IN THE NEWS

Which PBM Best Managed Drug Trend in 2014: CVS Health, Catamaran, or Express Scripts?

Three of the biggest pharmacy benefit managers (PBMs)—Catamaran, CVS Health, and Express Scripts—have now released their 2014 drug trend reports. That means it’s time for my annual review of what the reports say about drug spending—and which questions remain unanswered. Read more - May 27, 2015

Fruth Pharmacy partners with grocery chain

The regional drug chain said Tuesday that under a partnership with Forth Foods Inc., the grocer’s parent, Fruth Pharmacy will take over the pharmacy inside Powell’s Food Fair in Pomeroy, Ohio, in mid-June. Then in mid-July, Fruth Pharmacy will open inside the Food Fair in Grayson, Ky., which will mark the drug chain’s entry into Kentucky. The in-store Fruth locations will be reduced in size but offer Fruth’s full pharmacy services. Read more - May 27, 2015

CVS launches Hispanic drug store banner

CVS Health has launched a new drug store banner in Florida that’s aimed at Hispanic consumers. Called CVS/pharmacy y más, the stores cater to Latino shoppers to connect them with their favorite brands, products and services. Read more - May 27, 2015

Surprise! Government Data Again Show Rising Drugstore Profits

The U.S. Census Bureau recently released its latest Annual Retail Trade Report. These government-collected data provide the most complete industry picture of retail drugstore profits. Read more - May 19, 2015

Drug chain partners with Chronic Liver Disease Foundation

Beginning later this summer, the Chronic Liver Disease Foundation and Walgreens will provide free hepatitis C testing at more than 60 of the drug chain’s pharmacies in 12 cities across the country. The foundation said Tuesday that the testing program, which will use the OraQuick HCV Rapid Antibody Test, is set to launch in August and run through January. Trained health care professionals will administer the tests, which will be available on specific days and times each week, and provide patient education on site at each pharmacy location. Read more - May 19, 2015

Rite Aid launches integrated marketing campaign to introduce wellness+ with Plenti

Rite Aid Corporation RAD, +0.88% has launched a new integrated marketing campaign in support of wellness+ with Plenti. As a part of Plenti, the nation’s first coalition loyalty program, Rite Aid now offers its nearly 25 million active wellness+ members even more ways to earn and enjoy savings on top of the existing wellness+ benefits they currently receive. Read more - May 18, 2015

Surescripts handled more transactions than Amex or PayPal in 2014

Surescripts processed 6.5 billion health-data transactions in 2014, according to data reported in the 2014 National Progress Report released Tuesday. Signaling a major milestone in the digital transformation of health care in the United States, Surescripts handled more transactions in one year than American Express (6 billion) and PayPal (4.2 billion). Read more - May 19, 2015

CVS Health agrees to buy Omnicare in $12.7 billion deal

As the American population gets older, pharmacies and other health care providers are increasingly positioning themselves to capitalize and serve the needs of this demographic. Read more - May 21, 2015

Hy-Vee CEO Edeker talks pharmacy’s role in being a ‘catalyst for change’

Drug Store News editor in chief Rob Eder sat down with Randy Edeker, chairman president and CEO of Hy-Vee and recently appointed National Association of Chain Drug Stores chairman, to discuss the current state of retail pharmacy and the big challenges facing the industry. Read more - May 22, 2015


DIRECT FROM WASHINGTON

21st Century Cures legislation – “lock-in” and pay fors

Launched a year ago by House Energy and Commerce Committee Chairman Fred Upton (R-MI) and Representative Diane DeGette (D-CO), the bi-partisan “21st Century Cures” Initiative is a comprehensive examination of the steps Congress can take to accelerate the drug and device discovery, development and delivery process so that cures may reach patients faster. The 21st Century Cures Initiative solicited ideas from patients and experts from all components involved with drug and device development and, earlier this year, Chairman Upton introduced a discussion draft including many of the ideas gathered over the “Cures” process. On May 21, the Committee marked up and approved “Cures” legislation, or H.R. 6, by a unanimous vote of 51 to 0.

While most of the measures in the bill are aimed at innovation and pharmaceutical development, H.R. 6, as approved by the Committee, did include some provisions of particular interest to pharmacy. For instance, the bill included “lock-in” measures to limit beneficiaries to specific pharmacies for obtaining certain controlled substances, suspend pharmacies’ Part D payments when there is suspicion of fraud and require e-prescribing for Part D drugs. 

Organizations such as the Pharmaceutical Care Management Association (PCMA) support “lock-in” provisions as a means to address the prescription drug epidemic by preventing improper prescriptions from being filled. The National Community Pharmacists Association (NCPA), long term care pharmacies, and seniors’ advocates have raised concerns “lock-in” policies make it more difficult for Medicare beneficiaries to access needed medication. The NCPA also has raised concerns that plan sponsors may be incentivized to direct Medicare beneficiaries to a particular pharmacy in which they have a financial interest. To address these concerns, the Energy and Commerce Committee amended the “lock-in” provisions through the legislative process to ensure beneficiary access to critical medications. H.R. 6 would allow for beneficiary appeals of the policy and would ensure “lock-in” policies are optional for prescription drug plans. 

The Senior Care Pharmacy Coalition (SCPC), a trade association comprised of companies that own and operate independent LTC pharmacies, successfully lobbied to ensure Part D beneficiaries residing in long-term care facilities, intermediate care facilities, hospices “or another facility for which frequently abused drugs are dispensed for residents through a contract with a single pharmacy” are specifically exempted. The bill also grants authority to the Secretary of Health and Human Services (HHS) to treat other beneficiaries as exempt from the provision. 

The cost of H.R. 6, which includes $10 billion in funding for the National Institutes of Health, is estimated to be $13 billion and required the Committee to find offsets, or “pay fors” for the bill. One version of the legislation proposed to change the way Medicaid Federal Upper Limits (FULs) are calculated. After receiving feedback from the American Pharmacists Association, the National Association of Chain Drug Stores and the NCPA, the Committee removed this as an offset. Other ideas discussed but not included in legislation were allowing the government to negotiate Part D drug prices and addressing generic drug inflation. 

The 21st Century Cures legislation “lock-in” provisions may evolve further, as H.R. 6 has been referred to the House Ways and Means Committee, which shares jurisdiction over health issues and which has worked on “lock-in” pharmacy provisions earlier this year. Chairman Upton anticipates that the full House will vote on H.R. 6 in June. The Senate has been working on a related but separate “Innovation” effort which is expected to be a much smaller scale effort. It is unclear whether “lock-in” provisions will be considered as a part of legislation the Senate develops. 

Congress urging one year period to implement final FULs

Bipartisan members of the House and Senate are again urging CMS to allow states one year to fully implement the recalculation of the Medicaid FUL for prescription medications, as required by the Affordable Care Act. CMS has not yet released a final rule on Medicaid reimbursement for outpatient drugs and for the final FUL amounts last year, although it had planned to release the rule last year. Letters led by Senators Johnny Isakson (R-GA) and Mark Warner (D-VA) , as well as by Representatives Chris Collins (R-NY) and Dave Loebsack (D-IA), were sent to CMS in April, requesting an additional year compliance period, given that CMS’ final regulation was still under development. The Senate letter in particular asked CMS to “engage with retail community pharmacies and other stakeholders so that enrollees’ access to the medications that they need may not be disrupted.” The National Community Pharmacists Association and the National Association of Chain Drug Stores support the bipartisan effort to ensure a one year implementation period. 

Generic drug pricing

Senator Bernard Sanders (D-VT) and Representative Elijah Cummings (D-MD), who launched an investigation last year into generic drug pricing, requested that the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) investigate the recent increase in price of generic drugs within the Medicare and Medicaid programs. In an April response to lawmakers, IG Dan Levinson reported that his office will update the  2007 OIG review of generic drug price increases in the Medicaid drug rebate program by reviewing quarterly average manufacturer prices (AMPs) between 2005 and 2014 to determine the extent to which generic drug prices exceeded the inflation rate. IG Levinson indicated that there were no current plans to examine the effect of generic drug price increases on the Medicare program but promised his staff will continue to analyze whether it could perform such a review. IG Levinson also assured lawmakers his office would keep them informed as to the status of the analysis.

On May 18, Senator Sanders and Representative Cummings introduced the Medicaid Generic Drug Price Fairness Act (S. 1364/H.R. 2391) to require the payment of an additional rebate to the State Medicaid plan in the case of an increase in the price of a generic drug at a rate greater than the rate of inflation. The bills have only garnered Democratic cosponsors and have yet to draw Republican support, which will limit the bills’ chances for advancement in a Republican-controlled Congress.

CMS to require Part D plans to disclose access to preferred pharmacies

On April 6, CMS issued the 2016 Medicare Advantage and Part D Payment Policies and Final Call Letter, which outlines policy changes mandated for the 2016 contract year. For next year, Part D plans will be required to disclose that their networks offer limited access to preferred pharmacies with lower cost sharing. CMS will publish information on access levels for each plan offering preferred pharmacy networks, based upon plans’ analysis of preferred pharmacies as submitted in their Medicare Plan Finder files. Additionally, Part D plans whose access to preferred pharmacies ranked in the lowest 10th percentile as compared with all Part D plans will be required to disclose in their marketing materials for 2016 that their particular plan offers less access. CMS anticipates that Plans will evaluate their 2015 and 2016 networks to determine whether they are below this threshold, and if they fall within the bottom 10 percent in term of access, they will be required to make such disclosures public. To ensure beneficiaries have access to affordable coverage, CMS will work with plan sponsors that offer limited access to preferred cost sharing pharmacies in their networks. 

CMS is requiring greater disclosure in the wake of the $1 million civil monetary penalty imposed in April on Aetna for inaccurately representing which pharmacies were “in-network” in their 2015 marketing materials. 

The CMS Call Letter process draws comments from industry stakeholders before a final policy is announced. The NCPA is pleased that CMS included a number of provisions in its final Call Letter to provide additional clarity to Part D beneficiaries about plan offerings and representations regarding access to preferred cost sharing pharmacies. 

House approves bill to combat drug abuse

On April 21, by voice vote, the House passed H.R. 471, the Ensuring Patient Access and Effective Drug Enforcement Act. The legislation proposes to create a more transparent process to address the diversion of controlled substances and promotes a more collaborative working relationship between industry stakeholders and regulators, to fight the abuse and diversion of prescription drugs. H.R. 471 has been sent over to the Senate, where companion legislation, S. 483, introduced by Senators Orrin Hatch (R-UT) and Sheldon Whitehouse (D-RI) is pending. S. 483 has been referred to the Senate Judiciary Committee, which is currently grappling with the large scale issues of patent reform and sentencing guideline reform, and advocates are working to position S. 483 as the next legislative item up for committee consideration, potentially within this calendar year.

Reimportation

The prescription drug reimportation issue is one that will continue to surface again in this Congress, but remains unlikely to become law. While stand alone bills – such as H.R. 2228, the Safe and Affordable Drugs from Canada Act of 2015 sponsored by Representative Chellie Pingree (D-ME) – will be introduced and will draw bipartisan support, the greatest potential reimportation has to be enacted as a policy is if it is adopted as an amendment to a broader piece of legislation. 

For instance, in May during Senate consideration of legislation to allow the President of the United States to “fast track,” or submit trade legislation creating a Trans Pacific Partnership (TPP) for an up-or-down vote, Senator Bernard Sanders (D-VT) repeatedly announced that he planned to introduce an amendment to allow the United States “to import FDA-inspected prescription drugs from around the world.” That amendment was ultimately not considered in the “fast track” legislative debate, but it may well be proposed on another bill, particularly one before the Senate. 

Advocates for community pharmacists, distributors and pharmaceutical manufacturers are watching congressional activity on reimportation very closely and are poised and coordinated to act should any such legislation or amendments surface. 

HRSA 340B guidelines pending

The Health Resources and Services Administration (HRSA) expects to publish the 340B Drug Pricing Program’s omnibus proposed guidelines, which are now pending review by the White House Office of Management and Budget (OMB). Once the OMB review is completed, the guidelines will be published in the Federal Register, with a 60-day comment period. In November of last year, HRSA withdrew a proposed regulation that had progressed to the OMB review stage. 

HRSA also announced plans to launch a system to verify the accuracy of drug manufacturers’ 340B ceiling prices, and to collect drug manufacturers’ price setting data. Specifically, HRSA proposes to collect Average Manufacturer Price, unit rebate amount, package sizes, National Drug Code, period of sale and manufacturer-determined 340B ceiling prices. The Pharmaceutical Research and Manufacturers of America (PhRMA) notes that “HRSA’s data collection initiative is premature” as HRSA has not yet developed a process for calculating 340B ceiling prices.