Provider Relief Fund Deadline is Today
The deadline to apply for the Provider Relief Fund Phase 3 General Distribution is today, Friday November 6, 2020. Pharmacists are eligible to apply for the Provider Relief Fund, although please note that prescription drug sales and the sale of durable medical equipment should be excluded from the data submitted as part of revenue and operating expenses from patient care when applying. Information on how to apply can be found through the HHS Provider Relief Fund portal, and additional information can be found in the FAQ section or in NCPA’s summary. Please be sure to consult with your tax advisor and/or accountant before accepting a Provider Relief Fund payment.
NCPA Comments to CMS on COVID-19 Final Rule
NCPA submitted comments to the Centers for Medicare & Medicaid Services (CMS) in response to the interim final rule released on September 2, 2020 related to policy and regulatory revisions in response to the COVID-19 public health emergency (PHE). NCPA reiterated the need for a direct pathway for pharmacists to bill for specimen collection and other related services for patients, expressed concern regarding new enforcement requirements for long-term care facilities, and urged CMS to reconsider a new limit on the number of COVID-19 and related tests without an order from a physician or other practitioner.
Many Results Still Unknown as Votes Continue to be Counted
Election Day 2020 has passed and the final outcomes still remain uncertain, but you can access NCPA’s full analysis from Wednesday morning here. An exciting development is that Rep. Buddy Carter (R-Ga.) will no longer be the lone pharmacist in Congress as pharmacy owner Diana Harshbarger (R-Tenn.) won her race to be the first woman pharmacist in Congress.
At the presidential level, former Vice President Biden currently holds a narrow lead in the Electoral College, holding narrow leads in Nevada, Pennsylvania and Georgia, while President Trump leads in North Carolina, though results are not final and these states remain uncalled. However, if Biden holds onto the states where he is leading, he will win the presidency.
The makeup of the next Senate currently sits at 48-48, with Republican incumbents Dan Sullivan (R-Alaska) and Thom Tillis (R-N.C.) currently leading in their races, but both remain uncalled. If both incumbents prevail, and with pharmacy champions Shelley Moore Capito (R-W.V.), Joni Ernst (R-Iowa) and Roger Marshall (R-Kan.) winning their respective races, Republicans will have 50 seats to the Democrats 48. However, control of the Senate will not be known until Jan. 5 as it is likely both Georgia Senate races are headed to a runoff. In the first seat, Sen. David Perdue (R-Ga.) holds a lead, but is just shy of the 50% threshold required to avoid a runoff, and will face Democrat Jon Ossoff. In the second race, which is a special election, Sen. Kelly Loeffler advanced to the runoff and will face Democrat Raphael Warnock, as they were the top two vote getters in the 20 person race, which included pharmacy champion Rep. Doug Collins (R-Ga.). If Democrats were to prevail in both runoffs, the Senate would be 50-50 and the Vice President, either Vice President Pence (R) or Sen. Kamala Harris (D), would provide the 51st vote for their party.
In the House, Democrats will retain control. Pharmacy champions elected or reelected include pharmacy owner Jerry Carl (R-Ala.) newly elected Matt Rosendale (R-Mont.), and Reps. Morgan Griffith (R-Va.), Jaime Herrera Beutler (R-Wash.), Cathy McMorris Rodgers (R-Wash.), Vicente Gonzalez (D-Texas), Peter Welch (D-Vt.), and Austin Scott (R-Ga.).
NCPA will continue to keep you updated on developments as the impact of the results are more fully known.
How Do Manufacturer Actions on 340B Impact You?
As you may know, some pharmaceutical manufacturers have recently decided to restrict 340B drug shipments to contract pharmacies or require certain prescription data to be shared with them.
To better understand how this development may be affecting NCPA members, we would like you to please complete the following survey. It will only take a few minutes, and your answers will help inform our advocacy and education programs. The survey closes COB on November 10th.
FDA Releases Final Guidance
on Insanitary Conditions for Compounders
Under Sections 503A and 503B of the Food, Drug, and Cosmetic Act, compounders are exempted of compliance with certain provisions of the Act – however, any drugs produced in insanitary conditions are deemed to be adulterated under Section 501(a)(2)(A) regardless of any other application of the law.
In response to recent outbreaks and contaminated products, the FDA released this guidance for both 503A and 503B compounders – which does not have the force of law but serves as a basis for compliance and the FDA is encouraging further state regulatory action.
The FDA describes a non-exhaustive list of potentially contaminating practices and procedures which could result in insanitary conditions during drug production. Lastly, the FDA states corrective action might be taken for production of drugs in insanitary conditions including seizure of product and injunction. Additionally, states may pursue regulatory action under their authorities.
NCPA Responds to California Attempt
to Restrict Animal Compounding
In a letter to the California Board of Pharmacy, NCPA raised concerns with the board’s interpretation and application of federal law. The board has issued correction letters against pharmacies that compound animal drugs from bulk substances, but the federal law makes no reference to bulk drug substances. NCPA also believes that these actions could result in potential patient harm and impede patient access. NCPA will continue to monitor the board’s actions and advocate for patient access and safety.
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.