Healthcare Reform

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.

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.

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.”

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.

Georgia Medical Practices: Not Having a Compliance Program is AT YOUR FINANCIAL PERIL

February 26, 2015 | Little Health Law

law-education-series-3-68918-m Some critical details of The Affordable Care Act (ACA) are often omitted from the political rhetoric and other noise during public debate about whether the ACA is a “good” or “bad” thing. One such detail – and a huge one – is the ACA’s significant expansion of compliance risks for medical practices and other health care entities.

Our Georgia business and health care law firm follows compliance and other developing regulatory issues that impact the business of providing health care. The ACA mandates that health care providers, suppliers and nursing facilities who participate in Medicare or other federal programs establish effective compliance and ethics programs. See ACA § 6401. The United States Department of Health and Human Services, Office of the Inspector General (OIG) made the creation of guidelines for compliance programs a “major initiative” in its efforts to stem health care fraud. See Federal Register, Vol. 65, No. 1994. Copies of the OIG’s compliance program guidelines are on the government’s OIG website.

The OIG has formulated seven basic components that may serve as the core of a proper compliance program:

New Medicare Rules Strengthen Regulatory Oversight of Medicare Providers and Increase CMS’ Ability to Remove Providers from Medicare

December 31, 2014 | Little Health Law

Earlier this month, the Centers for Medicare and Medicaid Services (CMS) announced implementation of a Final Rule intended to increase oversight of Medicare providers and enable recoveries from those health care providers that commit fraud and violate Medicare rules. According to the press release, Marilyn Tavenner, the CMS Administrator, stated that the new rules “are common-sense safeguards to preserve Medicare for generations to come” and that “[t]he Administration is committed to using all appropriate tools as part of its comprehensive program integrity strategy shaped by the Affordable Care Act [ACA].”

Georgia Medicare Fraud Law Firm

Our Atlanta and Augusta, Georgia health care law firm has reviewed the Final Rule. The Final Rule’s new provisions are intended to preclude doctors and other health care providers with unpaid Medicare debt from re-entering the Medicare program, remove health care providers who engage in abusive Medicare billing, and authorize other provisions that will save more than $327 million annually. The Final Rule makes certain changes to the provider enrollment provisions of 42 CFR part 424, subpart P.

CMS has removed about 25,000 health care providers from the Medicare program. The new rules are designed to “stop bad actors from coming back in as we continue to protect our patients,” according to Ms. Tavenner. Under the ACA, CMS has increased ability to fight Medicare fraud, waste and abuse. CMS believes that removing providers from Medicare has a substantial positive impact on savings, contending that such removals have prevented $81 million in payments from being made.
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HHS 2015 Quality Improvement Awards for FQHC recipients: HHS Awards $36.3 Million in Affordable Care Act Funding for FQHCs and Other Health Centers

December 17, 2014 | Little Health Law

On December 9, 2014, the U.S. Department of Health & Human Services (HHS) announced substantial financial awards for numerous Federally Qualified Health Centers (FQHCs) and other health centers nationwide. Our Atlanta, Georgia business and health care law firm represents FQHCs and health centers. We learned from HHS’ press release that it awarded $36.3 million in Affordable Care Act funding for the purpose of rewarding and expanding the quality of care in FQHCs.

FQHCs and other HRSA-supported health centers are designed to provide comprehensive, high quality primary care services to the medically underserved communities of the United States. These health centers are sometimes referred to as “safety net providers.” FQHCs are community-based facilities that serve populations with less access to health care. Grant-supported FQHCs are public or private non-profit healthcare entities that meet particular qualifications under Section 330 of the Public Health Services Act. Non-grant-supported health centers, also referred to as “look-alikes,” are healthcare entities that HRSA and the Centers for Medicare and Medicaid Services have determined meet the definition of “health center” under Section 330 of the Public Health Services Act, but do not receive grant funding under Section 330.
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Physician Practices: Recent Survey Reviews the Effects of Expanded Patient Access

September 24, 2014 | Little Health Law

A well-intended objective of the Affordable Care Act (ACA) is to improve patient access to doctors. Sometimes this objective is artfully stated as “better” access to care, rather than “increased” access to care, perhaps to acknowledge the reality that as more patients become insured via the ACA, there may actually be less access to physicians. “Better” access may therefore be an argument that, even as an existing physician shortage worsens, new alternatives under the ACA nonetheless improve access to care for the population as a whole. For sure, millions of Americans have enrolled in new insurance coverage via the ACA health insurance exchanges. In any event, whether it will be easier for most Americans to actually see a doctor remains to be seen according to a recent national survey.

The survey, by The Physicians Foundation, concluded that patients are likely to face increased difficulties in finding true access to care if current health care reform trends continue. More than 20,000 doctors nationwide were surveyed by the Foundation, and its findings are detailed and compelling. Among other things, the survey indicates that: 81 percent of doctors believe they are over-extended or at full capacity; only 19 percent of doctors think they have time to see additional patients; and 44 percent of doctors are now planning steps that would reduce patient access to their services (e.g., cutting back on patients seen, retiring, going part-time, closing their practice).
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