Legislative Watch

We are nearing the finish line of session as today marks the 39th of 40 Legislative Days under the Gold Dome. Yesterday was a committee work day and tomorrow will be as well. We will continue to monitor both floor and committee action, as there as still a lot that can happen before the ultimate deadline of Sine Die on Thursday. 

As for last week, we saw Legislative Days 36 – 38, which are naturally eventful as the clock ticks down for final passage. SB 473, the Georgia Consumer Privacy Protection Act, had another hearing last Wednesday in the House Technology and Infrastructure Innovation committee. An omnibus amendment to the bill, offered from Chairman Todd Jones, passed. We do not believe changes made to the bill on Wednesday should be cause for member concern. However, if you would like more information on the amendment, please let us know. The bill, as amended, passed the committee and now lies with the Rules Committee for consideration. 

On Thursday afternoon, an amended version of the Senate substitute of House Bill 1339 was presented on and passed the House floor, containing new language that satisfied both the House and Senate. In relation to the Rural Hospital Tax Credit portion, the amended language includes an increase in the aggregate cap from $75 million to $100 million. The language also extends the sunset of the program to December 31, 2029. The Senate agreed to the House amended version of the Senate substitute for the bill by a vote of 34-17. The bill now moves to Governor Kemp’s desk for final consideration.

The Senate Regulated Industries and Utilities Committee also met on Thursday with HB 1077 being the large topic of discussion. Senator David Lucas, the newest sponsor of the bill, presented the substitute language known as the “Peachtree Plus Act of 2024,” which aims to expand Medicaid in Georgia and close the coverage gap. However, following the addition of two amendments by Senator Brass, the committee substitute failed to pass the committee by a vote of 7-7 with Chairman Cowsert offering the seventh vote to tie. 

As this session nears its end, please feel free to reach out to Melissa Carter should you have any remaining policy questions or concerns. We will continue to advocate for member priorities, monitor floor action, and update you accordingly. We appreciate everyone’s help and attention to this session.

FEDERAL UPDATES

Experts Call for VICP Reform at House Oversight Vaccine Hearing: 

The House Oversight Select Subcommittee on the Coronavirus Pandemic held a hearing, “Assessing America’s Vaccine Safety Systems, Part 2.” Experts called for modernizing VICP to ensure patients are fairly compensated without delay. Renee Gentry from George Washington University Law advocated for VICP to include COVID-19 vaccines to restore confidence in patients – highlighting the disparities in compensation under CICP. Also of note, Ranking Member Raul Ruiz, M.D. (D-CA) and Rep. Marionette Miller-Meeks, M.D. (R-IA) both called for faster compensation. BIO strongly supports the excise tax to ensure that COVID-19, RSV, and Dengue vaccines are covered in the VICP program. 

Lawmakers Urge Action on AMR in FY25 Budget Hearings: 

Busy week for HHS Secretary Xavier Becerra, as he testified before both the House Appropriations LHHS Subcommittee and the House Ways and Means Committee. As highlighted in Good Day BIO, action against Antimicrobial Resistance (AMR) was raised in both hearings – including passing the PASTEUR Act as a solution. BIO agrees action must be taken to address this public health issue.

CALL TO ACTION

As we continue our advocacy with BIO on the Medicaid Drug Rebate Program (MDRP) proposed rule, we are asking small and mid-sized biotech companies to consider signing on to a letter focusing on the proposed rule “stacking” provision, the covered outpatient drug definition, and the survey. If your CEO and/or company ** would like to see the letter, please email Mel by Tuesday, April 2.

ADDITIONAL LINKS

• BIO Comments to HHS on Medicare Prescription Payment Plan: Draft Part Two Guidance on Implementation of Section 1860D-2 of the Social Security Act for 2025

BIO LEGISLATIVE FLY-IN

When: April 16 -17

Where: Embassy Suites By Hilton Washington DC Convention Center – 900 10th St NW, Washington, DC 20001

It continues to be a busy time under the Gold Dome for both legislative chambers. Last week we saw Legislative Days 33-35, and yesterday marked Legislative Day 36. Today will be a committee work day at the Capitol as there is still much to be done by Sine Die, the fast approaching last day of session on March 28. 

SB 473, the Georgia Consumer Privacy Protection Act, had a hearing last Wednesday in the House Technology and Infrastructure Innovation committee. Previously, there were a number of concerns from member companies over this bill. However, the latest substitute that was presented in committee, which can be found here, seems to be amenable to our member companies and resolve said concerns. If you have any outstanding issues with this legislation, or just have questions, please do not hesitate to contact us. 

After the addition of two amendments in committee, HB 1339, the comprehensive CON reform bill, was engrossed and heard on the Senate floor on Thursday. The bill passed the floor by a vote of 43-11. HB 1339 eliminates certain CON requirements, creates new exemptions, modifies the Rural Hospital Tax Credit, and creates the Comprehensive Health Coverage Commission, which would be effective July 1, 2024. If you have specific questions regarding this legislation, let us know. 

 Senate Bill 427, which relates to disclosure requirements for pharmaceutical advertising, is no longer slated to be heard in committee. With how few Legislative Days remain this session, it is not likely for this bill to gain further traction. That said, we will continue to monitor and keep you updated. 

FEDERAL UPDATES

Senate Finance Hearing on 2025 Budget:

The Senate Finance Committee held a hearing on Thursday, March 14, on the FY 2025 budget request for the Department of Health and Human Services (HHS). Questions for HHS Secretary Xavier Becerra were predominately raised along party lines. Highlighting the bipartisanship in addressing PBM reforms, Ranking Member Crapo (R-ID) criticized the 2025 budget and the harmful effects it has on Congressional efforts regarding PBM reforms and IRA price controls impacting R&D and innovation. In addition, Chair Ron Wyden (D-OR) expressed the need to pass PBM reforms this congress. BIO supports this effort. 

USDA Plan to Boost Biomass Supply Chain: 

USDA unveiled a comprehensive plan to enhance the resilience of the biomass supply chain, aligning with President Biden's Executive Order 14081 to bolster the domestic bioeconomy. Secretary Tom Vilsack emphasizes the opportunity to create new markets and jobs for farmers and rural communities, with biomass supporting a wide range of biobased products contributing significantly to the U.S. economy. See the USDA press release. 

The Energy and Commerce Health Subcommittee announced today a hearing, “Evaluating Approaches to Diagnostic Test Regulation and the Impact of FDA’s Proposed Rule”, on Thursday, March 21 at 10:00 a.m. While the VALID Act is not the main focus of the hearing, we do expect that it will be discussed.

HR 5074: The Kidney Patient Act is being heard on Wednesday in the full House Energy and Commerce Committee. Ranking Member Pallone (NJ) is still opposed to passing The Kidney PATIENT Act (H.R. 5074) is The Kidney PATIENT Act (H.R. 5074) is bipartisan legislation that would delay the move of oral-only ESRD drugs into the ESRD bundle until 2033 or until new intravenous therapies come to the market. Please call or email Chief of Staff, tiffany.guarascio@mail.house.gov; (202)225-4671 today to ask that he support the Kidney Patient Act. RxinR has been working to get legislators to support the Kidney Act.

ADDITIONAL LINKS

• AdvaMed’s Board Chair Peter Arduini shared his priorities for AdvaMed and medtech in remarks this past week at the CEO Summit in Arizona

BIO LEGISLATIVE FLY-IN

When: April 16 -17

Where: Embassy Suites By Hilton Washington DC Convention Center – 900 10th St NW, Washington, DC 20001

Last week I had the pleasure of representing Georgia Bio and our medtech member companies in Washington, D.C., at the annual AdvaMed Fly-In. We were briefed by members of their staff, including senior VPs, with a special guest appearance by Senator Richard Burr (N.C.). We covered an array of topics including artificial intelligence in healthcare and wearable technology, R&D expensing deductions, the Verifying Accurate, Leading-edge IVCT Development (VALID) Act, and more. This event also allowed me to hear from other Bio and Life Sciences trade associations about things that are going well for them in their respective states and foster new ideas to best serve our member companies.

As for the state, last week the Georgia General Assembly convened on Monday, Tuesday, Thursday, and Friday, completing legislative day 32 of the 40 allotted legislative days. The legislature reconvened yesterday, March 11, for legislative day 33 and will work through Thursday, March 14, with a committee work day today. 

 We are continuing to closely monitor SB 473, the Georgia Consumer Privacy Protection Act, which is sponsored by Senator John Albers. We are aware of concerns over this legislation and are working closely with industry partners to either see that suitable amendments are made or that this bill does not make it to the Governor’s desk. SB 473 crossed over from the Senate to the House and has been assigned to the House Technology and Infrastructure Innovation committee, which will meet tomorrow, March 13, at 2:00p.m. It is also of note that the Georgia Chamber of Commerce currently holds an opposed position to this bill. 

 Additionally, we are tracking House Bill 1339, which passed the State House and has been assigned to the Senate Regulated Industries and Utilities Committee. This bill, sponsored by state Rep. Butch Parrish, seeks to establish the Comprehensive Health Coverage Commission, make modifications to the certificate of need system, or “CON”, modify tax provisions for those who donate to rural hospitals, and more. We expect to see a fair amount of change to this bill while it is in the Senate, and we will be sure to keep you updated. 

 Also of note is Senate Bill 427 as it relates to disclosure requirements for pharmaceutical advertising. This bill now lies with the House Small Business Development Committee and is on the agenda for Wednesday, March 13, at 3:00PM. Lastly, HB 991, relating to the Hospital Medicaid Financing Program so as to extend the sunset provision has been referred to the Senate Health and Human Services Committee, which also has a hearing scheduled for Wednesday, March 13. 

FEDERAL UPDATES

House Passes H.R. 2799, the Expanding Access to Capital Act:

The U.S. House of Representatives took steps to promote capital formation for innovative startups with the passage of H.R. 2799, the Expanding Access to Capital Act. The legislation included the text of Rep. Bryan Steil’s (R-WI) H.R. 2624, Helping Startups to Grow Act, which would extend regulatory relief under the JOBS Act for Emerging Growth Companies for an additional five years. The bill will extend the EGC exemption period for an additional five years, bringing the total regulatory relief period to 10 years.  This is especially important for biotech startups who are often in the lab without an FDA-approved product for a decade and therefore generating no revenues. This targeted fix will keep the regulatory costs of being a public company lower for longer without sacrificing the investor protections that become relevant once a company goes into production and expands its operations. 

The House also adopted a bipartisan amendment offered by Rep. Ann Wagner (R-MO) along with Reps. Gregory Meeks (D-NY), Wiley Nickel (D-NC), and David Scott (D-GA), which would enhance liquidity in private markets by allowing closed-end funds to invest in private securities. This affords investors and employees of small, private companies an extra exit opportunity outside of IPOs or mergers in which they can monetize their shares.  It would also allow non-accredited investors access to private market securities through an exchange-traded security, thus increasing the opportunity for economic exposure to one of the most robust markets in the U.S. 

The Securities and Exchange Commission issued a final Climate Disclosure Rule, which reflected several important changes urged by BIO to make the disclosure mandate more workable for smaller companies. These changes included: Basing reporting requirements on materiality; Eliminating management- and Board-level expertise requirements; Excluding Emerging Growth Companies from GHG reporting; Extension of phase-ins and inclusion of Emerging Growth Companies in phase-ins; and Attestations requirements curbs for small companies; and Inclusion of safe harbors.  

ADDITIONAL LINKS

• John Crowley Thoughts on State of the Union Address
• BIO Policy Pulse: White House PBMs Roundtable

BIO LEGISLATIVE FLY-IN

When: April 16 -17

Where: Embassy Suites By Hilton Washington DC Convention Center – 900 10th St NW, Washington, DC 20001

Last week was a crucial date for the legislative session as Thursday was Crossover Day—the last day that a bill can pass from its Chamber of origin and still be considered for final passage this session. There are 12 legislative workdays remaining and numerous others will be spent in committees. These committee days will continue to see lots of action and the possible amending of bills that cleared the Crossover Day threshold to insert language from previous measures that were unsuccessful in meeting that deadline. We will keep you updated as things continue to unfold under the Gold Dome. 

Senate Bill 473, the Georgia Consumer Privacy Protection Act, passed the State Senate and has been assigned to the House Technology and Infrastructure Innovation Committee. The Chairman of this committee, Rep. Todd Jones, has already expressed serious concerns with the language in this bill. We know there is a great deal of opposition toward this bill currently and are monitoring its activity closely. We are specifically watching for amendments that would revert this legislation back to the Tennessee version it was originally modeled after. 

House Bill 1339, passed the State House and has been assigned to the Senate Regulated Industries and Utilities Committee. This bill, sponsored by state Rep. Butch Parrish, seeks to establish the Comprehensive Health Coverage Commission to advise Governor Kemp, policymakers, and the legislature on issues related to access and the quality of healthcare for Georgia’s low income and uninsured populations. This bill also seeks to make modifications to the certificate of need system, or “CON”, tax provisions as it relates to those who donate to rural hospitals, and more. We expect to see a fair amount of change to this bill in the Senate and will keep you apprised. 

Also of note is Senate Bill 427 as it relates to disclosure requirements for pharmaceutical advertising. This bill now lies with the House Small Business Development Committee. Lastly, HB 991, relating to the Hospital Medicaid Financing Program so as to extend the sunset provision has been referred to the Senate Health and Human Services Committee. 

As we continue inching closer to the March 28th deadline of Sine Die, we are closely monitoring these and several other pieces of legislation. If you have questions or concerns about any legislation, please contact Director of Policy & Public Affairs Mel Carter.

FEDERAL UPDATES

E&C Health Subcommittee Rare Disease Legislative Hearing:

Last week the House Energy and Commerce Health Subcommittee held a hearing considering legislation focused on rare diseases, including proposals to modify the Inflation Reduction Act (IRA) to expand the exclusion for orphan drugs, and change the period for when Medicare could negotiate the prices of certain single-source drugs. The hearing addressed three of BIO’s legislative priorities – the ORPHAN Cures Act, the MINI Act, and the Creating Hope Reauthorization Act – where several committee members spoke favorably.

It’s a big week—the BIO CEO and Investor Conference  is kicking off in New York (all the best to GeoVax, Micron, and other member companies from Georgia attending,) Rare Disease Week is happening on the Hill, plus Rare Disease Day will be celebrated this Thursday, Feb. 19th.

This rare disease week we would like to:

• Encourage you to refresh your knowledge on the ORPHAN Cures Act here. And view the letter to Congressional Leadership we signed on to in October here.
• Be on the lookout for news about the Georgia Rare Disease Advisory Council (RDAC). After many delays this group is fully appointed and will begin meetings next month. As a reminder, our CEO, Maria Thacker sits on the RDAC as the industry representative.
• SHOW YOUR STRIPES® on Feb. 29! The zebra is the official mascot for rare disease patients. Take a picture of your striped look and share it on social media with the hashtags #ShowYourStripes and #RareDiseaseDay. More here.

Finally, I will be in DC next week for the AdvaMed FlyIn. If you are a device/medtech company and have questions or anything you want to share with me prior to FlyIn, do not hesitate to email me.

Mel Carter

Director of Policy & Public Affairs, Georgia Bio

---

STATE UPDATES

Last week saw legislative days 23 – 25 of the 40-day legislative session. This week is important as all bills seeking final passage this year must pass out of their chamber of origin to be considered by the other legislative body by Thursday, February 29, or Crossover Day. Therefore, expect a flurry of committee activity this week as bills are moved before the deadline. This week is also important because it is officially Rare Disease Week! Did you know that there are over 7,000 diseases and conditions considered rare? As a group, they affect almost 30 million Americans, including many Georgians.

One piece of legislation that we continue to monitor is SB 427 as it relates to disclosure requirements for pharmaceutical advertising. On Thursday of last week, the Senate Passed/Adopted As Amended this bill. It now switches chambers and awaits committee assignment in the House. The most current version of SB 427, as it passed in the Senate, can be found here. Also of note is SB 473, the Georgia Consumer Privacy Protection Act. We are watching this bill as it relates to patient data, HIPPA, and healthcare services information sharing. Members, please let us know if you have concerns regarding either of these bills. 

HB 1339, sponsored by state Rep. Butch Barrish, is another piece of legislation that we are tracking. Part of what this bill would do is establish the Comprehensive Health Coverage Commission to advise Governor Kemp, policymakers, and the legislature on issues related to access and the quality of healthcare for Georgia’s low income and uninsured populations. This bill also seeks to make modifications to the certificate of need system, or “CON”, tax provisions as it relates to those who donate to rural hospitals, and more. HB 1339 passed out of the House Health Committee this afternoon. A link to watch yesterday’s hearing can be found here. 

FEDERAL UPDATES

House E&C Committee Announces Rare Disease Legislative Hearing On Rare Disease Day:

Last week, the House Energy and Commerce Committee announced a legislative hearing will be held Thursday, February 29, to consider “Legislative Proposals to Support Patients with Rare Diseases.” The committee will consider 18 bills, including the ORPHAN Cures Act (H.R. 5539) and the Creating Hope Reauthorization Act (H.R 7384), two of BIO’s bipartisan legislative priorities. Chair Cathy McMorris Rodgers (R-WA) and Subcommittee on Health Chair Brett Guthrie (R-KY) stated, “By supporting research and fostering innovation, we can continue to support finding treatments and cures that provide hope to patients in need.” – See the press release here for the full list of bills.

FEDERAL FLY-INS

AdvaMed/SMTA:

March 5-6, 2024

Capitol Hill/AdvaMed Offices (1301 Pennsylvania Ave NW, Suite 400, Washington D.C. 20004)

BIO

April 16-17, 2024

More information available soon

Last week the Georgia General Assembly convened for legislative day 19 on Monday, February 12 and worked through Friday, February 16 (excluding Wednesday, February 14). The legislature reconvened yesterday, February 20 for legislative day 23 and will work through Thursday, February 22. As mentioned in last week’s newsletter, we are continuing to track SB 427 as it relates to disclosure requirements for pharmaceutical advertising. Originally, this bill was supposed to be on the Senate floor yesterday; however, it has been tabled. We will continue to monitor the bill’s status should it be brought back for a Senate vote between now and Crossover Day. 

Speaking of Crossover Day, we are nearing its February 28 arrival, so legislation will start to move much faster as the number of legislative days shrink down. We will do our best to keep you informed during this time, especially as we see the need for Calls to Action to legislators on certain issues. That said, please do not hesitate to reach out to us should you have any questions or concerns as we are here to represent you!

In other news, House Speaker Jon Burns announced last week that longtime state Rep. Butch Parrish will take over as chairman of the House Rules Committee following the loss of Rep. Richard Smith. Parrish is currently serving his 20th term in the Georgia House of Representatives. He represents House District 158, which includes Candler, Emanuel and Treutlen counties, along with portions of Bulloch County. He also chairs the House Special Committee on Health Care.

FEDERAL UPDATES

Bipartisan PPRV Bill Introduced in House:

The Creating Hope Reauthorization Act of 2024, legislation that would reauthorize the Pediatric Rare Disease Priority Voucher Program for an additional four years, was introduced in the House last Thursday, February 15. Rep. Michael McCaul (R-TX) introduced the bill with the following co-leads: Reps. Anna Eshoo (D-CA), Gus Bilirakis (R-FL), Nannette Barragan (D-CA), Michael Burgess, M.D. (R-TX), and Lori Trahan (D-MA). This sets the legislation up for hopeful committee action in the near future as it is set to expire September 30. BIO’s statement can be found here. 

Last week the Georgia General Assembly convened for legislative day 15 on Tuesday, February 6th and worked through Friday, February 9th with committees in full swing. Of note, we are tracking SB 427 as it relates to disclosure requirements for pharmaceutical advertising. This bill, sponsored by Senators Tillery, Setzler, and Burns, passed out of the Senate Judiciary Committee late yesterday and has been referred to the House Rules Committee for consideration. We will continue to keep you updated on this legislation should it gain further traction.

We are also tracking HB 1072 as it relates to the state’s drug repository program. Representative Sharon Cooper spoke on the bill, which ultimately passed out of the House Health Committee yesterday. Her comments from the hearing can be found here. This bill will now be referred to the House Rules Committee for consideration.  

FEDERAL UPDATES

March-In Rights Latest: 

Last week BIO submitted comments to NIST on the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights, in which BIO explains to the Biden Administration that the Bayh-Dole Act is intended to enable innovation, and the “march-in” rights clause cannot be used for price controls.

House Oversight & Accountability Committee Advances PBM Legislation:

H.R 6283, the Delinking Revenue from Unfair Gouging (DRUG) Act, was approved by 20-11 during the House Oversight Committee mark-up on Tuesday, February 6. This legislation, often referred to as “commercial delinking” would limit PBM revenues to fair-market service fees prohibiting them from charging health plans more than they pay pharmacies while also preventing PBMs from steering beneficiaries to pharmacies owned by the PBM. See Good Day BIO for highlights and more on the markup including acknowledgement by Chairman James Comer (R-KY) of BIO’s support of the DRUG Act.

New Leadership:

Last week AdvaMed announced that Kelvyn Cullimore, President and CEO of BioUtah, will serve as the next chair of the State Medtech Alliance (SMTA). A link to a detailed press release can be found here.

U.S. House Passes R&D Tax Fix: 

On January 31, the U.S. House of Representatives passed the Tax Relief for American Families and Workers Act by a broad, bipartisan vote of 357-70. A critical part of this legislation would restore the R&D tax deduction, making R&D expenses deductible through 2025.

EVENTS

AdvaMed/SMTA Fly-in:

March 5-6, 2023

Capitol Hill/AdvaMed Offices (1301 Pennsylvania Ave NW, Suite 400, Washington D.C. 20004)

RSVP

It’s been a busy few weeks at the State Capitol. First up was Budget Week (January 16-19) where Governor Kemp and the heads of all of his state agencies presented their budget requests to a joint session of the House and Senate Appropriations Committees. The House Appropriations Committee is currently in subcommittee meetings to address the Amended Fiscal Year (FY24) budget, the budget that will implement mid-year adjustments to the FY24 budget that was passed at the end of last session. We expect to see the Amended Budget sometime this week, meaning that subcommittees will begin considerations for FY25 soon.

Funding for Georgia Bio’s Rural Teacher Training Initiative (RTTI) is housed within the Department of Education’s budget and will be considered in the FY25 budget by the House and Senate Appropriations Education Subcommittees. We have received $323,000 each year for the program’s first five years but are requesting an increase in funding for year six to add an additional cohort of teachers to the training, support expansion of the Equipment Depot, and provide additional training and career education opportunities for teachers and guidance counselors. If you or your company work closely with our Office of Workforce Development and the RTTI program and would be willing to write a letter of support for our funding increase, please send an email to Mel Carter.

Legislative Days 6 – 9 were last week in addition to the first meeting of several House and Senate Committees. While no legislation has been taken up in committee yet, we expect to start seeing some committee action this week. As always, we will continue to monitor activity at the State Capitol and keep you updated and informed along the way.

Finally, and on a much more somber note, a longstanding member of the Georgia House of Representatives and Chairman of the House Rules Committee, State Rep. Richard Smith, passed away early this morning at the age of 78. Rep. Smith was first elected to the House in 2004 and was serving his 10th term in the General Assembly, where he proudly represented the 139th District. We send our condolences to his wife, Clara, three children, Shannon, Ashley, and Justin, and grandchildren. 

CALL TO ACTION: BIOaction Campaign

This week BIOaction launched its latest action campaign regarding R&D Amortization. BIO has asked for our help in spreading the word to Congress to pass legislation in the next funding vehicle to restore immediate R&D expensing. Suggested email copy, several graphics, and a link to BIO’s Phone2Action platform where you can quickly send an email and/or tweet to your Congressional representatives can be found here.

CALL TO ACTION: March-In Rights

The Biden Administration’s decision to exercise March-In Rights will be harmful to our membership because it will de-incentivize innovation. 

The National Institute of Standards and Technology (NIST) is seeking comments on the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights. Comments must be received by 5 p.m. Eastern time on February 6, 2024 to be considered.

We encourage you to submit comments here.

Update: HB 343: Share the Saving Act

Last Wednesday, HB 343, the Share the Savings Act, failed as a due pass motion in the Senate HHS Committee. We will be working with PhRMA on how we plan to move forward.