensure that competition is not hindered and that consumers are not harmed -Credentialing and peer review processes also may be scrutinized to ensure that privileges are not denied or restricted to limit competition -Physicians and hospitals cannot set different prices for services for one group of consumers, such as members of a particular health plan

Most providers believe that the FCA was not intended to

reach so far as to making a condition of receiving reimbursement from fed hc programs, they had to agree in principle to provide care in such a manner that will promote enhancement of patient's quality of life They believe that quality of care issues should be addressed through private malpractice actions or loss of provider status under Medicare or Medicaid, rather than through expanded application of the FCA

The FERA also expanded anti-retaliation protections for

whistleblowers by allowing nonemployees, including contractors and agents, to sue for retaliation