Week of December 18, 2023 — Legislative Update

Federal

• The Lower Costs, More Transparency Act, which advances policies to force pharmacy benefit managers and hospitals to meet price transparency standards, passed on the House floor last week by a vote of 320 to 71. This is the first PBM transparency legislation to pass a full chamber this Congress. (Fierce Healthcare)
• The Centers for Medicare & Medicaid Services (CMS) released final guidance for the Medicare Part B and Part D Prescription Drug Inflation Rebate Program for the implementation of the Inflation Reduction Act. CMS issued a notice in the Federal Register, and the final guidance is on the CMS website here.

Week of December 11, 2023 — Legislative Update

Federal

• The White House announced plans to use Bayh-Dole “march-in rights” to step in and license patent rights of drugs “developed with federal funding” to other manufacturers when the price of the drug is deemed too high. (Forbes | Wall Street Journal)
• The Congressional Budget Office (CBO) issued a cost estimate of H.R. 5378, the Lower Costs, More Transparency Act.  CBO and the Joint Commission on Taxation (JCT) estimate that H.R. 5378 would reduce the federal deficit by $715 million over the 2024-2033 period. (cbo.gov)
• FDA approves two gene therapies for sickle cell disease, including first that uses CRISPR-Cas9. (Endpoints)

State

• Governor Maura Healey hints at future of revamped Life Sciences Initiative in economic development plan released last week. (Boston Business Journal)

Week of December 4, 2023 — Legislative Update

Federal

• HHS announced they will not enforce a federal court ruling that says health insurers must count drug manufacturer copay assistance towards a beneficiary’s out-of-pocket costs in most instances. The Biden administration issued an unusual motion to clarify, and has filed an appeal with the United States Court of Appeals for the D.C. Circuit. All briefs associated with the case can be found here.
• House Democrats named Rep. Lori Trahan (D-MA) as their new co-chair of the Democratic Policy and Communications Committee (DPCC), the caucus' messaging arm, in a 132-71 vote on Wednesday morning. Trahan represents Massachusetts 3^rd District. (Politico)
• Vital Transformation (VT) released a new study indicating the pharmaceutical industry is the dominant source of innovation for funding new FDA approved medicines. VT discovered that 92% of the medicines newly approved by the FDA have no federally funded intellectual property or patents. (Vital Transformation)

State

• After some high-stakes drama, the legislature sent a $3 billion closeout spending bill to Governor Healey on Monday. The governor signed it last night. (WWLP, SHNS)

Week of November 13, 2023 — Legislative Update

Federal 

• Senate confirms NIH Director Monica Bertagnolli. (Science)
• The Senate Finance Committee voted 26-0 on Wednesday, November 8 to advance the Better Mental Health Care, Lower-Cost Drugs, and Extenders Act (Better Act). (Benefitspro.com)
• Members of Congress urge Centers for Medicare and Medicaid Services (CMS) to withdraw a proposed rule on the Medicaid drug rebate program that would harm patient access while creating fiscal uncertainty for states. (BIO.org)
• Patients are paying hundreds of dollars more for a prescription than they would if their health plan chose to cover a lower-priced twin. Why? The higher-priced drug can result in a bigger rebate to the PBM. (Wall Street Journal)
• President Joe Biden announces the first-ever White House Initiative on Women’s Health Research. (Fact Sheet)

State

• Senate Committee on Ways and Means released S2499, An Act Relative to pharmaceutical access, cost and transparency (The PACT Act), on Thursday. The Senate is scheduled to debate it this week. (State House News Service)

Week of October 30, 2023 — Legislative Update

Federal 

• Senators Barrasso (R-WY) and Carper (D-DE) introduced the Senate companion bill (S.3131) to the ORPHAN Cures Act (H.R.5539) filed last month by Reps. Joyce (R-PA) and Nickel (D-NC). These bills would amend the IRA to ensure orphan drugs treating one or more rare diseases or conditions are excluded from Medicare price negotiations. The legislation clarifies that the countdown to eligibility for price negotiation would only begin when an orphan drug loses this exclusion. (BIO)
• The Senate HELP Committee confirmed Dr. Monica Bertagnolli to be the Director of NIH, by a vote of 15-6. (The Hill)

State

• The Health Care Financing Committee polled its members last week on whether to recommend passage of nine bills, including a prescription drug pricing proposal expected to hit the Senate floor in the next few weeks. (State House News)

Week of October 16, 2023 — Legislative Update

Federal 

• Kendalle Burlin O’Connell joins the biotech sector in speaking out and expressing solidarity with Israel amidst tragic events. (BIO News) And, Beacon Hill lawmakers pass a resolution supporting Israel and condemning Hamas' attack on the country. (MA Legislature)
• The Centers for Medicare & Medicaid Services (CMS) issued a blog post providing an update on the development of three Center for Medicare & Medicaid Innovation (CMMI) models for testing in Medicare Parts B and D and Medicaid, “aimed at improving prescription drug affordability and access” for beneficiaries. (CMS.gov)
• All Copays Count Coalition sent a letter urging the HHS and DOL to enforce a rule requiring insurers and PBMs to count copay assistance toward their enrollees’ annual deductible and total out-of-pocket costs. (Coalition)
  • “Insurers and PBMs should not be diverting funds intended to help patients living with serious chronic illness toward their own bottom lines,” said Rachel Klein, Deputy Executive Director of The AIDS Institute.
• Price controls impact access. Nowhere is that clearer than in Europe, where, as STAT’s Drew Joesph makes clear, governments don't recognize the value of gene therapies and patients, therefore, can't get those treatments. (STAT)
• The FDA is following through on its promise to regulate more health software tools, starting with a public reprimand of Johnson & Johnson’s heart pump company, Abiomed. (STAT)

City

• Housing and life sciences project in Boston’s Andrew Square approved. (Boston Globe)

Week of October 10, 2023 — Legislative Update

State

• With peak season for respiratory illnesses like the flu and COVID-19 approaching, DPH on Thursday launched a refreshed dashboard to track trends and provide the public with helpful information focused on COVID-19, influenza, and RSV. (State House News Service)
• MassBio and BIO wrote last week to DPH to urge the agency to maintain Massachusetts’ historical commitment to provider choice following a decision at the Massachusetts Vaccine Purchasing Advisory Council to deviate from this precedent by limiting supply to only one pneumococcal conjugate vaccine (PCV). (Read the letter)

Federal 

• All drugmakers of the first 10 medicines selected for Medicare drug price negotiations have agreed to participate in the talks, though most contend that they had no real choice but to participate in the negotiations, specifically due to the penalties they could face if they choose not to. (CNBC)
  • “We have no choice other than to sign the ‘agreement.’ If we did not sign, we’d be required to pay impossibly high penalties unless we withdraw all of our medicines from Medicare and Medicaid. That is not a real choice,” a spokesperson for Bristol Myers Squibb told CNBC ahead of the Sunday deadline.

Week of October 3, 2023 — Legislative Update

• Last week, ARPA-H announced Massachusetts as its Investor Catalyst Hub to support the agency’s mission by fostering collaboration among researchers, entrepreneurs, and investors to accelerate innovative ideas that transform health care. (Press Release)
  • “Massachusetts plays an outsized role in addressing the world’s unmet medical needs, and the Biden Administration’s decision to locate the Investor Catalyst Hub for ARPA-H here puts this agency in a position to tap into the talent, funding, institutions, and innovation that are our ecosystem’s greatest assets,” Kendalle Burlin O’Connell, MassBio CEO and President, said.
• MassBio issued a statement in support of the bi-partisan Optimizing Research Progress Hope And New Cures (ORPHAN) Cures Act. Read the full statement.
  • “The ORPHAN Cures Act addresses one of the most problematic elements of the IRA’s drug price negotiation program. MassBio, which represents many of the biotechnology companies most deeply invested in the rare disease space, is eager to work with the Massachusetts delegation and Congress to quickly advance this bipartisan bill,” Kendalle Burlin O’Connell, MassBio CEO and President, said.
• Hours before the Sept. 30 deadline, Congress passed a stopgap spending bill to fund the government through Nov. 17, allowing time for a long-term funding deal as well as passage of other key priorities. (Good Day BIO)
  • The Pandemic All-Hazards Preparedness Act (PAHPA) and the Farm Bill were not renewed (yet), having expired on September 30.
• In a major victory for patients who depend on prescription drugs, U.S. District Court Judge John D. Bates struck down a Trump administration federal rule that allowed health insurers to not count drug manufacturer copay assistance towards a beneficiary’s out-of-pocket costs. (Press Release - PDF)

Week of September 25, 2023 — Legislative Update

Federal

• The bi-partisan Optimizing Research Progress Hope And New Cures (ORPHAN) Cures Act was introduced to change the incentive structure within the IRA to encourage follow-on investment into orphan drug development. (Good Day BIO)
• The House Committee on Oversight and Accountability held a hearing on the role of PBMs in prescription drug markets, during which Chair James Comer (R-KY) blasted “spread pricing, where PBMs overcharge payers and underpay pharmacies, and pocket the extra money.” (house.gov)

State 

• Healthcare and government leaders support legislation filed by the Health Equity Compact, a group of more than 80 leaders of color, to address health disparities in the state. (Boston Globe)
• Massachusetts legislative leaders said Thursday they have reached an agreement on a tax relief bill after months of closed-door negotiations. (Boston Globe)
• A new center at Northeastern will track infectious diseases and provide outbreak forecasts to communities, sort of like a "National Weather Service for epidemics,” thanks to $17.5M CDC grant. (Boston.com)

Week of September 18, 2023 — Legislative Update

Federal

• The U.S. Food and Drug Administration took action approving and authorizing for emergency use updated COVID-19 vaccines formulated to more closely target currently circulating variants and to provide better protection against serious consequences of COVID-19, including hospitalization and death.
• The White House announced new actions to advance the Cancer Moonshot, including $240 million in funding for the Advanced Research Projects Agency for Health (ARPA-H) to “accelerate new ways to prevent, detect, treat, and survive cancer.” (White House Fact Sheet | ARPA-H Release)
• The Congressional Budget Office (CBO) released a cost estimate for H.R. 5378, the Lower Costs, More Transparency Act, legislation to “increase health care price transparency and lower overall costs for patients and employers.” (CBO website | Section-by-Section)
  • CBO estimated that changes in direct spending and revenues as a result of the legislation would reduce the deficit by $833 million from 2023-2033, including a $369 million increase in the on-budget deficit, and a $1.202 billion decrease in the off-budget deficit.

State 

• MassBio’s Kendalle Burlin O’Connell joined leaders of Massachusetts business and trade associations to write in support of the request made to the Biden-Harris Administration by Governor Maura Healey to address the “state of emergency” relative to migrants entering the Commonwealth. (Read the letter)
• The Health Policy Commission published the latest in a series of annual health care cost trends reports, showcasing a wide range of data points and making nine policy recommendations. (SHNS)

Week of September 11, 2023 — Legislative Update

Federal

• The Centers for Medicare and Medicaid Services (CMS) has announced a series of Patient-Focused Listening Sessions scheduled for this Fall as part of the Medicare Drug Price Negotiation Program.  The Listening Sessions will be held October 30 – November 15, 2023 and “will provide an opportunity for patients, beneficiaries, caregivers, consumer and patient organizations, and other interested parties to share input relevant to the drugs selected for the first round of negotiations.”
• Senate HELP Committee Ranking Member Bill Cassidy, M.D. (R-LA) delivered a Senate floor speech on the “so called” Inflation Reduction Act (IRA) and he talks about his trip to Massachusetts in June.  Senator Cassidy visited small biotech firms and learned more about the negative impacts of the IRA on small and mid-sized biotech companies. (Press Release)
• Alexion’s Scott Weintraub writes about the IRA’s impacts on Boston biotechs in an op/ed in the Boston Business Journal saying “now is not the time to put the brakes on rare disease research and development…Given the significant leaps that the biotech industry has made in recent years, especially in gene and cell therapies, the Boston biotech community is on the cusp of even more life-changing developments for patients.” (BBJ)
• The final version of the “Lower Costs, More Transparency Act” — new bipartisan legislation “to increase health care price transparency and lower overall costs for patients and employers” — has been introduced by House Committee chairs.  The bill, which incorporates provisions advanced by three committees, “will provide patients with accurate and timely information about the cost of important health care procedures and services.” (Press Release)

State 

• The Greater Boston Chamber of Commerce and the Massachusetts Society of CPAs recently released a joint statement urging lawmakers to “quickly finalize the first step in strategic tax reform that will benefit residents, families, businesses, and the economy.” (SHNS)

Week of August 28, 2023 — Legislative Update

State 

• Last week, the MBTA announced they plan to shut down part of Red Line for repairs in October. The 16-day shutdown will impact the Ashmont Branch between JFK/UMass and Ashmont stations and the Mattapan Line between Ashmont and Mattapan stations (nbcboston)

Federal 

• Last week, AstraZeneca became the latest pharma company to sue over the drug pricing provisions in the IRA, raising concerns over 'unintended consequences' in rare disease R&D. (FiercePharma)
• This week, the Biden administration is set to name the first 10 drugs selected for the IRA’s drug price negotiation program. According to Politico, the announcement is expected to come on Tuesday ahead of an event at the White House. (Politico)

Week of August 21, 2023 — Legislative Update

State 

• Last week, Attorney General Andrea Campbell announced $1.5 million in grant funding to 11 community organizations and health centers in a bid to expand maternal health workforce and access to care (State House News)
• Nurse assistant exams to be offered in languages other than English, opening career pathways for non-native speakers (State House News)
  • The new language options were included in a policy section within the fiscal 2024 budget that was signed by the Governor this month, but lawmakers say it is only the first step in breaking down barriers for immigrant CNAs and improving care for nursing home residents who don't speak English.

Federal 

• Last week, Congresswoman Lori Trahan released a report detailing the impact of the Inflation Reduction Act (IRA) and the American Rescue Plan Act (ARP) on residents of the Third Congressional District.
  • As a result of the IRA, Medicare beneficiaries’ out-of-pocket insulins costs are now capped at $35 a month, and the ARP strengthened Medicaid’s ability to limit drug price increases starting in 2024.

Week of August 14, 2023 — Legislative Update

Local

• Last week, the Cambridge City Council took no action on Councilor Zondervan’s proposed BEUDO amendment setting 2030 as the net zero deadline for new, large buildings; the proposed amendment is expected to be taken up in September on a date TBD.
  • Read MassBio’s comment letter in opposition to this amendment.

State 

• With the signing of the budget, the Department of Public Health (DPH) has 180 days to develop a tiered system for transporting patients to hospitals that have various designations for providing stroke care. Stroke is the sixth leading cause of death in Massachusetts. (State House News)

Federal 

• Without the investment and expertise of the biopharmaceutical industry, the knowledge gained through research by NIH may generate interesting ideas, but very few, if any, new medicines. (PhRMA Blog)
  • What they’re saying: “There is a risk if we were to add some limitations in the contracting that we limit the number of companies that are willing to come forward and do this work,” said Dawn O’Connell, the United States Department of Health and Human Services assistant secretary for preparedness and response, at a recent hearing.
• Drugmakers were incentivized to get drugs on the market as fast as possible, regardless of which disease they would be approved to treat, writes STAT about an interview with Genentech CEO Alexander Hardy, but the Inflation Reduction Act’s new Medicare negotiation program could cause companies to prioritize indications with larger patient populations. (STAT)
  • What they’re saying: "We face a lot of difficult decisions to make squaring the science and the societal patient unmet need together with the business case. It’s frustrating that this is an artifact of government legislation, which is creating a disincentive for us to do the right thing for patients,” Hardy said in an interview with STAT.

Week of August 7, 2023 — Legislative Update

State

• Gov. Maura Healey said Wednesday that she's "anxious to work on a tax package" after the Legislature delivered to her an overdue spending plan that left a blank line item for long-promised tax relief. (SHNS)
• Life sciences industry leaders are also awaiting a forthcoming tax relief proposal, which is not reflected in the Legislature's compromise budget. The budget designates $580 million to cover the costs of that proposal, which remains in a conference committee. (Boston Business Journal)

Federal 

• In comments to a Senate working group, BIO says that the 340B Program has grown exponentially as hospitals take advantage of the opportunity to profit from drug discounts while the low-income and uninsured patients the program was meant to serve do not benefit. (Bio.News)
• Voters hold a favorable opinion of biotechnology (62 percent) and 67 percent said they support “government policies that seek to address the country’s challenges (i.e. food insecurity, climate change) through innovation in biotechnology.” (Bio.News)

Week of July 31, 2023 — Legislative Update

State 

• Legislative negotiators filed a compromise $56.2 billion annual state budget Sunday night that was approved by the House and Senate on Monday. (State House News)

Federal 

• Last week, top Democrats proposed legislation that would expand the number of drugs subject to government price negotiations. (Bloomberg Law)
• House and Senate Committees advanced legislation to control the way pharmacy benefit managers (PBMs) can profit by increasing drug prices. (Good Day Bio)
• Dr. Ted W. Love, current chair of the BIO board, writes in an op-ed how the new rules under the IRA and actions by the FTC would have kept patients from accessing his company’s sickle cell treatment. (Stat News)