POLICY AND ADVOCACY INITIATIVES

Protecting Massachusetts’ status as the best place
in the world for biotech

Through education and advocacy, MassBio promotes thoughtful legislative and regulatory solutions that give Massachusetts life sciences companies the best environment possible to research, develop, and commercialize breakthrough therapies and cures, and that ensure patients around the world have equitable, affordable access to those new treatments. Likewise, we oppose policies that threaten patient access, limit innovation, or hurt the Massachusetts life sciences industry’s competitiveness in the global economy.

When government, industry, and academia work together, our industry thrives and patients around the world benefit. MassBio is here to ensure that the relationship is strong, lasting, and mutually beneficial.

Policy News & Legislative Updates

MassBio regularly issues statements about our position on a variety of state and federal policy proposals that impact our industry, our members, and patients. In addition, every week we summarize what happened at the State House and on Capitol Hill, while looking forward at the week ahead in our Legislative Updates.

The Massachusetts Biotech Caucus

The Massachusetts State Legislative Biotech Caucus is a group of state legislators interested in and supportive of the life sciences industry. Caucus meetings may include company site visits, panel discussions on hot topics, or educational programs. By sharing information and resources with the Caucus Co-Chairs, MassBio helps inform the Caucus’ activities and educational opportunities.

Contact Susan Martin to learn more.

Policy Working Group

MassBio convenes a Policy Working Group of member company government affairs leads and key company contacts who meet regularly to discuss and formulate MassBio’s state and federal advocacy strategy. Inclusion in the Policy Working Group is by invitation only.

Contact Susan Martin to learn more.

Legislative Priorities

Our approach to legislative advocacy is driven by two aligned missions: protecting patient access to existing and future therapies; and, ensuring Massachusetts remains the best place in the world for life sciences companies to thrive. State and federal policy priorities are developed by MassBio’s government relations team in close consultation with our member companies through the Policy Working Group and other industry stakeholders.

State Priorities

Massachusetts is the world leader in life sciences innovation. We also lead in healthcare policy and access to high quality healthcare and breakthrough therapies. That’s why it’s critical we educate and inform state legislators as they make decisions that impact our ecosystem. Our state advocacy focuses on issues such as: commercial and Medicaid access and reimbursement, the proper use of health technology assessments (HTAs), co-pay assistance programs, transportation, housing, workforce development, and diversity & inclusion.

FY 2020 Budget

The final FY2020 Budget Conference Committee report was released Sunday, July 21 – three weeks after the start of the fiscal year on July 1. Of interest to the life sciences industry are sections 4, 6, and 46, which, together, create a new process designed to seek additional supplemental rebates for certain drugs that cost MassHealth more than $25,000 per patient per year or $10 million in aggregate. The policy gives Massachusetts’ HHS the authority to determine what they believe is a fair value for a drug and hold a public comment period and an optional public hearing to receive feedback on that valuation. HHS then will negotiate with a manufacturer to receive supplemental rebates to get the therapy’s cost down to that value level. If that negotiation fails, HHS can refer the matter to the HPC to determine if the drug’s price is unreasonable or excessive. In contrast to previous legislative proposals, this final language does not allow a referral to the Attorney General if the drug’s price is deemed excessive; there is no public hearing as part of the HPC process; and manufacturers are not required to testify at the HHS public hearing.  However, all testimony at that hearing is under oath, and HHS can cross-examine anyone testifying. As part of the law (Chapter 41 of the Acts of 2019, Sections 4, 6 and 46), both EOHHS and HPC were required to file regulations governing their respective processes.

The final HPC regulations were approved on February 5th, 2020 and can be found here. Of note, HPC will continue to develop the Standard Reporting Form as a sub-regulatory effort with the goal of releasing it in mid-spring 2020. The EOHHS proposed regulations can be found here. Both the HPC and EOHHS regulations will go into effect in March 2020.

MassBio Position: MassBio advocated to both EOHHS and HPC that the regulations must remain true and within the scope of the authorizing legislation. Any information required from drug manufacturers by the HPC must be relevant in its relationship to demonstrating value and it must be clearly articulated by the HPC how the criteria will be used. (Download our written testimony to EOHHS, here, and our written testimony to HPC, here)

Current Status: The Governor signed and approved the budget on Wednesday, July 31. Read MassBio CEO Bob Coughlin’s statement on the final budget language, here.

Prescription Drug Assistant Sunset Extension

The final FY2019 Supplemental Budget was signed into law by the Governor on December 13th, 2019 Included in the bill as Section 15 is language that would extend the sunset on copay assistance by 12 months from January 1, 2020 to January 1, 2021.

MassBio Position: Support. MassBio continues to advocate for the elimination of the co-pay assistance sunset.

Current Status: The Governor signed and approved the supplemental budget on December 13th, 2019. 

2019-2020 State Legislation

H229 / S159 : An Act to protect innovation and entrepreneurship in the Commonwealth (Sponsored by Rep. Erlich/ Sen. Lesser)

These bills aim to discourage bad faith assertions of patent infringement and target “patent trolls.”

MassBio Position: Support, with the inclusion of Section 2 (d). Patent protection ensures the viability of the discoveries from medical research institutions and universities, so they can be commercialized. Section 2 (d) protects these discoveries from any unintended consequences of patent reform. (Download the written testimony)

Current Status: Reported favorably as amended by the Joint Committee on Consumer Protection and Professional Licensure. New draft substituted (S2484), carrying H229, S159 and S154, and referred to the Senate Committee on Ways and Means.

H916 / S541: An Act Relative to co-pay assistance (Sponsored by Rep. Benson/Sen. Boncore)

This bill would eliminate the existing sunset of the state law allowing co-pay assistance programs which is currently set to expire on January 1, 2020. 

MassBio Position: Support. MassBio supports the elimination of the co-pay assistance sunset. (Download the letter to the MA HPC regarding its study on the impact of prescription drug coupons & the comment letter regarding HPC’s preliminary findings)

Current Status: As of February 6, 2020, both bills were sent to study and will not be taken up during this legislative session. The sunset on co-pay assistance was officially extended through the Fiscal Year 2019 Supplemental Budget. 

H1168: An Act Establishing a commission to review contracts between pharmaceutical benefit managers and MassHealth (Sponsored by Rep. Jones)

This bill would establish a commission of 10 members – representing each stakeholder in the pharmaceutical drug supply chain – to evaluate the transition of MassHealth from its existing drug purchasing contract model with pharmacy benefit managers to a pass-through model.

MassBio Position: Support. MassBio supports the state in its efforts to review the practices of pharmacy benefit managers and evaluate the transition to a pass-through model. PBMs have long exploited the state and its residents through spread pricing and this bill is a significant step to lower the cost of prescription drugs, without harming innovation or the biotech industry. (Download the written testimony)

Current Status: Testimony on the bill was heard on April 11, 2019.

 H1178: An Act Promoting transparency in the pharmaceutical industry (Sponsored by Rep. Mariano)

This bill would require the Center for Health and Information (CHIA) to report annually on the top 10 outpatient prescription drugs that accounted for a significant share of net state spending in the prior calendar year, and that experienced an increase in WAC cost of 25% or more in that prior year, considering any adjustments for rebates paid to the state.  Manufacturers of the 10 identified drugs must disclose factors that contributed to the increase in WAC in a form that is suitable for public release, as well as aggregate company level R&D costs and other capital costs that CHIA deems relevant.

It also includes transparency language relative to Pharmacy Benefit Managers (PBMs).

MassBio Position: Neutral. MassBio is supportive of the concepts contained in this bill. Any transparency legislation being considered should include transparency for all stakeholders across the entire healthcare system. 

Current Status: Testimony on the bill was heard on April 11, 2019.

 H1853/S1235: An act relative to fail first and patient safety/An act relative to step therapy and patient safety (Rep. Benson/Sen. Cyr)

These bills will improve patient care by adding important patient protections when health insurance companies require less expensive, and possibly less effective, treatment options, under a protocol known as “Fail First” or “Step Therapy.”

MassBio Position: Support. Step therapy/fail first must be reformed to ensure that patients have immediate access to the appropriate and necessary therapies prescribed by their physician. Current insurer use of step therapy negatively affects patient care and drives up health care costs due to increased doctor and/or hospital visits that could be avoided if patients are not forced to use less effective drugs for their specific condition. (Read MassBio’s written testimony). 

Current Status: New draft substituted (H4228 / SB2433). Both new drafts were referred to the House and Senate Committees on Ways and Means

H3481 / S1206: An Act to Ensure the fair, transparent and patient-focused use of health technology assessments by the Commonwealth (Sponsored by Rep. Coppinger/Sen. Boncore)

These bills seek to restrict the use of health technology assessments (HTAs) by the Executive Office of Health and Human Services (EOHHS) when negotiating supplemental rebate agreements.

MassBio Position: Support. If EOHHS engages with a third-party to evaluate the clinical, economic or public health value of medical innovations, including prescription drugs, the entity should be an independent, non-biased group and should not be funded or receive support from any health insurance company, pharmaceutical manufacturing company or pharmacy benefit manager. (Download the written testimony)

Current Status: As of February 4, 2020, both bills were sent to study and will not be taken up during this legislative session.

H4134: An Act to Improve Health Care by Investing in VALUE (Sponsored by Governor Baker)

As part of a larger healthcare reform bill filed by Governor Baker, Sections 7 and 37 of this bill would subject manufacturers of certain high cost (greater than $50,000/per person/per year), recently approved drugs to the Massachusetts Health Policy Commission (HPC) value determination process. It would also impose penalties on manufacturers that increase the price of a drug by greater than the Consumer Price Index (CPI) +2% in a given year. Other sections of the bill would increase state oversight and authority over pharmacy benefit managers (PBMs) through DOI certification and require reporting to the Center for Health Information Analysis (CHIA); require representatives from pharmaceutical industry to participate in cost trend hearings; and restrict PBMs from including gag clauses in contracts to ensure the consumer pays the lowest cost for a prescription.

MassBio Position: MassBio opposes Sections 7 and 37 of the bill. These sections would establish Massachusetts as one of the most highly regulated states for the biotechnology industry, stifling both progress and the pace of innovation, while threatening patient access to breakthrough treatments. (Read the statement by Bob Coughlin, President & CEO, MassBio and download the written testimony)

Current Status: Testimony on the bill was heard on January 28, 2020.

H4211: An Act to Improve Patient Access to Cancer Clinical Trial Programs

This bill aims to detail the difference between “inducement” for participation in a cancer clinical trial and reimbursement of expenses for participation in a clinical trial to ensure that insufficient financial means does not prevent a willing participant from being eligible to participate in a clinical trial and that reimbursement of ancillary costs may be provided. It defines travel and ancillary costs as including any reasonable cost, and requires clinical trial sponsors to notify potential subjects, at the time of the informed consent process, that reimbursement for travel and ancillary costs is available to all enrollees based on financial need.

MassBio Position: Support. This bill will expand the diversity of populations that enroll in cancer trials and ensure financial barriers do not turn away potential patients. In doing so, it will broaden the scope of the scientific research conducted through these trials. (Download the written testimony)

Current Status: Referred to the Joint Committee on Health Care Financing 

H4268: An Act to Create a Massachusetts Rare Disease Advisory Council

This bill would establish a rare disease advisory council in Massachusetts to advise the Governor, General Court, and Department of Public Health on the incidence of rare disease in the state. As drafted the bill would convene expert stakeholders including, two representatives from the biotech industry who are engaged in rare disease research to share perspectives and discuss innovative ways to improve the quality of life for all affected by rare disease. The council will also define a rare disease as one that affects less than 200,000 individuals in the United States.

MassBio Position: Support. The creation of a rare disease advisory council will advance the research being done in Massachusetts, enhance Massachusetts’ stature as the best place in the world for the life sciences, and improve lives of patients. (Download the written testimony)

Current Status: Referred to the Joint Committee on Health Care Financing

H4506 / H4508: An Act Authorizing and Accelerating Transportation Investment / An Act Relative to Transportation Finance

On February 26, 2020 the House released a $600 million tax bill to pay for improvements to the state’s transportation system. The package would increase the gas tax by 5 cents and by 9 cents for diesel; raise fees on Uber and Lyft rides, excluding shared rides; and impose a corporate minimum tax rate structure. The bill would commit $27 million more a year to the MBTA, dedicate a $27 million revenue stream for the state’s regional transit authorities, and provide $10 million to help rural communities.

Additionally, the transportation bond bill (4506) includes a $100 million increase, to $300 million, in annual Chapter 90 funding the state pays to fund local road and bridge maintenance. It also authorizes for several major projects already underway, including the Green Line Extension Project, the Allston multimodal project, and the South Coast Rail. 

MassBio Position: Support. MassBio supports efforts to alleviate the transportation crisis through new revenues and by changing behavior. The state’s current transportation infrastructure requires a broad enough package that doesn’t only address the near-term problems, but also provides resources necessary to future-proof the system and enable it to accommodate further economic growth. (Read the statement by Bob Coughlin, President & CEO, MassBio)

Current Status: The House passed the package on 3/4/2020. It will now move to the Senate.

S2397: An Act relative to pharmaceutical access, costs, and transparency (PACT Act) (Senate Committee on Ways & Means)

As drafted, this bill would require drug manufacturers to submit 60 days advanced notice of branded drug price increases over 20% of WAC price and generic drug price increases of 200% of WAC (for generics over $100); and 30 days advanced notice of drug launch. CHIA is given the authority to analyze factors related to drug costs from drug manufacturers and PBMs; and HPC can use its discretion to determine if a drug is reasonably priced, and create a value for that drug. If they deem the drug is unreasonably priced, they can ask the manufacturer to put together an Access Improvement Plan that outlines how it will increase patient access, and ultimately lower costs. Manufacturers will face monetary penalties if they fail to follow the plan in good faith, or will be subjected to a public hearing where representatives are required to testify, if they fail to submit an Access Improvement Plan. The bill also includes measures to create a licensing process for PBMs; caps out-of-pocket costs for insulin at $25 a month, eliminating deductibles and coinsurance; and requires pharmacists to notify patients when the retail price of a prescription drug is cheaper than what it would cost with insurance

MassBio Position: Opposed. Read MassBio CEO Bob Coughlin’s statement on the bill, here.

Current Status: Passed to be engrossed; the bill was printed as amended (S2409) and referred to the House Committee on Ways and Means.

H629, H1016, H1133, H1148, H1154, H1162, H1167, H1193, H3551, H1167, S552, S696, S706, S712: Legislation Related to Price Setting and Transparency of Prescription Drug Prices 

MassBio Position: Oppose. MassBio is in strong opposition of any legislation that would set a cap on the price a manufacturer can charge for a drug. Any form of price setting would severely harm innovation in the Commonwealth, threaten patient access to potentially life-saving therapies, and impair the reputation of Massachusetts as the number one life sciences cluster in the world. Further, any drug price transparency legislation must apply fairly to all pieces of the drug supply chain including PBMs and payers. (Download the written testimony)

Current Status: Testimony on all of these bills was heard on April 11, 2019 (H629, H1133, H1148, H1154, H1162, H1167, H1193, H3551, H1167, S696, S706, S712) and September 23, 2019 (H1016, S552).

Local Legislation

Cambridge Ordinance: Prohibition of Natural Gas Infrastructure in New Buildings

This policy aims to ban oil and natural gas hookups in new construction, extending the provision to properties undergoing extensive renovation, and require all properties to use only electricity for heat. It would also require all businesses and homeowners in Cambridge to install heat and hot water appliances that use electricity.

MassBio Position: Oppose. This ordinance will seriously harm companies located in Cambridge, especially early stage biotechs that would be forced to pay for electricity for heat at prices that are among the highest in the country. Additionally, a large number of biotech companies, research institutions, and universities will be disproportionally affected by this ordinance due to the size and nature of their operations. Any effort to prohibit natural gas infrastructure in new or retrofitted building that is necessary for lab usage will have a lasting impact on the life sciences industry in Cambridge. (Download MassBio’s letter to the Cambridge City Council). 

Current Status: The proposal has been tabled until further notice. Councillor Zondervan, who introduced the draft ordinance, hopes to bring the issue back before the full Council for possible adoption at some point in March.

Transportation

Transportation is one of the biggest threats facing the continued success of the life sciences industry in Massachusetts. In a recent survey, 30% of residents statewide with full-time jobs said they have considered changing jobs for a better commute. For those with commutes longer than 45 minutes, including many of those coming to Cambridge every day, it’s even worse: 51% have thought about changing jobs and 30% have considered moving out of Greater Boston completely.

MassBio is committed to being part of the solution. We are members of the Massachusetts Business Coalition for Transportation, joining business and community associations across the state that are developing potential solutions to our traffic and public transportation problems.

Workforce

MassBioEd estimates the Massachusetts life sciences industry to add 12,000 jobs by 2023. Finding talent to fill these roles will require a public/private commitment to training students from across the state, from early in their education through college, whether they are attending MIT or Bridgewater State University, to become proficient in science, technology, engineering and math (STEM).

MassBio regularly advocates in support of policies that will increase the number of students studying STEM and allow these same students to access careers in the life sciences. Additionally, we have a leading Diversity & Inclusion initiative that seeks to create pathways for students of diverse backgrounds to obtain careers in the life sciences through programs such as Project Onramp.   

Federal Priorities

MassBio consistently works to promote a regulatory and legislative environment that enables the life sciences industry to thrive. MassBio has established long-lasting relationships with both lawmakers and regulators in Washington DC and continues to advocate for policies and initiatives on behalf of the industry. Our federal advocacy focuses on a range of issues from: access to reimbursement, paying for value, tax reform, workforce development, immigration, NIH funding, and the regulatory environment.

Federal Legislation

Elijah E. Cummings Lower Drug Costs Now Act (Pelosi)

Under this legislation, the Secretary of Health and Human Services (HHS) would be required to identify 250 brand-name drugs, every year, that lack price competition with the greatest cost to Medicare and the whole U.S health system. The HHS Secretary would directly negotiate with drug manufacturers as many drugs as possible each year, at a minimum of 25, to establish a fair price. The legislation also would establish an upper limit for the price reached in any negotiation as no more than 1.2 times (or 120 percent) of the volume-weighted average of the price of six countries (Australia, Canada, France, Germany, Japan, and the United Kingdom). If a manufacturer refuses to enter into negotiations after being selected, or if the manufacturer leaves the negotiation before a maximum fair price is agreed to, then the manufacturer would be taxed on the gross sales of that drug – starting at 65 percent and increasing by 10 percentage points every quarter out of compliance, to a maximum of 95 percent. This legislation passed in the House by a vote of 230-192 and is now before the Senate. 

MassBio Position: Oppose. This legislation would severely threaten patient access to potentially curative therapies and threaten innovation in the life sciences by compelling companies to enter into forced negotiations and penalizing those that cannot meet the price deemed appropriate by the government. Read MassBio CEO Bob Coughlin’s statement on the House passage of this bill, here.

Current Status: This legislation passed in the House and moved to the Senate where it awaits further action.

Lower Costs, More Cures Act of 2019 (Walden)

Introduced by Republican leadership as an alternative to Speaker Pelosi’s Lower Drug Prices Now Act (H.R. 3), the Lower Costs, More Cures Act strips the most aggressive elements of H.R. 3. However, as drafted, the legislation would require drug manufacturers to pay 10% of drug costs at every stage of Medicare Part D coverage. It would also cap out-of-pocket expenditures for Medicare beneficiaries at $3,100, add a monthly cap for Medicare beneficiaries, and cap co-payments for insulin at $50 per month under Medicare

MassBio Position: Neutral. MassBio supports policies to cap out-of-pocket expenditures for patients, but drug manufacturers should not solely be held liable for drug costs throughout coverage.  

Current Status: Introduced on December 9, 2019 and awaiting action in the House.

United States Mexico Canada Agreement (USMCA)

In the Spring of 2019, the Trump Administration proposed a replacement for the North American Free Trade Agreement (NAFTA).  The proposed replacement, the United States-Mexico-Canada-Agreement (USMCA), included language to provide additional patent protection in Canada and Mexico for biologic medicines developed in the United States. The agreement would have extended exclusivity in Canada and Mexico for 10 years.  On December 10, 2019, House Democrats announced changes to the USMCA that were negotiated with the Trump Administration and approved by the United States, Canada, and Mexico. Among the changes was the removal of the patent protection and data exclusivity language. 

MassBio Position: Oppose. Patents reward innovation for companies that have spent decades and billions of dollars to develop breakthrough treatments. Any attempt to remove IP protections threatens this ingenuity and disincentivizes risk-taking, ultimately harming patients waiting for treatment. Read MassBio CEO Bob Coughlin’s statement on the bill, here.

Current Status: Signed by President Trump on January 29, 2020. The bill must be approved in Canada before it can go into effect.

Drug Importation from Canada

In late July 2019, the Trump Administration outlined a plan to allow the United States to legally import prescription drugs from Canada in hopes of lowering drug prices and out-of-pocket costs for Americans. The Department of Health and Human Services (HHS) and the FDA have developed two pathways under the Trump Administration’s plan to import prescription drugs from Canada. Under Pathway 1, “states, wholesalers, or pharmacists can submit plans for demonstration projects for HHS to review outlining how they would import Health-Canada approved drugs.” Through the second pathway, “manufacturers of FDA-approved drug products would be able to import versions of these FDA-approved drugs that they sell in foreign countries into the U.S.”

Currently, there is no clear number the Administration is expected to save through the outlined drug importation plan. The Congressional Budget Office estimates a similar plan, proposed by Bernie Sanders, could save the government roughly $7 billion over 10 years, but in 2004 CBO concluded that any “reduction in drug spending from importation would be small.”

MassBio Position: Oppose. Any legislation that allows importation from foreign countries opens the potential for fake or counterfeit drugs, threatening the nation’s drug supply and posing significant consequences for patients. Nonpartisan budget experts assert that the costs of drug importation will outweigh any savings expected from the Administration, and, therefore, this proposal will not address the underlying problems around health care costs but will instead lead to a new range of issues that have the potential to inflict harm on patients and local communities.

Current Status: As of December 18th, the Trump Administration had moved forward with the two proposed rulings, but it could still take years before the plan goes into effect. Any state interested in importing drugs would have to write its own plan to be approved by HHS.

Medicaid Block Grant Program – Healthy Adult Opportunity

In January 2020, the Trump Administration released a new Medicaid block grant plan that would let states that have expanded Medicaid coverage under the Affordable Care Act (ACA) close their prescription drug formulary in exchange for capping the federal funding they receive for their Medicaid programs. The plan would still require states to cover one drug per class and all drugs for certain diseases but would give state Medicaid programs the discretion to deny coverage for all other drugs they choose.

MassBio Position: Oppose. MassBio opposes any efforts to close Medicaid formularies. Government should not have the ability to limit the prescription drugs available to patients who are most in need and have no other choice in insurance.

Current Status: Announced on January 30, 2020. To take action, states will have to ask Centers for Medicare and Medicaid Services (CMS) for a waiver and wait for approval.

Medicare Negotiation and Competitive Licensing Act (Doggett, Welch, Cummings)

This bill would allow government interference and price setting of drugs in Part D and permit the U.S. Government to unilaterally bypass existing patent and exclusivity protections to grant ‘compulsory licenses’ to generic or biosimilar manufacturers

MassBio Position: Oppose (Download the letter to the MA Delegation here).

Current Status: Introduced on February 7, 2019. The House heard testimony on the legislation on September 25, 2019.

The Prescription Drug Price Relief Act (Sanders, Khanna)

This bill would require the Secretary of Health and Human Services to ensure that the cost of prescription drugs is no more that the median price of the following five countries: Canada, the United Kingdom, France, Germany, and Japan

MassBio Position: Oppose.

Current Status: Read twice and referred to the Committee on Health, Education, Labor, and Pensions (HELP).

The Medicare Drug Price Negotiation Act (Sanders, Booker, Gillibrand, Harris, Leahy, Reed, Smith and Warren)

This bill would direct the Secretary of the Department of Health and Human Services (HHS) to negotiate lower drug prices in Medicare each year and establish a formulary.

MassBio Position: Oppose.

Current Status: Read twice and referred to the Committee on Finance.

The Affordable and Safe Prescription Drug Importation Act (Sanders)

This bill would allow patients, pharmacists and wholesalers to import safe, affordable medicine from Canada and other major countries.

MassBio Position: Oppose.

Current Status: Introduced January 10, 2019 and referred to the Committee on Health, Education, Labor, and Pensions (HELP).

Hatch-Waxman Integrity Act (Tillis, Flores)

Requires a generic manufacturer wishing to challenge a brand-name drug patent to choose between the Hatch-Waxman framework, which affords certain advantages such as being able to rely on the drug innovator’s safety and efficacy studies for FDA approval, and inter parties review, or IPR, which is cheaper and faster than Hatch Waxman litigation but does not provide the advantages of a streamlined generic approval process. This would apply similarly to patents on biologics.

MassBio Position: Support (Download the letter to the MA Delegation here).

Current Status: Read twice and referred to the Committee on Health, Education, Labor, and Pensions. 

Prescription Drug STAR Act (Neal)

The Prescription Drug STAR Act, which stands for Sunshine, Transparency, Accountability and Reporting would, requires drug manufacturers to publicly justify large price increases for existing drugs and high launch prices on new drugs. When a product increases more than 10 percent a year or 25 percent over three years, manufacturers must report on the cause of that increase.

 It would also require all drug manufacturers to submit information about the average sales prices for doctor-prescribed drugs covered under Medicare Part B; would require that certain manufacturers report the monetary value and quantity of samples they have provided; and would require the Secretary of Health and Human Services to conduct a study on inpatient (Medicare Part A) drug costs, including trends in inpatient drug use by hospital type.

MassBio Position: Any transparency legislation being considered should include transparency for all stakeholders across the entire healthcare system. 

Current Status: Ordered to be Reported by Voice Vote.

International Pricing Index (IPI) Demonstration Model for Medicare Part B (Trump Administration)

This regulatory proposal would create a payment model that would more closely align the cost of physician administered drugs (Medicare Part B) with the prices paid for the same drugs in other countries.

MassBio Position: Oppose (Download the letter to Secretary Azar here).

Current Status: Awaiting further action.

 Prescription Drug Pricing Reduction Act (PDPRA) of 2019 (Grassley)

This bill aims to lower prescription drug prices for seniors in Medicare. As passed out of committee, this bill would set an out-of-pocket maximum of $3,100 for Medicare beneficiaries, beginning in 2022. Once the $3,100 maximum is reached, triggering catastrophic coverage, Medicare is responsible for 20% of drug spending, and insurers are responsible for 60%, reducing federal payment obligations. PDPRA would also penalize pharmaceutical companies, forcing them to pay a rebate, if the price of their drugs in Medicare rise faster than the rate of inflation. For Medicare Part B, the rebate requirement is triggered when the prices for drugs and biologics exceed inflation; and for Medicare Part D, the rebate requirement is triggered if the list price for brand drugs or biologics increases faster than inflation over a 6-month period. After considering 110 amendments to the proposal, the Senate Finance Committee approved this bill by a 19-9 vote, as modified, and advanced it to the full Senate. This bill is viewed as the most likely to move through Congress and enact drug pricing reform.

MassBio Position: Oppose.

Current Status: Placed on Senate Legislative Calendar under General Orders.