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Despite a decrease in the number of prescriptions for brand-name drugs going down, Part D spending and out-of-pocket costs both spiked up from 2011 to 2015, according to a new report from the Office of the Inspector General...The total reimbursement for all brand-name drugs in Part D rose by 77 percent from 2011 to 2015 even though there was a 17-percent drop in prescriptions for those drugs. Even after taking into account manufacturer rebates, reimbursement for Part D brand-name drugs still swelled by 62 percent during that time period,...the number of beneficiaries shouldering at least $2000 in out-of-pocket costs per year nearly doubled across the five-year time span and unit costs for brand-name drugs rose nearly 6 times faster than inflation...for small, rural or struggling hospitals whose razor thin margins are already the source of angst for c-suiters, watching drug spend totals steadily rise could force painful decisions like opting to not modernize EHRs or update equipment...

...the FDA has a compassionate use program to allow people access to experimental drugs, it can’t compel a company to provide those drugs. The newly signed “right-to-try” law doesn’t either...the Food and Drug Administration calls its expanded access program, also known as compassionate use. It governs the use of an investigational medicine that has not been approved by the FDA outside of a clinical trial...Here’s how it is supposed to work. A physician caring for a patient with a terminal illness who has exhausted all other treatment options and isn’t eligible for a clinical trial appeals to the pharmaceutical company to provide an investigational drug that has undergone at least a Phase 1 trial, which studies the safety of a drug. If the pharmaceutical company agrees, the treating physician applies to the FDA for approval for expanded access to the investigational drug...Large pharmaceutical companies are notoriously risk averse when it comes to expanding access to medications that are still in the testing phase. Many refuse to grant access to investigational drugs outside of clinical trials...One fear they have is that an adverse event, like an injury or death — even if it is not directly due to the medication — will derail a company’s ability to push a drug forward for FDA approval...Pharmaceutical companies also worry that if an experimental medication is given to one patient through compassionate use, it must be given to all patients who request it. In the case of rare diseases...this could mean that a company would have trouble enrolling enough patients when it eventually opens a clinical trial...

King's Daughters Medical Center...found it challenging to provide an accurate, verifiable home medication record for its providers to trust as they made important decisions about existing medications both during an inpatient visit and after discharge...King's Daughters now uses external medication history from pharmacy fill data as well as insurance claims data, provided by vendor DrFirst, to complement verification and push the information to the providers...While it is not intended as a replacement for the patient/family interview, its integration into the electronic health record greatly augments the conversation and can prompt a patient to include easily forgotten information...This reduces the risk of prescription loss and makes the process more efficient for the patient while ensuring the health record is updated in advance of future visits...King's Daughters is required to report its performance on both medication reconciliation (with a threshold goal of 50 percent) and e-prescription (10 percent) to the Centers for Medicare and Medicaid Services...most recent reporting period, Q4 2017, our stats were 77 percent and 52 percent, respectively...integrating medication management tech into the EHR also helped King’s Daughters more effectively retrieve historical data and deliver that information to providers to facilitate new prescriptions in a trustworthy manner that both reduces errors and the abuse of controlled substances...

Nevada health officials are examining how the state could license consultants who transfer mentally ill people to unregulated group homes, a step prompted by a Las Vegas Review-Journal investigation that highlighted the death of a suicidal woman after she was placed in an unsupervised residence...“This story has been really motivating for people,” said Julie Kotchevar, deputy director at the Nevada Department of Health and Human Services. “It’s certainly been motivating for me to make sure it doesn’t happen again.”...Kotchevar presented lawmakers with an idea: Broaden the state statute that governs “referral agencies” to require anyone doing that type of work to obtain a license. Currently, state law requires a license only for businesses that refer patients to “residential facilities for groups.”

...FDA Commissioner Scott Gottlieb, MD, announced that the Center for Drug Evaluation and Research would be taking steps to modernize the organization and functions of the Office of New Drugs in order to address scientific and medical advances within the industry. The goal is to make the review process more integrated across science and regulatory expertise. Janet Woodcock, director of CDER, plans on elevating the role of FDA scientists and medical officers and providing these officers with more tools and support “to advance the clinical and regulatory principles that the FDA uses to evaluate new drugs for safety and efficacy.”...Other changes will include the development of guidance documents, giving review staff more time with sponsors, and getting sponsors involved earlier in the development process. Engaging disease specialists, academic researchers, regulatory partners at other agencies, and patient groups is also a goal of CDER.

Officials are considering adding an “export manufacturing waiver” to the Supplementary Protection Certificates that extend patent protection. The waiver would allow companies to manufacture drugs covered by SPCs at sites in Europe, provided the products are destined for export to markets in which patent protection has lapsed or never existed...The Commission is proposing the waiver to enable companies based in the European Union to meet demand for biosimilars and generics in emerging markets and other overseas territories. Currently, SPCs can prevent manufacturers from using their European operations to supply drugs for export, potentially making them less competitive than their foreign peers...This will help create growth and high-skilled jobs in the EU. It could generate €1bn ($1.2bn) net additional sales per year and up to 25,000 new jobs over 10 years...the European Federation of Pharmaceutical Industries and Associations questioned whether the policy will achieve its objectives and said it may create friction between the EU and its trading partners...EFPIA...perceives clear downsides to a policy it sees as devaluing the European intellectual property framework and deterring investment in the region...

A Las Vegas counseling and mental health care provider has been fined more than $1 million and placed on three years of probation after fraudulently billing Medicaid...We Care Behavioral Health Agency LLC was convicted on a gross misdemeanor charge of intentional failure to maintain adequate records...(the agency) didn’t keep documentation on when or which billed services it actually provided to Medicaid recipients

The...Food and Drug Administration...sent warning letters to nine online networks operating a total of 53 websites to stop illegally marketing unapproved versions of opioid medications...The regulator said... it is taking additional steps with these warning letters by going right to the source of the illegal supply of unapproved and misbranded versions of opioid drugs, including tramadol and oxycodone...The internet is virtually awash in illegal narcotics...Drug dealers and rogue website operators are using the internet to fuel the opioid crisis...The regulator has requested responses from the nine companies within 10 working days, or they may be subject to product seizure or injunction.

High-priced prescription drugs will soon become 5% cheaper, thanks to simplification of the mechanism that controls their maximum permitted prices. This will lead to savings of NIS 150m. to NIS 200m., the Treasury and Health ministries announced...“This is an additional step to reduce the cost of living and make health more accessible to the public,” Finance Minister Moshe Kahlon said. “This change is part of a series of steps we have taken in the past three years to strengthen the public health system”...ministries have been working on implementing a reform in the mechanism for determining the maximum prices of prescription drugs...The committee carried out international reviews and consultations with representatives of health funds and the pharmaceutical companies. It decided to revise the drug price-control model to bring down the prices of expensive prescription drugs and increase the supply of inexpensive medications...

Hospitals that joined the 340B Drug Pricing Program at its onset provided more uncompensated care and low-profit services to patients than those who joined in its later years, according to a new research letter published in JAMA from researchers at Vanderbilt University and the University of Chicago...Allan Coukell and Sean Dickson...write...that policymakers would be "well served by greater transparency on hospitals' use of 340B revenues," but warn that reductions in 340B eligibility will lead to a transfer from Medicare spending on 340B hospitals to increased revenue for drug manufacturers...In January, a final rule went into effect that cut drug payments to 340B hospitals by almost 30%. The American Hospital Association and other groups are currently suing the U.S. Department of Health and Human Services over the rule. Earlier this month, the U.S. Court of Appeals for the District of Columbia Circuit heard oral arguments for the case...