Little Health Law Blog

Prosecutors Investigate Pharmaceutical Drug Pricing Practices

October 16, 2015 | Little Health Law

Exorbitant inflation of the price of prescription medication is a lingering concern for U.S. patients unable to afford to pay for the medication they need. According to a 2013 study by Walgreens, four out of ten senior citizens delay prescription refills or skip doses to save money.

The recent dramatic price increases of certain specialty pharmaceutical drugs has prompted recent action by federal prosecutors, according to articles by MSN and the Wall Street Journal.

The MSN article notes that two pharmaceutical companies: Valeant Pharmaceuticals International and Turing Pharmaceuticals, described as among the “worst offenders” in so-called drug “price gouging” received formal requests from prosecutors investigating their drug pricing and other business practices. This action followed a Congressional hearing last summer addressing Valeant’s price increases of Isuprel, a drug used to treat cardiac arrest, and Nitropress, a blood pressure drug. The cost of Isuprel increased more than 600%, from $215 to over $1,300, while the cost of Nitropress increased more than 300%, from$257 to just over $800 per vial. Turing made waves last summer when it purchased the marketing rights to Daraprim, used to treat an infection that can be life threatening in infants and patients with diseases such as AIDS and cancer, raising the price of the 60-year old drug from $13.50 to $750 a pill. Responding to public criticism, its CEO, Martin Shkreli, agreed to lower the price of the medication, but never did so.

The Eleventh Circuit Court of Appeals: A violation of AKS or Stark Law cannot be used to prove state law claims against a competitor for statutory unfair competition and common law

October 2, 2015 | Little Health Law

1330873_courthouse This litigation involves claims of unfair competition and tortious interference under nine different states’ laws, where the claims are based, in part, upon alleged violations of the federal Anti-Kickback Statute (AKS), 42 U.S.C. § 1320a-7b(b), and Stark law (“Stark”), 42 U.S.C. § 1395nn(a). Our Georgia business and healthcare law firm follows legal developments in the world of healthcare.

This particular dispute is between Ameritox Ltd and Millenium Laboratories, Inc. These laboratories are competitors in the drug-screening/testing marketplace. Each sells to physician practices and other healthcare providers products and services that facilitate analysis of patient drug use, including point-of-care (POCT) cups. POCT cups are used by physician practices to collect and store urine samples. Additionally, POCT cups contain chemically activated strips that indicate the presence of particular drugs in the patient’s system. POCT cups thereby facilitate “qualitative testing,” informative of patients’ drug use. Such information is very limited, however; it does not, for example, reveal the precise quantity of a drug in the patient’s system. To obtain more meaningful information about the patient, a doctor must send the POCT cup to a clinical laboratory, for “confirmatory testing.” These two laboratories compete for that business.

Will Employee Flexible Spending Accounts Be Eliminated Under Looming ACA Tax?

September 14, 2015 | Little Health Law

dark-dollar-2-1193021-m Many employers planning ahead as to their employee health benefit plans are considering modifying or eliminating employee flexible spending accounts (FSAs), according to an article this week in the Atlanta Business Chronicle. The Affordable Care Act (ACA) will begin to tax high-cost employer health insurance at 40 percent on benefits over a set threshold in 2018. The Chronicle notes that numerous other news sources have cautioned that this upcoming tax, known as the “High Cost Plan Tax” or “Cadillac Tax,” will cause employers to rethink their offering of employee FSAs, with some employers capping the amounts their employees may place in the accounts, and other employers eliminating FSAs altogether. See Wall Street Journal article; Politico article; Healthline article. The intent behind the ACA’s Cadillac Tax was to discourage employers from offering premium health insurance plans that drive up healthcare costs and to generate revenue to help pay for coverage of the uninsured.

The Continuing Trend of Physician Employment

August 25, 2015 | Little Health Law

medical-doctor-1314903-m A recent survey by search agency The Medicus Firm shows steady continuation of the national trend toward employment of physicians. In representing employers and employees, our Georgia physician practice law firm follows physician employment trends and issues. According to the Medicus survey results, the vast majority of physicians hired in the first half of 2015 — nearly 90% — were hired by either hospital systems or group practices.

The Medicus survey also revealed other interesting aspects of the physician employment trend. For example, the survey shows that one aspect of the current employment trend is increased placement in urban and mid-sized communities, compared to recent years. The survey also shows that the top four placement categories (by specialty) during the same time frame were:

Family Medicine (almost 19%)
Internal Medicine (11%)
Ob/Gyn (almost 6%)
Psychiatrists (5%) and hospitalists (5%)

Where the Current Physician Employment Trend and Employment Law Meet

As many drivers of the trend toward physician employment remain on the horizon, more employment law disputes will involve physicians as plaintiffs. There are many examples:

Majority of Georgia Hospitals Face Medicare Penalties

August 14, 2015 | Little Health Law

usa-dollar-bills-1431130-m About two-thirds of Georgia hospitals can expect to be fined for excessive Medicare readmissions, according to a recent article in the Atlanta Journal. According to our Georgia business and healthcare law firm’s research, this places Georgia hospitals well above the national average of 54% of hospitals facing similar fines. The fines are imposed by way of reduced Medicare reimbursement rates for those hospitals with excessive readmissions (readmissions within 30 days of discharge).

Medicare fines imposed as penalties against hospitals with too many patients returning in a month’s time for follow-up treatment, are part of healthcare reform. For the past several years, the federal government has promoted a program to reduce Medicare readmissions, for purposes of improving patient treatment outcomes and saving money. The federal readmission penalty program reflects a strong effort to remove a financial incentive to hospitals for readmitting sick patients. A 2013 article referenced an estimate of The Medicare Payment Advisory Commission (MedPAC), which advises Congress, that 12 percent of Medicare patients may be readmitted for potentially avoidable reasons. “Averting one out of every 10 of those returns could save Medicare $1 billion,” MedPAC says. The readmission penalty program strives to modify hospital behavior by replacing previous financial incentives with financial penalties for avoidable patient readmissions, so that hospital administrators and providers work affirmatively to keep patients healthier and avoid untimely readmissions. Statistics comparing hospital performance as to the readmission reduction program are available on a website maintained by the Centers for Medicare and Medicaid Services (CMS), called “Hospital Compare.”

FRAUD DOESN’T PAY: HEALTHCARE PROVIDERS BEWARE CIVIL MONETARY PENALTIES LAW

July 31, 2015 | Little Health Law

hammer-to-fall-673264-m Physicians and other healthcare providers and businesses who seek to stay in the center of the court and avoid fraud allegations often inquire of our Georgia business and healthcare law firm about the applicability of STARK (civil statute) or the Federal Anti-kickback (criminal) statute to particular circumstances or transactions. While those laws have great importance and severe penalties for violations, another federal law often warrants review to ensure business is conducted in a legally compliant manner. Many physicians and healthcare businesses have not heard of the “Civil Monetary Penalties” law (CMP), found at 42 U.S.C. § 1320a-7a.

Under the CMP law, the United States Office of Inspector General (OIG) may impose civil monetary penalties upon persons, organizations or entities who knowingly present (or cause to be presented) to a state or federal government certain types of false claims. Such penalties can be severe, ranging from $2,000 to $50,000. Further, the law gives the OIG the ability to treble damages.

So, what triggers CMP?

Physician Payment Sunshine Act: Should it Be Expanded to Include Nurse Practitioners and Physician Assistants?

July 15, 2015 | Little Health Law

medical-doctor-1314902-m Recent articles by ProPublica and NPR spotlight the absence of reporting requirements by pharmaceutical companies of their payments to nurse practitioners and physician assistants under the Affordable Care Act’s (ACA) Physician Payment Sunshine Act. The two web articles reference a case in which a Connecticut nurse practitioner pled guilty to accepting $83 million in kickbacks “from a drug company in exchange for prescribing its high-priced drug to treat cancer pain. In some cases, she delivered promotional talks attended only by herself and a company sales representative.” Because the law does not require reporting of industry payments to nurse practitioners such as this Connecticut provider, if not for the lawsuit, the public might have remained unaware of such payments to her and others like her.

Supreme Court Decision Keeps Affordable Care Act Alive: Benefits to Georgians and Health Providers Across the U.S. Continue

June 26, 2015 | Little Health Law

u-s--supreme-court-1-745242-m This week in a 6 to 3 ruling, the United States Supreme Court issued its decision in King versus Burwell, a case brought as a major threat to the viability of the Affordable Care Act (ACA). Congress, health providers, Supreme Court and Affordable Care Act watchers and more than 6.4 million consumers who benefit from health coverage assistance in the form of federal subsidies under the Affordable Care Act (ACA) had anxiously awaited a ruling in the case following the presentation of oral arguments in March.

Justice John Roberts issued the majority opinion, stating: “Congress passed the Affordable Care Act to improve health insurance markets, not to destroy them. If at all possible, we must interpret the Act in a way that is consistent with the former, and avoids the latter.”

Plaintiffs in the King case had argued that the language of the ACA allows for certain subsidies only as to state-established exchanges, but not as to federally-established exchanges. This premise challenged the Internal Revenue Service interpretation that U.S. Treasury regulation 26 C.F.R. § 1.36B provides for tax subsidies as to both federal- and state-established health insurance exchanges, not just exchanges established by the states. The Plaintiffs’ rationale was that their more narrow interpretation of the ACA revealed Congressional intent in establishing tax subsidies as incentives for states to benefit their citizens by creating health exchanges.

“Affordable” Care Act: the Irony of Rising Healthcare Costs for Families and Employers

June 11, 2015 | Little Health Law

woman-in-hospital-1051476-m In the wake of the Affordable Care Act (ACA), healthcare costs continue to rise both for the average American family and for their employers sponsoring healthcare plans. According to a recent article in the Insurance Journal, healthcare costs for the typical American family of four will increase by $1,456 this year, or 6.3% over last year’s costs. Total healthcare costs for this family are projected at $24,671, with the employer paying $14,198 of those costs and families paying the remainder. Our Atlanta and Augusta Healthcare and Employment law firm sees these numbers as a continuing trend of increased healthcare costs to families and employers, which have doubled in the last ten years, according to the article.

Employer Healthcare Coverage Responsibilities Under the Affordable Care Act

Businesses defined as larger employers under the ACA (those with 100 or more employees as of 2015 and 50 or more employees subject to the Employer Shared Responsibility provisions as of 2016) must offer to applicable employees affordable healthcare coverage that meets particular standards. Under the Employer Shared Responsibility provisions, employers who fail to offer required coverage at a required minimum level to full-time employees and their dependents face penalty payments.

Neurosurgeon Pleads Guilty to Healthcare Fraud

June 3, 2015 | Little Health Law

US-SUP-CT-300x225 Large financial recoveries are often seen as the principal motivation for the government’s unrelenting efforts to combat healthcare fraud. Perhaps a more important objective of the government’s efforts to combat healthcare fraud, however, is protecting patient safety. Chronic overutilization of healthcare, driven by a fee-for-service system with patient cost covered by a third-party payer (public or private), is not just a financial problem, it is a public health problem. The DOJ’s announcement on May 22, 2015, of a guilty plea by a Detroit Neurosurgeon is a strong example.

Atlanta and Augusta Business and Healthcare Lawyers

Dr. Aria O. Sabit, M.D., 39, operated the Michigan Brain and Spine Physicians Group, with multiple locations in Michigan. Dr. Sabit has plead guilty to four counts of healthcare fraud involving his alleged performance of medically unnecessary, invasive spinal surgeries and implanting expensive medical devices that were not medically necessary. According to the indictment, Dr. Sabit persuaded some patients to undergo spinal infusion surgeries, which he did not render, and then billed government programs for the fraudulent services. Additionally, Dr. Sabit admitted that while operating on certain patients, he dictated false operative reports that he had performed spinal infusion with particular instrumentation, which had not been done. The invasive surgeries caused serious bodily injury to the patients, according to the indictment.