Clinical laboratories are in a difficult position: although laboratory tests must be medically necessary to be reimbursable by federal healthcare programmes, laboratories often do not directly engage with patients in a way that would permit them to assess medical necessity. A district court recently corrected its ruling regarding the extent to which laboratories can be held liable under the False Claims Act when the tests for which they submit claims are not medically necessary.
California recently passed two bills with significant implications for pharmaceutical manufacturers: one imposing prescription drug price transparency requirements and another prohibiting certain types of co-pay coupon and other prescription drug discounting programmes that lower patient cost-sharing amounts for prescription drugs.
The Fifth Circuit recently affirmed summary judgment for a pharmaceuticals manufacturer on allegations that the company had violated the False Claims Act as a result of off-label marketing efforts and kickbacks to physicians. In its decision, the court emphasised the relators' failure to demonstrate a causal link between the alleged improper conduct and any false claims.
The US District Court for the Northern District of Illinois recently dismissed the False Claims Act claims brought by the federal government and two state governments based on allegations that Par Pharmaceuticals had orchestrated an unlawful prescription-switching scheme. While the judge acknowledged that Par may have conspired to increase its own profits, it rejected the federal and state governments' claims due to their failure to allege the submission of any claims that actually were false.
A bipartisan group of senators recently introduced Section 870 of the Creating High-Quality Results and Outcomes Necessary to Improve Chronic Care Act, which reflects proposals to extend home healthcare, expand benefits for chronically ill Medicare beneficiaries and direct the Government Accountability Office to issue reports, among other things.
The House of Representatives recently passed the American Health Care Act seven years after Republicans pledged to repeal the Affordable Care Act. Amendments to the legislation would allow states to seek waivers from the Affordable Care Act's essential health benefit requirement, age rating requirement and community rating rules for individuals who fail to maintain continuous coverage.
Judge Vasquez recently granted summary judgment to Bayer in a consumer class action over its probiotic dietary supplement. This decision should help to rein in the onslaught of lawsuits that improperly target dietary supplements. First, it reinforces that dietary supplements are not regulated as drugs and structure/function claims need not be supported by randomised controlled clinical trials. Second, it makes clear that private consumer class actions cannot be premised on a 'lack of substantiation' theory.
With draft Affordable Care Act repeal and replace legislation under consideration by Congress, the clinical laboratory community should prepare for significant disruptions in the healthcare marketplace, even as it continues to grapple with major policy shifts set in motion in the final years of former President Barack Obama's administration.
Senator Bernie Sanders recently introduced the Affordable and Safe Prescription Drug Importation Act, which would amend the Federal Food, Drug and Cosmetic Act to allow the importation of drugs from Canada and possibly other countries. The bill directs the Department of Health and Human Services secretary to promulgate regulations permitting the importation of prescription drugs by individuals, wholesalers and pharmacies within 180 days of its enactment.
The Senate recently approved Republican Tom Price (R-GA) to be secretary of the Department of Health and Human Services by a party-line vote of 52 to 47. During the nearly 30-hour debate that preceded the vote, a number of Republican senators voiced their strong support for Price. In contrast, Democrats expressed opposition to his nomination and reiterated their concerns about his stockholdings in certain healthcare companies and his views regarding the Affordable Care Act, Medicaid and Medicare.
In an unusual move, the Food and Drug Administration (FDA) recently published a discussion paper which proposes a new regulatory framework for laboratory-developed tests. The discussion paper describes a risk-based approach that differs significantly from the FDA's initial proposal in a draft guidance document issued in 2014 and reflects a lighter touch for most laboratory-developed tests.
The Republican Study Committee recently released the American Healthcare Reform Act of 2017, which would repeal and replace the Affordable Care Act of 2010. Although the act has not (to date) been formally introduced, it is expected to garner support from conservative members of the House of Representatives and serve as a basis for negotiation with other key lawmakers.
The US Department of Health and Human Services Office of Inspector General (OIG) recently published a final rule that provides guidance on its new and expanded bases for permissive exclusion from federal healthcare programmes. The preamble to the final rule addressing the OIG's enlarged exclusion authority suggests that the agency views its enforcement oversight as mirroring the reach of the False Claims Act.
As the Obama administration drew to a close, the Food and Drug Administration's Centre for Food Safety and Applied Nutrition (CFSAN) continued to release multiple final or interim final rules and guidance documents pertaining to food safety, nutrition labelling and cosmetic safety. The CFSAN also began posting adverse event reports for foods and cosmetics and extended its comment period for 'healthy' claims in food labelling.
A priority of Republicans in Congress and President Trump is to 'repeal and replace' the Affordable Care Act; however, this is replete with challenges. Among other procedural and political hurdles, the budget reconciliation process limits the types of provision that the legislation can include to those that affect the federal budget, and it remains to be seen which provisions Republicans will seek to repeal and which they will seek to keep.
The US Office of Inspector General recently finalised two key proposed rules. The first relates to the civil monetary penalties and exclusion statutes, and the second amends the safe harbours to the Anti-kickback Statute and the definition of 'remuneration' under the beneficiary inducements civil monetary penalty.
Advocate Health Care Center has agreed to pay $5.55 million to settle multiple violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). This is the largest HIPAA settlement to date against a single entity and is reportedly due to the severity of the HIPAA violations and the length of time that they were allowed to persist.
President Obama recently signed into law S764, which mandates the establishment of federal disclosure standards applicable to "bioengineered" foods. The enactment of S764 moves the United States one step closer to a coherent disclosure regime for certain foods that have been genetically engineered (GE) or that contain components of genetic engineering. Although S764 is a significant achievement, the debate over the role of GE foods is expected to continue.
The Centres for Medicare and Medicaid Services (CMS) recently issued frequently asked questions (FAQs) regarding the Covered Outpatient Drug Final Rule and a state Medicaid director letter. The FAQs address topics such as calculating the average manufacturer price, determining the best price, the treatment of line extensions and the setting of state reimbursement rates.
Recent securities class actions brought against life sciences companies offer valuable insight into developments in this field. At the most basic level, the cases analysed share a common feature. In each, a life sciences company suffered a setback that, when publicised, was followed first by a stock price decline and then by litigation initiated by shareholders seeking to recover investment losses.