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McBrayer Blogs
Controlling Compounding: The Drug Quality and Security Act, Part II
Earlier this week we discussed the new Drug Quality and Security Act (“DQSA”) that establishes and regulates a new class of compounding pharmacies called “outsourcing facilities.” To qualify as an “outsourcing facility”, the entity must compound sterile drugs with or without patient prescriptions and comply with the DQSA’s new rules, including registering with the FDA. An outsourcing facility is not required to be a licensed pharmacy. Registering as an outsourcing facility is completely voluntary, but entities that do not register may be prohibited from compounding drugs for office use and will be required to obtain prescriptions for individual patients. More >
Controlling Compounding: The Drug Quality and Security Act
In October 2012, a fatal meningitis outbreak killed 64 people in the United States and infected more than 750 in 20 states. The outbreak was traced back to contaminated vials of an injectable painkilling steroid that was compounded by the New England Compounding Center (“NECC”). More >
Arbitration and Interlocutory Appeals in Kentucky
Earlier this week, we wrote about the recent Kentucky Court of Appeals case Kindred Healthcare, Inc. v. Cherolis, No. 2012-CA-002074-MR (Ky. Ct. App. Oct. 11, 2013). In Cherolis, the Daviess Circuit Court denied a motion by Kindred to compel arbitration of the claims brought by Cherolis (as Executrix of her mother’s estate). Immediately following the trial court’s ruling on the motion, Kindred appealed to the Kentucky Court of Appeals. More >
Does Ping Still Pack a Punch? Court Says Broader POA Can Sign Arbitration Agreement
Shockwaves rippled through Kentucky’s long-term care communities in 2012 when the Kentucky Supreme Court ruled in Ping v. Beverly Enterprises, Inc. that a power of attorney (POA) for property, financial affairs and health care was insufficient the principal (or her estate) to an optional arbitration agreement.[1] More >
Complying with KASPER, Part II
On Tuesday, I provided some common sense tips for prescribers to use when issuing a KASPER-regulated medication. Now, let’s take a look at how the prescriber can better understand the KASPER report.[1] More >
Complying with KASPER
The Kentucky General Assembly passed House Bill 1, also known as the “pill mill bill” in 2012. Following its enactment, the Cabinet for Health and Family Services and various licensure boards issued regulations implementing its requirements. It was soon realized that the law would need some refinement to address concerns raised by the provider community and stakeholders. In 2013, House Bill 217 amended portions of House Bill 1 to address some unintended consequences of the original legislation. One of those amendments was giving an exemption to hospitals, long-term care facilities and approved researchers from the law’s requirement to report controlled substances administered directly to patients through the state’s description drug monitoring system, KASPER. However, for those licensees not exempt from the reporting, it remains a stringent requirement that a KASPER report is filed within one day of dispensing a controlled substance. (See more on HB 217 here.) More >
The Young and the Restless
HealthCare.gov’s technical woes are expected to be fixed by November 30th. But, those fixes might come too late for a certain subset of needed enrollees – the young and healthy. The purpose behind the Affordable Care Act’s individual health insurance mandate was to ensure that private insurers would get enough young, healthy people in the system who could offset the costs of covering older and sicker, Medicaid-eligible patients. More >
How Kentucky Got Lucky: The Success of kynect.gov
It is no secret that the federal HealthCare.gov has received less than rave reviews since its October 1st roll-out. The states who have relied on the federal government to run their marketplaces have encountered numerous problems, from glitches to process delays to complete inaccessibility. Kentucky (the only southern state which opted to run its own health insurance marketplace and expand Medicaid), however, has shone like a beacon in the turbulent exchange introduction period. It is quite surprising that Kentucky, consistently near the bottom in health rankings and with approximately 625,000 uninsured citizens, would be the model for anything health care-related. Here is how Kentucky is leading the nation with its exchange site: More >
The Kentucky Office of Health Policy Wants Your Comments
On October 1, 2013, the Kentucky Office of Health Policy issued a Special Notice stating that the Cabinet for Health and Family Services is accepting written comments in preparation of the filing of the 2014 update to the 2013-2015 State Health Plan. According to the Special Notice, the Cabinet is particularly interested in comments regarding revisions to the State Health Plan in order for it to comply with the Affordable Care Act. Although the State Health Plan is only prepared triennially, it is updated and signed by the Governor annually. More >
An Unlikely Consequence, cont.
On Tuesday, I discussed the recent trend of hospital layoffs of staff, administrative and professional alike, in order to reduce costs despite expectations of an unprecedented number of individuals seeking health care services under the ACA. More >
