Proposed rule heeds community pharmacy’s call

NCPA and community pharmacies have persistently advocated for increased transparency and a more competitive and comprehensive Part D program, and on Monday, CMS made a step towards making that happen. CMS released a proposed drug pricing rule, and a significant part of the proposal calls for accounting for pharmacy price concessions, also known as pharmacy DIR fees, at the point of sale. Referring to what he – and the proposed rule – called the current "one-sided nature of pharmacy payment arrangements," NCPA CEO Doug Hoey said, "We wholeheartedly support moving pharmacy price concessions to point-of-sale to benefit patients in the form of lower cost shares. Such a move would also eliminate retroactive claw-backs charged by PBMs and allow pharmacies a more accurate accounting of drug costs and reimbursements. We're grateful CMS crafted the proposed rule to reflect NCPA's recommendations, and we plan to advocate aggressively for formal adoption of that measure."

In a blog post on the proposed rule, Health and Human Services Secretary Alex Azar and CMS Administrator Seema Verma said, "Independent pharmacies have raised concerns that back-end deals with health insurance plans are eroding competition and making it harder for them to continue providing medications to beneficiaries." Their statement went on to reference unachievable performance requirements put on pharmacies by PBMs, resulting in "large financial clawbacks from pharmacies and swings in revenues that pharmacies cannot manage," and providing no financial benefit to patients. We're grateful CMS crafted the proposed rule to reflect NCPA's recommendations, and we plan to advocate aggressively for formal adoption of that measure. Here are NCPA's detailed analysis of the proposed rule, a press release lauding the proposed rule, and a joint statement on the proposed rule from NCPA, NACDS, and NASP.

NCOIL to consider model PBM legislation
at upcoming meeting

The National Council of Insurance Legislators committee on Health, Long-Term Care & Health Retirement Issues is expected to consider adoption of a model PBM regulation act at its upcoming meeting Dec. 5-8 in Oklahoma City. NCPA and pharmacy allies have been working vigorously with the committee and offering suggestions on strengthening the model act.

NCPA staff members Anne Cassity and Ronna Hauser will both be in attendance at the NCOIL meeting in Oklahoma City to continue advocating for a strong model bill. In advance of this meeting, it is critical that members of the committee continue to hear from pharmacists in their respective states echoing this call. Help disseminate this sample email to stakeholders and ask them to send to their respective committee members only. A list of committee members can be found here.

32 states, D.C. back Arkansas petition
for Supreme Court review of 2015 PBM law

Thirty-two states and the District of Columbia have joined California in a bipartisan friend-of-the-court brief in support of the state of Arkansas's petition seeking U.S. Supreme Court review of an 8th Circuit decision from earlier this year that held that Arkansas's 2015 law was preempted by ERISA. The Arkansas statute sought to impose common-sense regulations on PBMs that would ensure that Arkansans continue to have fair access to their prescription drug benefits and would bring more transparency to the PBM industry. Signing onto the brief are Colorado, Connecticut, Delaware, Georgia, Hawaii, Idaho, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Minnesota, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Texas, Utah, Vermont, Virginia, Washington, Wyoming, and the District of Columbia.

NCPA worked with many of these states to encourage their support of the petition.

Congressional leadership takes shape following midterms

This week, House Democrats held their leadership elections for the 116th Congress. As expected, Rep. Nancy Pelosi (D-Calif.) won the caucus’ nomination for Speaker while Rep. Steny Hoyer (D-Md.) was elected Majority Leader and Rep. James Clyburn (D-S.C.) was elected Majority Whip. With these elections, the leadership for both the House and Senate has taken shape. Click here for a complete leadership list for the next Congress for both houses.

Pharmacy champion Rep. Doug Collins
elected House Judiciary Committee Ranking Member

Rep. Doug Collins (R-Ga.) edged out Steve Chabot (R-Ohio) to become the ranking member of the House Judiciary Committee. Collins, a community pharmacy champion who currently serves as vice chairman of the House Republican Conference, will play a key role in defending President Trump as Democrats take back the majority in the House next year. The committee, which would handle impeachment proceedings and many other investigations into the administration, will be in the spotlight, but the committee also has broad jurisdiction over important hot button issues such as abortion, civil rights, immigration, and gun control, as well as mergers and antitrust law. NCPA congratulates Rep. Collins on his new leadership position and looks forward to working with him next year.

In floor speech, Sen. Grassley signals intent
to investigate mergers of PBMs and health insurers

On Thursday, Sen. Chuck Grassley (R-Iowa), the incoming Finance Committee Chairman, took to the Senate floor to outline his commitment to taking on the cost of medicines next Congress. Grassley, a longtime community pharmacy champion, touched on ideas he's long pushed, such as drug importation and cracking down on "pay for delay" patent settlements, in which a brand drug company pays a generic maker to stay off the market for a period of time. Grassley, who has a bipartisan track record on drug pricing issues, welcomed collaboration with House Democrats. Most importantly, Grassley detailed plans he has to perform oversight and keep tabs on recent mergers in the pharmaceutical supply chain that unite pharmacy benefits managers and insurers, including Cigna's merger with Express Scripts and CVS-Aetna. NCPA led a letter with state pharmacy associations earlier this year detailing harmful PBM practices and urging Senator Grassley to call an oversight hearing of these mergers.

NCPA joins call for further delay of health insurance tax

On Thursday, NCPA joined with 20 other members of the Stop the HIT coalition to send a letter to House and Senate leadership urging for an extension of a moratorium on the Affordable Care Act’s health insurance tax during Congress’s lame duck session. The tax on health insurance, which has been delayed several times by Congress, is set to return in 2020. Without another delay or repeal, insurers would need to incorporate the tax into premiums, which would drive up rates for Medicare Advantage, small group and individual market plans. Additionally, Sens. John Barrasso (R-Wyo.), Jeanne Shaheen (D-N.H.), Cory Gardner (R-Colo.) and Doug Jones (D-Ala.) sent a letter to leadership requesting action on the moratorium as the tax and associated premium increase would be harmful to small businesses and seniors.

NCPA meets with Pennsylvania Auditor General

This week, NCPA met with Pennsylvania Auditor General Eugene DesPasquale to discuss his ongoing review/investigation of PBM transparency and accountability in the Pennsylvania Medicaid program. Last summer, DesPasquale launched a series of town hall meetings after the Pa. Department of Human Services reported that it paid pharmacy benefit managers $3.4 billion in the state Medicaid program last year, almost double the $1.8 billion paid in 2013. NCPA offered recommendations on how to address the lack of transparency in the Medicaid program in a way that makes PBMs accountable to the taxpayer and the program. The Auditor General’s report with recommendations to the state will be released in mid-December.

States win pharmacy concessions from CVS-Aetna

This week, the Georgia Pharmacy Association and its partners won substantive pharmacy concessions as a result of their opposition to the CVS/Aetna merger in that state. They lobbied the state insurance commissioner to protect patients from restrictions on access to care that would result from the merger. In response, the insurance commissioner demanded several patient and pharmacy protections before approving the merger – which CVS agreed to – including:

• CVS/Aetna must invite non-CVS health care providers (pharmacies, physicians, clinics, etc.) to join its networks, and must set the same criteria for all those providers.
• CVS/Aetna must allow Georgia patients to use any health care provider – in or out of network – if that provider accepts the same conditions as those within the network.
• CVS/Aetna cannot require patients to use CVS-owned pharmacies, period – not for regular prescriptions, refills, or specialty drugs. These concessions reduce the chance that a combined CVS/Aetna can limit patients' choice of health care providers. (As a pharmacy benefits manager, CVS Health already requires patients on some plans to get their specialty medications from CVS pharmacies. This practice will no longer be allowed in Georgia.)
• CVS/Aetna must disclose the amount of rebates it receives from drug makers and how much of those it passed on to insurers.

In New York, thanks to the efforts of the Pharmacists Society of the State of New York, regulators set conditions on the merger, including enhanced consumer and health insurance rate protections, privacy controls, cybersecurity compliance, and a $40 million commitment to support health insurance education, enrollment, and other consumer health protections. Of particular interest to community pharmacy: Regulators required that participating provider networks for insured products will maintain access to non-chain New York pharmacies for three years.

In California, regulators approved the merger only if CVS and Aetna agreed to keep premium increases "to a minimum."

The victories in Georgia and New York, in particular, set a precedent for other states proposing similar reforms via legislation. CVS can no longer say they've never agreed to such concessions.

***Note- the provisions won by the states apply only to pharmacies in those respective states

NCPA provides insight to FDA on human-readable
product identifier for supply chain security

This week was a big week for upstream trading partners and the Drug Supply Chain Security Act (DSCSA or the “track and trace” law). As of as Nov. 27, 2018, manufacturers are now required to begin including a product identifier on prescription drug packages and cases (product identifiers must be in electronic and human-readable format). The FDA released draft guidance on this requirement, which included a number of clarifications on the form of human-readable product identifiers on product. Last week, NCPA provided comments to the FDA on the draft guidance, highlighting the importance of standardization of the product identifier as a critical component to efficient workflow in a community pharmacy. Further, NCPA applauded FDA’s recognition that the NDC must be provided on packages and that the human-readable NDC may not be substituted for a GTIN (a global identification number recognized by other trading partners). NCPA continues to monitor the implementation of the DSCSA as additional dispenser requirements under the law quickly approach. Of note, starting on Nov. 27, 2020, dispensers must only accept a product that is affixed or imprinted with a product identifier.

NCPA Submits Comments on USP <797> Revisions

Today, NCPA submitted comments to USP on its revisions to General Chapter <797> Pharmaceutical Compounding – Sterile Preparations, which modified classifications of compounded sterile preparations and Beyond Use Dates (BUDs). These revisions amended simplified compounded sterile preparation (CSP) microbial risk levels from three (low, medium, and high) to two (Category 1 CSPs and Category 2 CSPs). USP also established shorter maximum BUDs for certain compounded medications. In our comments, NCPA expressed concern that USP provided very few references to scientific studies or other evidence that would support some of the new requirements. We stressed that additionally burdensome revisions in this chapter could make it difficult for independent pharmacies to continue sterile compounding and providing access to its patients.

CMS releases industry guidance
on lock-ins in the Medicare program

Last week CMS released industry guidance on voluntary drug management programs (also known as “lock-ins”) for beneficiaries at risk for misuse or abuse of frequently abused drugs in Medicare Part D. The guidance is meant to supplement lock-in requirements outlined in the 2019 Part D final rule that was released in April. The guidance includes drafts of sample beneficiary notice letters that will be sent to beneficiaries who will be enrolled in a lock-in program. NCPA is currently reviewing the notices and will provide comments to CMS urging that the notices appropriately inform patients of their rights to stay with their local community pharmacy. NCPA remains engaged in the implementation of lock-ins as the programs continue to become more prevalent. As previously noted, lock-ins are currently voluntary in Part D. However, pursuant to Congress’ recently passed opioids package, lock-in programs will be mandatory for all plans beginning on Jan. 1, 2022.

CMS Announces Nursing Home Initiative

CMS recently announced the Civil Monetary Penalty Reinvestment Program (“CMPRP”), which is a three-year initiative to improve nursing home resident care and outcomes by equipping nursing home staff and stakeholders with technical tools and assistance. The program is funded by the federal portion of Civil Monetary Penalties (“CMP”) that nursing homes must pay CMS when they are noncompliant with certain regulations. CMS anticipates partnering with “many organizations” in the CMPRP “due to the breadth of activities this program will engage in.” NCPA will monitor the implementation of this program for its effect on long-term care pharmacy.

NCPA urges the CDC to align vaccination classification
with FDA’s standards

On October 5, 2018, the Food and Drug Administration (FDA) approved to expand the use of the Gardasil 9 (Human Papillomavirus (HPV) 9-valent Vaccine, Recombinant) vaccine to women and men aged 27 through 45 years. This week NCPA sent a letter to the CDC urging the agency’s Advisory Committee on Immunization Practices’ (ACIP) to recommend the HPV vaccine to be included in Category A, which would be in alignment with the FDA’s recent approval for expanded use of the vaccine. NCPA highlighted this move would ensure community pharmacists can provide this critically necessary vaccine and bolster access of the vaccine to individuals in the expanded use age group.

NCPA Policy and Regulatory team provides pharmacists
with a checklist and 2019 outlook

This week NCPA’s policy and regulatory team reviewed via their annual webinar checklist the regulatory and legislative actions that have happened over the past year that impact the pharmacy space, including the recent passage of the gag clause and opioid legislation. NCPA staff also reviewed the recently released Part D proposed rule on drug price transparency, which includes a proposal to change the application of pharmacy DIR fees. A recording of the webinar is available on the NCPA website. NCPA will be releasing a checklist in the coming days that outlines the information covered in the webinar.

NCPA’s Advocacy Center Update provides a weekly detailed summary of recent and breaking legislative, regulatory, and state developments impacting independent community pharmacy and NCPA’s efforts to affect policies benefitting its membership and the industry. The weekly update is distributed to NCPA leadership, steering committees, allied organizations/stakeholders and major contributors to the NCPA LDF and PAC.