On January 22, 2015, in the case of Barrows v. Burwell, No. 3:11-cv-1703, 2015 WL 264727 (2nd Cir., January 22, 2015), the United States Court of Appeals for the Second Circuit ruled that Medicare beneficiaries be granted the opportunity to demonstrate a Constitutionally-protected property interest to challenge their patient status designations as hospital outpatients rather than inpatients.
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With the fight against prescription drug abuse reaching an all-time high, health insurance plans are now taking a proactive role in attempting to reduce the quantity of some of the most abused drugs in the marketplace. As of September 2, 2014, Blue Cross Blue Shield of Michigan (BCBSM) commercial plans (non-Medicare) will implement new quantity limits for Oxycodone immediate release tablets and capsules (sold under the brand names of Roxicodone an OxyIR) and Oxymorphone immediate release tablets (sold under the brand name of Opana) of 180 per 30 days. These new limits apply to all strengths of the generic and brand-name versions of these drugs. Some pain management physicians have expressed concern that such limitations are an attempt by the health insurance companies to usurp the medical judgment of treating physicians due to cost containment measures while others believe that such limitations are helpful in reducing the potential for unsupervised use, misuse or abuse of prescription painkillers that can lead to addiction, hospitalization and even death. BCBSM will entertain a written request from a prescriber for an override of the limitation that includes documentation that the amount prescribed is medically necessary. A quantity limit override form is available from BCBSM on its website.
The attorneys at The Health Law Partners have a significant amount of experience in the defense of health care fraud investigations and pharmacy legal matters. For more information regarding such matters, please contact Robert S. Iwrey, Esq. at (248) 996-8510 or email@example.com.
The U.S. Justice Department's Medicare Fraud Strike Force set record numbers for health care prosecutions throughout the Country in Fiscal Year (FY) 2013.
The Medicare Fraud Strike Force is a coordinated team of investigators and prosecutors from the Justice Department, the U.S. Department of Health and Human Services and the FBI who, under the supervision of the U.S. Attorney's Offices and Justice Department's Criminal Division, analyze Medicare claims data for unusual billing patterns in specific geographic areas. The Medicare Fraud Strike Force currently operates out of 9 cities: Baton Rouge, La.; Brooklyn, N.Y.; Chicago; Dallas; Detroit; Houston; Los Angeles; Miami and Tampa, Fla. Since its inception in March 2007, its operations have resulted in more than 1,700 defendants being charged.
In FY 2013 alone, the Medicare Fraud Strike Force filed 137 cases charging 345 individuals. Moreover, there were 234 guilty pleas and 46 jury trial convictions. In addition, the defendants who were charged and sentenced in FY 2013 faced an average of 52 months in prison compared to an average of 47 months for those sentenced since 2007.
In light of a recent statistic from the OIG that for every $1 spent in fraud enforcement nearly $8 is received, rest assured such enforcement will continue and likely increase for the foreseeable future.
New Jersey Hospital Settles Anti-Kickback Qui Tam Case for $12.5 Million; Case Alleged Cardiologists Were Compensated $18,000 Per Year to Serve on Advisory Board That Was Actually Tied to Patient Referrals
On January 24, 2013, the U.S. Attorney's Office for the State of New Jersey unsealed a $12.5 Million Dollar settlement with Cooper Health System, headquartered in the Camden, New Jersey area, but serving regions of New Jersey, Pennsylvania and Delaware. The settlement was the result of cardiologist Nicholas DePace's whistleblower qui tam lawsuit, which alleged that the government had been defrauded.
The case arose out of an arrangement where cardiologists were paid $18,000 per year to sit on an advisory board. The physicians were paid to sit on the board from 2004 until 2010. Under the participating physicians' "consulting" and "compensation" agreements, they were required to attend at least four board meetings per year to receive the $18,000 payment. The complaint alleged that these physicians did little "advising" on the advisory board, and simply listened to lectures at the meetings.
In his qui tam complaint, DePace alleged that the hospital violated the Federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), Federal "Stark Law" (42 U.S.C. § 1395nn), the New Jersey Anti-Kickback Statute (N.J.S.A. 30:4D-14(c)), and New Jersey's physician self-referral law (N.J.S.A. 45:9-22.4, et seq., or the "Codey Law"). The U.S. Attorney's office alleged that Cooper's payments to physicians sitting on the board were at least in part to compensate them for their referrals of patients to the hospital, and that some of those patients were Medicare or Medicaid recipients. Dr. DePace was paid $2.39 Million from the United States and New Jersey for reporting the claims.
The $12.6 Million Dollar settlement will have a significant financial impact on the Camden-based healthcare system, which posted a 2012 11-month operating income of $13 Million, according to financial disclosures.
On January 15, 2013, Richard Behnan, DPM., a 56 year old podiatrist from Fenton, MI was sentenced by a federal judge to 55 months in prison and ordered to pay over $1.4 million in restitution to Medicare and nearly $200,000 to BCBSM for his participation in a $1.6 million fraudulent medical billing scheme. Dr.Behnan previously pleaded guilty on November 21, 2011 to one count of conspiracy to commit health care fraud. According to the plea documents, from approximately 2000 through 2010, Dr. Behnan, provided services to patients at various senior centers and assisted living facilities in Bay City, Flint, Detroit, and Lansing submitting claims to BCBSM and Medicare for nail avulsion procedures when he had merely trimmed and polished the patients' toenails. At times, Dr. Behnan submitted claims for nail avulsion procedures when he was traveling outside of the United States.
On December 11, 2012, Hetal Barot, a physical therapy assistant from Westland, Michigan, was sentenced today to serve 30 months in prison followed by 2 years of supervised release after pleading guilty to 1 count of conspiracy to commit health care fraud. She was also ordered to pay $1,336,739 in restitution, jointly and severally with her co-defendants. Barot falsified medical documentation for home health agencies owned by her co-conspirators, creating evaluations, therapy revisit notes and other medical documentation to support physical therapy services that were billed but never rendered. From approximately May 2009 through September 2011, Medicare paid approximately $1,336,739 to four home health care companies for fraudulent physical therapy claims based on falsified files and notes signed by Barot. The four home health companies for which Barot worked were paid in total approximately $13.8 million by Medicare. With regard to Barot's co-defendants, 9 have pleaded guilty, 3 are fugitives, and 6 await trial.
On Monday, December 10, 2012, Boris Sachakov, MD, a colorectal surgeon, was sentenced to serve 30 months in prison for Medicare and private insurance fraud for billing for procedures such as hemorrhoidectomies that he never performed. On June 13, 2012, Dr. Sachakov was found guilty by a jury of one count of health care fraud and five counts of health care false statements after a 2-week trial in federal court. At trial, 11 of his patients testified that they never received the surgeries and medical services for which Dr. Sachakov had billed their insurance companies. In addition, when confronted by 2 of the insurance companies for allegations of billing for services not rendered, Dr. Sachakov sent letters to his patients asking them to falsely certify that they did receive the surgeries. Dr. Sachakov was charged with submitting more than $22.6 million in false claims and receiving more than $9 million from those claims.
In addition, on December 10, 2012, Ho Yon Kim, M.D. plead guilty to conspiracy to commit health care fraud. Dr. Kim admitted that he conspired with others in 2 Brooklyn clinics to induce Medicare beneficiaries to allow the clinics to bill their Medicare numbers for services that were never rendered or medical unnecessary in exchange for a variety of spa services (e.g., facials, massages), lunches and dance classes.
California Courts Uphold Governor Schwarzenegger's Interpretation That California State Law Allows CNRAs to Administer Anesthesia Without Physician Supervision
On June 13, 2012, the California Supreme Court unanimously denied review in the case of California Society of Anesthesiologists v. Superior Court, 204 Cal.App.4th 390 (1st Dist. 2012) ending an over two year battle by the California Society of Anesthesiologists and the California Medical Association who challenged former governor Arnold Schwarzenegger's certification to the federal government that California law allowed Certified Registered Nurse Anesthetists (CRNAs) to administer anesthesia without physician supervision.
Medicare regulations require physician supervision of CNRAs as a condition of receiving Medicare reimbursement. 42 C.F.R. §§ 482.52(a)(4); 485.639(c)(2); 416.42(b)(2). However, additional Medicare regulations allow a state to opt out of the physician supervision of CNRAs requirement. In order to opt out of the physician supervision requirement, the state's governor must submit a letter to the Centers for Medicare and Medicaid Services (CMS) requesting an exemption. The letter "must attest" that the governor has: (1) consulted with State Boards of Medicine and Nursing about issues related to access to and the quality of anesthesia services in the State; (2) concluded that it is in the "best interests of the State's citizens" to opt out of the current federal physician supervision requirement; and (3) concluded that the opt out is "consistent with State law." 42 C.F.R. §§ 482.52(c)(1), 485.639(c)(1), 416.42(c)(1). Former Governor Schwarzenegger opted California out of this requirement on June 10, 2009, finding that California law allowed CNRAs to administer anesthesia without physician supervision.
The California Society of Anesthesiologists and the California Medical Association challenged the certification by Schwarzenegger and argued that California law did not allow CNRAs to administer anesthesia without physician supervision. The California Nursing Practice Act provides that CRNAs are authorized to administer medications necessary to implement treatment "ordered" by a physician. West's Ann.Cal.Bus. & Prof.Code § 2725(b)(2).
The trial court which heard the case found that the Nursing Practice Act allowed CNRAs to administer anesthesia without physician supervision. On appeal to the California First District Court of Appeals, the appellate court likewise found that the plain language of the Nursing Practice Act authorizes CRNAs to administer anesthesia without physician supervision. The appellate court also relied on the conclusion reached by the Board of Registered Nursing and other agencies and officials, including the State Attorney General and denied the challenge by California Society of Anesthesiologists and the California Medical Association.
Fifteen other states have opted out of the Medicare requirement requiring CNRAs to be supervised by a physician while administering anesthesia: Washington, Oregon, Iowa, Nebraska, Idaho, Minnesota, New Hampshire, New Mexico, Kansas, North Dakota, Alaska, Montana, South Dakota, Wisconsin, and Colorado.
By an order dated March 30, 2012, the United States District Court for the Eastern District of Michigan dismissed an antitrust claim brought by the City of Pontiac against Blue Cross Blue Shield (BCBS), the largest private health insurance provider in Michigan. In the case of City of Pontiac v. Blue Cross Blue Shield of Michigan, the City alleged that BCBS' practice of requiring hospitals to charge higher fees to competitor insurance carriers is anti-competitive and results in higher prices for other insurers, thereby threatening their ability to remain viable. BCBS essentially trades higher payments for services to the hospitals in consideration of their agreement to this provision. This practice, which is known as "most favored nation plus" status, was asserted to be a "violation per se" of antitrust laws, resulting in higher prices for competitors.
To make a determination of whether an arrangement is a "per se" violation, one must first evaluate whether the collaborative arrangement involves agreements--such as jointly agreeing on prices--that are inherently anticompetitive. If so, the arrangement must demonstrate the following to avoid being determined per se unlawful:
1. the arrangement has the potential to yield significant benefits or efficiencies for consumers; and
2. the arrangement's anticompetitive agreements and practices are subordinate to and reasonably necessary to achieve these potential benefits and/or efficiencies.
The court dismissed the City's complaint because it determined that the arrangement was not horizontal in nature (i.e., among the hospital providers themselves who are direct competitors), but rather, was one of a vertical nature (i.e., between the provider and an entity at a different level within the same market; meaning, BCBS as a purchaser of hospital services). Horizontal arrangements are initially evaluated by the "per se" rule. An arrangement that is not "per se" unlawful is instead subject to the "rule of reason" analysis.
The "rule of reason" analysis primarily involves an assessment of whether a collaborative arrangement is likely to have anticompetitive effects--for example, result in prices above competitive levels--and if so, whether these potential effects are outweighed by any procompetitive efficiencies which would justify the collaborative arrangement or agreement. When assessing potential anticompetitive effects, one consideration is whether providers and health plans are capable of raising, and likely to raise, prices in their market above competitive levels. Another consideration is whether a collaborative arrangement is likely to prevent or impede the operation of other health
plans or providers.
In order to survive the motion to dismiss, the City had to allege sufficient facts to justify proceeding on a "rule of reason" claim (because the arrangment was vertical instead of horizontal), but it failed to state factual bases for such allegations since it focused on the "per se" allegations. The complaint was, in short, determined to be inadequate.
The U.S. Department of Justice (DOJ) and the Michigan Attorney General also previously filed an antitrust action on the same matter (United States of America v. Blue Cross Blue Shield of Michigan), which is still proceeding. The parties to the DOJ case initially acknowledged that the "rule of reason" analysis applies.
In an opinion issued March 30, 2012, the United States Court of Appeals for the Fourth Circuit overturned a $45 million judgment against Tuomey Healthcare System, Inc. ("Tuomey"), a private, nonprofit corporation which owns and operates Tuomey Hospital in Sumter County, South Carolina. A former physician brought a qui tam action against Tuomey alleging that certain contracts entered with physicians violated the Stark Law and that billings resulting from referrals from those physicians constituted false claims under the False Claims Act. The United States government intervened in the action, which proceeded to a jury trial, with the False Claims Act violations and other equitable theories pursued by the government, such as unjust enrichment and payment by mistake.
The jury found that the contracts between Tuomey and the physicians violated the Stark Law, but also found that Tuomey did not violate the False Claims Act. After the jury verdict, the District Court set aside the jury verdict and ordered a new trial on the False Claims Act allegations. Additionally, the District Court found that because the jury had found that the contracts in question violated the Stark Law, the government was entitled to judgment against Tuomey on the equitable claims. The District Court then entered judgment against Tuomey for approximately $45 million plus interest on the equitable claims.
The Fourth Circuit vacated the decision of the District Court to enter judgment against Tuomey on the equitable claims, finding that the Judge's decision to set aside the jury verdict and order a new trial on the False Claims Act allegations precluded his use of the jury's finding of Stark Law violations to enter judgment against Tuomey on the government's equitable claims. The Fourth Circuit found that the manner in which the District Court reached his conclusions violated Tuomey's Seventh Amendment rights. A new trial should take place in the near future.
Going forward, this will be an important case to monitor for further developments as they related to the Stark Law and the physician compensation arrangements.
According to a Department of Justice press release, on Thursday March 15, 2012, a man residing in Dearborn Heights, Michigan was charged by Criminal Complaint with health care fraud. 51-year-old Fitzgerald Anthony Hudson was arrested, and could face a maximum penalty of 10 years imprisonment and a fine of $250,000. Assistant U.S. Attorney Aaron J. Mango is handling the case, and has alleged that in October 2007, the defendant obtained a New York State medical license by listing false information on his application by stating that he graduated from York University-Facility of Science, North York, Ontario, Canada. It is further alleged that he does not hold such a degree and, in fact, had been dismissed from the Warren Hospital Family Practice residency program in July of 2003.
The complaint also states that the defendant provided medical care to patients in the Western District of New York at Jones Memorial Hospital in Wellsville, N.Y. and Nicholas H. Noyes Memorial Hospital in Dansville, N.Y. from August of 2008 to August of 2010. It is alleged that he was improperly reimbursed approximately $200,000 under the Medicare Part-B and Part-D programs.
Mr. Hudson's initial appearance on the charge has been scheduled for March 29, 2012 at 3 p.m. before United States Magistrate Judge H. Kenneth Schroeder, Jr. This arrest was the culmination of an investigation on the part of the Federal Bureau of Investigation.
Until October 2009, physicians could lawfully act as service providers to hospitals by furnishing their services "under arrangements" where a physician or group of physicians would provide services, equipment and supplies to a hospital's patients by contracting with the hospital to provide the services. Urologists, for instance, regularly furnished lithotripsy services under arrangements. The relationship was permissible under Stark because the hospital would bill for the services, deeming the hospital the entity furnishing the designated health services ("DHS"), not the physicians. However, in October 2009, new Stark regulations made these relationships impermissible as the regulations declared entities providing under arrangement services (e.g., the urologists) were furnishing DHS.
After the regulations were issued, but before they became effective, the Council for Urological Interests ("Council") filed suit in the US District Court for the District of Columbia, challenging the new regulations. Generally, the Social Security Act provides for judicial review of reimbursement decisions only after administrative remedies have been exhausted. The Supreme Court held in Shalala v. Illinois Council on Long Term Care, Inc. ("Illinois Council") that an exception to this requirement existed where application of the general rule "would not lead to a channeling of review through the agency, but would mean no review at all." The District Court, relying on Illinois Council, held that Council's claims must be channeled through the agency's administrative procedures prior to seeking judicial review. Despite Council's contention that physician groups are not afforded administrative review (as administrative review was limited to "providers" only), the District Court dismissed Council's complaint for lack of subject matter jurisdiction, holding that the hospitals (i.e. providers) could challenge the regulation through the administrative process.
On December 23, 2011, the US Court of Appeals for the District of Columbia Circuit overturned the District Court's decision holding that the channeling requirement under Illinois Council was not a requirement of complete preclusion of judicial review. "Particularly considering the Supreme Court's characterization of section 405(h) [of the Act] as 'a channeling requirement, not a foreclosure provision' we see no 'clear and convincing evidence' in the statute's language or structure indicating that Congress deliberately intended to completely bar non-providers from seeking review of regulations that target them directly" (internal citations omitted).
This ruling is a victory for physicians and physician groups in that the DC Appeals Court has recognized the administrative and judicial limitations imposed upon them to represent their interests and has rectified this bar.
According to a press release, the Department of Health and Human Services ("HHS") announced that it will be awarding $9 million from the Centers for Medicare and Medicaid Services ("CMS") to Senior Medicare Patrol ("SMP") programs across the country tasked at fighting Medicare fraud. SMP is operated by the Administration on Aging in close partnership with CMS and the HHS Office of Inspector General. The new grants will allow for increased awareness for Medicare beneficiaries about how to prevent, detect and report healthcare fraud.
According to the press release:
The SMP volunteers work in their communities to educate Medicare beneficiaries, family members, and caregivers about the importance of reviewing their Medicare notices, and Medicaid claims if dually-eligible, to identify errors and potentially fraudulent activity. Program volunteers also encourage seniors to make inquiries to the SMP Program when such issues are identified, so that the project may ensure appropriate resolution or referral.
Therefore, providers must continue to emphasize compliance within their practices and also have strong communications with patients to avoid misunderstandings by patients as scrutiny has spread beyond just government officials. The government is investing in patients to help them in the fight against Medicare fraud.
CPAP Supplier Agrees to Pay $578,820 for Failure to Use Licensed Respiratory Therapists for PAP Set-Up's
Premier Home Care, a Durable Medical Equipment company operating in Indiana and Kentucky, agreed to pay a $578,820 settlement with the United States Department of Justice and the State of Indiana in a Whistleblower action alleging violations of the False Claims Act.
In 2008, a former employee filed suit against Premier under seal alleging that the company was not using licensed respiratory therapists to set up patients with CPAP and BiPAP. Indiana law is broad enough to include CPAP set-up's in the definition of "respiratory care." Only persons licensed as respiratory therapists in the state of Indiana are permitted to perform respiratory care services under Indiana law.
A joint investigation by the Office of the Inspector General of the US Department of Health and Human Services, the Department of Justice and the Indiana Attorney General's office ensued. The complaint alleged that Premier violated the False Claims Act by certifying to Medicare that it was in compliance with Indiana's respiratory therapy law when it used unlicensed personnel to set-up CPAP and BiPAP.
The False Claims Act allows for civil recoveries of up to three times the amount of actual damages, and allows whistleblowers to collect up to 25% of the award. Premier agreed to settle its suit for $578,820 to the United States and $21,180 to the State of Indiana, an amount representing more than twice the estimated damages to the Medicare and Medicaid programs.
You can access the Department of Justice's Press Release story at: http://www.justice.gov/usao/ins/press_releases/Pressrelease11/Premier.20111019.pdf.
In an indictment unsealed on October 12, Matthew Kolodesh (a/k/a "Matvei Kolodech") was charged with a laundry list of crimes, including 1 count of conspiracy to commit healthcare fraud, 21 counts of healthcare fraud, 2 counts of mail fraud and 11 counts of money laundering of monetary instruments over $10,000. Kolodesh set up, controlled and operated Home Care Hospice, Inc. wherein he allegedly "authorized the submission of claims to Medicare totaling approximately $14.3 million, which claims defendant Kolodesh and A.P. knew were false and fraudulent." "A.P." is the name given in the indictment to Kolodesh's business partner.
The government alleges, in part, that in committing healthcare fraud Kolodesh paid for referrals, paid for certifications of hospice eligibility, authorized fabrication of patient records and supporting documentation, created phony schedules of continuous care visits to patients who were not qualified for continuous care or were never provided continuous care, falsified records submitted in connection with a Medicare audit and siphoned funds from Home Care Hospice that were "fraudulently obtained Medicare payments" to unjustly enrich himself and his family.
According to the Department of Justice press release, "if convicted of all charges, Kolodesh faces a statutory maximum sentence of 370 years in prison. The government will also seek restitution to Medicare in the amount of $14.3 million and proceeds from the money laundering."