Submitted by Thomas Buckley, RPh, MPH, CSHP Legislative Chair
The impact of the COVID-19 pandemic continues to affect healthcare and virtually every aspect of our lives.
At the time of this writing, the Connecticut General Assembly may be going back into a special session sometime this summer, although it is unclear what type of legislation may be deliberated. There have been multiple considerations of how pharmacy could be impacted and play a more expanded more role during the pandemic, with potential implications of a lasting impact after the pandemic period. The Governor’s office and the various health agencies have been contacted by numerous entities within and outside of the state, with potential pharmacy public health roles at both the local and state level. ASHP has created a document with a sample list of these roles that can be accessed here.
On April 8, 2020 the U.S. Department of Health and Human Services released a guidance that licensed pharmacists are authorized to order and administer FDA-approved COVID-19 tests, including serology tests. The guidance adds pharmacists as “covered persons” under the Public Readiness and Emergency Preparedness (PREP) Act, and frees them from liability “with respect to all claims for loss caused by, arising out of, relating to, or resulting from, the administration or use of FDA-authorized COVID-19 tests.” The guidance, issued by the Office of the Assistant Secretary for Health (OASH), states that pharmacists, “in partnership with other health care providers, are well-positioned to aid COVID-19 testing expansion.” OASH, which has jurisdiction to categorize professionals as “covered persons” under the PREP Act, highlights pharmacists’ established and trusting relationships with patients, connection to and ability to make referrals to medical providers and hospitals, and accessibility.
OASH’s April 8 guidance specifies that authority is granted to “licensed pharmacists,” and is therefore not expected to preempt state scope of practice laws. Point-of-care testing for COVID-19 is critical to the national pandemic response. Some states already permitted pharmacists, under their scope of practice or through collaborative practice agreements, to order and administer these tests. Pennsylvania, which previously allowed pharmacists to order and administer tests, has taken emergency measures to grant pharmacists explicit authority to order and administer COVID-19 tests. States like Florida, Illinois, Kentucky, and, most recently New York, issued executive orders that permit pharmacists to order and administer COVID-19 tests.
Just as this newsletter was going to press, the Connecticut Governor announced this Executive Order: Pharmacists are Permitted to Order and Administer Food and Drug Administration Approved Tests for COVID-19. It specifically that “pharmacists licensed pursuant to Chapter 400j of the Connecticut General Statutes are expressly permitted to order COVID-19 diagnostic tests consistent with Clinical Laboratory Improvement Amendments (CLIA), including serology tests that do not require venipuncture, that the Food and Drug Administration (FDA) has authorized.” Here is a link to the actual Executive Order: https://portal.ct.gov/-/media/Office-of-the-Governor/Executive-Orders/Lamont-Executive-Orders/Executive-Order-No-7KK.pdf?la=en
State-level COVID-19 response is a rapidly changing situation as local healthcare providers respond to patient surges and the demand for testing, so we will try to keep you informed with as much up-to-date information as possible. ASHP also provides an excellent COVID-19 resource center, which includes an “Assessment of Evidence for COVID-19-Related Treatments”, the updated 5/4/2020 version can be found here.
We are excited to have an active legislative advocacy team of Steph Luon, Cory Heck, and Tom Buckley. Please don’t hesitate to contact us with your questions, concerns, and most importantly with your willingness to reach out to our policymakers when needed.
Wed. April 8, 2020, the HHS issued new guidance under the Public Readiness and Emergency Preparedness Act authorizing licensed pharmacists to order and administer COVID-19 tests that the U.S. Food and Drug Administration has authorized.
HHS Secretary Alex Azar issued the following statement: "Giving pharmacists the authorization to order and administer COVID-19 tests to their patients means easier access to testing for Americans who need it. Pharmacists play a vital role in delivering convenient access to important public health services and information. The Trump Administration is pleased to give pharmacists the chance to play a bigger role in the COVID-19 response, alongside all of America's heroic healthcare workers."
HHS Assistant Secretary for Health Brett P. Giroir, M.D. issued the following statement: "In an effort to expand testing capabilities, we are authorizing licensed pharmacists to order and administer COVID-19 tests to their patients. The accessibility and distribution of retail and independent community-based pharmacies make pharmacists the first point of contact with a healthcare professional for many Americans. This will further expand testing for Americans, particularly our healthcare workers and first responders who are working around the clock to provide care, compassion and safety to others."
Please note per Tom Buckley, CSHP Legislative Chair: This is federal authorization. Connecticut has not yet released anything with regard to procedure, regulation or reimbursement. The Governor announced that CVS will be having 2 drive-through testing sites in CT within a week or so (Stamford and New London). We don't know if pharmacists will be ordering and administering at these sites.
OASH's Guidance for Licensed Pharmacists, COVID-19 Testing, and Immunity under the PREP Act is available here - PDF.
FDA's Emergency Use Authorizations for diagnostic and therapeutic medical devices to diagnose and respond to public health emergencies is available here.
Priorities for testing patients with suspected COVID-19 infection are available here - PDF.
CSHP's Legislative Committee reports that the Dept of Consumer Protection released new modifications to some regulations today. One of them is the change in pharmacist/tech ratios in "Institution outpatient, inpatient and satellite pharmacies". Please see the attached announcement
At the time of this writing, it looks like all remaining public hearings for this session will be canceled; however, written testimony can still be submitted for any bill in a committee that is still actively reviewing bills. This includes the Public Health Committee, and CSHP has been working with that committee to see if our revised language changes for the collaborative practice law could be included in a bill that involves clinical practice changes for other health professionals.
In addition to that advocacy effort, we have been responding to a great deal of legislation that has an impact on our profession. You can find the talking points document that was prepared in collaboration with our Pharmacy Day partners at this link. This has been a particularly active short session for healthcare-related bills, and we have both given our support and opposition to a number of raised bills. These include support of the vaccine religious exemption bill, support of a diabetes bill for the affordability of insulin, and opposition to a drug importation bill.
Finally, we have reached out to our state legislators with potential ways that CSHP and our professionals can assist with the coronavirus crisis. We gave them this document from ASHP that details policy recommendations to state lawmakers how pharmacists can effectively support prevention and response efforts for outbreaks such as the COVID-19. These include actions that relate to our collaborative practice law changes, such as ensuring that pharmacists are authorized under our state pharmacy practice act to order point-of-care testing for infectious diseases, and can initiate time-sensitive therapies, such as antivirals. This also includes ensuring that pharmacists are reimbursed for direct patient care services related to the prevention and treatment of infectious diseases, which could be extremely impactful for future reimbursement advocacy efforts.
The 2020 Connecticut legislative session is a “short” session, meaning it is only active from February 5th to May 6th. During these short, non-budget sessions, it is challenging to introduce new legislation, especially if it incurs any impact to the state budget. The state operates a two-year budget, which is deliberated during the “long” session or odd years. There is opportunity to modify current legislation or even introduce new legislation which would not impact the budget. We are currently discussing potential legislative opportunities to modify and update the current collaborative practice and immunization administration laws, and possibly re-visit tobacco cessation legislation. We, of course, will also be actively monitoring any proposed legislation that affects pharmacy practice. Finally, we are also building the framework to discuss introducing legislation next year focusing on reimbursement for pharmacist services. This will indeed be an exciting time to be involved in transforming your profession. Advocacy begins from the ground up – which means it starts with you!
We look forward to your participation.
Thomas Buckley, CSHP Legislative Chair
Submitted by Thomas Buckley, RPH, MPH; CSHP Legislative Chair
The 2019 Connecticut General Assembly came to a close in early June, and finished with a flurry of bills passed that affects pharmacy practice. In addition to monitoring over 3000 bills introduced in this session, CSHP raised and coordinated the effort for 2 specific bills. Both of these bills had numerous live and written testimony in support of passage from CSHP members, and we can be very proud of our efforts to raise the awareness of pharmacy practice in legislators’ minds.
Our bill to permit pharmacists to prescribe tobacco cessation therapy was raised and received a public hearing, but it ran out of time on the legislative calendar to come to a vote in the public health committee. However, our bill to expand collaborative drug therapy management to include APRNs, in addition to physicians, did pass and will become effective October 1, 2019 (Senate Bill 921). The language to expand collaborative practice was included in the overall APRN bill that affects their scope of practice, as Section 22 of SB 921. The impact of granting APRNs authority to collaborate with pharmacists through protocols will be reflected primarily in ambulatory care clinic settings, where APRNs are having an increasing role in primary care. This bill should result in significantly more protocol-driven medication management by pharmacists in various settings around the state.
Of the many legislators who supported this bill, these legislators should be thanked for their efforts – please make an effort to email or call them to thank them for their support of pharmacy practice:
Senator Mary Abrams: http://www.senatedems.ct.gov/abrams-contact
Rep. Chris Perone: Chris.Perone@cga.ct.gov
Rep. Jonathan Steinberg: Jonathan.Steinberg@cga.ct.gov
Rep. William Petit: https://www.cthousegop.com/Petit/
Rep. Vincent Candelora: https://www.cthousegop.com/Candelora/
Note: The flu vaccine bill to administer to age 12+ did not pass. If you've questions, please contact Tom Buckley. Thomas.email@example.com
submitted by Thomas Buckley, CSHP Legislative Chair
With one month to go in the Connecticut legislative session, there are a number of bills that we are following and are close to being at the end of their journeys. SB 921, the APRN scope of practice bill that includes allowing pharmacists to collaborate with APRNs (in addition to physicians) in the current collaborative practice (CDTM) law, has passed the Senate and is awaiting action in the House. You can help assure this bill is passed by calling or emailing your State House member and urge them to pass it in the House chamber. Here is the link to the legislation, which includes the history of the bill and the bill language. The pharmacist/APRN collaborative practice language in this bill is Section 22. https://www.cga.ct.gov/asp/cgabillstatus/cgabillstatus.asp?selBillType=Bill&which_year=2019&bill_num=921
HB 6543, the bill allowing pharmacists to prescribe tobacco cessation products, received a public hearing in the Public Health Committee. Despite outstanding oral testimony and presence at the hearing by our members, and numerous written testimonies submitted, due to the Public Health Committee’s full agenda, the bill failed to make it out of committee, and we will advocate for prescriptive authority next year.
Two other bills we are following are ready to be voted on in the Senate. SB 94 allows pharmacists to administer influenza vaccine to children ages 12-17, with the consent of their parent or guardian. SB 48 requires brand name drug manufacturers to make available samples to generic drug manufacturers so they can conduct testing required to support an application for generic drug approval.
The effort to legalize recreational marijuana is comprised of multiple bills in various committees. We continue to monitor this activity and its potential impact on current medical marijuana pharmacist dispensaries. As of early May, three legislative committees have passed companion bills that would legalize, regulate and tax cannabis for use in ages 21 and older. There is still a great deal of policy details that needs to be worked on, and it’s unclear if full passage would occur before the end of the regular session. The legislative session ends on June 5, and we will be continually apprised of legislative updates.
CSHP has become a member of Patient Access to Pharmacists’ Care Coalition (PAPCC), a coalition spearheaded by ASHP that is working to obtain nationwide provider status for pharmacists in the Medicare program. For information about PAPCC, go to http://pharmacistscare.org To see who are current members of the coalition (more being added each day), go to http://pharmacistscare.org/about-papcc/
The Connecticut General Assembly has begun with a new Governor, many new Commissioners, and many new legislators and legislative committee chairs. This represents an opportunity for pharmacists to make their voices heard to improve their professional workplace and their ability to serve patients.
CSHP has been working with Fred Knous and Knous Associates as their legislative lobbyist for the past 18 years, assisting us in shepherding new laws, such as collaborative practice authority and immunization administration, and monitoring all proposed bills related to our profession that may affect us in a positive or negative way. Over 3,000 new bills will be proposed this session, with perhaps 300 leading to a new or revised law by the time the legislative session ends in early June. Each week the bill monitoring service Fred provides releases a brief review of current bills of interest in the legislative pipeline (Click to read the first “bill book” for this session).
CSHP, working in collaboration with other interested pharmacy entities in the state such as CPA, will be working on three significant new legislative initiatives this session, in addition to closely monitoring other health care and pharmacy-related bills.
1. We will work toward expanding collaborative practice authority (CDTM) legislation to include APRNs, in addition to physicians, with whom pharmacists can collaborate on protocol-driven prescriptive authority.
2. We have proposed HB 6543, a bill that focuses on a major issue of the public health committee this legislative session, tobacco and e-cigarettes, by advocating for pharmacist prescriptive authority for tobacco cessation treatment. There are currently 8-10 states that have some form of pharmacist prescriptive authority for tobacco cessation treatment, and Connecticut will likely pursue legislation similar to Indiana and Idaho that have created state-wide protocols for pharmacist treatment management. This could result in a practice similar to our current immunization administration law, in which pharmacists provide treatment management per protocol upon patient request of services. Click for a good graphic summary of the pharmacist's role in tobacco cessation.
3. The third area of focus for this session and beyond is pharmacist provider status recognition by Medicaid and commercial payers, thereby opening the door for potential reimbursement of pharmacist services from all payers in Connecticut. This initiative will likely require a coalition of pharmacy entities, such as the professional organizations, pharmacy schools, health-system administrators, and other policymakers that understand the cost-effective impact of pharmacists on patient health care outcomes. A law similar to what was recently passed in Ohio provides a potential roadmap of how this initiative could proceed, enabling pharmacists to be on the same playing field as any other provider rendering a service, creating a direct contractual payer/provider relationship.
All of these issues will require a coordinated, active engagement of our members. Please be receptive to reach out to your legislator, particularly if they are a member of a specific committee that oversees our legislative initiatives. CSHP may contact you to advocate directly to your legislator, or through collective advocacy in events such as Pharmacy Day at the Capitol on March 7th at the Legislative Office Building in Hartford. More information will be forthcoming on this event, and talking point documents will be produced for each active legislative initiative of interest to us. This event will be in collaboration with CPA, so we anticipate a large turnout of pharmacists from throughout the state, both at the evening reception from 4:30 – 7:00 p.m., and for one-on-one meetings with legislators from 9 a.m. to 4 p.m.
Submitted by Thomas Buckley, CSHP Legislative Chair
Advocacy isn’t just about what happens in Washington, D.C. It’s about what you can do close to home as you build relationships with elected officials, policymakers and colleagues. The CSHP Legislative Committee works with the CSHP Board, the CSHP lobbyist and other interested parties around Connecticut to advocate for issues specifically relevant to pharmacy practice. Our lobbyist is Fred Knous, a veteran healthcare lobbyist in Hartford and a former state Senator from Portland, CT. He has tremendous relationships with all legislators and other key policymakers, and is more than willing to help any CSHP member work legislative chair of CSHP, Tom Buckley, was a hospital pharmacist for 18 years, then worked as a medical outcomes researcher with Pfizer, and has been a full-time UConn Pharmacy faculty member for the past 9 years, coordinating their public health curriculum.
CSHP works closely with other pharmacy entities in Connecticut, including CPA, CT-ASCP and other health care entities with interest in legislative or policy initiatives affecting pharmacy practice. CSHP was a leader in developing and passing collaborative drug therapy management (CDTM) legislation, starting with the publication of a White Paper in 1994, through the initial passing of the CDTM bill in 2002, and ultimately the current version of the law in 2012, enabling pharmacists in any practice setting to develop and manage collaborative practice protocols with physicians for any medication or medical condition. CSHP also was very active in immunization administration legislation, allowing pharmacists to provide any immunization on the CDC adult immunization schedule.
CSHP has been continually involved in provider recognition and reimbursement policies for pharmacy practice. This includes working with CT Medicaid and all commercial payers in the state, and with Medicare on the federal level, particularly with the current bill in Congress. Becoming a “provider” in the Social Security Act means that pharmacists can participate in Part B of the Medicare program and bill Medicare for services that are allowed under their state scope of practice. The Pharmacy and Medically Underserved Areas Enhancement Act (H.R. 592/ S. 109) is bipartisan legislation that will amend section 1861 (s) (2) of the Social Security Act to include pharmacists on the list of recognized healthcare providers. CSHP asks all members to discuss this legislation with their members of Congress (both House and Senate), and ask them to become co-sponsors. Currently in Connecticut, H.R. 592 has 3 co-sponsors (DeLauro, Larson, Courtney), while S. 109 has only Senator Blumenthal as a co-sponsor.
CSHP works closely with our lobbyist especially when the General Assembly is in session. Connecticut has a part-time legislature, meeting during odd years from January to June, while in even years from February to May. However, if CSHP is strongly advocating for new or current legislation that may be seeking a change, the advocacy work required to push legislation to a successful conclusion typically can be a year-round endeavor. This is where the CSHP legislative committee and the CSHP Board cannot possibly accomplish advocacy gains without the grassroots efforts of practicing pharmacists and the CSHP membership. When the word goes out through email alerts or other communication vehicles that an important initiative is occurring that may affect pharmacy practice, your voice, your action in clinical practice, your email, your phone call, or just your interactions with your neighbors play a critical role in advancing pharmacy practice initiatives in our state. Connecticut is blessed to have a very tight pharmacy community, meaning it is a small state with active practitioners and pharmacy leaders. Therefore, very simple actions can create major change.
Lobbying comes in all shapes and sizes, dispositions and attitudes. We lobby because we are the best representative of pharmacy. Legislators cannot possibly be informed of every issue, therefore a responsibility of our job of being a “good steward” of our profession, is to inform legislators about pharmacy. When told the President is a lobbyist for the people, Harry Truman responded: “God knows they need it!” Making an impact in a small state like Connecticut can come from a simple phone call, email, letter, and most effectively through a one-on-one visit – whether it’s at a legislative office, or at your practice site. The CSHP legislative committee and Board will guide you through the process, provide you with all the background information you will need for a specific issue, and set up appointments for you with influential policymakers. There is an old adage on how a legislator interprets communication from a constituent that is particularly relevant in Connecticut: one letter received is “a kook”, 2 letters received is “a kook with a friend”, 3 letters received means “someone had a meeting”, while 4 letters received is considered “a movement.”
Pharmacy advocacy means creating that movement – for your practice, your profession, and most importantly for your patients. The CSHP legislative committee has a long history of understanding health care issues and their relevance to pharmacy practice, and stands poised to work with you to open new doors for pharmacists to use your extensive clinical knowledge to care for your patients.
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