Bipartisan Support for Addressing Pharmacy DIR Fees

A bipartisan letter led by Reps. Buddy Carter (R-Ga.), Peter Welch (D-Vt.), Raja Krishnamoorthi (D-Ill.), John Rose (R-Tenn.), Vicente Gonzales (D-Texas), and Doug Collins (R-Ga.) is closing today with 114 signatories at last count, the most signatures of any Congressional sign on letter on this issue. The letter addressed to House and Senate leadership urges inclusion of pharmacy DIR reform in the next CoVID-19 relief package. Thank you to all those who took grassroots action. In total, more than 3,200 messages were sent to 405 House offices. A final version of the letter will be available Monday, and we expect a Senate letter to begin circulating early next week.

President Trump Signs Paycheck Protection Program
and Health Care Enhancement Act

President Trump signed the Paycheck Protection Program and Health Care Enhancement Act today that NCPA successfully advocated for along with a coalition of small business organizations, which provides an additional $310 billion for the Paycheck Protection Program, $50 billion for the Disaster Loans Program Account, $75 billion for reimbursements to healthcare providers to support COVID-19 related expenses and lost revenue, and $25 billion for necessary expenses related to COVID-19 tests. If you have not yet applied, it’s important that you submit your application immediately. You can click here for the loan application. For NCPA’s summary of the bill click here.

Survey: 'Essential' Pharmacies Seek CARES Act Aid

Nearly 90 percent of community pharmacy owners say they'll apply for small business federal aid under the CARES Act to help them get through the coronavirus pandemic, according to a survey released this week by NCPA. Nearly half of pharmacy owners rank the overall financial health of their business as somewhat poor or very poor, according to the survey.

CMS Updates COVID-19 Guidance
to Medicare Advantage and Part D Plans

This week, CMS released a guidance document to Medicare Advantage organizations, Part D sponsors, and Medicare-Medicaid plans updating previously released information from March 10. The guidance includes several relevant provisions for community and long-term care pharmacies, including:

• Coverage of testing and testing-related services for COVID-19
• Relaxed enforcement of signature log and prior authorization requirements
• Suspension of plan-coordinated pharmacy audits
• Requirement for Part D sponsors to permit 90-day fills, refills, or transition fills
• Relaxation of short-cycle fill requirements for LTC patients.

NCPA successfully advocated that CMS temporarily waive Part D medication delivery documentation and signature log requirements during the public health emergency and adopt a temporary policy suspending plan-coordinated pharmacy audits. NCPA also successfully advocated for community and LTC pharmacies regarding relaxing prior authorization, point-of-sale edits, and short-cycle dispensing requirements. For more information, see NCPA’s member summary.

Hoey: Empower Pharmacists to Practice
to the Top of their License

In a column posted this week on the Fox Business website, NCPA CEO Douglas Hoey made the case for the role pharmacists can play in ending the COVID pandemic. "The only thing community pharmacists ask of state and federal officials throughout it all is to be unleashed to help this nation in crisis," Hoey writes. "Because now more than ever, pharmacists are here to serve."

Important CARES Act Updates

The April 2 webinar, How the CARES Act Can Help Improve Cash Flow and How to Act on it, was a big hit, full of helpful information for pharmacy owners. NCPA's Kurt Proctor has recorded an update to the webinar with accountants Ollin and Scotty Sykes with the important new information on the small business loan program and more. If you weren't able to get SBA funding in the first round, you'll want to listen. Access the update here. Here are some other funding suggestions.

HHS Begins Distributing Remaining
Provider Relief Fund General Allocation

Beginning on April 24, HHS will begin distributing the remaining $20 billion of the Provider Relief Fund general allocation to Medicare facilities and providers impacted by COVID-19 based on eligible providers’ 2018 net patient revenue. Read the NCPA summary of details regarding eligibility, payment distribution determination, and more.

HHS Broadly Interprets PREP Act Immunity

The Department of Health and Human Services (HHS) issued an advisory opinion to expand on the scope of the Public Readiness and Emergency Preparedness (PREP) Act, which protects licensed pharmacists from products liability suits related to the use of certain products. This new document supplements the earlier advisory opinion HHS issued specific to PREP Act immunity for licensed pharmacists who order and administer COVID-19 serology tests.

Bipartisan Policy Center Report Encourages
Utilization of Non-Physician Providers

The Bipartisan Policy Center Rural Health Task Force released a report on April 21 that addresses the ongoing COVID-19 crisis in rural communities. Relevant recommendations to community pharmacy include improving utilization of the currently available workforce, expanding reimbursement to additional types of providers, and removing regulatory and legislative barriers that prevent non-physician providers from practicing at the top of their license.

FDA Clarifies Pharmacist COVID-19 Testing Capabilities

This week NCPA participated on a call with officials from the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) and pharmacy organizations regarding COVID-19 testing and actions that would enable pharmacists to fully and effectively support the nation’s COVID-19 response. FDA officials clarified that if they say a test is for use at the point of care, that pharmacies are included and the test can be used in pharmacies. The most important thing is FDA has to authorize tests for tests to be CLIA waived and therefore authorized for use at point of care (and therefore can be used in pharmacies). Pharmacists should start by checking the list of test kit manufacturers with an FDA emergency use authorization. There must be a "W" in the column titled "Authorized Settings" for any test to be performed in a CLIA-waived laboratory, including pharmacies who have obtained their CLIA certificate of waiver.

Court Allows Enforcement of Oklahoma PBM Law

The federal court in Oklahoma granted the state’s request to allow for the implementation of the state’s PBM law. However, PCMA may file an opposition, in which case, the state’s law cannot be implemented while the matter is proceeding. NCPA is monitoring the docket and will provide updates as more information becomes available.

NCPA Win: FDA Issues Temporary Guidance
for 503A Compounding

In a letter to the Food and Drug Administration (FDA), NCPA, the Alliance for Pharmacy Compounding, and the American Pharmacists Association asked FDA to immediately issue guidance providing enforcement discretion for pharmacists to compound products that are “essentially a copy” of an FDA-approved drug that FDA identifies may be or is anticipated to be, in shortage during this public health emergency. On Monday, FDA released guidance consistent with our ask, stating it does not intend to take action against a 503A pharmacy for compounding a drug that is essentially a copy of a commercially available drug, or providing a drug to a hospital without obtaining a patient-specific prescription, if certain circumstances are met. Among some of the requirements: the compounded drug product appears on the guidance’s list in Appendix A (sterile drugs), the hospital is treating patients with COVID-19 and unable to obtain the drug product, and the compounding pharmacy must seek approval from its state board of pharmacy. The guidance also provides information on beyond-use dates that must follow Appendix B of the guidance. NCPA encourages 503A compounding pharmacies to closely adhere to these guidelines and ensure patient access and safety when compounding the drugs listed in this guidance during the COVID-19 public health emergency.

NCPA Joins LTC pharmacy Groups in Asking FDA
to Revisit Labeling for Insulin Pens

NCPA joined the American Society of Consultant Pharmacists and the Senior Care Pharmacy Coalition in a letter to the Food and Drug Administration (FDA) raising concern with FDA’s recently revised labeling requirements for insulin syringes. Specifically, we brought FDA’s attention to the unintended consequences that may result from the FDA’s November 2019 requirement that boxes of insulin pens must be dispensed unopened; such consequences could include medication errors, increase in patient costs, significant drug product waste, and impact on pharmacy operations. NCPA’s LTC Division will continue working with industry stakeholders to ensure FDA is aware of these risks with its labeling requirements for insulin syringes.

Missouri Expedites CLIA-Waiver Applications

According to the Missouri Board of Pharmacy, pharmacies are allowed to order and administer COVID-19 CLIA-waived tests authorized by the Food and Drug Administration (FDA) under an emergency use authorization. Along with allowing testing by pharmacies, the Missouri Department of Health is currently expediting CLIA waiver applications. Testing may be performed outside of a licensed pharmacy and may be performed by an intern under pharmacist supervision.

Virginia General Assembly Rejects Proposal
to Weaken PBM Network Adequacy Requirements

The Virginia Senate rejected an amendment to SB 251 that would have weakened PBM provider network adequacy standards that were signed into law earlier in the session. When the amendment was proposed, NCPA sent a call-to-action to members asking them to urge their legislators to oppose the proposal.

NCPA State Legislative Activity Update

NCPA tracks state legislation related to our top three state priorities: Medicaid reform, scope of practice and compensation for services, and PBM reform and regulation. Click each issue for a report of bills that have been introduced so far this session specifically dealing with these three issue areas. You can access the individual bill language and basic information on the bill by clicking on the bill numbers in the attached report. Bills that have moved this week are listed at the top in the “Recently Updated” section.

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