NCL health policy at work

Script Your Future Medication Adherence Team Challenge

In January, NCL launched the eighth annual Medication Adherence Team Challenge. From January 21 through March 22, inter-professional teams—including student pharmacists, doctors, nurses, and others—implemented outreach activities in their communities to raise awareness and improve understanding about medication adherence, using Script Your Future. Since the Challenge began in 2011, more than 15,000 future healthcare professionals have directly counseled nearly 65,000 patients and reached more than 24.5 million consumers about the importance of medication adherence. Stay tuned for NCL’s announcement of this year’s winners in May.

Vaccine advocacy 

NCL is a strong supporter of vaccines and works to dispel the myths about vaccine safety and educate consumers about the importance of vaccines in protecting themselves, their families, and their communities. This quarter, NCL has been actively engaged in the vaccine policy arena. NCL submitted comments to the Advisory Committee on Immunization Practices (ACIP) urging the Committee to maintain its recommendation for the pneumococcal vaccine for adults ages 65+.

In response to the measles outbreak, NCL renewed its call for legislation requiring child vaccinations.

Finally, NCL joined the Adult Vaccine Access Coalition’s (AVAC) comments on the CMS 2020 Medicare Advantage and Part D Advance Notice Part II and Draft Call Letter. The comments urge Medicare Advantage and Medicare Part D plans to place vaccines on the no cost-sharing or low cost-sharing tiers; support the flu Star Rating measure; request inclusion of the 4-vaccine adult composite in the Star Ratings; and support Medication Therapy Management (MTM), which increases adult vaccination rates.       

Counterfeit drugs and importation 

NCL continues to have a strong focus on counterfeit drugs. On January 14, NCL issued a statement on drug importation legislation introduced in Congress. NCL expressed concern that the legislation would open the U.S. market to a flood of counterfeit and/or substandard drugs, putting patient health and safety at risk. Rather than considering misguided importation proposals, NCL encouraged Congress to strengthen our drug supply chain and pursue other strategies to ensure the affordability and accessibility of safe and effective prescription drugs.  

On January 31, NCL cosponsored the Partnership For Safe Medicines’ Congressional briefings on counterfeit drugs. At the briefings, victims of counterfeit medicines and their families, local law enforcement, former DEA agents, and other experts in the fight against counterfeit drugs discussed the widespread impact fake drugs are having on communities and the enormous burden the problem places on regulators who are responsible for ensuring public safety.

Counterfeit drugs consumer education campaign

NCL appreciates the support of Eli Lilly, PhRMA, Pfizer, Allergan, and Gilead for NCL’s Counterfeit Drugs Consumer Education Campaign. We anticipate launching the campaign in the fall of 2019, and are still seeking additional campaign partners. Please contact Karin Bolte at karinb@nclnet.org for information about how your organization can join this resource-rich platform to educate consumers on making smart decisions. 

Alliance for Advancing Women’s Health

On February 4, the Journal of Women’s Health published a consensus paper on the barriers to better female sexual health authored by several of NCL’s partners from the Alliance for Advancing Women’s Health (AAWH). Titled “Female Sexual Health: Barriers to Optimal Outcomes and a Roadmap for Improved Patient–Clinician Communications,” the paper details ways to overcome the barriers currently impeding patient–clinician communication about women’s sexual health. The publication will be the scientific foundation for the clinical and consumer resources that AAWH plans to develop this year to facilitate patient-clinician conversations on this topic. As a co-chair of AAWH, NCL will be spearheading the development of the patient tools.

Fighting the opioid epidemic

Continuing our focus on the opioid epidemic, on February 6 in Columbus, Ohio, NCL’s Health Policy and Programs Associate Nissa Shaffi (right) joined Ohio state legislators and allies at the Ohio Statehouse for the launch of Rx Abuse Leadership Initiative (RALI) – Ohio, a broad-based coalition of more than 2 dozen local, state, and national organizations dedicated to finding solutions to end the opioid crisis in the state. NCL is committed to partnering with RALI coalitions across the country to educate consumers about the safe use and disposal of opioids and resources available to support addiction prevention, treatment, and recovery services.   

FDA appropriations and Commissioner Gottlieb’s resignation 

Each year, NCL advocates for a solid base of budget authority appropriations for the FDA. On February 13 and March 19, NCL participated in the Alliance for a Stronger FDA’s Capitol Hill Advocacy Days. NCL met with staff of members of the House and Senate Agriculture/FDA Appropriations Subcommittees, including the office of Senator Jeff Merkley (D-OR), Ranking Member of the subcommittee. Altogether, Alliance teams met with over 70 Congressional offices to advocate for additional investment in the FDA that will result in substantial added value to the American public.

NCL also expressed its disappointment at the resignation of FDA Commissioner Scott Gottlieb, and urged the next FDA Commissioner to put the interests of consumers first by maintaining the agency’s strong oversight of the safety and effectiveness of drugs and medical devices.

Protecting Medicare

On January 25, NCL joined with over 50 organizations in urging CMS not to finalize the proposed changes to the Medicare Part D six protected classes of drugs (anticonvulsants, antidepressants, antineoplastics, antipsychotics, antiretrovirals, and immunosuppressants). Led by the American Cancer Society Cancer Action Network, the letter expresses concern that the proposed changes could result in cost-shifting to beneficiaries and could jeopardize vulnerable beneficiaries’ access to medically-necessary prescription drugs.

AARP

On March 12, 2019, AARP announced the launch of ‘Stop Rx Greed,’ a nationwide campaign aimed at lowering prescription drug prices. The goal of the campaign is to help drive down drug prices for all Americans by advocating for a variety of legislative, executive, and regulatory actions at both the federal and state level. As part of the campaign, AARP conducted a national survey of likely voters ages 50 and older which found that significant majorities of them shared concerns about the high price of drugs, and support common-sense policies that will lower prices.

AMAG Pharmaceuticals

On January 17, 2019, AMAG Pharmaceuticals announced that it completed its acquisition of Perosphere Pharmaceuticals Inc., a private biopharmaceutical company. AMAG’s acquisition is an opportunity to add an innovative, durable and differentiated clinical asset to its portfolio. Through this acquisition, AMAG adds ciraparantag to its development portfolio. Ciraparantag is in development as a single dose, ready-to-use solution for use in patients treated with novel oral anticoagulants (NOACs) or low molecular weight heparin (LMWH) when reversal of the anticoagulant effect of these products is needed for emergency surgery, urgent procedures, or due to life-threatening or uncontrolled bleeding. Ciraparantag has been granted Fast Track review designation by the U.S. Food and Drug Administration (FDA) and has patent protection until 2034. 

America’s Health Insurance Plans

Earlier this year, AHIP launched Better Care America, a healthcare information project. Through BCA, AHIP is working with policymakers and the public on real solutions to improve care, lower costs, and ensure every American has affordable coverage, access to high-quality care, and the ability to make healthcare choices that are right for them. Health care shouldn’t be complicated and confusing – Better Care America provides tools and resources to build on what’s working and fix what isn’t in today’s system.

Association for Accessible Medicines

The Association for Accessible Medicines (AAM) was one of many organizations that weighed-in with the Centers for Medicare and Medicaid Services (CMS) on April 1^st to support its recent proposal that, if implemented, would immediately lower patient spending on drugs by a large degree. In its call letter outlining policies for Medicare Advantage and Medicare Part D prescription drug plans for 2020, CMS suggested the straightforward proposition that generic drugs belong on plans’ generic drug formulary tiers with low copays instead of co-mingled onto tiers with brands as they are today. The proposal would increase access, reduce patient confusion, and save our nation’s patients more than $4 billion per year.

A new report from Avalere Health provided further evidence that America’s patients are needlessly spending too much out-of-pocket for affordable generics: Since 2015, seniors have paid nearly $22 billion in additional out-of-pocket costs for their prescription drugs in Medicare. This means that seniors using low-cost generic drugs were forced to pay billions more for low-cost medicines even as the prices of their drugs declined. America’s patients and taxpayers should receive the full value of competition from more affordable generic and biosimilar medicines. Instead of using higher co-pays for generic drugs, health plans and policymakers can help patients by ensuring that generic and biosimilar medicines are immediately placed on accessible, low-cost tiers. You can read AAM’s comment letter here.

BeMedWise at NeedyMeds 

BeMedWise at NeedyMeds announces a new partnership with Maryland’s Worcester County Health Department (includes Ocean City, MD). This spring, the Worcester County Health Department will launch BeMedWise’s Talk Before You Take program with a focus on the importance of patient advocacy and awareness about opioids. Educational materials including rack cards (English and Spanish) have been developed with messaging for patients and healthcare professionals to enhance understanding and evaluate the benefits and potential risks when using opioid medications. The educational materials will be distributed to doctor’s offices, clinics, and health fairs throughout the county.

Sharps disposal is a public health and safety issue that is commonly overlooked. Information about safely disposing of sharps is difficult to come by and often misunderstood. SafeNeedleDisposal.org, a project of NeedyMeds, is the most comprehensive information resource for home-generated sharps disposal in the United States. It is listed on the FDA website and has been mentioned in Consumer Reports. The website provides information on state guidelines as well as listings of disposal locations and programs. There is also guidance on sharps management and a Resource Center to download or order educational materials.

Read the latest BeMedWise blog, Patient Safety & Poison Prevention, in recognition of Poison Prevention Week (March 17-23, 2019). To learn more or find out how you can get involved in BeMedWise, contact Deborah.Davidson@needymeds.org.

Consumer Healthcare Products Association

The Consumer Healthcare Products Association (CHPA) recently released the results of a study on the value of over-the-counter (OTC) medicines to the U.S. healthcare system. The new research, conducted by IRI for CHPA, looked at nine major therapeutic categories of OTC medicines, finding that the availability of OTC medicines provides $146 billion in value to the U.S. healthcare system every year. Additionally, OTC medicines provide additional value through expanded access to more than 27 million consumers who would otherwise forgo treatment – more than 13 million Americans for allergies alone.

CHPA has launched a multi-pronged communications strategy and encourages all stakeholders to leverage our new findings and collateral, including infographics, video, and a social media kit. Check out our new microsite to learn more: www.chpa.org.

Eli Lilly and Company

Eli Lilly and Company recently announced plans to make available a lower-priced authorized generic version of its most commonly used insulin. Its list price will be 50 percent less than the branded version – immediately providing a more affordable option for certain Americans in high-deductible health insurance plans, the uninsured, and seniors that hit the coverage gap in their Medicare Part D plans.

Lilly is working with partners in the supply chain to stock U.S. pharmacies as quickly as possible.

The significant rebates companies like Lilly pay on insulins do not directly benefit all patients, and this needs to change. In the meantime, Lilly’s solutions can help address gaps in the healthcare system until a more sustainable model is achieved.

FDA Office of Women’s Health

The FDA Office of Women’s Health (OWH) is pleased to announce Kaveeta Vasisht M.D., Pharm.D as the new Deputy Director and Acting Associate Commissioner. OWH is also excited to have Rashetta Fairnot MSW, LMSW on board as the new Director of Outreach and Communications.

OWH is actively updating its publications to include content updates and a refreshed visual identity, ensuring that OWH continues to provide women timely and free health information in a clear and easy-to-read format.

National Association of Nurse Practitioners in Women’s Health

NPWH will hold its sixth annual Women’s Sexual Health Course for NPs in Orlando, FL May 30 – June 2. We recently released the first look at H.E.R. Hub, our upcoming patient portal. Finally, we are continuing to work to advance older women’s health care with our bOlder Women’s Health Coalition and anticipate an official Coalition launch in May 2019. To learn more about the Coalition, click here.

National Community Pharmacists Association

Drug pricing

The 2020 Medicare Part C/D Pricing Proposed Rule closed its comment period on January 25. NCPA submitted comments, a joint letter with more than 150 pharmacy stakeholder organizations, joint comments with the National Association of Chain Drug Stores (NACDS) and the National Association of Specialty Pharmacy (NASP), as well as joint comments with the American Society of Consultant Pharmacists (ASCP) and Senior Care Pharmacy Coalition (SCPC). Additionally, more than 3,300 pharmacists voiced their support and two dozen patient advocacy organizations supported the rule.

NCPA continues to advocate for the elimination of, or at the very least, prospective application of pharmacy price concessions (also known as pharmacy DIR) in Medicare Part D, which CMS estimates could save beneficiaries about $7.1 to $9.2 billion over 10 years resulting from reduced cost-sharing. This is because patients’ out-of-pocket spending is reduced when pharmacy price concessions are included in the negotiated price and applied at the point of sale. In a recently proposed rule, CMS correctly stated, “beneficiary cost-sharing is generally calculated as a percentage of the negotiated price. When pharmacy price concessions are not reflected in the negotiated price at the point of sale … beneficiary cost-sharing increases, covering a larger share of the actual cost of a drug.” NCPA’s analysis of the recently proposed rule on pharmacy price concessions is available here. Should your organization have any questions regarding this proposed policy change, please contact NCPA’s advocacy team.

Facebook reportedly nears hefty FTC settlement; national cybersecurity at risk from external hackers and internal ineptitude

By John Breyault (@jammingecono, johnb@nclnet.org)
NCL Vice President of Public Policy, Telecommunications and Fraud

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Editor’s note: As Facebook and the Federal Trade Commission (FTC) reportedly near a record-setting privacy settlement, Chinese and Iranian hackers are beefing up their efforts to steal military and trade secrets from the United States. Meanwhile, both the Census Bureau and Federal Housing Finance Agency received bad publicity for failing basic cybersecurity best practices. Amid this storm of bad data security news, the Senate Homeland Security Chairman finds himself on the receiving end of condemnation from both sides of the aisle for blocking key cyber bills during his tenure as chairman of the Senate Homeland Security Committee.

And now, on to the clips!

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Chinese and Iranian hackers take aim at U.S. companies and military. @nicoleperlroth reports that the “Iranian attacks on American banks, businesses and government agencies have been more extensive than previously reported. Dozens of corporations and multiple United States agencies have been hit. …” Meanwhile, cyber watchers have observed a “renewed Chinese offensive geared toward stealing trade and military secrets from American military contractors and technology companies.” (Source: New York Times)

Chairman Johnson stalls efforts to enact cybersecurity legislation. @timstarksand @ericgellerreport that,while cyber threats have grown, Senate Homeland Security Committee Chairman Sen.Ron Johnson (R-WI) has “derailed many of the most significant cybersecurity-related bills in the past four years, including legislation to secure elections, study whether the growing use of encrypted apps hampers law enforcement and hold companies accountable for the proliferation of insecure connected devices.”@MiekeEoyangcommented that @RonJohnsonWI’s committee “is the place where legislation goes to die on cybersecurity.” Former Chairman Michael McCaul (R-TX) also publicly lamented Johnson’s leadership stating that “[t]he record speaks for itself.” Source: Politico)

Facebook reportedly negotiating multi-billion fine with FTC for privacy violations. @tonyromm reports that, while a deal has not yet been reached, the fine “would be the largest the agency has ever imposed on a technology company. … If talks break down, the FTC could take the matter to court in what would likely be a bruising legal fight.” (Source: Washington Post)

Census Bureau finds data collected in the 2010 Census to be vulnerable. While a breach is not thought to have occurred, the age, gender, location, race, and ethnicity data collected from millions of Americans was found to be improperly secured. “The Census Bureau is now scrapping its old data shielding technique for a state-of-the-art method that [Census Bureau Chief Scientist John] Abowd claimed is far better than Google’s or Apple’s.” (Source: AP News)

Quick hit: Patient healthcare data breaches nearly triple. The Protenus 2019 Breach Barometer found that patient record data breaches surged from 5 million records in 2017 to 15 million in 2018. (Source: Health IT Security)

Breach du jour: Dating app notifies users of Valentine’s Day breach. The breach at“Coffee Meets Bagel” is believed to have compromised a partial list of user details, including names and email addresses. Thankfully, users’ financial information and passwords do not seem to be at risk in this breach. However, the breach is still troubling as “dating apps run a risk of leaving users’most intimate communications vulnerable.” (Source: Axios)

Stolen Equifax data has yet to surface. Seventeen months after the historic breach, the records of 143 million Americans “never appeared on any [of the] hundreds of underground websites selling stolen information. Security experts haven’t seen the data used in any of the ways they’d expect in a theft like this — not for impersonating victims, not for accessing other websites, nothing.” The lack of movement of the valuable data has led many researchers to suspect that the Equifax breach was the work of an international spy agency. (Source: CNBC)

One in three FHFA employees fail phishing test. An audit found that one-third of tested employees at the Federal Housing Finance Agency (which oversees Fannie Mae, Freddie Mac, and the Federal Home Loan Bank System) failed to properly handle suspicious emails. (Source: FCW)

Upcoming Events

June 27, 2019: Federal Trade Commission’s PrivacyCon – Washington, DC
Each year, the FTC convenes a group of privacy experts, academics, policymakers, and regulators to discuss the latest research surrounding consumer privacy and data security. Researchers are encouraged to apply to present at the conference by March 15, 2019. (Source: Federal Trade Commission)

National Consumers League
Published February 21, 2019

Washington, DC – NCL Statement on resolution of lawsuit against Walmart, JC Penney and The Children’s Place 

The National Consumers League (“NCL”) and Walmart, JC Penney and The Children’s Place (“the Retailers”) are pleased to announce that they have resolved consumer-related litigation pending in the Superior Court of the District of Columbia, in National Consumers League v. Wal-Mart Stores, Inc. et al., No. 2015 CA 007731 B. The Retailers recognize the value of helping consumers learn about the measures that they have in place to assess and improve working conditions in factories that make goods for sale in the District of Columbia and elsewhere. 

• Amended Complaint

Defendants’ Answers

• Walmart
• JC Penney
• Children’s Place

Order on Motion to Dismiss