Regulatory Compliance -

Regulatory Compliance -

Regulatory & Compliance Issues and Pitfalls Presented For CPA Leadership Institute Thomas P. McGuinness, CPA, CVA Reimer, McGuinness & Associates, PC August 27 , 2013 We are from the Government and were Here to Help? -- Ronald Reagan Famous Quote

If you put the federal government in charge of the Sahara Desert, in five years thered be a shortage of sand. --Milton Friedman The 1990s, Managed Care and the Criminalization of Medicine Medical costs were increasing at rates higher than the average percentage growth of the economy The American consumer wanted million

dollar healthcare at low premiums Government payments for healthcare (via Medicare and Medicaid) were increasing annually as a % of GNP and Congress was worried Insurance companies were paying out ever increasing amounts for healthcare insurance claims and their profitability is Criminalization of Medicine, contd Physicians and Hospitals were receiving the bulk of these payments

Physicians controlled medical spending through written orders; their businesses were highly disjointed and known as a cottage industry Clinton Administration survey results concluded, Physicians shouldnt make more than $100K per year Something had to give There is No Nirvana There were and are abuses in the healthcare industry

Rather than create screens to identify and prosecute those that abused the rules, Congress created a massive series of legislation to REGULATE medicine 1970s=Oil: 1980s=Thrifts: 1990s=Medicine Does this sound familiar Enron, WorldCom, Global Crossing, Anderson and the Accounting Profession: 2000s=Accounting Profession What about the 2010s Wall Street If Your Gonna Play their Game If you are a hospital, physician, manager or

consultant you better know the Rules Ignorance is not bliss intent, in most cases doesnt matter Civil money penalties 2. Criminal penalties 3. Prison 4. All of the above 1. Major Legislation Affecting Physicians and Hospitals Medicare Fraud and Abuse EMTALA

CLIA Stark I Stark II HIPAA Stark III Hi-Tech Act of 2009 Individual State Legislation PPACA and The Affordable Care Act (OBAMACARE) Medicare Fraud and Abuse A large set of regulations promulgated by the Office of the Inspector General of HHS

The object of these regulations is to regulate physicians and hospitals from engaging in activities that over bill or fraudulently bill CMS for services including self-referrals Private inurement activities in the tax exempt entity arena Fraud and Abuse, contd The main tools of CMS is the post payment audit The False Claims Act Any person convicted under this statute Three times the amount of any overpayment, plus

Mandatory penalties between $5,000 and $10,000 for each false claim submitted (each line of a HCFA/CMS 1500 Form) A typical tactic of the OIG is a combined civil and criminal investigation to crush subjects into submission (large fines and the threat of prison for physicians, administrators and corporate executives) Fraud and Abuse, contd

HCA Hialeah Hospital, Florida Convicted of overbilling Medicare for $7 million out of $394 million in billing Hermann Hospital Consent Order In 1994 pays IRS $993,500 to keep from losing its tax exempt status (amount of fine was equal to the amount of tax had Hermann not been a tax exempt entity) Emergency Medical Treatment and Active Labor Act of 1986 (EMTALA) Enacted to mandate that hospitals treat

patients presenting for treatment regardless of their ability to pay Also known as the Patient Anti-Dumping Act of 1986 To assure that emergency departments treated and stabilized patients rather than refusing treatment, transferring or discharging them before the patient was stabilized EMTALA, contd Penalties for non compliance:

$2,000 for each wrongful act occurring before January 1, 1997 $10,000 for each wrongful act occurring after January 1, 1997 OIG may impose up to $15,000 for each person making a false statement OIG may impose up to $100,000 for each arrangement or scheme subject to investigation Other penalties Clinical Lab Improvement Act (CLIA)

CLIA was enacted in 1988 in an attempt to elevate the standards of laboratory testing Enacted in response to outcry re: deaths ascribed to false negative pap smears Congress decided to regulate every lab test in the US, including those in physician offices These false readings ironically ended up coming from federal labs and no problems came from UAs CLIA, contd Result of federal regulation

the cost of a pap smear in NY state had over tripled by 1992 Cost of compliance with CLIA is between $1,800 and $9,000 per practice depending on testing performed (waivered v. full lab) Reduced number of labs in total and in-office laboratories in physician offices Reduction in competition in the lab industry CLIA, contd There are certain lab tests that are in a physicians office (waivered tests) without

having to comply with the totality of CLIA regulations, but waivered labs still need to comply, register and be subject to inspection Strep, UA, Glucose tolerance, pregnancy and rapid flu CLIA regulations are included in 242 pages Most Federal labs are exempt from CLIA including the VA, public health laboratories, forensic, research and teaching laboratories CLIA, contd Penalties One year in prison

Civil money penalties of $10,000 per day Exclusion from federal programs Infractions noted In 2002 there were 132 labs sanctioned* Out of 177,617 registered labs* - .00074%! Source: Association of American Physicians and Surgeons, Inc. Stark I A part of the Omnibus Budget Reconciliation Act of 1989 (OBRA 1989). Became effective in 1992 to regulate

physician self-referral for Medicare and Medicaid patients to entities where physicians had a financial interest (direct or indirect) ownership This initial legislation covered only a limited number of clinical laboratory services, but set the stage for the rest of the Stark law Stark I, contd Civil Penalties for noncompliance: Civil money penalty for each item or service (each line of HCFA 1500 Form) of $10,000 Civil money penalties of $15,000 for each

individual for which a false claim was made $10,000 for each day a prohibited relationship continues $50,000 for each such act Stark I, contd Criminal penalties for noncompliance: Each count of a felony conviction up to $25,000 Up to five years imprisonment Or both Each count of a misdemeanor conviction up to $10,000

Up to one year imprisonment Or both Stark II Enacted as Part of the Omnibus Budget Reconciliation Act of 1993 (OBRA 1993) Became effective January 1, 1995 to expand the initial legislation by identifying eleven specified services, called Designated Health Services Clinical laboratory services (80000 series CPT codes)

Physical therapy services (97000 series and some HCPCS level 2 codes) Occupational therapy services (same codes as PT) Stark II, contd Radiology services, including MRI, CAT scans and

ultrasound services (but not nuclear medicine) Radiation therapy services and supplies (some 70000 series codes, but not nuclear medicine) Durable medical equipment and supplies Parenteral and enteral nutrients, equipment and supplies Prosthetics, orthotics and prosthetic devices and supplies Home health services

Outpatient prescription drugs Inpatient and outpatient hospital supplies Stark II, contd Specified that a physician could not refer (request or order) tests or services for Medicare or Medicaid patients where the physician (or immediate family member) has a financial relationship Created the incident to definition services performed by ancillary employees or other group practice doctors under the supervision

of a qualified Medicare provider Stark II, contd Group practice exception regulation discusses what constitutes a group practice Unprecedented regulation of the structure and internal workings of physician groups

Single legal entity Two physician test Substantially all services test Distribution of income and expenses Unified business test Compensation test Patient encounter test

In office ancillary exception law permits doctors to offer DHS that supplement routine patient care in the same building where the physician otherwise provides services Stark II, contd Caused a massive dump of ownership interests in MRI and CT centers across U.S. and created such a glut in those markets that many investors lost most of their investment due to the oversupply of centers for sale on the market.

Created scenarios where collaborative efforts to efficiently use assets became illegal activities overnight. Dictated how physicians can set compensation how they split their own ancillary revenue pie! Name another business where this occurs Stark II, contd Penalties for noncompliance Up to $15,000 for each service plus twice the reimbursement claimed Exclusion from Medicare and Medicaid

programs Health Insurance Portability and Accountability Act of 1996 (HIPAA) Enacted to allow employee insurance to move with employees when they change jobs Enacted during the time when Congress was addressing Universal Health Insurance coverage for All Americans Other stated remedies within the Act were provisions to combat fraud and

abuse in health insurance and health care delivery and for the confidentiality and security of patient data HIPAA, contd Embedded in the Act were provisions for the privacy and security of patient data Privacy rule Published December 28, 2000 Major goal was to assure that individuals health information is properly protected while allowing the

flow of health information and promote high quality health care The Rule applied to health plans, health clearinghouses and to any health care provider who transmits health information in electronic form Business Associate contracts for contractors For entire Rule: HIPAA - Reality The origin of HIPAA healthcare provisions Printers Full Employment Act Cost to physicians and hospitals

approximately $10 billion in basic compliance costs Created a whole new set of experts HIPAA consultants HIPAA, contd Security Ruletook effect in 2005 Rule applies to electronic protected health information (EPHI), which is individually identifiable health information in electronic form Electronic safeguards Physical safeguards

Technical safeguards HIPAA, contd Eight Keys to consider in complying with the Security Rule Obtain and maintain senior mgmt support Develop and implement security policies Conduct and maintain inventory of EPHI Be aware of political and cultural issues raised by HIPAA Conduct regular and detailed risk analysis

Determine what is appropriate and reasonable Documentation Prepare for ongoing compliance HIPAA Enforcement Penalties for noncompliance Civil penalties are $100 per failure to comply with a Privacy Rule requirement and cannot exceed $25,000 per year for multiple violations of the identical Rule Criminal penalty is $50,000 and up to one year in prison for false pretenses and up to $250,000 and ten years

imprisonment for sale or transfer for personal gain or malicious harm (i.e. Britney Spears & Farrah Fawcett unauthorized medical record access at California hospital) Doctor fined $7,500 for document filed in wrong patients chart Has anyone been exposed to an actual HIPAA violation? HIPAA Violation A person calls a patient the night before a life

threatening surgery and tells the patient that he should not have the described surgery with the named surgeon. Rather, he should revisit his named family physician and obtain names of other much more skilled surgeons than the named surgeon. Stark II, Phase III (Stark III) CMS Published final rulemaking on September 5, 2007 Becomes effective December 4, 2007* Does not further restrict permitted financial

relationships with and interests held by physicians Revises definition of incident to services to clarify that it includes both services and supplies that meet the incident to requirements Stark III, contd Validated that a physician in a group practice may receive a productivity bonus for supplies (including drugs), assuming they properly qualify and are billed on an incident to

basis Expressly states that diagnostic tests cannot qualify as incident to services Therefore, x-ray, laboratory tests and other diagnostic tests may not be billed as incident to services. Specify that productivity bonuses can be based directly on services incident to the physicians personally performed services even if those services are otherwise DHS referrals.

Stark III, contd This is a critical clarification as it relates to physician compensation in group practices and especially where productivity bonuses are concerned. Eliminates the Safe Harbor Method of Establishing Fair Market Value of personal services (based upon use of Surveys) Permits medical group to impose non-competes to protect its asset (disallowed in Stark II) Removes office space rentals from the FMV exception because CMS felt office space leases have been subject to abuse

Stark III, contd CMS appeared to also exclude the per unit of service or per click rental payments. This would have the effect of up-ending many legitimate arrangements entered to do businessa later clarification allowed this arrangement to continue in certain circumstances Does allow physician retention payments in certain circumstances (underserved areas, etc.)

Stark III updated penalties Denial of payment for a service that is the subject of a violation Refund of payment via recoupment $15,000 per service, civil money penalty $100,000 civil money penalty for each arrangement considered to be a circumvention scheme HITECH Act of 2009 Provides new data breach rules

To the affected patient To the media if the breach is big To HHS De-identified and secured (encrypted) data breaches need not be reported If PHI has been compromised, reporting is required Hide Rule allows for a patient who pays in full, out of pocket for a service to request provider NOT to disclose information to

patients insurer HITECH Act, contd We, as consultants are required to fully comply with the HIPAA Security Rule if we receive PHI. We, as consultants are required to perform a risk assessment of PHI Security and have a compliance plan and procedures in place. HiTech Act--Enforcement State attorneys general can pursue HIPAA

violations, not just HHS OIG Individual victims of HIPAA violations may participate in recovery of penalty funds Increases high end of penalties to $1.5 million Individual State Legislation As a participant/consultant in this field you will need to be familiar with the regulations in the State(s) in which you perform services Find one or more good healthcare attorneys

in your area Use these attorneys as sources for Federal and State regulations and as resources for yourself and clients Review State Dept. of Insurance enforcement criteria Review State OIG healthcare statutes OBAMACARE The Patient Protection and Affordable Care Act was signed into law by President Obama on March 23, 2010

The law was challenged in Federal Court as being unconstitutional under the Commerce Clause There are currently waivers that have been allowed for Employers such as McDonalds, large insurers such as Aetna and Cigna and 185 union plans covering approximately 1 million employees. OBAMACARE, Contd Only time will tell whether this Law will be

allowed to proceed and a class on this Law by itself would take more time than available within this session. Congress is currently and quietly trying to exempt itself from the law you can make your own conclusions Healthcare reform is needed however the mechanism to provide such reform is still the subject of intense debate There are no easy answers but there are severe penalties for providers that do not play well with the Government Conclusion

Obtain copies of the rules we work with Read and understand the rules as best you can Dont get too cute you can go to jail too! Enlist the assistance of one or more qualified health care attorneys and dont be afraid to utilize them Pray that the HHS Boogie Man stays away!! Good Luck to each of you!!!

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