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Durable Medical Equipment Company’s Pricing Structure Violates Anti-Kickback Statute

DMEDurable Medical Equipment (DME) manufacturers can face serious fines for violating the Anti‑Kickback Statute (“AKS”). In a recent settlement, Respironics, a manufacturer of sleep therapy products, agreed to settle allegations that its bundled pricing structure for sleep apnea masks violated the AKS. Since violations of the AKS give rise to fines under the False Claims Act, DME manufacturers can face trebled damages and fines up to $10,000 per violation.

According to Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division, “The payment of illegal remuneration in any form to induce patient referrals threatens public confidence in the health care system. Americans deserve to know that when they are prescribed a device to treat a serious health care problem, the supplier’s judgment has not been compromised by illegal payments from equipment manufacturers.”

Respironics, Inc. provided call center services to DME companies at no cost so long as the patients ordered Respironics masks. DME companies had to pay a monthly fee based on the number of patients who used masks manufactured by Respironics’ competitors. According to the U.S. Department of Justice, this made suppliers more likely to use Respironics masks. Respironics has since changed the pricing structure of its call center services.

A South Carolina pharmacists recognized that the arrangement likely violated the AKS and filed a qui tam (whistle-blower) lawsuit. The U.S. Justice Department intervened along with 29 other states and the District of Columbia.

Respironics agreed to pay $34.8 million in order to settle the lawsuit even without admitting wrongdoing, and the company continues to maintain that its pricing structure fit within the discount Safe Harbor. However, this settlement serves as a powerful reminder that companies must be aware of potential AKS violations. Respironics’ “good-faith belief” that the arrangement met a Safe Harbor did not save it from AKS scrutiny or a multimillion dollar settlement.

If you have any questions or need assistance with healthcare regulatory issues, Jeyaram & Associates attorneys can help. Contact DJ Jeyaram at DJ@Jeylaw.com or 678.325.3872.

Free Introductory Home Health Visits Don’t Violate Anti-Kickback Law

Anti-Kickback StatuteInspector General: No Kickback violation for free home health introductory visits

The Office of the Inspector General issued an advisory opinion clearing the way for home health providers who provide “introductory” home visits to individuals who eventually become their clients. The OIG advised that home healthcare providers who contact  patients after being selected by that patient and provide information to those patients about their services, do not violate the federal Anti-Kickback statute.

The Federal Anti-Kickback law makes it a criminal offense to knowingly and willfully offer, pay, solicit or receive anything of value in exchange for inducing or rewarding referrals of items or services reimbursable by a Federal health program

The OIG’s office stated that the “primary purpose of the Introductory Visit is to facilitate the patient’s transition to home health services in an effort to increase compliance with the post-acute treatment plan.” In addition, the OIG”s noted that during the “Introductory” visit, the health care provider ‘”does not provide any type of  any federally reimbursable diagnostic or therapeutic services during the Introductory Visits,” which occur where a patient is receiving care whether it’s a physician’s office, hospital or personal home. Further, the home health provider is not involved in any way in the patient’s selection process and “Introductory Visits” do not provide any actual or economic benefit to the patients. .

It’s important to reiterate, that healthcare providers should not contact the patient prior to receiving notification from the  patient that they have been selected nor can the “Introductory Visits” be a covered service under Medicare or Medicaid, or reimbursed by third-party payors. These actions could violate the Anti-Kickback statute.

To read the full opinion, click here.

For more information, please contact Kimberly Sheridan at 678-708-4703.

Physicians’ Compensation For Certain Referrals Could Violate Anti-Kickback Statue

Anti-KickbackOIG Reminds Physicians That They Will Be Held Liable For Illegal Payments Under The Anti-kickback Statute

On June 9, the Department of Health and Human Services Office of Inspector General (OIG) issued a Special Fraud Alert warning against potential liability for physicians who enter into certain financial arrangements with healthcare institutions.

The Fraud Alert states that “if even one purpose of the arrangement is to compensate a physician for his or her past or future referrals” the compensation arrangement would violate the federal Anti-kickback statute.

The Fraud Alert discussed a recent settlement regarding an arrangement between several physicians and a healthcare institution. It emphasized that the following factors resulted in an OIG determination that there was improper remuneration:

  • Payments to physicians took into account the physician’s volume or value of referrals and did not reflect fair market value for the services performed
  • Physicians did not actually provide the services called for under the arrangement
  • The arrangement relieved the physician of a financial burden that such physician would have otherwise incurred, e.g., a healthcare institution paid for the physician’s office staff at his or her practice

Although the Fraud Alert does not change any existing laws, it is a reminder that physicians (not just the hospitals) will be held liable for illegal payments. Physicians should heed OIG’s warning and ensure that arrangements with healthcare institutions do not violate any laws. All arrangements must not only comply with the federal Anti-kickback statute, but also other fraud and abuse laws such as the Stark Law, the Civil Money Penalties Law (CMP Law), and the state law Stark and Anti-kickback counterparts.

The Special Fraud Alert can be found here.

If you are a physician with questions about a current or proposed arrangement with a healthcare institution, please call Danielle Hildebrand or DJ Jeyaram at 678-325-3872 for legal counsel.

Healthcare Providers Need To Examine Billing Practices To Ensure Compliance

healthcare fraudLast month, the Department of Health and Human Services released its annual report for the Health Care Fraud and Abuse Control Program. According to the report, in 2014 more than 900 new criminal health care fraud investigations were opened by the Department of Justice. There was a slight increase in the number of criminal cases and convictions from last year, with 496 cases and 735 defendants convicted of criminal health care fraud. Civil cases alone resulted in $2.3 Billion in settlements and judgments.

The government’s press release reiterated that detecting and eliminating fraud and abuse continues to be a top priority. The government attributes its high recoveries to a change in strategy which uses real-time data analysis to detect fraud more quickly. The Centers for Medicare and Medicaid currently uses advanced analytics on Medicare fee-for-service claims. The goal of this is to detect aberrant and suspicious billing patterns which would then trigger an investigation or enforcement action by the government.

Now is the time to for Medicare and Medicaid providers to review their billing practices and financial relationships to ensure that they are compliant with federal laws. Charges against providers were made under the False Claims Act, as well as Anti-Kickback Statute, the Stark Law (Physician Self-Referral Law), and other federal laws.

The full annual report is available at www.oig.hhs.gov/publications/hcfac.asp.

If you have any questions about the legality of your billing practices or financial relationships, please contact DJ Jeyaram at DJ@jeylaw.com or Danielle Hildebrand at dhildebrand@jeylaw.com.

 

Is it O.K. to Waive Medicare and Medicaid Beneficiary Co-Pays?

AntiKickback Medicaid MedicareThe answer is sometimes.  However, providers must be very careful to consider the implications of waiving beneficiary co-pays.  Primarily, waiving co-pays may trigger The Anti-Kickback Statute.

The Anti-Kickback Statute provides in relevant part:

Whoever knowingly and willfully offers or pays any remuneration (including any kickback, bribe, or rebate) directly or indirectly…, in cash or in kind, to any person to induce such person to refer an individual [for] any item or service for which payment may be made … under a Federal health care program, … shall be guilty of a felony.42 U.S.C. § 1320a-7b(b).

Basically, the statute prohibits giving anything of value in order to induce referrals for business covered by Medicaid and other federally funded health care programs, and may apply to any transaction between providers and program beneficiaries.

However, the statue does not apply if a health care provider acts without any intent to induce improper referrals. In addition, the provider must know about the law, and act “with the specific intent to violate the law.” Hanlester Network v. Shalala, 51 F.3d 1390 (9th Cir. 1995).

Thus, actions taken in good faith for the benefit of patients or program beneficiaries without any improper intent to generate referrals or violate the law do not implicate Anti-Kickback.

The Department may examine any transaction that could generate improper referrals, especially those in which a provider offers free or discounted items or services to program beneficiaries, or those that would otherwise promote over-utilization or create a risk of fraudulent claims. See OIG Special Advisory Bulletin, Offering Gifts and Other Inducements to Beneficiaries (8/02).

Copays and deductibles help discourage unnecessary services and lower the cost of government programs. A provider’s routine waiver of copays and deductibles may create an incentive to over-utilize program resources and violate the Anti-Kickback Statute. See OIG Special Fraud Alert (12/94).

The OIG has set out some safe harbor guidelines.  Waiving Medicaid and Medicare copays or deductibles does not violate the Anti-Kickback Statute if:

  • the waiver is not offered as part of any advertisement or solicitation;
  • the provider does not routinely waive coinsurance or deductibles; and
  • the provider waives the coinsurance and deductibles after determining in good faith that the individual is in financial need or reasonable collection efforts have failed.

The beneficiary’s “financial need” will depend on the individual’s circumstances.  Providers should have a written policy and guidelines in place showing consideration of factors such as the local cost of living, the patient’s income, assets and expenses, and the scope and extent of the patient’s medical bills. The documentation of financial need should be placed in that patient’s file to prove that the analysis was undertaken and the policy was followed.  In addition, collection should always be attempted.

By taking these factors into consideration, a Provider may greatly reduce the risk of being flagged for fraudulent waiver of copays.

For more information, contact DJ Jeyaram at DJ@Jeylaw.com or  678.325.3872.