02 Jan January 2, 2019

Happy New Year!

Judge Rules in Favor of Hospitals in 340B Case
In a major development, Federal D.C. district court Judge Rudolph Contreras sided with hospitals stating that CMS overstepped its authority when cutting 340B drug reimbursement by almost 30 percent as part of the 2018 hospital outpatient pay rule. “The changes that the Secretary imposed are not modest,” Judge Contreras wrote in his opinion, “The rate reduction’s magnitude and its wide applicability inexorably lead to the conclusion that the Secretary fundamentally altered the statutory scheme established by Congress.” The Judge did not, however, throw out the rule imposing the cuts all together over concerns that it would be too disruptive to the overall payment system. He instead granted a permanent injunction and asked the two sides to develop ideas on how to make up for the $1.6 billion in hospital payment cuts. “We are disappointed with the court’s ruling and are evaluating next steps,” HHS spokesperson Caitlin Oakley said in a statement. She added, “We look forward to briefing the court on this important matter.” Click here for the decision.

“Unconstitutional” ACA Law May Stand While Ruling is Under Appeal: Federal Judge
U.S. District Court Judge Reed O’Connor, the Federal Judge who earlier this month declared the Affordable Care Act unconstitutional, granted a stay and final partial judgment in the case while it is under appeal. Judge Reed stated that while he believes the entire ACA cannot stand without its individual mandate penalty, which Congress eliminated last year, overturning the law should not take effect while the case is being appealed, noting that “many everyday Americans would otherwise face great uncertainty.” Seventeen states who have already declared their intention to appeal the decision requested that Judge O’Connor clarify the ramifications of his ruling so they would be able to file an immediate appeal to the Fifth Circuit Court of Appeals leading to the stay. To read the ruling by Judge O’Connor, click here.

CMS to Raise Lab Fees for the First Time in 20 Years
CMS last week announced that it would raise laboratory user-fees by 20-percent immediately for all labs certified under the Clinical Laboratory Improvement Amendments of 1988, or every lab that performs tests on human specimens, including hospitals’ in-house facilities and independent diagnostic labs. The agency stated the increased fees – the first in 20 years – for lab certification and compliance inspections for non-accredited labs should close a $9.3 million gap between current costs and CLIA fee coverage. CMS stated, “While we recognize that the 20 percent increase to CLIA Fees across all schedule codes can be perceived as a major increase for laboratories, we intend for this approach to be a onetime adjustment to address the projected shortfall.” To view the CMS notice, click here.

A News Analysis of Hospital ED Bills Raises More than Just Eyebrows

A $5,571 bill to sit in a waiting room, $238 eyedrops, and a $60 ibuprofen tell the story of how emergency room visits are squeezing patients, according to a Vox news analysis undertaken over the past 15 months. “One bill that left an impression on me,” wrote the reporter, “came from a woman seen in the emergency room the day after her wedding. Her eye was irritated from the fake eyelashes she’d worn the night before, and she worried that her cornea might have been scratched. The providers checked out her eye, squeezed in some eyedrops, and sent her home. She later got a bill that charged $238 for those eyedrops, a generic drug called ofloxacin. According to a website that tracks drug prices, an entire vial of this drug can be purchased at a retail pharmacy for between $15 and $50.” Click here for the full story.

Cold Turkey or Medicated Assistance: the Drug Treatment Debate
According to a new study conducted by the Pew Charitable Trusts, Medication-assisted treatment – a combination of psychosocial therapy and FDA-approved medication – is the most effective intervention to treat opioid use disorder.  Due to lack of funding and unqualified providers, the treatment is not universally used. The drugs (methadone, buprenorphine, and naltrexone) are available in various product formulations and doses, are patient specific and are created with input from the patient, the physician, and other members of the health care team. However, patients and providers have been slow to take up the approach as only 23-percent of treatment programs offer the treatments and patients often say they prefer abstinence while recovering. Click here for the report.

Pain Task Force Recommends Non-Opioids as First Option for Treatment 
In a draft report released last week, the Pain Management Best Practices Inter-Agency Task Force created under the Comprehensive Addiction and Recovery Act of 2016 recommended non-opioid medicines should be the first option whenever possible and payers should reconfigure reimbursement plans to encourage their use. The Task Force, which consists of 29 experts with experience across the disciplines of pain management, patient advocacy, substance use disorders, mental health, and minority health, conclude that non-opioid medicines like acetaminophen, NSAIDs, anticonvulsants, local anesthetics and dexmedetomidine have been underused as hospitals apply “simple medication rules” to diverse patient populations. The Task Force also recommended using non-drug therapies such as behavioral health and mindfulness training, physical therapy, massage and transcutaneous electric nerve stimulation when possible as well as boosting interstate cooperation between prescription drug monitoring programs. Click here to view the report.

Number of Uninsured Americans Increasing
The number of unisured Americans went up to 27.4 million people in 2017, an increase of about 700,000 over 2016, according to the Kaiser Family Foundation.  This marks the first rise in the number of uninsured since the implementation of the ACA in 2014, which brought the number of uninsured people in the U.S. down from 44 million in 2013 to under 27 million in 2016. The numbers range by state; however, the 31 states that implemented Medicaid expansion saw almost no change in uninsured rates, while 13 of the 18 states with the highest uninsured rates in 2017 were non-expansion states. To view all the statistics, click here.