Public Affairs

Board Regulatory of

New Board Member Sherill Whisenand was appointed by Governor Reynolds and began serving on the Board May 1, 2020. Her current term will end April 30, 2023. She is the Project Director for the Iowa Secretary of State and has previously served three terms on the Board of Behavioral Sciences.

Board of Pharmacy Legislation The Board discussed the outcome of several pieces of legislation introduced by the Board. This included the Board’s PMP bill to require schedule V controlled substances, including when dispensed by a pharmacist without a prescription, to be reported to the PMP. This bill passed both chambers and was recently signed by the Governor.

The Board also discussed their recommended changes to the Practice Act, which included establishing broad statutory authority for collaborative practice in Iowa, allowing for prescription adaptation, expanding Iowa’s emergency dispensing laws, and changes to telepharmacy staffing requirements. Unfortunately, these did not pass following the suspension of the legislative session in March.

Phar macy Update

Discussion on Board Guidance Pertaining to COVID-19 The Board discussed conditions which should be met by a graduate pharmacist intern prior to the issuance of an emergency pharmacist license and directed staff to provide detailed guidance. Related to continuing education requirements, the Board determined that there appeared to be no reason to delay or reduce the required hours and would be willing to consider individual waiver petitions if there are pharmacists who are unable to timely complete CE requirements due to COVID-19.

Vote of Adoption on New Regulations Controlled Substance Registration The Board adopted an amendment to Chapter 10, “Controlled Substances,” of Iowa Administrative Code, that clarifies the Board’s expectation that an individual Controlled Substances Act registrant cancels their registration when the registration is no longer needed (such as when discontinuing practice in Iowa) and, when having done so, is allowed to later renew when the registrant returns to practice in Iowa or wishes to again engage in activities which require a registration for the standard renewal fee. ■

Tune-in to IPA’s BOP: What, Why & How podcast following each Iowa Board of Pharmacy meeting to recap the board’s actions and earn pharmacy law CE. More information at www.iarx.org/BOP_Podcast.

MOC Update Throughout the months of April, May and June, pharmacy billing exceptions related to COVID-19 continued to be in place for Medicaid Fee-for-Service and Managed Care patients. The changes and exceptions include: early prescription refills and up to ninety-day-supply allowances, addition of short acting beta agonist inhalers to the preferred drug list due to intermittent drug shortages, suspension of current and delay in start of new pharmacy audits by PBMs, waiver of patient signature requirements on delivered and picked-up prescriptions, and waiver of the $1.00 patient copays. In addition, the deadline for pharmacies to complete the cost of dispensing survey was extended to April 30, 2020. On June 1, 2020, Iowa Medicaid announced changes to existing prior authorization criteria for hepatitis C treatments that would take effect July 1. Patients no longer have to have advanced liver disease corresponding to a Metavir score of 2 or greater fibrosis in order to qualify for hepatitis C treatments. For regimens containing sofosbuvir, renal impairment with a creatinine clearance <30 mL/min or end stage renal disease, are also no longer an exclusion for patients obtaining a prior authorization.

Iowa AG Joins Lawsuit Alleging Generic Drug Price Fixing Attorney General Tom Miller joined a coalition of 51 attorney generals filing the third lawsuit stemming from an antitrust investigation into a widespread conspiracy by generic drug manufacturers to artificially inflate and manipulate prices, reduce competition, and unreasonably restrain trade for generic drugs sold across the United States. Between 2007 and 2014, three generic drug manufacturers, Taro, Perrigo, and Fougera (now Sandoz) sold nearly two-thirds of all generic topical products dispensed in the United States. The multistate investigation has uncovered comprehensive evidence of unlawful agreements to minimize competition and raise prices on dozens of topical products.

IPA Legislative Advisory Committee Post-Session Meeting The IPA Legislative Advisory Committee met virtually on July 8 to recap the 2020 legislative session and prepare for the year ahead. This was the second year of a post-session meeting, which has allowed for immediate discussion of what has transpired in the legislative session. This also provides IPA’s lobbying team with a clear sense of direction on IPA’s legislative priorities as they meet with legislators over the summer months. Included on the agenda for the meeting was discussion on re-introducing legislation to expand pharmacist immunization authority, pharmacist test and treat authority, updating Iowa’s collaborative practice laws, and continuing the fight against PBMs. The Committee will still meet in the fall to adopt IPA’s official legislative priorities for the 2021 legislative session.

Federal Update Since the extent of the COVID-19 pandemic became apparent, IPA has worked diligently to encourage Iowa’s congressional delegation to help position pharmacists to adequately respond and serve patients during this emergency. In March, IPA held a virtual meeting with Congresswoman Cindy Axne and her staff to share pharmacy’s perspective and encourage inclusion of pharmacists in federal legislation. IPA also sent official requests for support from Iowa’s congressional members as signatories on a letter to congressional leadership requesting DIR relief be included in next COVID-19 relief package. All of Iowa’s House Members signed on to the letter to include language permanently prohibiting pharmacy direct and indirect remuneration clawbacks by pharmacy benefit managers.

In May, Senator Joni Ernst visited Rex Pharmacy in Atlantic to discuss specific challenges faced by pharmacy during the COVID-19 pandemic. Also in May, IPA joined ASHP and 24 other state affiliates in a letter to Congressional leaders requesting an increase in federal funding for Medicaid in response to COVID-19.

CARES Act IPA has also worked closely with our national partners to lobby Senator Grassley and the Senate Finance Committee for inclusion of provider status and direct and indirect renumeration (DIR) fee relief in one of the COVID-19 relief packages. While these provisions were not included in the CARES act, there is optimism that they will find a place in the next round of COVID-19 legislation expected in August. The CARES act did include several wins for pharmacy though, including new drug shortages protection, telehealth changes, and COVID-19 diagnostic testing and immunization coverage.

2020 Legislative Recap

Casey Ficek | IPA’s Director of Public Affairs

Impact for Pharmacists The 2020 Legislative Session and final year of the 88th General Assembly concluded in mid-June after nearly a three-month suspension due to COVID-19. These unique circumstances presented many challenges in resuming a normal schedule and resulted in many policy priorities being put on hold. However, IPA was still able to help secure several propharmacy policies while ensuring detrimental bills did not reach the Governor’s office.

Victories

Medicaid Reimbursement IPA was again successful in ensuring Iowa Medicaid continues reimbursing pharmacies in accordance with a sustainable and transparent methodology. The Health and Human Services budget passed for FY 2021 includes language that will require pharmacies to be reimbursed for products according to average acquisition cost, plus a dispensing fee based on a biannual survey.

COVID-19 Liability Protection Senate File 2338, the COVID-19 Response and Backto-Business Limited Liability Act, would prohibit individuals from filing a civil lawsuit against a business or health care organization unless it relates to a minimum medical condition (a diagnosis of COVID-19 that requires inpatient hospitalization or results in death). The provisions, which will be retroactive to Jan. 1, also shield health care providers from liability for civil damages stemming from a health care provider’s acts or omissions while providing or arranging health care in support of the state’s response to COVID-19.

Defended Against Harmful Legislation Again in 2020, legislation was introduced that would restrict pharmacies from receiving more than one dispensing fee a month for the same drug. This would have disincentivized practices utilized to increase adherence, such as medication synchronization

Session

and partial fills. With the end of the 88th General Assembly, this legislation is now ineligible for further consideration.

Medical Cannabis/CBD Two pieces of legislation related to CBD and medical cannabis also passed during the 2020 session that will affect pharmacists in Iowa. Legislation updating Iowa’s medical cannabis program will now require dispensaries to employ a pharmacist or pharmacy technician, ensuring patients have access to a medication expert. Additionally, legislation passed that will create a legal pathway for pharmacies interested in selling approved over-the-counter CBD products.

Where Work Remains…

While these pieces are all positive, much work remains to ensure Iowa pharmacists can practice at the top of their license. Expanding pharmacists’ ability to immunize, test and treat, and reign in PBM practices to ensure the viability of pharmacies are more essential than ever before. While it is unfortunate the session was abruptly suspended with all our priorities still alive and gaining momentum, we plan to continue advocating for pro-pharmacy policies immediately.

The road to a successful 2021 Legislative Session starts right now. Here’s how to help: Hosting a legislator at your practice site, sitting down for a meeting to discuss pharmacy, or donating to the Iowa Pharmacy Political Action Committee are essential components to passing meaningful legislation next year. Additionally, if you are interested in the political process and pharmacy advocacy, consider signing up for IPA’s Champion Advocate program.

Please contact IPA’s Director of Public Affairs Casey Ficek at cficek@iarx.org to learn more about how you can get involved in IPA’s advocacy efforts this year. ■