FDA clears first 2 generics of Sensipar
The Food and Drug Administration on Thursday approved the first generics of Amgen’s Sensipar. The generic Sensipar tablets (cinacalcet hydrochloride) — from Aurobindo and Cipla — mark the ninth and 10th approvals this year of first-time generics from the FDA.
Both Aurobindo’s and Cipla’s generic Sensipar will be available in 30-, 60- and 90-mg dosage strengths.
The drug is indicated to treat secondary hyperparathyroidism in adult patients with chronic kidney disease on dialysis, Hypercalcemia in adult patients with Parathyroid Carcinoma (PC), and severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy.
CVS Health shares efforts to address drug costs at AHIP conference
At the AHIP National Policy and External Affairs Conference in Washington, D.C., this past week, CVS Health chief policy and external affairs officer Tom Moriarty discussed how the company is confronting rising drug prices for payers and patients. He outlined the company’s efforts, which include a new program that offers drug cost transparency for patients, pharmacists and prescribers.
“With more and more consumers in health plans with high deductibles, many are seeing the true cost of their medications for the first time, often at the pharmacy counter when they go to pick up their prescription,” Moriarty said. “That is why we developed and introduced a system that provides true cost transparency by sharing member-specific drug cost information, formulary coverage and available lower-cost alternatives with doctors at the moment when they are writing the prescription.”
He noted that prescribers using CVS Health’s real-time benefits capabilities through their electronic health record have switched a patient’s drug when it’s not in their formulary or when a cheaper option presents itself.
“With more and more consumers in health plans with high deductibles, many are seeing the true cost of their medications for the first time, often at the pharmacy counter when they go to pick up their prescription,” said Moriarty. “That is why we developed and introduced a system that provides true cost transparency by sharing member-specific drug cost information, formulary coverage and available lower-cost alternatives with doctors at the moment when they are writing the prescription.”
Moriarty also noted that CVS Health has implemented a point-of sale rebate effort that passes negotiated drug rebates to patients when they pay for their medication.
“Another way we help make prescription drugs more affordable for consumers is through Point of Sale rebates, which we have offered to our commercial clients since 2013,” added Moriarty. “We currently cover nearly 12 million people under this option, by which the estimated value of negotiated rebates on branded drugs is passed along to the consumer when they get their prescription.”
Wrong provider data is a huge burden on pharmacies
Pharmacies dedicate countless hours and unquantifiable resources to maintain the integrity of both their data and provider data that’s channeling behind the counter. Patient safety requires it; regulatory bodies demand it. But according to the last available study done by the Office of the Inspector General (OIG) in 2013, the National Plan and Provider Enumeration System provider data was inaccurate on 48% of records. Even worse, records found in National Provider Identifiers (NPI) and Provider Enrollment, Chain and Ownership System were inconsistent 97% of the time.
If you’re shaking your head in frustration over that figure, you are not alone. Pharmacies understand there’s a hefty price of provider data gone bad — both from quality and resource allocation perspectives — and aren’t sure where to turn.
The OIG notes, “Inaccurate, incomplete and inconsistent provider data coupled with insufficient oversight place the integrity of the Medicare program at risk and present vulnerabilities in all health care programs.”
Healthy, successful operations depend on accurate, current data about every single prescriber. Unfortunately, provider data is continually changing, and at an alarming rate. According to LexisNexis, active healthcare practitioner data changes in just one week include:
- 33,000 primary addresses,
- 3,300 names,
- 1,750 phones
- 1,500 fax numbers,
- 86,000 state license expirations,
- 17,000 state license statuses,
- 7,000 qualifiers, and
- 1,000 DEA numbers
Before a pharmacist fills a prescription, he or she needs to verify the provider information on each federal and state Web site. The more steps that are involved in this process, the more room there is for error. In some cases, pharmacy staff glances quickly at the registry, and selects the wrong prescriber for the insurance claim, resulting in the payers recovering payment. Additionally, not having full access to sanctions at the state or federal level could result in payment recoveries, leading to substantial financial impact for the pharmacy. Most damaging, selecting a prescriber with the wrong prescriptive authority could result in patient harm as well has significant fines from the Drug Enforcement Administration (DEA).
Many errors in provider data points are simply demographic or affiliative issues that erode over time to become outdated or inaccurate. When a pharmacy isn’t taking a proactive role to monitor the quality of its data, operational effectiveness will be compromised. Any and all information-powered functions are at risk if the information on file isn’t current or complete.
In other situations, pharmacy staff battles customers’ increasing accessibility of prescriptions in general and pain-reducing medications in particular. The United States is indeed experiencing a crisis of huge proportions in the opioid epidemic, which spurs addicts to exploit weaknesses in the prescribing system in supplying their addiction. According to the Department of Health and Human Services (HHS), 11.5 million Americans misused prescription opioids in 2016, and 2.1 million suffered from a reported opioid use disorder. Inaccurate provider data is a liability in the successful monitoring and appropriate distribution of potentially dangerous narcotics.
The scope of provider data is enormous, and manually monitoring this data is a tedious and costly process for pharmacy employees who strive to operate diligently in increasing profits and staying ahead of the competition. To say nothing of recovered payments and prescriptive authority violations, the financial burden of keeping data clean is a heavy one.
Some seek their solutions in state license board data, but that information is not always as reliable or accurate as one would hope. The data integrity is compromised by differences in the credential acquisition by state and board, credential requirement/recognition differentiation, data availability and data quality control, and federal/state standardization inconsistencies. The manpower required to navigate numerous systems to crosscheck vital information is significant and is viewed as more of a “workaround” than a lasting solution for maintaining data integrity.
The LexisNexis Provider Data MasterFile combines healthcare-specific, public and private proprietary records from about 2,000 sources to form the largest provider referential database. The scope and breadth of this information are designed to improve completeness, accuracy, consistency, and governance, while access to current records is data-driven and automated to optimize daily integration for pharmacies across the country.
While data is a pharmacy’s greatest asset, its scope is overwhelming. Uncertainty about how to manage the data deluge can have financial implications that impact the success of your operation. If the management of accurate information is spinning out of your control, consider the options for driving not just survival but success.