Texas Pharmacy Today - Texas Pharmacy Association

Advocacy
Charles Perry Declares Victory in Special Texas Senate Election
No runoff is necessary as Perry pulled 53 percent.With 85 percent of precincts reporting in Senate District 28, Rep. Charles Perry’s campaign declared victory in the special election to succeed former Sen. Robert Duncan on Tuesday

September 9.

His chief opponent, former Texas Tech System Vice Chancellor Jodey Arrington, one of Perry’s fellow Republicans, got right around 30 percent. There were six candidates in the race, including one Democrat.

"I’m just really proud of our team,” Perry’s spokesman Jordan Berry told QR. He thanked groups like Texans for Lawsuit Reform, Texas Right to Life, and the Young Conservatives of Texas for "being the very first people to stand up and say 'we are with you' and help us see the race through.”

DEA Places Hydrocodone Combination Products in Schedule II
On August 22 the DEA issued a final rule placing hydrocodone products in

Schedule II of the Controlled Substances Act effective October 6, 2014. The rule applies to all products containing hydrocodone, whether in combination or not, including syrups or other liquids.

Although manufacturers and distributors will have only 45 days to convert to properly labeled products, pharmacies may continue to dispense hydrocodone products labeled as C-III drugs as long as they comply with requirements to conduct an inventory on October 6 and with other requirements for C-II products. All orders for hydrocodone products will require DEA Form 222 starting on October 6, including any returns of C-III labeled products distributed "upstream.” C-III labeled hydrocodone products must be treated as C-II for storage and security purposes after October 6; retail pharmacies may continue to disperse these products in their stock along with other C-II drugs, unless otherwise required under state law.

Prescriptions for hydrocodone products written on or after October 6 may not specify refills. Prescriptions issued before October 6, 2014, and authorized for refilling, may be dispensed as if they are C-III prescriptions, as long as all dispensing occurs prior to April 8, 2015. (Note: no additional refills of these prescriptions could be issued after October 6, 2014.)

[USDOJ, DEA. 21 CFR Part 1308 (Docket No. DEA-389) Schedules of controlled substances: Rescheduling of hydrocodone combination products from Schedule III to Schedule II. Final Rule. 79 Fed. Reg. 49661-49682, August 22, 2014; http://1.usa.gov/1BVc34y]

Reprinted with permission from the August 2014 issue of the ASPL Pharma Law e-News. For more information about ASPL, visit their web site at www.aspl.org.

Federal District Court Dismisses FCA Suit Concerning Generics

Federal district court dismisses FCA suit alleging that defendants failed to dispense generics when allowed and dispensed drugs on dates after the drug product’s NDC had expired

The qui tam relator in this case is a former prescription drug plan (PDP) sponsor under Medicare Part D, which asserts that it plus states and the federal government were victims of alleged fraudulent practices engaged in by the defendants, three of whom are providers of pharmacy services to long-term care facilities, and the fourth is a network of independent LTCF providers. The relator alleges that pharmacy providers under various contracts have an "obligation to ensure that any pharmacist who is performing on behalf of the Pharmacy Provider shall use his or her professional judgment when filling prescript [sic] orders, and will comply with all legal, professional and ethical obligations applicable to pharmacists under the laws of the jurisdiction in which the prescription service is received.” The contracts also require that the "Pharmacy Provider agrees to inform [prescription drug plan] Part D enrollees at the point of sale of any differential between the price of the lowest-priced therapeutically equivalent and bio-equivalent generic drug unless the lowest price drug is being purchased in accordance with r42 CFR § 423.132(a). [bracketed material in original]”

Claims by providers are submitted to a PDP – usually through a PBM – and the PDP must submit a resulting Prescription Drug Event (PDE) record to the Centers for Medicare & Medicaid Services (CMS) as part of the PDP’s claims to CMS. The Court noted that CMS’s "instructions” to PDPs indicate that although a number of the 37 fields in a PDE record, such as "dollar fields, will be used primarily for payment … some of the other data elements, such as pharmacy and prescriber identifiers, will be used for validation of the claims as well as for legislated functions such as quality monitoring, program integrity, and oversight.” The data fields were derived by CMS from the National Council for Prescription Drug Programs (NCPDP) industry standard, but some additional fields were established by CMS. Where NCPDP fields are used, the NCPDP definitions apply. The PDE is the responsibility of the sponsor, and is a "summary record that documents the final adjudication of a dispensing event,” which may follow "several rounds of transactions between [the PBMs and providers] before the plan finally adjudicates a claim for payment.”

The relator alleged that some Medicare Part D claims submitted by defendants also related to Medicaid recipients in those cases where recipients were dually eligible, but did not submit any Medicaid-specific claim examples.

One issue in the relator’s second amended complaint arises from entries associated with PDE field number 17 – the DAW code. According to the NCPCP definition as recited by the Court, possible values in this field range from 0 to 9, where 0 is "the field default value that is appropriately used for prescriptions where the product selection is not an issue. Examples include prescription [sic] written for single source brand products and prescriptions written using the generic name and a generic product is dispensed.” The Court noted that CMS instructs plans that "’[i]f plans do not have source data to populate these fields, plans will use’ a ‘default value’ of ‘‘’0-No Product Selection Indicated.”’” Other codes include 1 – substitution not allowed by prescriber, and 8 – substitution was allowed but generic not available in the marketplace. The relator claims that defendants have entered a "0” code when they have chosen not to substitute an available generic, even when state laws and their contracts require the substitution. The Court summarized generic substitution requirements for 9 selected states that reflected varied approaches among the jurisdictions.

The second major claim is that drugs dispensed after the date for which the individual product’s NDC number has expired are not eligible for dispensing either because they are past the manufacturer’s indicated shelf-life or have been withdrawn from the market for health or safety reasons. As such "any claims submitted to Medicare and Medicaid for drugs dispensed after the NDC termination date are invalid and are not reimbursable.” The Court noted, however, that the relator "has identified no statute or regulation that bars coverage under Medicare for the dispensation of a drug after its termination date.” In fact, the Court noted, CMS was invited by the OIG in 2010 to promulgate a rule prohibiting such dispensing, and CMS declined, opining that "the use of NDC termination dates ‘is likely flawed, and cannot be relied upon as a proxy for identifying the dispensing of outdated products.’” CMS noted that discrepancies such as submitting a claim "using an NDC for the correct drug product but the incorrect package size … do not support a finding that outdated drugs were dispensed.”

The Court found that regulations or contract requirements specifying that PDPs must obtain commitments from downstream entities to adhere to federal and state laws are components "of the regulatory framework rather than a condition of payment of any claim.” The Court found that the relator had failed to support its theory of liability for implied certification by citing such requirements.

The Court also found that the relator had failed to substantiate factual falsity of any claim arising from the use of "0” in the DAW field. The relator "has not alleged or argued that any federal statute or regulation required the substitution of generic for brand-name drugs, except insofar as Plan D sponsors are to comply with state pharmacy law.” It was undisputed by the parties, the Court found, that the claims "at issue here correctly listed the brand-name drug that was dispensed and for which reimbursement was sought. They also agree that the existence of a generic substitute for the branded drug was publicly available information that any sponsor could examine if it were material to its decision-making. And they agree that there is no federal regulation requiring the substitution of a generic for a branded drug.”

The Court found regarding the NDC expiration theory that because the relator "has failed to adequately plead, however, that the termination date of an NDC number and the expiration date of a quantity of manufactured drugs are the same, these claims must be dismissed. As noted above, an NDC is a unique number for every drug. When an NDC number is terminated, that may reflect a simple change in the quantity of pills contained in a given package. In contrast, the expiration date for a batch of drugs is placed on the packaging for the drugs and is commonly understood to reflect the shelf-life of the product contained within that package.”

The Court granted defendants’ motion to dismiss. [United States, et al. ex rel. Fox Rx, Inc. v. Omnicare, Inc., et al. No. 12cv275 (DLC), S.D.N.Y., 2014 WL 3928780, August 12, 2014]

Federal District Court also dismisses FCA case against Walgreens alleging similar facts to suit against Omnicare et al.
The same relator as in the Omnicare case, above, filed a FCA action naming Walgreens. Finding that the amended complaint "in this action mirrors, in all material respects, the Second Amended Complaint [relator] filed against Omnicare, Inc. [et al.] …,” the Court incorporated for reference its opinion in United States v. Omnicare, Inc. et al., and dismissed the amended complaint for failure to state a claim. [United States, et al., ex rel. Fox Rx Inc., v. Walgreen Co., No. 12 Civ. 7382 (DLC), S.D. N.Y., August 18, 2014]

Reprinted with permission from the August 2014 issue of the ASPL Pharma Law e-News. For more information about ASPL, visit their web site at www.aspl.org.

CVS Caremark Announces Corporate Name Change to CVS Health to Reflect Broader Health Care Commitment; Tobacco Sales End Early
CVS Caremark Corporation announced recently that it is changing its corporate name to CVS Health to reflect its broader health care commitment and its expertise in driving the innovations needed to shape the future of health.

"For our patients and customers, health is everything and CVS Health is changing the way health care is delivered to increase access, lower costs and improve quality,” announced Larry J. Merlo, President and CEO, CVS Health. "As a pharmacy innovation company at the forefront of a changing health care landscape, we are delivering breakthrough products and services, from advising on prescriptions to helping manage chronic and specialty conditions.”

CVS Health includes the company’s retail business, which continues to be called CVS/pharmacy; its pharmacy benefit management business, which is known as CVS/caremark; its walk-in medical clinics, CVS/minuteclinic; and its growing specialty pharmacy services, CVS/specialty. With 7,700 retail pharmacies, 900 walk-in medical clinics, a leading pharmacy benefits manager with nearly 65 million plan members, and expanding specialty pharmacy services, CVS Health enables people, businesses and communities to manage health in more affordable, effective ways.

"Each year, CVS Health touches more than 100 million people by playing an active, supportive role in each person’s unique health experience and in the greater health care environment,” said Merlo. "Consumers are increasingly taking control of their own health and, through our 26,000 pharmacists and nurse practitioners, we are helping people on their path to better health.”

CVS Health has a portfolio of programs to help people manage chronic disease and connects patients with pharmacists who help them stay on their prescribed medications. Digital capabilities are supplementing these programs to give customers a full view of their prescriptions. CVS Health’s Specialty Connect and Maintenance Choice programs integrate the company’s mail and retail capabilities, providing choice and convenience for patients. CVS Health is also forging strategic alliances with physicians and health plans through both CVS/pharmacy and CVS/minuteclinic to provide clinical support, medication counseling, chronic disease monitoring and wellness programs for their members.

As a further demonstration of its commitment to health, CVS Health also announced the end of tobacco sales at CVS/pharmacy as of September 3, nearly a month ahead of the previously targeted date of October 1. In February, the company announced that it would end the sale of cigarettes and tobacco products at its CVS/pharmacy stores, making CVS/pharmacy the first and only national pharmacy chain to take this step in support of the health and well-being of its patients and customers.

"Along with the start of CVS Health, the sale of cigarettes and tobacco products at CVS/pharmacy ends today. By eliminating cigarettes and tobacco products from sale in our stores, we can make a difference in the health of all Americans,” Merlo declared.

Around Texas

2014-15 Synagis® Season Begins October 1

The 2014-15 respiratory syncytial virus (RSV) season begins October 1 for a majority of the state and November 1 for counties in the western part of Texas. Providers must obtain Synagis (palivizumab) through the Vendor Drug Program for all eligible fee-for-service Medicaid and Children with Special Health Care Needs (CSHCN) clients.

Health plans will adapt the same criteria used by VDP. Please note that this direction is different from past RSV seasons.

Providers can now use the prior authorization request form, with approvals through VDP beginning September 23. The prior authorization request form and county schedule are available at TxVendorDrug.com/dur/synagis.shtml

Prescription Fraud Alert

Edward Nelson Wright, MD 11212 State Highway 151, San Antonio, TX 78251 has reported numerous fraudulent prescriptions being called in to pharmacies. Telephoned prescriptions are for large quantities of Norco and use the correct DEA number. Suspect is unknown and no description is available at this time. For further information, please contact Dr. Wright at (210) 703-8501.

Association News

Member Spotlight: Kalyn Marie Acker- University of Texas College of Pharmacy

As a Bio-chemistry major at Texas Tech University in Lubbock, Kalyn Marie Acker was on a pre-med track. But by her sophomore year she realized it wasn’t a good fit, and an exploration of other career paths led to pharmacy.

"I knew I wanted to help people,” she said. "I have a friend who is a pharmacy technician, and she suggested that I go for pharmacy.”

Acker received her degree in Bio-chemistry in May of 2011, and began as a P1 at the University of Texas College of Pharmacy that fall. Now a P4, Acker is doing clinical rotations at the UT Health Science Center in San Antonio—specifically an in-patient adult medication rotation.

"Right now I’m following nine patients, monitoring their drug therapies and making recommendations regarding their medications," says Acker. "I love doing it. I’ve had amazing preceptors and and I’m learning a lot, while having a lot of fun.”

Ultimately, Acker is interested in the administration side of pharmacy.

"I’d like to do a pharmacy administration residency,” she says. "In a residency, you apply and rank your choices of jobs, and then you are ranked within a database. It’s post-graduate work, and can lead to a better job offer once you begin your career search,” says Acker. "I’d like to become a pharmacy director—in charge of the entire pharmacy department. Even though I may not be directly involved in patient care, by making sure the pharmacists you are directing have all the resources they need, I too will be impacting patient care.”

Leadership
Acker, the 2014 Luther and Mary Ann Parker scholarship recipient, has made a point of being involved with student leadership at UT during her pharmacy education, and has set a great example for other pharmacy students.
"At UT, I’ve been privileged to have a lot of different roles,” she says. "I’m on the admissions committee for the College of Pharmacy; I’ve served as social chair, student political advocacy chair, and president (2013-14) for the student American Pharmacists Association (APhA) chapter. I’m also the regional delegate (Region 6) for APhA.”

Provider Initiative has been on her radar, and she’s done "hill” visits in both Texas and Washington, DC.

"In 2013, I met with offices of senatorsTed Cruz and John Cornyn, discussing the importance of pharmacists on the healthcare team, and how provider status is crucial for that,” says Acker. "We also met with Texas state senator Leticia Van de Putte, and we’ve done letter-writing campaigns to local legislators.”

TPA Involvement
Acker became aware of TPA through APhA, and her first experience with TPA was when she attended the Leadership Symposium in 2012.

"I’ve been to every TPA Leadership Sympoisum and Annual Conference since,” says Acker. "TPA is my favorite of all the pharmacy conferences, including national—because it’s local, and it’s easy to speak with pharmacists and learn about different professional settings. As a student I’m exploring, and at TPA everyone is so friendly…it’s easy to talk to different pharmacists, so it helps with my career choices. It’s an opportunity to learn about the profession from practicing pharmacists.”

Additionally, Acker has taken advantage of the different competitions offered in these settings— she was on the winning 2013 UT Student Self-Care Championship team, and took second in student patient counseling competition that same year.

"I really like the student programming and competitions, because they help you grow professionally and personally,” says Acker. "The competitions helped reinforce my clinical knowledge and my confidence in interacting with patients. You get great feedback on how you did, and you can become better.”

This program is an interactive format to include lecture material and interactive self-assessment questions to highlight objectives. This program will provide pharmacists with a review of the diagnosis and management of asthma. As asthma medications are commonly prescribed and dispensed, pharmacists periodically need updated knowledge in order to make the best recommendations for patients. Register by September 30!

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