Wednesday, September 21, 2011

Provider Scrutiny Only Going to Continue with Recent Announcement.

Calling healthcare spending the "single biggest financial issue facing the nation," this week, a group of four national health insurers announced plans to pool more than 5 billion healthcare claims into a single database that researchers can mine to identify trends in cost, utilization and intensity of care. ( I INTERPRET THAT AS GOING AFTER PROVIDERS FOR RETURNS.)


The Health Care Cost Institute is a not-for-profit research group governed by a six-member board of academic, actuarial and medical professionals who will oversee the database created using data from four insurers: Aetna, Humana, Kaiser Permanente and UnitedHealthcare. The database will include government data from Medicare and Medicare Advantage plans, and it may eventually include information from other private insurers.

The size of this pooling is massive. It is expected that the initial data provided by the insurers will cover more than $1 trillion in healthcare spending spanning the period from 2000-2011. The plan is to periodically update the system with new claims. (That is a primary concern of any health care provider)

The institute announced that it plans to release public "score cards" twice a year summarizing national trends in the data, as well as information on a handful of specific geographic regions, though it will not identify specific healthcare providers in any market. The full deidentified data set will not be released publicly, but it will be provided for use by qualified researchers selected by the institute.

Medicare has taken such steps for years, but this announcement depicts four private payors joining forces to identify "waste." A number of challenges to this process could be forthconing, such as privacy concerns, anti-trust, price-fixing, collusion, etc., but that is a subject for another day. Suffice it to say that the pressure is only going to mount for providers with respect to retrospective audits and denials.

Thursday, September 15, 2011

MEDICAID FOLLOWS MEDICARE – PROVIDERS TO BE UNDER THE GUN.

September 15, 2011

Building on the Medicare Recovery Audit Contractor program, on September 14, 2011, the DHHS issued a final rule to establish a Medicaid Recovery Audit Contractor program that the agency expects will save $2.1 billion in waste over the next five years. (You will note this follows Medicare's efforts in the past.)

The rule was released on the same day Vice President Joe Biden convened a Cabinet meeting at the White House to discuss the Obama administration's Campaign to Cut Waste.

“Today's announcements on cutting waste in Medicare, Medicaid and Unemployment Insurance shows that we can make our government more efficient and responsible to the American people, if we're going to spur jobs and economic growth and restore long-term fiscal solvency, we need to make sure hard-earned tax dollars don't go to waste.”

DHHS pointed to about $668 million in recoveries from the Medicare RAC program this year, and that the Patient Protection and Affordable Care Act included the anti-fraud provision of expanding the RAC program to Medicaid. Of the anticipated $2.1 billion in recovered funds, about $900 million is expected to be returned to the states, the official said. It's also expected that Medicaid RAC auditors would be paid about the same percentage—10% to 12%—of recovered funds as Medicare RAC contractors.

Effective Jan. 2, 2012, the rule gives guidance to states about federal and state funding for the start-up, operation, and maintenance costs of Medicaid RAC contractors and the payment methodology for state payments to Medicaid RACs. It also directs states to ensure that proper appeal processes are in place for providers to dispute “adverse determinations” from the contractors, according to the rule.

Thursday, July 7, 2011

Non-Compliance is Both Costly and Risky for Practitioners

It is no longer an option for healthcare providers, no matter how small, to roll the dice and take a chance that their organization does not need to have a compliance program because they believe that it is unlikely that they will be subject to an audit or cited for violations of the various federal laws and regulations for not having a compliance program. The risks and potential financial exposure are too great to ignore putting an effective compliance program in place.

Compliance, enforcement and accountabilty are now at the forefront of government initiatives and the current environment for healthcare providers. Through the Patient Protection and Affordable Care Act of 2010 (PPACA) Congress took away many of the defenses that were available and laws were enacted that increased government funding for dealing with healthcare fraud and abuse; created additional agencies and entities that would now be able to conduct audits and levy penalties for non-compliance; made it easier for individuals (whistleblowers) to report violations and recover monies for them doing so, raised the dollar amount of penalties that could be levied, allowed HHS to suspend Medicare and Medicaid payments ” pending an investigation of a credible allegation of fraud,” allowed senior level managers and board of director members to be sued individually and not allowed to be released personally for an organization’s non-compliance, etc.

Congress and OIG are now looking for more accountability for compliance and more accountability for resolution of healthcare issues. This accountability is not only focused on the healthcare providers, but it is spilling over onto senior level managers and board of director members individually.

Not only is non-compliance risky for a healthcare provider, but it is also costly. Some of the increased cost risks are: increased financial penalties; costs associated with harm to the organization’s reputation; loss of income if a provider is excluded or debarred from government programs; increased costs resulting from more whistleblower actions; fees for lawyers and consultants.

The key to minimize these additional risks and costs is to have an effective compliance program in place which will have adequate controls to deal with potential violations and to take prompt, remedial action if a violation does occur. The bottom line is that OIG, HHS and the government take compliance very seriously and expect healthcare organizations to do likewise.

Friday, April 15, 2011

Back to the Basics - 5 Most Important Fraud & Abuse Laws for Providers

SUMMARY OF THE FIVE MOST IMPORTANT FEDERAL FRAUD AND ABUSE LAWS FOR PHYSICIANS

The five most important Federal fraud and abuse laws that apply to physicians are the
False Claims Act (FCA), the Anti-Kickback Statute (AKS), the Physician Self-Referral
Law (Stark law), the Exclusion Authorities, and the Civil Monetary Penalties Law
(CMPL). Government agencies, including the Department of Justice, the Department
of Health & Human Services Office of Inspector General (OIG), and the Centers for
Medicare & Medicaid Services (CMS), are charged with enforcing these laws. As you
begin your career, it is crucial to understand these laws not only because following
them is the right thing to do, but also because violating them could result in criminal
penalties, civil fines, exclusion from the Federal health care programs, or loss of your
medical license from your State medical board.

False Claims Act [31 U.S.C. §§ 3729–3733]

The civil FCA protects the Government from being overcharged or sold shoddy
goods or services. It is illegal to submit claims for payment to Medicare or
Medicaid that you know or should know are false or fraudulent. Filing false
claims may result in fines of up to three times the programs’ loss plus $11,000 per claim
filed. Under the civil FCA, each instance of an item or a service billed to Medicare or
Medicaid counts as a claim, so fines can add up quickly. The fact that a claim results
from a kickback or is made in violation of the Stark law also may render it false or
fraudulent, creating liability under the civil FCA as well as the AKS or Stark law.
Under the civil FCA, no specific intent to defraud is required. The civil FCA defines
“knowing” to include not only actual knowledge but also instances in which the
person acted in deliberate ignorance or reckless disregard of the truth or falsity of
the information. Further, the civil FCA contains a whistleblower provision that allows
a private individual to file a lawsuit on behalf of the United States and entitles that
whistleblower to a percentage of any recoveries. Whistleblowers could be current or
ex-business partners, hospital or office staff, patients, or competitors.
There also is a criminal FCA (18 U.S.C. § 287). Criminal penalties for submitting false
claims include imprisonment and criminal fines. Physicians have gone to prison for
submitting false health care claims. OIG also may impose administrative civil monetary
penalties for false or fraudulent claims, as discussed below.

Anti-Kickback Statute [42 U.S.C. § 1320a-7b(b)]

The AKS is a criminal law that prohibits the knowing and willful payment of
“remuneration” to induce or reward patient referrals or the generation of business
involving any item or service payable by the Federal health care programs (e.g., drugs,
supplies, or health care services for Medicare or Medicaid patients). Remuneration
includes anything of value and can take many forms besides cash, such as free
rent, expensive hotel stays and meals, and excessive compensation for medical
directorships or consultancies. In some industries, it is acceptable to reward those who refer
business to you. However, in the Federal health care programs, paying for referrals is a crime. The statute covers the payers of kickbacks—those who offer or pay remuneration— as well as the recipients of kickbacks—those who solicit or receive remuneration. Each party’s intent is a
key element of their liability under the AKS.

Criminal penalties and administrative sanctions for violating the AKS include fines, jail terms, and exclusion from participation in the Federal health care programs. Under the CMPL,
physicians who pay or accept kickbacks also face penalties of up to $50,000 per kickback plus three times the amount of the remuneration.

Safe harbors protect certain payment and business practices that could otherwise
implicate the AKS from criminal and civil prosecution. To be protected by a safe harbor,
an arrangement must fit squarely in the safe harbor and satisfy all of its requirements.
Some safe harbors address personal services and rental agreements, investments in
ambulatory surgical centers, and payments to bona fide employees.

For additional information on safe harbors, see “OIG’s Safe Harbor Regulations”
available at http://oig.hhs.gov/fraud/safeharborregulations.asp.

As a physician, you are an attractive target for kickback schemes because
you can be a source of referrals for fellow physicians or other health care providers
and suppliers. You decide what drugs your patients use, which specialists they see, and what health care services and supplies they receive.

Many people and companies want your patients’ business and would pay you to send that business their way. Just as it is illegal for you to take money from providers and suppliers in return for the referral of your Medicare and Medicaid patients, it is illegal for you to pay others to refer their Medicare and Medicaid patients to you.
Kickbacks in health care can lead to:

- Overutilization
- Increased Medicare costs
- Corruption of medical decision making
- Patient steering
- Unfair competition

The kickback prohibition applies to all sources of referrals, even patients. For example, where the Medicare and Medicaid programs require patients to pay copays for services, you are generally required to collect that money from your patients. Routinely waiving these copays could implicate the AKS and you may not advertise that you will forgive copayments. However, you are free to waive a copayment if you make an individual determination that the patient cannot afford to pay or if your reasonable collection efforts fail. It is also legal to provide free or discounted services to uninsured people.

Besides the AKS, the beneficiary inducement statute (42 U.S.C. § 1320a-7a(a)(5)) also imposes civil monetary penalties on physicians who offer remuneration to Medicare and Medicaid beneficiaries to influence them to use their services.

The Government does not need to prove patient harm or financial loss to the programs to show that a physician violated the AKS. A physician can be guilty of violating the AKS even if the physician actually rendered the service and the service was medically necessary. Taking money or gifts from a drug or device company or a durable medical equipment (DME) supplier is not justified by the argument that you would have prescribed that drug or ordered that wheelchair even without a kickback.

Physician Self-Referral Law [42 U.S.C. § 1395nn] – Stark Law

The Physician Self-Referral Law, commonly referred to as the Stark law, prohibits
physicians from referring patients to receive “designated health services” payable by
Medicare or Medicaid from entities with which the physician or an immediate family
member has a financial relationship, unless an exception applies. Financial relationships
include both ownership/investment interests and compensation arrangements. For
example, if you invest in an imaging center, the Stark law requires the resulting
financial relationship to fit within an exception or you may not refer patients to the
facility and the entity may not bill for the referred imaging services.
“Designated health services” are:

• clinical laboratory services;
• physical therapy, occupational therapy, and outpatient speech-language
pathology services;
• radiology and certain other imaging services;
• radiation therapy services and supplies;
• DME and supplies;
• parenteral and enteral nutrients,
equipment, and supplies;
• prosthetics, orthotics, and prosthetic
devices and supplies;
• home health services;
• outpatient prescription drugs; and
• inpatient and outpatient hospital services.

The Stark law is a strict liability statute, which means proof of specific intent to
violate the law is not required. The Stark law prohibits the submission, or causing
the submission, of claims in violation of the law’s restrictions on referrals. Penalties
for physicians who violate the Stark law include fines as well as exclusion from
participation in the Federal health care programs.

For more information, see CMS’s Stark law Web site available at
http://www.cms.gov/physicianselfreferral/.

Exclusion Statute [42 U.S.C. § 1320a-7]

OIG is legally required to exclude from participation in all Federal health care programs individuals and entities convicted of the following types of criminal offenses: (1) Medicare or Medicaid fraud, as well as any other offenses related to the delivery of items or services under Medicare or Medicaid; (2) patient abuse or neglect; (3) felony convictions for other health-care-related fraud, theft, or other financial misconduct; and (4) felony convictions for unlawful manufacture, distribution, prescription, or dispensing of controlled substances. OIG has discretion to exclude individuals and entities on several other grounds, including misdemeanor convictions related to health care fraud other than Medicare or Medicaid fraud or misdemeanor convictions in connection with the unlawful manufacture, distribution, prescription, or dispensing of controlled substances; suspension, revocation, or surrender of a license to provide health care for reasons bearing on professional competence, professional performance, or financial integrity; provision of unnecessary or substandard services; submission of false or fraudulent claims to a Federal health care program; engaging in unlawful kickback arrangements; and defaulting on health education loan or scholarship obligations.
If you are excluded by OIG from participation in the Federal health care programs, then Medicare, Medicaid, and other Federal health care programs, such as TRICARE and the Veterans Health Administration, will not pay for items or services that you furnish, order, or prescribe. Excluded physicians may not bill directly for treating Medicare and Medicaid patients, nor may their services be billed indirectly through an employer or a group practice. In addition, if you furnish services to a patient on a private-pay basis, no order or prescription that you give to that patient will be reimbursable by any Federal health care program.

For more information, see OIG’s Special Advisory Bulletin entitled “The Effect of Exclusion From Participation in Federal Health Care Programs” available at http://oig.hhs.gov/fraud/docs/alertsandbulletins/effected.htm.

You are responsible for ensuring that you do not employ or contract with excluded individuals or entities, whether in a physician practice, a clinic, or in any capacity or setting in which Federal health care programs may reimburse for the items or services furnished by those employees or contractors. This responsibility requires screening all current and prospective employees and contractors against OIG’s List of Excluded Individuals and Entities. This online database can be accessed from OIG’s Exclusion Web site. If you employ or contract with an excluded individual or entity and Federal health care program payment is made for items or services that person or entity furnishes, whether directly or indirectly, you may be subject to a civil monetary penalty and/or an obligation to repay any amounts attributable to the services of the excluded individual or entity.
For more information, see OIG’s exclusion Web site available at http://oig.hhs.gov/fraud/exclusions.asp.

Civil Monetary Penalties Law [42 U.S.C. § 1320a-7a]

OIG may seek civil monetary penalties and sometimes exclusion for a wide variety of conduct and is authorized to seek different amounts of penalties and assessments based on the type of violation at issue. Penalties range from $10,000 to $50,000 per violation. Some examples of CMPL violations include:
- presenting a claim that the person knows or should know is for an item or service that was not provided as claimed or is false or fraudulent;
- presenting a claim that the person knows or should know is for an item or service for which payment may not be made;
- violating the AKS;
- violating Medicare assignment provisions;
- violating the Medicare physician agreement;
- providing false or misleading information expected to influence a decision to discharge;
- failing to provide an adequate medical screening examination for patients who present to a hospital emergency department with an emergency medical condition or in labor; and
- making false statements or misrepresentations on applications or contracts to participate in the Federal health care programs.


While this summary might be second nature for many of you, it is never a bad idea to refresh on the basics!

Thursday, April 14, 2011

OIG Provides Provider Speciic Details

CHeck out www.oig.hhs.gov/fraud/physician education as the Feds are really trying to educate providers as to common pitfalls. Some examples from the site include:

A cardiologist paid the Government $435,000 and entered into a 5-year Integrity Agreement with OIG to settle allegations that he knowingly submitted claims for consultation services that were not supported by patient medical records and did not meet the criteria for a consultation. The physician also allegedly knowingly submitted false claims for E&M services when he had already received payment for such services in connection with previous claims for nuclear stress testing.


A physician paid $107,000 to resolve potential liability for charging patients, including Medicare beneficiaries, an annual fee. In exchange for the fee, the physician offered: (1) an annual physical; (2) same- or next-day appointments; (3) dedicated support personnel; (4) around-the-clock physician availability; (5) prescription facilitation; (6) expedited and coordinated referrals; and (7) other amenities at the physician’s discretion. The physician’s activities allegedly violated the assignment agreement because some of the services outlined in the annual fee were already covered by Medicare.


A physician group practice paid the Government $1 million and entered into a 5-year Corporate Integrity Agreement to settle alleged violations of the AKS, FCA, and Stark law related to medical directorships with a medical center. Allegedly, the agreements were not in writing, the physicians were paid more than fair market value for the services they rendered, and the payment amounts were based on the value of referrals the physicians sent to the medical center.


Tranpsarancy in the Physician - Vendor Industry...

Although some physicians believe that free lunches, subsidized trips, and gifts do not affect their medical judgment, research shows that these types of perquisites can influence prescribing practices. Recent pharmaceutical company settlements with the Department of Justice and OIG require “transparency” in physician-industry relationships, whether by requiring the pharmaceutical company to provide the Government with a list of physicians whom the company paid and/or by requiring ongoing public disclosure by the company of physician payments. The public will soon know what gifts and payments a physician receives from industry. The Patient Protection and Affordable Care Act of 2010 requires drug, device, and biologic companies to publicly report nearly all gifts or payments they make to physicians beginning in 2013.

Academic institutions also may impose various restrictions

Wednesday, April 13, 2011

How ACO's May Alter Healthcare Regulatory Oversight.

PPACA and ACO’s Add to the “Alphabet Soup” that is Today’s Healthcare.

The Patient Protection and Affordable Care Act of 2010 (PPACA) created the Medicare Shared Savings Program, more commonly referred to as Accountable Care Organizations (ACOs). The National Committee for Quality Assurance defines ACOs as provider-based organizations that take responsibility for meeting the health care needs of a defined population with the goal of simultaneously improving health, improving patient experience, and reducing per capita costs.
However, the implementation of ACOs could potentially violate certain fraud and abuse laws currently in place. To facilitate the establishment of ACOs, the PPACA grants the Secretary of Health and Human Services the authority to waive certain provisions of the fraud and abuse laws under the Social Security Act or other provisions of the Medicare law. The possible waivers of these well-established laws pave the way towards the development of ACOs.

The PPACA specified five provisions of the Social Security Act that the Secretary of HHS may waive in order to allow the creation of an ACO program. Those laws are the following:
• Civil Monetary Penalty Law Prohibition on Payments to Reduce or Limit Care. A provider may not knowingly make a payment, directly or indirectly, to another provider as an inducement to reduce or limit services provided to a Medicare or Medicaid beneficiary.
• Beneficiary Inducement. Persons may not provide remuneration to a Medicare or Medicaid beneficiary where the person knows or should know that the remuneration is likely to influence the beneficiary to order or receive a service from a particular provider, practitioner or supplier where the item may be covered under the Medicare or Medicaid programs.
• The Stark Law. A physician may not refer Medicare patients for certain designated health services to an entity with which the physician or an immediate family member has a financial relationship, unless an exception applies. An entity receiving a prohibited referral may not bill the Medicare program for the resulting items and services.
• The Anti-Kickback Statute. Persons may not knowingly offer or receive, directly or indirectly, overtly or covertly, in cash or in kind, any remuneration to induce or influence the furnishing, arrangement, purchase, leasing, or ordering of items or services for which payment may be made under a federal health care program.
• Prohibitions Against Charging or Collecting More Than the Medicare Allowable. If a provider accepts assignment, Medicare will directly pay the fee schedule amount for the services, and the beneficiary will be responsible for paying the coinsurance and any remaining deductible. Collectively, the fee schedule payment and coinsurance/deductible are referred to as the "allowed amount." By accepting assignment, the provider agrees to accept the "allowed amount" as "payment in full" for the services.

Some of the unknowns moving forward would be: (1) How can a hospital fund the cost of developing the legal and operational infrastructure of an ACO if physicians who refer to that hospital will be members of the ACO, have an active role in governance and are entitled to a portion of the ACOs shared savings? (2) Can the ACO pay primary care physician members a per patient per month management fee for overseeing the delivery of care to the beneficiaries attributed to that ACO? (3) Can the ACO offer Medicare beneficiaries cash or other remuneration to induce the beneficiaries to seek care from providers affiliated with the ACO?
Even with the recent banter about repealing “Obama-Care,” or legal battles questioning the Constitutionality of the same, ACO’s represents a market-oriented approach that likely will survive any modifications to the law. If true, DHHS will need to clarify to all providers how the above laws will operate in the new financial world created by ACO’s. Stay Tuned.

Thursday, February 24, 2011

DHHS Secretary Sebelius' Feb. 23, 2011 Comments on Fraud and Abuse

Thank you, Attorney General Holder. It has been a privilege to join forces with you and your team at Justice over the last two years to keep criminals out of our health care system.

I want to thank FBI Director Robert Mueller, HHS Inspector General Daniel Levinson, and Assistant Attorney General Lanny Breuer for their leadership

And I want to recognize the countless public servants -- investigators, attorneys, and law enforcement including a record number of OIG agents, more than 300 -- who participated in the massive takedown we’re announcing today.

Today’s news is the culmination of a lot of hard work and an unprecendented level of collaboration across government, in cities across the country.

Under the HEAT partnership that Attorney General Holder described we’re sharing information, spotting trends, coordinating strategy, and developing new fraud prevention tools.

As Attorney General Holder pointed out, over the last two years we have more than quadrupled the number of anti-fraud Strike Force teams operating in fraud hot spots around the country from two to nine -- with the latest additions Chicago and Dallas -- bringing hundreds of charges against criminals who had billed Medicare for hundreds of millions of dollars.

And it’s paying off. Last year alone, our partnership recovered a record $4 billion on behalf of taxpayers. From 2008 to 2010, every dollar the Federal Government spent under its Health Care Fraud and Abuse Control programs averaged a return on investment of $6.80.

We’ve also been recruiting new partners. In 2010, we held health care fraud prevention summits in Washington DC, Miami, Los Angeles, Brooklyn, and Boston and there are more to come in 2011 in Philadelphia, Las Vegas, and Detroit.

Last March, we got some help when Congress passed and the President signed the Affordable Care Act -- one of the strongest health care anti-fraud bills in American history.

Just last month, we announced new rules under the health care law that include new screening and enforcement measures to help keep bad actors out of our programs.

When it comes to programs like Medicare and Medicaid that tens of millions of Americans count on every day, we have a responsibility to make every dollar count – especially at a time when so many families are doing the same.

That’s why the 2012 budget request that President Obama released on Monday includes new support for our health care fraud prevention efforts.

For example, the new budget proposal would allow us to expand the very successful Strike Force model to even more locations across the country.

This is the kind of investment we know pays off by making our health care system stronger, more responsive, and less vulnerable to costly criminals and scam artists.

For decades, our fight against fraud and abuse in health care has been a bipartisan effort. If we are to truly win this fight, we will need to continue to stand united against the crooks who would rob the Medicare trust fund.