STOCKTON, Calif., November 5, 2018 — Therapeutic Research Center (TRC® Healthcare, or TRC), a leading provider of medication advisory and learning solutions and the author of Pharmacist’s Letter, and the Utah Pharmacy Association (UPhA), an organization committed to serving, advancing, and promoting the Pharmacy profession in Utah, announced today an agreement that enables UPhA to offer its individual members and Utah-based retail pharmacies employer-based training via subscription to Pharmacy Technicians University, a one-of-a-kind online training program for pharmacy technicians. In addition, UPhA can now offer subscriptions for its retail pharmacy store members to the Community Pharmacy Standard Bundle from TRC, which includes access to Pharmacist’s Letter, Pharmacy Technician’s Letter, the Learning Management Portal and CE Organizer for assigning and tracking continuing education, and Natural Medicines, the most comprehensive natural/alternative medicine and supplement database available.

“This is a great new, affordable option, especially for our independent pharmacy owners and their members, to access a top-quality technician training and education program. It gives our pharmacists and pharmacy technicians an opportunity to prepare for the National exam, as well as access certification and re-certification resources that were previously hard to find at a reasonable price.” said Shane Jensen, President of the Utah Pharmacy Association. “Utah has a number of independent and community pharmacies that often can’t get the services that larger organizations or chains are able to get at sustainable costs. This program, which many already find familiar, now accessible through the UPhA, makes it possible to continue to enrich the Pharmacy and Technicians education community in Utah and will help UPhA move its mission forward.”

“Skilled pharmacy technicians are increasingly important members of the modern pharmacy team and are providing efficiency and economic advantages to pharmacy teams,” said Wes Crews, Chief Executive Officer at TRC Healthcare. “However, training requirements for techs change often, are becoming more complex, and vary from state to state, creating a shortage of qualified pharmacy technicians. We are proud to partner with state associations such as UPhA to advance the pharmacy profession by delivering the online, competency-based curriculum in Pharmacy Technicians University. PTU helps simplify the educational experience, improve efficiencies, and reduce medication errors. With this agreement, UPhA can extend the PTU offering to Utah community pharmacy teams and to individual technicians in Utah, providing the tools and information they need to prepare for employment.”

TRC’s Pharmacy Technicians University (PTU) is committed to delivering the highest standard of excellence and value in its accredited remote learning program, including training programs that accommodate industry growth. Benefits include:

• Staying informed of and meeting new and existing state-mandated training and certification requirements
• Significant cost savings versus brick-and-mortar university courses, which offer less flexibility and limited course variety
  

The combination of PTU with Pharmacy Technician’s Letter delivers additional complementary benefits, including:

• Access to an intuitive CE organizer that allows users to easily track progress and effectively monitor and manage their training program and courses needs for licensure and compliance
• All-in-one-place tracking of due dates, renewal periods, and certificates of completion
  

Access to PTU for individuals and community pharmacies via this partnership is a strong compliment to the enterprise offerings for retail chains, larger community pharmacies and hospitals from TRC. This partnership helps technicians who want or need access to the highest quality evidence-based training and certifications programs have options.

PTU offers the most extensive and robust interactive courseware and training videos for medication learning available today and provides up to 600 hours of didactic, simulation, and experiential course content and the highest-quality technician training resources. PTU also offers a low-impact retail-pharmacy only program for those areas organizations that require less investment to meet standards in their state(s). PTU is one of the only online technician training programs that supports or exceeds the requirements for technician training in 50 states, including Washington D.C. And, PTU supports employer-designed training curriculums to allow organizations to “right-size” training in accordance with the state requirements where they operate.

TRC is committed to expanding and contextualizing its PTU course offerings to accommodate both retail and hospital pharmacy technician training needs for medication learning, including offering different levels of curriculum to align with various state board regulations and care- setting requirements.

To learn more about this new program, please contact UPhA at 801.438.2524 or visit www.UPhA.com.

About Utah Pharmacy Association (UPhA) The Utah Pharmacy Association is the organization that represents all aspects of pharmacy in Utah. UPhA is a non-profit trade association organized and committed to serving, advancing, and promoting the Pharmacy profession in Utah. UPhA represents pharmacists and technicians from all areas of the profession. UPhA’s strategic goals include providing new and quality education opportunities and resources to its members.

About Therapeutic Research Center (TRC) TRC is the leading provider of digital medication learning that updates, informs, and educates healthcare providers across the continuum of care. In addition to its highly regarded Pharmacist’s Letter, Prescriber’s Letter, Pharmacy Technician’s Letter, Nurse’s Letter and Natural Medicines online resources, TRC provides additional online solutions for hospital and community clinicians that expand on its trusted recommendations, such as drug comparison charts, patient education handouts, FAQs, and tutorials in its web-based products. In addition, TRC provides online continuing education programs for medication learning, competency, and compliance programs, and keeps clinicians and administrators informed via its continuing education (CE) dashboard and CE & Training Organizer. TRC provides the largest catalog of education and advisory services in the industry for pharmacy, delivering nearly 500 course options to help technicians and clinicians. TRC leads the way in the training of new pharmacy technicians with Pharmacy Technicians University (PTU), the first online accredited, interactive training program of its kind. Nearly 500,000 healthcare professionals rely on TRC’s advisory and education service to access concise, unbiased, timely information to improve medication use, prevent medication errors, and improve overall patient care, quality and outcomes.

Media Contact: Andrea Lashnits
Andrea.lashnits@trchealthcare.com
303-810-2995

December 10, 2020

Supreme Court Rules in Favor of Pharmacists, Patients

Decision in Rutledge v. PCMA Validates State Efforts to Rein in PBMs

Midvale, Utah – The Supreme Court of the United States today issued its landmark decision in Rutledge v. Pharmaceutical Care Management Association (PCMA), ruling in favor of an Arkansas law to prevent abusive PBM payment practices. 

The unanimous decision empowers states to take action to hold pharmacy benefit managers (PBMs) accountable for their role in managing drug benefits that profit at the expense of local pharmacists, pharmacies and the patients who depend on them.

“This ruling removes a significant barrier in providing patients with access to their pharmacy of choice and increased price transparency” said Jayme Garcia, UPhA President. “This is a big win for our pharmacies, pharmacists, and patients. But, there’s much more work to do to strengthen PBM regulations to benefit patients in the future.”

The Arkansas law upheld by the Supreme court today prohibits PBMs from reimbursing local pharmacies at a lower rate than what the pharmacies pay to fill prescriptions. PBMs often profit by reimbursing pharmacies at less than a pharmacy’s cost to acquire a drug. This is just one of the many ways the PBM system puts pharmacies and patients at a disadvantage.

“Today is a historic day for the millions of men and women who play a critical role in ensuring public health. As we all navigate an ever-changing COVID-19 world, it’s critical that we let pharmacists and pharmacies do what they do best: serve patients and communities,” said Adam Jones, UPhA Executive Director. 

To learn more about our efforts to protect pharmacists and patients, visit www.UPhA.com.

On October 2, 2020, through investigative means, agents and Fontana Police Department investigators established surveillance on the courier’s residence. During surveillance, Fontana Police Department investigators observed the target and a secondary associate load two duffle bags into a vehicle and leave the location. The courier target and the associate ultimately met with a third associate at a Sam’s Club parking lot in the city of Moreno Valley where they unloaded and delivered the two duffle bags to the third associate. During that time, investigators detained the courier target and the two other associates in the parking lot for questioning and they were later released.

Based upon the investigation and locations previously identified, agents authored state search warrants for multiple locations, including the courier target’s residence and a narcotics stash house within the city of Perris. During a search of the courier’s residence, agents located approximately 25 duffle bags within the garage of the residence containing approximately 406 kilograms of cocaine, six kilograms of heroin, and 650 pounds of crystal methamphetamine.
Additionally, during a search of the narcotics stash house in Perris, agents located approximately 1,600 pounds of crystal methamphetamine. This is an ongoing investigation.

“The largest DEA domestic seizure of methamphetamine in history is a significant blow to the cartels, but more importantly it is a gigantic victory for communities throughout Southern California and the United States who have had to deal with the torrent of methamphetamine coming into their neighborhoods,” said Acting Administrator Shea. “We continue to work with our state and local partners to attack drug trafficking at all levels and this seizure sends a clear message that we mean business.”
“Los Angeles is the major transshipment hub for Mexican cartels trafficking illicit drugs across our southwest border,” said Special Agent in Charge Bodner. “Successful seizures like these save lives and reduce the exploitation and victimization of our local communities.”

“The significant seizures announced today thwarted drug traffickers’ plans to profit from these dangerous drugs that cause incredible harm to our communities,” said Acting Assistant Attorney General Brian C. Rabbitt of the Justice Department’s Criminal Division. “The Justice Department is committed to making our neighborhoods safer by aggressively disrupting drug cartel operations in the United States.”

Participating law enforcement partners include the Southwest Border Group 2 – including the South Gate Police Department, Simi Valley Police Department, Huntington Park Police Department, Glendora Police Department, Downey Police Department, El Monte Police Department, Irwindale Police Department, Los Angeles County District Attorney’s Office, and the Los Angeles County Sheriff’s Department – and the Criminal Division’s Narcotic and Dangerous Drug Section of the U.S. Department of Justice.

The Consumer Bankers Association, International Franchise Association and U.S. Chamber of Commerce led a coalition of more than 130 trade groups representing small business borrowers and lenders in a letter to Congressional Leaders advocating for the passage of bipartisan legislation introduced by Sens. Kevin Cramer (R-N.D.), Bob Menendez (D-N.J.), Thom Tillis (R-N.C.) and Kyrsten Sinema (D-Ariz.) to streamline Paycheck Protection Program forgiveness for the smallest borrowers.

The bipartisan legislation calls for streamlined forgiveness of PPP loans less than $150,000 if the borrower answers a simple, one-question attestation the funds were used in accordance to PPP guidelines to retain employees. The simplified forgiveness could collectively save the smallest small businesses owners more than $7 billion dollars and hours of paperwork.

"This bipartisan legislation would ensure our nation's small business owners can focus their time, energy, and resources back into their business and communities instead of allocating significant time and resources into completing complex forgiveness forms," the associations wrote.

The coalition letter notes independent analysis by AQN Strategies anticipates the combined small business resource requirements of time and/or third-party expenses could represent an effective cost of $2,000-$4,000 for each business that applies for forgiveness, requiring 20-100 hours of time.

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Today, the Centers for Medicare & Medicaid Services (CMS) is announcing several actions aimed at limiting the spread of the Novel Coronavirus 2019 (COVID-19). Specifically, CMS is issuing a call to action to health care providers across the country to ensure they are implementing their infection control procedures, which they are required to maintain at all times. Additionally, CMS is announcing that, effective immediately and, until further notice, State Survey Agencies and Accrediting Organizations will focus their facility inspections exclusively on issues related to infection control and other serious health and safety threats, like allegations of abuse – beginning with nursing homes and hospitals. Critically, this shift in approach, first announced yesterday by Vice President Pence, will allow inspectors to focus their energies on addressing the spread of COVID-19.

As the agency responsible for Medicare and Medicaid, CMS requires facilities to maintain infection control and prevention policies as a condition for participation in the programs. CMS is also issuing three memoranda to State Survey Agencies, State Survey Agency directors and Accrediting Organizations – to inspect thousands of Medicare-participating health care providers across the country, including nursing homes and hospitals.

“Today’s actions, taken together, represent a call to action across the health care system,” said CMS Administrator Seema Verma. “All health care providers must immediately review their procedures to ensure compliance with CMS’ infection control requirements, as well as the guidelines from the Centers for Disease Control and Prevention (CDC). We sincerely appreciate the proactive efforts of the nursing home and hospital associations that have already galvanized to provide up-to-the-minute information to their members. We must continue working together to keep American patients and residents safe and healthy and prevent the spread of COVID-19.”

The first memorandum released today provides important detail with respect to the temporary focus of surveys on infection control and other emergent issues. Importantly, it notes that, in addition to the focused inspections, statutorily-required inspections will also continue in the 15,000 nursing homes across the country using the approximately 8,200 state survey agency surveyors. Surveys will be conducted according to the following regime:

    •    All immediate jeopardy complaints (a situation in which entity noncompliance has placed the health and safety of recipients in its care at risk for serious injury, serious harm, serious impairment or death or harm) and allegations of abuse and neglect;
    •    Complaints alleging infection control concerns, including facilities with potential COVID-19 or other respiratory illnesses;
    •    Statutorily required recertification surveys (Nursing Home, Home Health, Hospice, and ICF/IID facilities);
    •    Any re-visits necessary to resolve current enforcement actions;
    •    Initial certifications;
    •    Surveys of facilities/hospitals that have a history of infection control deficiencies at the immediate jeopardy level in the last three years;
    •    Surveys of facilities/hospitals/dialysis centers that have a history of infection control deficiencies at lower levels than immediate jeopardy.

The memorandum also includes protocols for the inspection process in situations in which COVID-19 is identified or suspected. These protocols include working closely with CMS regional offices, coordinating with CDC, and other relevant agencies at all levels of government. The agency is also providing key guidance related to inspectors’ usage of adequate personal protective equipment.

The other two memoranda provide critical answers to common questions that nursing homes and hospitals may have with respect to addressing cases of COVID-19. For example, the memoranda discuss concerns like screening staff and visitors with questions about recent travel to countries with known cases and the severity of infection that would warrant hospitalization instead of self-isolation. They detail the process for transferring patients between nursing homes and hospitals in cases for which COVID-19 is suspected or diagnosed. They also describe the circumstances under which providers should take precautionary measures (like isolation and mask wearing) for patients and residents diagnosed with COVID-19, or showing signs and symptoms of COVID-19.

Finally, the agency is announcing that it has deployed an infection prevention specialist to CDC’s Atlanta headquarters to assist with real-time in guidance development.

Today’s actions from CMS are focused on protecting American patients and residents by ensuring health care facilities have up-to-date information to adequately respond to COVID-19 concerns while also making it clear to providers that as always, CMS will hold them accountable for effective infection control standards. The agency is also supplying inspectors with necessary and timely information to safely and accurately inspect facilities.

To view each memo, please visit the below links:

Suspension of Survey Activities: https://www.cms.gov/medicareprovider-enrollment-and-certificationsurveycertificationgeninfopolicy-and/suspension-survey-activities

Guidance for Infection Control and Prevention Concerning Coronavirus Disease (COVID-19): FAQs and Considerations for Patient Triage, Placement and Hospital Discharge: https://www.cms.gov/medicareprovider-enrollment-and-certificationsurveycertificationgeninfopolicy-and/guidance-infection-control-and-prevention-concerning-coronavirus-disease-covid-19-faqs-and

Guidance for Infection Control and Prevention of Coronavirus Disease 2019 (COVID-19) in nursing homes: https://www.cms.gov/medicareprovider-enrollment-and-certificationsurveycertificationgeninfopolicy-and/guidance-infection-control-and-prevention-coronavirus-disease-2019-covid-19-nursing-homes

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“XCOPRI is a new option to treat adults with partial-onset seizures, which is an often difficult-to-control condition that can have a significant impact on patient quality of life,” said Billy Dunn, M.D., director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. “Patients can have different responses to the various seizure medicines that are available. This approval provides an additional needed treatment option for people with this condition.”

A seizure is a usually short episode of abnormal electrical activity in the brain. Seizures can cause uncontrolled movements,  abnormal thinking or behavior, and abnormal sensations. Movements can be violent, and changes in consciousness can occur. Seizures occur when clusters of nerve cells (neurons) in the brain undergo uncontrolled activation. A partial-onset seizure begins in a limited area of the brain.

The safety and efficacy of XCOPRI to treat partial-onset seizures was established in two randomized, double-blind, placebo-controlled studies that enrolled 655 adults. In these studies, patients had partial-onset seizures with or without secondary generalization for an average of approximately 24 years and median seizure frequency of 8.5 seizures per 28 days during an 8-week baseline period. During the trials, doses of 100, 200, and 400 milligrams (mg) daily of XCOPRI reduced the percent of seizures per 28 days compared with the placebo group. The recommended maintenance dose of XCOPRI, following a titration (medication adjustment) period, is 200 mg daily; however, some patients may need an additional titration to 400 mg daily, the maximum recommended dose, based on their clinical response and tolerability.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multiorgan hypersensitivity, has been reported among patients taking XCOPRI. In the clinical trials, some patients experienced DRESS, and one patient died, when XCOPRI was titrated rapidly (weekly or faster titration). No cases of DRESS were reported in an open-label safety study of 1,339 epilepsy patients when XCOPRI was started at 12.5 mg per day and adjusted every two weeks; however, this finding does not show that the risk of DRESS is prevented by a slower titration. A higher percentage of patients who took XCOPRI also had a shortening of the QT interval (an assessment of certain electrical properties of the heart) of greater than twenty milliseconds compared to placebo. XCOPRI should not be used in patients with hypersensitivity to cenobamate or any of the inactive ingredients in XCOPRI or Familial Short QT syndrome. QT shortening can be associated with ventricular fibrillation, a serious heart rhythm problem.

Antiepileptic drugs (AEDs), including XCOPRI, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients taking an AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. XCOPRI may cause neurological adverse reactions, including somnolence (sleepiness) and fatigue, dizziness, trouble with walking and coordination, trouble with thinking, and visual changes. Patients should also be advised not to drive or operate machinery until the effect of XCOPRI is known.

The most common side effects that patients in the clinical trials reported were somnolence (sleepiness), dizziness, fatigue, diplopia (double vision), and headaches.

The FDA granted the approval of XCOPRI to SK Life Science Inc.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

“Protecting patient health and safety is our highest priority, and the FDA continues to investigate and take action against companies that place U.S. patients at risk. Americans expect and deserve drugs that are safe, effective and that meet our standards for quality. The importation and distribution of drugs and other products from manufacturers that violate federal law is unacceptable,” said Donald D. Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “In this case, Dollar Tree has the ultimate responsibility to ensure that it does not sell potentially unsafe drugs and other FDA-regulated products to Americans. We will remain vigilant in our efforts to protect the U.S. public from companies who put the health of Americans at risk – whether through the manufacturing and distribution of products we regulate or other means.”

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Today, the Trump Administration and the Centers for Medicare & Medicaid Services (CMS) issued a notice of proposed rulemaking to strengthen the fiscal integrity of the Medicaid program and help ensure that state supplemental payments and financing arrangements are transparent and consistent with all applicable statutory requirements.  

The proposed Medicaid Fiscal Accountability Rule (MFAR) would take historic steps to ensure transparency in Medicaid payments and clamp down on impermissible financing arrangements to ensure that federal Medicaid dollars are spent in ways that support the direct needs of Medicaid beneficiaries. The proposed rule aims to strengthen accountability, increase transparency of Medicaid payments, and improve program integrity to ensure the Medicaid program is sustainable for future generations

“We have seen a proliferation of payment arrangements that mask or circumvent the rules where shady recycling schemes drive up taxpayer costs and pervert the system,” said CMS Administrator Seema Verma. “Today’s rule proposal will shine a light on these practices, allowing CMS to better protect taxpayer dollars and ensure that Medicaid spending is directed toward high-value services that benefit patient needs.”

States often make additional payments to providers above the normal reimbursement for billed services.  Oversight agencies, including the Government Accountability Office (GAO) and Office of Inspector General (OIG), have recommended changes to better oversee and understand these Medicaid supplemental payments, which have steadily increased from 9.4 percent of all other Medicaid payments in FY 2010 to 17.5 percent in FY 2017.  The proposed rule will address several additional areas of program vulnerabilities while clarifying existing financial policies.  The proposed rule would establish new requirements for states to report provider-level information on Medicaid supplemental payments, responding to calls from oversight organizations to increase transparency.  

CMS is aware of numerous schemes states have used that are not consistent with federal statute. Some examples include states that generate extra payments for private nursing facilities that enter into arrangements with local governments to bypass tax and donation rules, and the use of a loophole to tax managed care entities 25 times higher for Medicaid business than for similar commercial business. States can then use that tax revenue to generate additional payments, with no commiserate increase in state spending

Many of the vulnerabilities in Medicaid financing arise from high risk financing mechanisms that states have used, or sought to use, to finance the state portion of Medicaid payments. These include intergovernmental fund transfers, certified public expenditures, provider taxes, and provider donations that provide additional payments to institutions with no clear link to improving care for patients.  The proposed rule would provide clearer guidance on the law to states and other stakeholders, help close regulatory loopholes, and improve reporting to help CMS ensure that states fund their share of payments to providers through only permissible sources and with methodologies that comport with statutory requirements and align with Medicaid program goals

The proposed rule would also clarify Medicaid financing definitions by proposing new regulatory definitions for Medicaid “base” and “supplemental” payments, which would allow CMS to better monitor and enforce statutory requirements around the non-federal share of Medicaid expenditures and regulatory requirements for upper payment limits.  It would also clarify definitions and processes associated with provider ownership categories to close loopholes that have allowed states to attempt to inappropriately fund their share of Medicaid expenditures and to be more consistent with the statute.

To ensure payment arrangements align with both state and federal Medicaid program goals, states would also be required to sunset supplemental payments and tax waivers after no more than three years, with the option to request renewal.

Comments on the proposals will be due 60 days from the release of the NPRM.

To view a summary of the proposed changes, visit Medicaid.gov at: https://www.medicaid.gov/federal-policy-guidance/downloads/reg111219.pdf

For a copy of Administrator Verma’s November 12, 2019 speech at the National Association of Medicaid Directors conference, click here: https://www.cms.gov/newsroom/press-releases/cms-administrator-seema-vermas-speech-national-association-medicaid-directors-washington-dc

For more information, you can refer to the fact sheet here: https://www.cms.gov/newsroom/fact-sheets/fact-sheet-2019-medicaid-fiscal-accountability-regulation-mfar

On Saturday, October 26, in continuation of this effort, DEA and its national, tribal and community partners will hold the 18th National Prescription Drug Take Back Day across the country. The service is free and anonymous.

For the first time, DEA will now accept vaping devices and cartridges at any of its drop off locations during National Prescription Drug Take Back Day. It is important to note that DEA cannot accept devices containing lithium ion batteries. If batteries cannot be removed prior to drop-off, DEA encourages individuals to consult with stores that recycle lithium ion batteries.

Concerns have been raised across the United States over illnesses and death caused by vaping and the high youth vaping initiation rates. In an effort to support a healthy lifestyle and energetic population, especially amongst America’s youth, DEA is committed to doing all it can to help safely dispose of vaping devices and substances. 

“DEA’s National Prescription Drug Take Back Initiative helps get unused and unwanted prescription medications out of circulation and ensures their safe disposal,” said Acting Administrator Uttam Dhillon.  “This year, we are taking a step further by accepting vaping devices and cartridges as we work with our federal partners to combat this emerging public health threat to the nation’s youth.”

Now in its tenth year, DEA has collected a total of more than 11 million pounds (almost 6,000 tons) of expired, unused and unwanted prescription medications through its Take Back Day events. DEA is continuing to register law enforcement partners and collection sites for the upcoming Take Back Day. As of Oct. 15, more than 4,500 registered law enforcement partners will assist with more than 5,250 registered sites and 135 tribal locations across the country, with more being added each day Collection sites will be open from 10 a.m. to 2 p.m. local time. The public can find a nearby collection site at www.DEATakeBack.com or by calling 800-882-9539.

National Prescription Drug Take Back Day has received enthusiastic public support since its inception in 2010. Last April, the public turned in 469 tons (937,443pounds) of prescription drugs at more than 6,258 sites operated by the DEA and its 4,969 local and tribal partners.  

For more information about the harms of youth vaping, please visit DEA's site JustThinkTwice.

Consistent with the direction of President Trump’s recent Executive Order on Strengthening and Improving Medicare for Our Nation’s Seniors, the Centers for Medicare & Medicaid Services (CMS) announced today that seniors will have access to more high-quality Medicare Advantage and Part D prescription drug plans in 2020. Most people with Medicare will have access to Medicare Advantage and Part D plans with four or more stars in 2020, and approximately 81 percent of Medicare Advantage enrollees with prescription drug coverage will be in plans with four and five stars in 2020, an increase from 69 percent in 2017.

Medicare Advantage remains a popular choice among beneficiaries and has high satisfaction rates. Due to recent actions CMS has made to protect and strengthen Medicare Advantage, Medicare Advantage plans are better able to compete on the basis of cost and quality. As a result, beneficiaries are benefiting from more plan choices, lower costs and increased quality. As announced last month, on average, Medicare Advantage premiums are expected to decline by 23 percent from 2018, and will be the lowest in the last thirteen years for the more than 24 million people with Medicare who are projected to enroll in Medicare Advantage for 2020. Beneficiaries will have more plan choices, with about 1,200 more Medicare Advantage plans operating in 2020 than in 2018.

“President Trump continues to be the great protector of the Medicare program for our nation’s seniors,” said CMS Administrator Seema Verma. “Thanks to the President’s leadership and commitment, the improvements that CMS has made to the Medicare Advantage and Part D programs means that seniors will have access to more high-quality plans. Proposals for more government in our healthcare – such as Medicare-for-All – would eviscerate the progress we’ve made to strengthen the program by empowering patients to make informed choices in choosing high-quality plans that best fit their needs.”

Approximately 52 percent of Medicare Advantage plans that offer prescription drug coverage will have an overall rating of four stars or higher, compared to approximately 45 percent in 2019. The average star rating for all Medicare Advantage plans with prescription drug coverage has improved to 4.16 out of 5 stars, increasing from 4.02 in 2017.

More Medicare beneficiaries will have access to a greater number of high-quality stand-alone Medicare Part D prescription drug plans. In 2020, based on current enrollment, approximately 28 percent of enrollees will be in stand-alone prescription drug plans with 4 stars or higher, an increase from approximately 3 percent in 2018. And the average star rating for a stand-alone prescription drug plan has improved from 3.34 in 2019 to 3.50 in 2020.

Earlier this year, CMS made improvements to the Medicare Advantage and Part D Star Ratings so that consumers can more easily identify high-value and high-quality plans. The Star Ratings methodology was enhanced to better account for differences in a plan’s enrollee population.

The Star Ratings system helps people with Medicare, their families, and their caregivers compare the quality of health and drug plans being offered. Medicare health and drug plans are given a rating on a 1 to 5 star scale, with 1 representing poor performance and 5 stars representing excellent performance. Medicare beneficiaries can compare health coverage choices and the Star Ratings through the online Medicare Plan Finder tool available at Medicare.gov (https://www.medicare.gov). CMS publishes the Medicare Advantage and Part D Star Ratings every year to measure the quality of, and reflect the experiences of beneficiaries in, Medicare Advantage and Part D plans.

It will be easier than ever to compare Medicare Advantage and Part D plans on Medicare.gov. As the 2020 Medicare Open Enrollment period approaches, CMS for the first time in a decade launched a modernized and redesigned Medicare Plan Finder – the most-used tool on Medicare.gov – that allows users to shop and compare Medicare Advantage and Part D plans (including by total costs of estimated annual drug costs plus premiums) as well as compare costs between original Medicare, Medicare prescription drug plans, Medicare Advantage plans and Medicare supplemental insurance (Medigap) policies.

Medicare Open Enrollment begins on October 15, 2019, and ends on December 7, 2019. During this time, Medicare beneficiaries can compare coverage options like Original Medicare and Medicare Advantage and choose health and drug plans for 2020. Medicare health and drug plan costs and covered benefits can change from year to year, so people with Medicare should look at their coverage choices and decide on the options that best meet their health needs. They can visit Medicare.gov (https://www.medicare.gov), call 1-800-MEDICARE, or contact their State Health Insurance Assistance Program.

For more information on the 2020 Medicare Advantage and Part D Star Ratings, including a fact sheet, please visit: https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovGenIn/PerformanceData.html, and download the “2020 Part C and D Medicare Star Ratings Data” zip file in the downloads section.

To view the premiums and costs of the 2020 Medicare Advantage and Part D plans, please visit: https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovGenIn/index.html.

Dublin, Ireland-based Endo Pharmaceuticals announced Tuesday that it has agreed to pay the Ohio counties of Cuyahoga and Summit, home to Cleveland and Akron, a total of $10 million to settle their suits, which are still scheduled to go to trial against other drugmakers and distributors Oct. 21.

As part of the deal, Endo also agreed to supply $1 million worth of blood pressure medicines it produces for the counties. The counties will determine how the settlement is divided.

And Allergan, also based in Dublin, has agreed to pay $5 million to settle claims related to its branded opioid. The settlement does not resolve claims regarding its generic opioids, Frank Gallucci, a lawyer for Cuyahoga County, told Cleveland.com and other media outlets.

The settlements came one day after the Summit County Council passed a resolution to OK settlements with any companies with less than 10% of the opioid market share in the county.

Matthew Maletta, an Endo executive vice president, said it would have cost the company $10 million in legal expenses just to go to trial.

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“FDA regulations require all drug manufacturers to register their manufacturing facilities and provide a list of all drugs they are actively manufacturing for commercial distribution in the U.S. as one of the safeguards protecting our drug supply chain. It is vital that the FDA database accurately describes drugs currently available to patients in the U.S. so the FDA can more quickly respond to and assess drug quality issues, adverse event reports, inspections, recalls, shortages and other supply chain security issues,” said FDA Acting Commissioner Ned Sharpless, M.D. “While most companies are compliant, we have observed that some drug listings contain obsolete or inaccurate information. While there hasn’t been any public health consequence yet of these outdated listings, inaccurate information has the potential to compromise the integrity of the FDA’s database and the FDA’s ability to make accurate and timely decisions to protect public health. To ensure we’re working with the most updated and complete information, the agency is putting companies on notice that these outdated records will be inactivated. Products with inactivated listings may not be legally marketed in the U.S. until the company brings their records up to date. We’ll continue to enforce drug establishment registration and listing requirements, and we’ll work closely with manufacturers to ensure that registration or listing deficiencies do not affect the availability and quality of medicines for patients or result in drug shortages.”

Today, the U.S. Food and Drug Administration announced that it will inactivate listing recordsExternal Link Disclaimer in its database that have not been recently updated or certified, as required by regulation, or that include an establishment with an expired registration. The agency has found that tens of thousands of drug listing records have not been updated or certified in the past year, and are therefore not in compliance with federal regulations, which can slow down surveillance operations for certain FDA programs. Many of these listings are for products that are no longer being marketed in the United States, but for which the manufacturer never updated the listing. Such outdated listings nonetheless compromise the integrity of the FDA’s database and the FDA’s ability to make accurate and timely decisions to protect public health. Listing records that are up to date are publicly available in the FDA’s National Drug Code Directory. Drugs with inactivated listing records may not be legally marketed or imported in the U.S.

Domestic and foreign establishments that manufacture, repack or re-label drugs in the U.S. are required to register with the FDA. Domestic and foreign drug manufacturers, repackers or re-labelers are also required to list all of their drug products manufactured for commercial distribution in the U.S. This information helps the FDA maintain a catalog of all drugs in commercial distribution in the U.S. Drug manufacturers must provide registration and listing information or updates regarding any drug listing data changes twice each year, in June and December, or must certify that there have been no changes to previously submitted drug listing data by December 31 each year. The FDA has been actively working to alert companies of their issues, and this approach will help the agency ensure the integrity and accuracy of the FDA’s public databases. The agency urges companies to update inaccurate active drug listing submissions as soon as possible, as inactive listings as of September 12, 2019 will be removed from the database. Additional updating requirements and deadlines are available in the federal register notice below.

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