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Representative Jonathan Jackson Joins 71 Members of Congress Advocating for Continued Prescription Drug Imports

Representative Jonathan Jackson Joins 71 Members of Congress Advocating for Continued Prescription Drug Imports

Representative Jonathan Jackson (D-Illinois) is among 71 members of Congress who have signed a letter urging the Secretary of Health and Human Services (HHS), the Secretary of Homeland Security (DHS), and the commissioners of the Food and Drug Administration (FDA) and Customs and Border Protection (CBP) to ensure the continued allowance of prescription drug imports for personal use. The letter, led by U.S. Representatives Jan Schakowsky (IL-09) and Mark Pocan (WI-02), expresses concern that new CBP procedures for international mail shipments, set to take effect on October 22, could disrupt the ability of approximately 2.3 million Americans to obtain lower-cost prescription medicines from Canada and other countries. The members acknowledge CBP's goal of using better data to identify and intercept high-risk shipments but are worried that the new process might prevent or routinely refuse personal-use prescription medicines, including those obtained from licensed pharmacies abroad. They advocate for using impr...

Congresswoman Diana Harshbarger Introduces Dietary Supplement Innovation Act to Modernize FDA Drug Preclusion

Congresswoman Diana Harshbarger Introduces Dietary Supplement Innovation Act to Modernize FDA Drug Preclusion

Congresswoman Diana Harshbarger (R-TN) has introduced the Dietary Supplement Innovation Act (H.R. 10336), a legislative effort aimed at modernizing the Food and Drug Administration’s (FDA) drug preclusion provision. This bill seeks to resolve long-standing disputes within the dietary supplement industry regarding drug preclusion. The proposed legislation would replace the current ambiguous standard of “substantial clinical investigations” with a more defined trigger based on Phase 2 or Phase 3 clinical trials. Additionally, it aims to provide relief for drug programs that have been inactive for extended periods, direct the FDA to consider differences in dose, route, concentration, and composition, and offer enhanced judicial-review protections. While some dietary supplement trade associations, such as CRN, CHPA, and AHPA, have welcomed the bill as a balanced compromise, others, like the NPA, express concerns that it might inadvertently enshrine pharmaceutical gatekeeping mechanisms into law, potentially li...

CMS Finalizes Narrowed GLOBE Model for Medicare Part B Drug Pricing, Projecting Reduced Savings

CMS Finalizes Narrowed GLOBE Model for Medicare Part B Drug Pricing, Projecting Reduced Savings

The Centers for Medicare & Medicaid Services (CMS) has finalized the Global Benchmark for Efficient Drug Pricing (GLOBE) Model, a new payment model designed to lower prescription drug costs under Medicare Part B. This model targets certain drugs administered in clinical settings, such as those for cancer or autoimmune conditions, by requiring manufacturers to provide rebates if their prices exceed those in economically comparable countries. The GLOBE Model, which will launch on January 1, 2027, and run for five years, is significantly narrower in scope than initially proposed. Exclusions from the model now include orphan-only drugs, biosimilars and their reference biologics once biosimilar competition enters the U.S. market, Inflation Reduction Act drug price negotiation-eligible drugs, plasma-derived products, and certain cell and gene therapies. These expanded exclusions have drastically reduced the projected savings from $11.9 billion in the proposed rule to an estimated $440 million over five years in ...

Representatives Introduce Surge to Save Newborns Act to Expand Federally Recommended Screenings

Representatives Introduce Surge to Save Newborns Act to Expand Federally Recommended Screenings

U.S. Representatives Nick Langworthy and Kim Schrier have introduced the bipartisan Surge to Save Newborns Act. This legislation aims to provide $35 million annually from 2027 through 2031 to assist states in implementing federally recommended newborn screenings, including for conditions like Krabbe disease. The initiative follows the federal government's decision on January 30, 2024, to include Krabbe disease on the national Recommended Uniform Screening Panel. However, federal approval does not automatically ensure that all states have the necessary funding or infrastructure to conduct these tests. The bill seeks to bridge this gap, ensuring that every state can adopt and effectively utilize these critical screenings. The effort is championed by individuals like Jill Kelly, wife of NFL legend Jim Kelly, whose son Hunter passed away from Krabbe Leukodystrophy, a condition treatable if diagnosed at birth.

Cerapedics' PearlMatrix Bone Graft Receives Medicare NTAP Status, Accelerating Lumbar Fusion Reimbursement

Cerapedics' PearlMatrix Bone Graft Receives Medicare NTAP Status, Accelerating Lumbar Fusion Reimbursement

Cerapedics Inc., a musculoskeletal company, has announced that its PearlMatrix P-15 Peptide Enhanced Bone Graft has been granted New Technology Add-On Payment (NTAP) status by the Centers for Medicare & Medicaid Services (CMS). This designation, effective October 1, 2026, provides supplemental Medicare reimbursement to hospitals and healthcare facilities utilizing PearlMatrix for skeletally mature patients with degenerative disc disease in the lumbar spine. PearlMatrix is a Class III drug-device combination product that has received U.S. FDA Breakthrough Device designation. The NTAP status was granted under CMS' alternative pathway, recognizing the product's transformative nature and its potential to address a critical need for faster fusion products. PearlMatrix is the first and only bone growth accelerator proven to substantially increase lumbar fusion speed, demonstrating superior results in a pivotal premarket approval study, including for high-risk patients.

Trump says US to send one-time $90 payment to 20 million seniors enrolled in Medicare

Trump says US to send one-time $90 payment to 20 million seniors enrolled in Medicare

By Kanishka Singh WASHINGTON, Oct 2 (Reuters) - President Donald Trump said the US government will send a one-time $90 payment to more than 20 million Americans enrolled in Medicare, a health insurance program for the elderly, to help offset the cost of their monthly medical insurance premiums.

Lawmakers Reintroduce Bill to Establish National Critical Minerals Council

Lawmakers Reintroduce Bill to Establish National Critical Minerals Council

A bipartisan group of lawmakers in both the House and Senate has reintroduced legislation aimed at creating a 'National Critical Minerals Council.' The proposed council would be responsible for developing a comprehensive national strategy for critical minerals and coordinating related policies across various federal government agencies. Senators John Hickenlooper (D-CO), Thom Tillis (R-NC), Jacky Rosen (D-NV), Tim Sheehy (R-MT), and Kevin Cramer (R-ND) announced the 'National Critical Minerals Council Act.' They are joined by Representatives Susie Lee (D-NV) and Russ Fulcher (R-ID). This initiative underscores a growing recognition within Congress of the strategic importance of critical minerals for national security, economic competitiveness, and technological advancement. The reintroduction of this bill suggests a continued push to address the nation's reliance on foreign sources for these essential materials and to bolster domestic supply chains.

Rep. Beth Van Duyne Co-Sponsors Bipartisan Bill to Reform Hospice Oversight and Increase Penalties

Rep. Beth Van Duyne Co-Sponsors Bipartisan Bill to Reform Hospice Oversight and Increase Penalties

Rep. Beth Van Duyne (R-Texas) has co-sponsored the Enhancing Hospice Oversight and Transparency Act alongside Rep. Panetta. This bipartisan bill aims to reform the Hospice Special Focus Program (SFP), which is currently on hold by the Centers for Medicare and Medicaid Services (CMS). The proposed legislation seeks to improve the program's implementation and increase transparency. A key provision of the bill is to raise the penalty for hospices that fail to report quality measure data. Currently, the penalty stands at 4%, but the new act would increase it to 10% by 2027. The bill also intends to delay the implementation of the SFP until CMS can align it with congressional intent and requires the agency to provide hospices with a report 60 days before any public designation. This initiative is driven by a desire to prevent fraudulent activities within the hospice industry while ensuring that legitimate providers are not unfairly penalized.

Representative Glenn Grothman Reintroduces Cancer Drug Parity Act to Address Oral Chemotherapy Costs

Representative Glenn Grothman Reintroduces Cancer Drug Parity Act to Address Oral Chemotherapy Costs

Representative Glenn Grothman (R, Wisconsin) has reintroduced the Cancer Drug Parity Act (H.R. 4101). This proposed legislation aims to amend the federal Employee Retirement Income Security Act (ERISA) to ensure that self-funded employer health plans provide no-less-favorable cost-sharing for oral anticancer drugs compared to intravenous (IV) anticancer drugs. The reintroduction follows a September 15 House Oversight subcommittee hearing where witnesses highlighted significant disparities in out-of-pocket costs for oral chemotherapy. Dr. Sheetal M. Kircher of Northwestern University presented research indicating that patients facing over $500 in out-of-pocket costs were four times more likely to abandon oral cancer treatment than those paying $100 or less. While 43 states and the District of Columbia have oral chemotherapy parity laws, these laws do not apply to self-funded employer plans, which fall under federal ERISA regulations, creating a gap in coverage equity.

Congressman Bentz Introduces Legislation to Centralize Federal Health Data Access

Congressman Bentz Introduces Legislation to Centralize Federal Health Data Access

U.S. Representative Cliff Bentz of Oregon's 2nd Congressional District has introduced the Public Access to HHS Health Data Act (H.R. 10616). This legislation, introduced on September 28, aims to mandate the U.S. Department of Health and Human Services (HHS) to consolidate its publicly available datasets onto a single, centralized website. According to Bentz's office, HHS currently maintains tens of thousands of datasets spread across numerous websites, making it challenging for individuals to locate crucial healthcare information. The proposed bill would also require HHS to provide Congress with reports detailing the number and types of datasets made accessible, their update frequency, and any obstacles preventing the publication of additional information. Congressman Bentz emphasized that improved access to data is essential for enhancing the healthcare system, stating that his act would help various groups quickly access vital information. This initiative focuses on public access to de-identified health ...

HHS Office of Inspector General Identifies $72 Million in Improper Medicare Payments to Excluded Providers

HHS Office of Inspector General Identifies $72 Million in Improper Medicare Payments to Excluded Providers

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) has uncovered that Medicare Advantage Organizations and Prescription Drug Plans made approximately $72 million in payments over a three-year period (2022-2024) for services associated with providers or individuals who were excluded from federal healthcare programs or convicted of certain felonies. The OIG's audit revealed vulnerabilities in the Centers for Medicare & Medicaid Services (CMS) preclusion process. Specifically, 249 out of 1,017 revoked National Provider Identifiers (NPIs) received payments for Medicare Part C and Part D services. The issues identified include timing discrepancies and errors in CMS's process of adding or removing providers from the Preclusion List. Additionally, some organizations were not included on the Preclusion List even when their owners had exclusions or felony convictions. Current regulations also exempt pharmacies that only fill prescriptions, not prescribe Part D drugs, from precl...

Senator Angus King Co-Sponsors Bipartisan Bill to Expand Veterans' Access to High-Cost Medications

Senator Angus King Co-Sponsors Bipartisan Bill to Expand Veterans' Access to High-Cost Medications

U.S. Senator Angus King (I-Maine) has co-sponsored a bipartisan bill, the 'Providing Veterans Essential Medications Act,' aimed at expanding access to high-cost medications for veterans residing in state veterans' homes. The proposed legislation would mandate the Department of Veterans Affairs (VA) to reimburse these state facilities for medications exceeding 8.5% of their per diem rate, or alternatively, provide the medications directly. This initiative seeks to align the reimbursement policies for state veterans' homes with those already available to many private nursing homes that contract with the VA. Currently, the VA covers high-cost medications for severely disabled veterans living outside these state facilities but does not extend the same coverage to those within them. Senator King emphasized that veterans should receive consistent care regardless of their chosen living arrangement, stating that if the VA covers medications in private nursing homes, the same should apply to state-run veterans' hom...