Katie Eder, Senior Editor

Did you know that health plans completely cover certain OTC products when patients present a prescription?

Under Affordable Care Act requirements, insurers must cover certain OTC preventive medications at 100% with no co-pays, co-insurance, or deductibles, but only when the patient obtains a prescription.

In addition, health care reform rules effective January 1, 2011, allow distributions from health flexible spending arrangements (FSAs) and health reimbursement arrangements (HRAs) to reimburse the cost of OTC medicines or drugs when they are purchased with a prescription. Eligible prescribed OTC expenses that Aetna FSAs may pay, for example, are OTC acid controllers, anti-diarrheals, cold sore remedies, sleep aids, painkillers, and respiratory treatments, among others.

To get these OTC expenses reimbursed from their employer’s health FSA or HRA, patients need to provide documentation such as a customer receipt issued by a pharmacy that reflects the date of sale and the amount of the charge, along with a copy of the prescription, according to the Internal Revenue Service.

To provide pharmacists with opportunities to add value to patient counseling by informing their patients of these potential medication cost savings, 

reached out to America’s largest health insurers to find out which OTC product categories they cover when the medicines are age-, gender-, and condition-appropriate and prescribed by a licensed health care professional for preventive care purposes.

The 7 OTC product categories where complete coverage overlaps across UnitedHealthcare, Anthem, Aetna, Cigna, and Humana are as follows:

All 5 major health insurers cover aspirin use for the prevention of cardiovascular disease for men aged 45 to 79 years and women aged 55 to 79, though Humana and Anthem expand the latter group to include women aged 45 to 79.

Since September 1, 2015, they have also been covering aspirin use for the prevention of preeclampsia during pregnancy in female patients of childbearing ages.

All 5 major health insurers cover certain forms of OTC birth control for women.

Anthem specifics that it covers OTC items like female condoms and spermicides—a benefit that it also applies to those younger than 19 years.

UnitedHealthcare specifies that it covers OTC contraceptive foams, gels, and sponges, as well as the OTC generics of Plan B and Plan B One-Step, and also female condoms.

Cigna says it covers barrier contraception such as vaginal foam and film.

UnitedHealthcare, Anthem, Aetna, Cigna, and Humana all cover fluoride supplements for the prevention of dental cavities in children, but each has different requirements for 100% coverage.

UnitedHealthcare only specifies coverage for prescription fluoride tablets or solution (not toothpaste or rinses) for children aged 0 to 6 years whose water source is deficient in fluoride.

Anthem specifies OTC fluoride supplements for children from birth through 6 years of age, as well as dental fluoride varnish to prevent tooth decay of primary teeth for children from birth to 5 years of age.

Aetna specifies oral fluoride for children aged 6 months through 5 years, while Cigna specifics fluoride supplementation only for children aged 6 to 12 months.

Finally, Humana specifies OTC fluoride for children aged 6 months to 6 years whose primary water source is deficient in fluoride.

All 5 major health insurers cover OTC folic acid supplementation to prevent birth defects in female patients of childbearing ages.

Anthem defines this group as all women aged 55 years or younger, while UnitedHealthcare and Cigna specify coverage for only products containing 400 mcg to 800 mcg of folic acid.

Similar to fluoride supplementation, each of the 5 major health insurers has different requirements for 100% coverage of iron supplementation for the prevention of anemia due to iron deficiency in children.

Both UnitedHealthcare and Anthem cover iron supplements for children aged 0 to 12 months, though UnitedHealthcare specifies coverage for iron liquid supplements.

Meanwhile, Cigna, Aetna, and Humana cover the supplements for children aged 6 to 12 months, with the latter 2 insurers specifying coverage for children at increased risk for anemia.

All 5 major health insurers cover FDA-approved OTC tobacco cessation medications for those 18 years or older.

UnitedHealthcare specifies that in order for patients to qualify for the 100% coverage, their prescriber must let the insurer know that they are also getting counseling to quit tobacco. It also requires prior authorization for OTC nicotine replacement gum, lozenges, and patches.

UnitedHealthcare, Anthem, Aetna, Cigna, and Humana all cover vitamin D supplements for the prevention of falls in men and women 65 years or older.

Humana specifies that patients must live in a residential care setting to qualify for the 100% coverage.

Of note, Aetna covers the following preventive supplies for pregnant women:

		Non—hospital-grade electric breast-feeding pumps anytime during pregnancy or once every 3 years while breast-feeding

		Manual breast pumps anytime during pregnancy or after delivery for the duration of breast-feeding

		Breast pump supplies if patients get pregnant again before they are eligible for a new pump

In addition, Anthem covers OTC colonoscopy prep kits when they are prescribed for preventive colon screening.

Click “Continue reading” to download each major health insurer’s information resources about OTC product coverage. 

Articles

7 OTC Product Categories Completely Covered by Insurance

Warnings about the risk of ketoacidosis and serious urinary tract infections have been added to the labels of sodium-glucose cotransporter-2 (SGLT2) inhibitors, a class of type 2 diabetes drugs.

, the FDA is advising health care professionals to look for symptoms of ketoacidosis and urinary tract infections in patients taking any of the following FDA-approved SGLT2 inhibitors for type 2 diabetes:

		Canagliflozin and metformin (Invokamet)

		Dapagliflozin and metformin extended-release (Xigduo XR)

		Empagliflozin and linagliptin (Glyxambi)

The symptoms of ketoacidosis include nausea, vomiting, abdominal pain, unusual fatigue, and shortness of breath, while the symptoms of a urinary tract infection include a feeling of burning when urinating or the need to urinate often or right away, pain in the lower part of the stomach area or pelvis, fever, or blood in the urine.

The FDA noted that ketoacidosis associated with the use of SGLT2 inhibitors can occur even if the blood sugar level is not very high. The SGLT2 inhibitor should be discontinued if ketoacidosis is suspected, the FDA said.

A review of the FDA Adverse Event Reporting System from March 2013 and May 2015 uncovered 73 reported cases of ketoacidosis in patients with type 1 or type 2 diabetes treated with SGLT-2 inhibitors, as well as 19 cases of life-threatening blood infections and kidney infections that started as urinary tract infections.

In all cases, the patients were hospitalized, and in many of the reported cases of ketoacidosis, the condition was not immediately recognized, and treatment was delayed because the presenting blood glucose levels were below those typically expected for diabetic ketoacidosis.

In addition to adding new warnings to the labels of all SGLT2 inhibitors, the FDA is requiring the manufacturers of these drugs to conduct an enhanced pharmacovigilance study that analyze spontaneous postmarketing reports of ketoacidosis in patients treated with SGLT2 inhibitors, including specialized follow-up to collect additional information, for a period of 5 years.

In the meantime, health care professionals and patients are encouraged to contact the FDA’s MedWatch program about any side effects involving these drugs.

Warnings about the risk of ketoacidosis and serious urinary tract infections have been added to the labels of SGLT2 inhibitors.

SGLT2 Inhibitor Labels Include New Risks

FDA previously recommended Qualgen cease all sterile compounding until it corrected unsanitary conditions and poor sterile production practices.

In response to an FDA warning about its sterile products, Qualgen LLC has taken corrective actions concerning its compounding facility conditions and sterility processes.

In October, the FDA alerted health care professionals and patients that investigators observed unsanitary conditions and poor sterile production practices at Qualgen’s facilities in Edmond, Oklahoma. Based on these findings, the FDA recommended that Qualgen cease all sterile compounding operations until it corrected these problems.

Qualgen general manager Shaun Riney stated the company started making corrections “as soon as we became aware of what the FDA was observing during its September audit,” even before the agency 

 to health care professionals in October.

Although the FDA reported that Qualgen did not stop its sterile compounding operations, the company did comply with the agency’s recommendation to voluntarily recall 67 lots of non-expired drugs compounded before September 1, 2015, “even though [the products] had already been tested and proven sterile,” Riney said.

According to Riney, no adverse events have been reported in relation to Qualgen’s products, which encompass a wide range of compounded estradiol and testosterone pellets. He maintained that the company has “done everything to be in compliance with the FDA’s recommendations.”

Qualgen pharmacist Peggy Ray stated that this experience “helped us improve our overall processes and heighten our awareness of everything we do.”

“This situation has not only improved our sterility processes in the lab, but it has allowed us to more reliably document the safety and efficacy of our products, ensuring the highest quality and safety for our providers and their patients,” Raley added in a statement.

Qualgen is registered as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act.

Sterile Compounding Processes Corrected at Qualgen

According to Riney, no adverse events have been reported in relation to Qualgen’s products, which encompass a wide range of compounded estradiol and testosterone pellets.

He maintained that the company has “done everything to be in compliance with the FDA’s recommendations.”

Qualgen has taken corrective actions concerning its compounding facility conditions and sterility processes.


The FDA has once again delayed its enforcement of product tracing requirements for pharmacies under the 

 (DSCSA) of the Drug Quality and Security Act (DQSA).

Although these track-and-trace requirements 

, the FDA said it would not enforce the product tracing obligations for pharmacies until November 1, 2015, which it has now extended to March.

The FDA granted this latest extension because “some dispensers—primarily smaller, independent pharmacies and health systems&mdash;have expressed that they need additional time,” the agency explained.

Many pharmacy organizations previously called for the FDA to delay implementation in order to allow pharmacies to prepare for product tracing requirements.

Back in June, the American Society of Health-System Pharmacists (ASHP) suggested that a January 1, 2016, deadline would give drug dispensers enough time to implement new systems. Now, the FDA has gone even further in delaying enforcement of the requirements until March 1, 2016.

“ASHP has remained engaged with the FDA on this challenging issue, and we are pleased with the decision to extend the deadline,” Kasey K. Thompson, PharmD, MS, MBA, ASHP vice president for policy, planning, and communications, said today in a statement. “We will continue to work with FDA to ensure that ASHP members have the necessary tools and resources to comply with this important regulation.”

The updated DSCSA compliance policy recognizes that many pharmacies are working toward using electronic systems to keep track of product tracing information, such as transaction history, but may need more time to work with trading partners to ensure that they can capture and maintain these data.

In the meantime, pharmacies that do not capture and maintain product tracing information, or accept prescription drugs without product tracing information prior to or during a transaction, will not be penalized.

However, this compliance policy does not extend to other requirements for dispensers under the DSCSA, which include verification related to suspect and illegitimate product (including quarantine, investigation, notification, and recordkeeping) and engaging in transactions only with authorized trading partners.

The FDA has once again delayed its enforcement of product tracing requirements for pharmacies.

Pharmacy Track-and-Trace Compliance Deadline Again Delayed by FDA

October is American Pharmacists Month (APhM), the perfect time to promote the pharmacy profession and recognize the important role of the pharmacist.

Throughout the month, pharmacists are encouraged to spread the word about their work and celebrate their contributions to their communities.

Some ways to celebrate in all practice settings include making time for face time with patients, holding brown bag medication reviews, and hosting local legislators, according to the American Pharmacists Association (APhA), which sponsors APhM.

Pharmacists in all settings can also participate in social media challenges, including the 

By using the hashtag #ThankAPharmacist and tagging @Pharmacy_Times throughout APhM, participants will have an opportunity to generate awareness and goodwill for their favorite pharmacists or pharmacy colleagues.

Other ideas for community pharmacists in particular include:

		Conducting OTC aisle tours to emphasize the importance of reading drug labels and asking pharmacists questions.

		Making a presentation at a local cooking class about the importance of speaking with a pharmacist about food-drug interactions.

		Hosting a “sidewalk sale” where local businesses publicize themselves while pharmacists promote their patient care services.

For pharmacists in hospital and managed care settings, the APhA recommends:

		Making patient rounds, answering any questions patients may have about their medications.

		Inviting all hospital and managed care staff to visit the pharmacy.

		Offering curbside medication therapy management sessions.

"There are more ways to celebrate American Pharmacists Month than there are days in October,” the APhA wrote on its website. “You just need to figure out what works best for your pharmacy.”

Pharmacy technicians and student pharmacists can also play big roles during APhM.

For instance, the APhA advises technicians to remind their team members about National Pharmacy Technician Day, which falls on October 20 this year. To celebrate, techs can set up a special health event where they can conduct blood pressure screenings or other pharmacy-based patient care services.

Student pharmacists can inspire their peers on campus to “Know Your Pharmacist, Know Your Medicine” by writing an op-ed about the importance of pharmacy for their school paper or school-connected professional journal. APhA-ASP chapters can partner with faculty members to conduct free health screenings and medication check-ups for local businesses and organizations. 