Close

BIO Submits Comments re: CY 2020 Medicare Physician Fee Schedule Proposed Rule

BIO offers comments on the following areas in the proposed rule, with an emphasis on ensuring that Medicare beneficiaries have access to the full range of items and services necessary to their health: • BIO appreciates the opportunity to comment on the agency’s future consideration of bundled payments under the PFS but urges CMS to prioritize patient access to appropriate therapies and to weigh the results of other demonstrations underway rather than attempting to swiftly implement bundled payments. • BIO supports the proposal to retain more granular payments for Evaluation and Management (E/M) services, which we think will support access to appropriate care for the sickest patients. • BIO appreciates the efforts CMS is making to treat patients with opioid addiction and offers comments about the agency’s proposals in this area, again with an emphasis on ensuring patient access to appropriate care.

BIO Submits Comments Re: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems (OPPS) and Quality Reporting Programs Proposed Rule

On September 27, BIO submitted final comments in response to the CY 2020 Outpatient Prospective Payment System Proposed Rule. BIO members are eager to improve health care through the discovery and advancement of new therapies and thus are supportive of appropriate reimbursement in our health care system both to ensure that beneficiaries have proper access to care and to encourage investment in innovation. BIO has evaluated each of CMS's proposals to ensure that they support continued access to crucial treatments and therapies in the hospital outpatient setting for Medicare beneficiaries. We briefly describe our feedback on these proposals in more detail in the balance of the letter. 

BIO Submits Comments Re: Medicare CY 2020 Part D Draft Call Letter

BIO supports CMS’ commitment to improving the quality and delivery of care in the MA and Part D programs. We believe it is critically important to ensure that policies in these programs advance patient access to timely and appropriate treatment, particularly for prescription drugs and vaccines. To that end, we provide comments in the following areas: The specialty tier is an outdated approach that presents risks for vulnerable beneficiaries and should be re-evaluated; Coinsurance in the Part D non-preferred drug tier can unduly limit access to care for patients with severe and complex diseases; Increased enforcement of nondiscrimination should be used when evaluating benefit design in the MA and Part D programs; MA and Part D plans should prioritize and increase access to vaccinations for Medicare beneficiaries; The timeframes and processes for formulary updates should support the inclusion of new therapies; CMS must go further in protecting beneficiaries enrolled in Medicare Advantage who may be subject to step therapy; CMS should mitigate the impact of the increase in the out-of-pocket (OOP) threshold for CY 2020; MA plans should have the flexibility to determine what constitutes a chronic condition for purposes of providing special supplemental benefits for the chronically ill; Additional flexibility in design of maximum OOP costs should be considered to assist beneficiaries; Drug tier labels should accurately reflect the tier’s composition; Inclusion of additional measures in the Star Ratings are critical to accurate assessment of patient care and quality; Access to innovative treatment options for pain and addiction should be prioritized as a part of addressing opioid overutilization in MA and Part D plans.

BIO Submits Comments re: Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses Proposed Rule

On January 25, BIO submitted comments in response to the Centers for Medicare and Medicaid Services' (CMS') Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses Proposed Rule. BIO is extremely concerned to see the Agency continue to focus on policy changes that erode the value of the Medicare benefit for seniors, placing patient access at risk. This Proposed Rule is yet another in a series of proposals that prioritize cost containment policies over patient healthcare needs. BIO respectfully requests that the Agency and Administration instead focus on holistic solutions that balance the financial sustainability of the Medicare program, while addressing patient out-of-pocket cost and access to appropriate treatment. Our concerns, detailed further in the balance of this letter, focus on the following: I. CMS should not allow plans to restrict access in the Medicare Part D six protected classes, as plans already have flexibility to manage these drugs in a clinically appropriate manner. II. CMS must go further in protecting beneficiaries enrolled in Medicare Advantage who may be subject to step therapy for their Part B drugs. III. CMS should not move forward with the inclusion of drug pricing information in the explanation of benefits, and instead focus on the updates to e-Prescribing standard to appropriately share cost information. IV. CMS must continue to work to ensure that patients see the benefit of negotiated prices reflected in their out-of-pocket (OOP) costs. V. CMS should move forward with the proposed requirements prohibiting gag clauses.

BIO Submits Comments Re: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems (OPPS) and Quality Reporting Programs Proposed Rule

On September 24, BIO submitted final comments in response to the CY 2019 Outpatient Prospective Payment System Proposed Rule. This year’s OPPS rule included a Request for Information (RFI) around the potential development of a new innovation model for delivery of Part B drugs, using CMS’ authority under the previously existing Competitive Acquisition Program (CAP) – of which the original iteration was discontinued in 2008 after failing to attract participants and costing more than the traditional reimbursement structure in Part B. BIO outlined the need for CMS to be thoughtful and measured in the development of models that are voluntary and support a competitive, market-driven approach, including that any models properly address: (1) adequate protections for patient access to clinically appropriate care and lowering costs to beneficiaries; (2) not creating interference that erodes the existing coverage and reimbursement structure, (3) encouraging robust competition and avoiding misaligned incentives; (4) ensuring workability for physicians who may choose to participate; (5) considering appropriate exemptions for certain drugs and biologicals; and (6) transparency in model design, development, and assessment processes.

BIO Submits Comments Re: CY 2019 Medicare Physician Fee Schedule and Other Revisions to Part B

BIO represents an industry that is devoted to discovering new treatments and ensuring patient access to them. Accordingly, we closely monitor changes to Medicare’s reimbursement rates and payment policies for their potential impact on innovation and patient access to drugs and biologicals. As a threshold matter, we raise our concern with the implementation of a policy that can have such impacts in limiting access for beneficiaries in MA via the application of step therapy, as detailed in the Administration’s August 7th memo.2 As detailed in our letter to the Administration, we are particularly concerned with the lack of specificity or detail in this memo around critical patient protections and appropriate implementation, including ensuring: sufficient oversight by CMS; clear clinical criteria for step therapy policies; transparency into, and communication of, step therapy policies to beneficiaries and robust beneficiary protections; timely exceptions and appeals processes; sufficient protections for those on existing therapies; and protection for beneficiaries from higher cost-sharing.

BIO Submits Comments Re: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs

First and foremost, this is an extraordinary time for biotechnology. The therapies in development and coming to the market are unlike any we have seen in the history of medicine. We have entered into a new era of medicine, and BIO members are making discoveries that were unimaginable a decade ago. The days of traditional chemical drugs that treat broad classes of patients in blunt ways are giving way to the development of entirely new ways to treat and ultimately cure disease for targeted patient populations using living organisms, including a patient’s own cells. We have already seen the first wave of these advances reach the marketplace, with many more already in the Food & Drug Administration (FDA) regulatory process. However, BIO and our members recognize that too many patients – even those with insurance – cannot afford the life-saving cures and treatments that biopharmaceutical companies are developing. We stand with the Trump Administration in our shared commitment to addressing this serious problem. To accomplish this, we must harness – not abandon – the free market that has delivered amazing innovations for patients and made America first in the world in biomedical innovation. That’s why BIO has joined with stakeholders across the healthcare spectrum – including insurers, Pharmacy Benefit Mangers (PBMs), employers, and patient groups – in a coalition that developed and supports consensus, market-based reforms to lower drug costs without harming innovation.

BIO Submits Comments Re: Hospital Inpatient Prospective Payment Systems (IPPS) Proposed Rule

BIO’s comments on the Proposed Rule are focused on the following areas:  Proposed changes to the IPPS for coverage and payment of Chimeric Antigen Receptor T-cell (CAR T) Therapy and other Transformative Therapies;  Updates to the Medicare Severity – Diagnosis Related Groups (MS-DRG) to appropriately account for care delivered, including for patients with rare diseases;      Applications for FY 2019 New Technology Add-On Payments (NTAP) and the process for determination of receipt of NTAP status;  Improving patient outcomes and reducing burden through meaningful measures and expanding access to vaccines through appropriate quality measures; and  Requirements for hospitals to make public a list of their standard charges via the Internet.

BIO Submits Comments Re: CY 2019 Medicare Advantage and Part D Call Letter

BIO supports CMS’s commitment to improving the quality and delivery of care in the MA and Part D programs. We believe it is critically important to ensure that policies in these programs advance patient access to timely and appropriate treatment, particularly for prescription drugs and vaccines. To that end, we provide comments in the following areas: The specialty tier eligibility cost threshold should be increased for 2019 and in future years and the exceptions process expanded to ensure that the specialty tier does not discriminate against vulnerable beneficiaries;  Co-insurance in the Part D non-preferred drug tier can unduly limit access to care for patients with severe and complex diseases;  Increased enforcement of nondiscrimination should be used when evaluating benefit design in the MA and Part D programs;  Access to innovative treatment options for pain and addiction should be prioritized as a part of addressing opioid overutilization in MA Part D plans;  MA and Part D plans should prioritize and increase access to vaccinations for Medicare beneficiaries;  The timeframes and processes for formulary updates should support the inclusion of new therapies;  Drug tier labels should be accurately reflective of the tier’s composition.  The inclusion of prescription drug costs in Medicare advantage uniformity flexibility should provide patient access to the most appropriate treatment;  Additional flexibility in design of maximum out-of-pocket costs should be considered to assist beneficiaries;  The availability of suitable plan offerings should be increased through removal of the meaningful difference requirements;      Additions to the Star Ratings are critical to accurate assessment of patient care quality; and  Efforts to expand coverage for certain subsets of products MA-PD plans should focus across all drugs offered under the Part D program.

BIO Applauds Introduction of the Ensuring the Value of the 340B Program Act of 2018

Washington, DC (March 1, 2018) – BIO President and CEO Jim Greenwood issued the following statement today regarding the introduction by Senator Charles Grassley of S. 2453, the Ensuring the Value of the 340B Program Act of 2018: