On Nov. 8, 2023, the Senate Finance Committee voted 26-0 to approve the Better Mental Health, Lower Cost Drugs, and Extenders Act. Among its other provisions, the bill, for which final legislative text has not yet been released, would, for the first time, mandate minimum prices that Medicare Part D plans, and the pharmacy
CMS Specifies Info Needed for Small Biotech Exception to Medicare Drug Price Negotiation
As the September 1, 2023 deadline for Centers for Medicare & Medicaid Services (CMS) to publish the first 10 “selected drugs” subject to negotiation of “maximum fair prices” under Medicare Parts B and D fast approaches, CMS has recently specified information that manufacturers must submit in order for their drugs to qualify for the “Small Biotech Exception” to being included on the list. The information is to be submitted during the summer of 2023; the specific deadline has not yet been announced.
On August 16, 2022, President Biden signed into law the Inflation Reduction Act of 2022 (IRA). Among other provisions, the IRA provides for the CMS to negotiate “maximum fair prices” with manufacturers of “selected drugs” covered under Medicare Parts B and D. The price negotiation process begins on September 1, 2023, when CMS is required to publish the list of the first 10 selected drugs subject to negotiation, for maximum fair prices which will take effect beginning January 1, 2026.
The IRA provides that the selected drugs will be the 10 “negotiation-eligible drugs” having the highest total expenditures under Medicare Part D during the period June 1, 2022 through May 31, 2023. Negotiation-eligible drugs generally consist of “qualifying single-source drugs”, which are generally defined as branded drugs and biologicals approved by the Food and Drug Administration (FDA) at least 7 years (with respect to drugs) or 11 years (with respect to biologicals) before the date the list is published, and which do not have a marketed generic equivalent or biosimilar. However, for 2026 through 2028, the IRA provides that negotiation-eligible drugs exclude certain drugs under what CMS refers to as the “Small Biotech Exception”.Continue Reading CMS Specifies Info Needed for Small Biotech Exception to Medicare Drug Price Negotiation
FTC announces inquiry into PBM practices and orders PBMs to provide information
On June 7, 2022, the Federal Trade Commission (FTC) announced that it would conduct an inquiry into the competitive impact of contracting and other business practices of pharmacy benefit managers (PBMs), including their effects on access to and affordability of prescription drugs. As part of the inquiry, which is similar to FTC inquiries into other aspects of the health care industry, the FTC issued orders under Section 6(b) of the FTC Act requiring the six largest PBMs to provide information and records to the Commission.
The five FTC commissioners voted unanimously on June 6, 2022 to conduct the study and issue the Section 6(b) orders. According to the FTC mission statement, Section 6(b) “enables [the FTC] to conduct wide-ranging studies that do not have a specific law enforcement purpose.”
In February, an earlier proposed review of PBMs failed to receive approval on a 2-2 party-line vote, with the two Republican Commissioners, Noah J. Phillips and Christine S. Wilson, voting against the proposed study. Commissioner Alvaro Bedoya was confirmed by the Senate in May, giving Democrats three seats on the Commission.
Commissioners Phillips and Wilson issued a statement indicating that they had voted to approve the current inquiry because it has a different scope than the previously proposed study, including relationships between PBMs and both pharmacies and pharmaceutical manufacturers, “including, critically, how those practices might impact out-of-pocket costs for consumers.”
The FTC stated that its inquiry will examine PBMs’ role as middlemen who are hired by health plans to negotiate rebates and fees with drug manufacturers, create drug formularies and related policies, and reimburse pharmacies for patients’ prescriptions. The Commission said that PBMs “often have enormous influence on which drugs are prescribed to patients, which pharmacies patients can use, and how much patients ultimately pay at the pharmacy counter.” Chair Linda M. Khan stated that the FTC had received complaints about PBM practices from patients and professionals across the healthcare system, several of which the inquiry will examine. Continue Reading FTC announces inquiry into PBM practices and orders PBMs to provide information
CMS Rolls Out New Medicare Part D “Senior Savings Model” Designed to Drive Down Insulin Copayments
The Centers for Medicare and Medicaid Services (CMS) has announced a new voluntary Part D Senior Savings Model (the Model) intended to reduce Medicare beneficiary cost sharing for insulin. Under the Model, participating insulin manufacturers and participating sponsors of Medicare Part D prescription drug plans (PDPs) and Medicare Advantage Part D plans (MA-PDs) will make available 30-day supplies of insulin to beneficiaries of certain “enhanced benefit” PDPs and MA-PDs, with cost-sharing capped at no more than $35 during all phases of the Part D benefit, other than the catastrophic benefit.
The Model appears to reflect a balancing of plan and manufacturer concerns. If there is significant participation by Part D sponsors, the Model could provide meaningful relief to beneficiaries facing high out-of-pocket costs for insulin under Part D. As of the writing of this post, three of the largest insulin manufacturers – Eli Lilly, Novo Nordisk and Sanofi Aventis –have announced their intention to participate.
The Model, which was announced March 11, 2019, will be a five-year program, beginning in plan year 2021. CMS is offering the Model through the Center for Medicare and Medicaid Innovation (CMMI) pursuant to authority under section 1115A of the Social Security Act (added by the Affordable Care Act). The following is a summary of the new Model, along with our initial observations regarding some of its implications.Continue Reading CMS Rolls Out New Medicare Part D “Senior Savings Model” Designed to Drive Down Insulin Copayments
OIG’s Proposed Drug Pricing Safe Harbor Amendments: “Hot Takes”
Late yesterday, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) released a proposed rule to amend the anti-kickback safe harbors[1] in response to perceived risks that rebates paid by pharmaceutical manufacturers to payors and pharmacy benefit managers (PBMs) may contribute to pharmaceutical list price inflation and not benefit patients and payors. The proposed rule would (i) remove safe harbor protection for drug manufacturer rebates to Part D plans, Medicaid managed care organizations, and PBMs acting under contract with either type of entity, (ii) establish a new safe harbor protecting manufacturer “point of sale” price reductions on Part D and Medicaid managed care drug utilization, and (iii) establish a new safe harbor protecting certain service fees paid by drug manufacturers to PBMs. The proposed rule is scheduled to be published in the Federal Register on February 6, 2019, with a 60-day public comment period.
Reed Smith’s Life Sciences and Health Industry Group will be preparing a more detailed client bulletin analyzing the potential implications of the proposed rule and identifying areas for comment. In the meantime, here are a few of our “hot takes” to consider as you review the proposal.
Continue Reading OIG’s Proposed Drug Pricing Safe Harbor Amendments: “Hot Takes”
HHS Proposes Changes to HIPAA Transaction Standard for Prescriptions for Schedule II Drugs in Retail Pharmacy Transactions
The Department of Health and Human Services (HHS) has issued a proposed rule that would modify the current HIPAA transaction standard for retail pharmacy transactions (the August 2007 revision of NCPDP telecommunications standard D.0) with respect to claims and similar transactions for Schedule II drugs. HHS states that the change would enable covered entities to
CMS Launches New Medicare Part D Payment Modernization Model
The Centers for Medicare & Medicaid Services (CMS) has announced a new Medicare Part D Payment Modernization Model (Part D Model), which will be tested by the CMS Center for Medicare and Medicaid Innovation. CMS unveiled the Part D Model on January 18, 2019, at the same time the agency released details on extensive revisions to its current Medicare Advantage Value-Based Insurance Design (VBID) model. On January 31, 2019, CMS provided additional detail on the new Part D Model during a webinar (the webinar will be repeated on February 6, 2019).
The Part D Model is a voluntary, five-year (CY 2020-2024) model open to standalone prescription drug plans (PDPs) and Medicare Advantage Prescription Drug Plans (MA-PDs), on a nationwide basis. As discussed below, the model is intended to decrease Part D program spending by: (i) introducing two-sided risk to participating plans for spending in the catastrophic portion of the Part D benefit, and (2) enhancing plan flexibilities to propose clinically-based drug utilization management techniques, including through rewards and incentives programs for plan beneficiaries.
Two-sided risk for the catastrophic portion of the Part D benefit.
For plans accepted into the program, CMS will retrospectively (after the plan year has been completed) establish a target benchmark representing the federal catastrophic reinsurance subsidy amount (80% of Part D catastrophic phase costs after manufacturer rebates and other Direct and Indirect Remuneration) that would have been paid to participating organizations if they were not participating in the model. The benchmark will be calculated after adjustment for certain factors, such as enrollee health and low-income subsidy status, and separate benchmarks will be calculated for participating PDPs and MA-PDs. If the reinsurance subsidy amount (after adjustment) for the organization’s participating PDPs or MA-PDs (as applicable), calculated at the parent organization level, is lower than the applicable target benchmark, the organization will receive a portion of the difference (referred to by CMS as “savings”), and if it is higher than the benchmark, the organization must pay to CMS a portion of the difference (referred to by CMS as “losses”). Specifically:
Continue Reading CMS Launches New Medicare Part D Payment Modernization Model
CMS Announces Significant Expansion of and Increased Flexibility under Medicare Advantage Value-Based Insurance Design (VBID) Model
The Centers for Medicare & Medicaid Services (CMS) is making extensive revisions to its Medicare Advantage (MA) Value-Based Insurance Design model in order “to contribute to the modernization of Medicare Advantage through increasing choice, lowering cost, and improving the quality of care for Medicare beneficiaries.”
By way of background, the VBID innovation model was launched
OIG Moving Ahead on Changes to Anti-Kickback Safe Harbor Protection for Drug Rebates to Plans, PBMs
On July 18, 2018, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) submitted to the Office of Management and Budget (OMB) for regulatory review a proposed rule entitled “Removal Of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor
Trump Administration Proposes Rules to Expand Short-Term, Limited Duration Insurance Plans
The Trump Administration has issued a potentially highly-significant proposed rule intended to expand the availability of short-term, limited duration insurance policies that are exempt from Affordable Care Act (ACA) qualified health plan standards. Under the proposed rule, issued by the Departments of Treasury, Labor, and Health and Human Services (the “Departments”), the maximum duration of
Looking Ahead to a Trump Administration: Health Care and Life Sciences Industry Perspectives
Observers are digesting what the Trump Administration will mean for the health care and life sciences industry. Forecasting is more challenging for this incoming Administration than most given the relatively sparse policy details released during the campaign and the lack of a government service record to examine for clues. Today President-elect Trump’s transition team released a one-page statement on health care policy, but many questions remain. Nevertheless, we offer below our initial observations and issues to watch in the months to come.
- Potential Sea Change. Uncertainty is, as some like to say, the “obvious comment” that characterizes the whole prospective Trump Administration. Other than an intended “repeal and replacement” of the Affordable Care Act (ACA), President-elect Trump has provided relatively few details on a proposed health care agenda. Until these policies are fleshed-out, expect an environment where some business decisions and investments may be delayed, with a resulting impact on merger and acquisition activity. That said, other transactions may become more likely, as the threat of new restrictions under a Clinton administration are removed, along with the prospect of potential regulatory relief under a Republican-controlled federal government.
- Affordable Care Act Repeal and Replacement. Trump has repeatedly indicated his desire to repeal and replace the ACA, including a vow to summon Congress into a special session for this task. If the law is repealed, however, what would take its place, and how would Congress address the roughly 20 million Americans currently covered in some way under the ACA (and the potential rise in uncompensated care costs that also would result)? Despite the call for repeal, certain parts of the law are popular. For instance, President-elect Trump noted on the campaign trail that he was in support of the ACA’s prohibition against the use of pre-existing health conditions to deny coverage (or as a basis for premium-setting). Other proposals offered by Trump as candidate include allowing for the sale of health insurance across state lines as long as plans comply with state requirements, various tax benefits, and more transparency in health care pricing. In today’s policy statement, President-elect Trump added support for high-risk pools, which he characterizes as “a proven approach to ensuring access to health insurance coverage for individuals who have significant medical expenses and who have not maintained continuous coverage.” Congressional Republicans have offered a number of alternatives that are likely to be a springboard for reform, most notably the “Better Way” plan proposed by House Speaker Paul Ryan. In fact, according to the Speaker’s office, “in the 114th Congress alone, House Republicans have introduced more than 400 individual bills that would improve our nation’s health care system” – demonstrating that Congress is not reticent about legislating on health care issues. The new Senate’s Republican majority will not have the 60 votes required to override a potential Democratic filibuster of legislation to fully repeal the law. While Congress could use budget reconciliation authority (which requires only 50 votes in the Senate) to make significant changes, the drawn-out pace of the budget process may not satisfy those who want quick action in this area. Regardless of the legislative vehicle, after years of calling for Obamacare repeal while President Obama was in office, the Republican Congress will be under tremendous pressure to act quickly – even if it is a “down-payment” on reform — now that Republicans will control the presidency and the Congress.
Donald Trump Proposes Prescription Drug Importation as Element of Health Reform Plan
Donald Trump has released his plan for “Healthcare Reform to Make America Great Again”, which includes a proposal for allowing importation of cheaper prescription drugs from other countries as one of the reforms he believes should be enacted in connection with repealing and replacing “ObamaCare.” Specifically, the plan states that Congress must:
Remove barriers to
HHS OIG Paints with Broad Brush in Criticizing Drug Manufacturer Coupon Programs
On September 19, 2014, the Office of Inspector General (OIG) of the Department of Health & Human Services issued a Special Advisory Bulletin (SAB) in which it identified several potential regulatory risks to federal health care programs as the result of coupon programs used by drug manufacturers to reduce or eliminate patient copayments for brand-name drugs. In the SAB, the OIG explains that coupon program sponsors and pharmacies will risk the receipt of penalties if they do not take steps to actively prevent federal health care program beneficiaries from using the coupons. According to the OIG, these coupon programs qualify as examples of remuneration offered to consumers to encourage the purchase and use of specific items, and therefore implicate the federal Anti-Kickback Statute. In addition, a claim that includes items or services resulting from such a kickback violation would constitute a false or fraudulent claim under the False Claims Act.
Continue Reading HHS OIG Paints with Broad Brush in Criticizing Drug Manufacturer Coupon Programs
CMS Releases Long-Awaited Proposed Rule to Implement ACA Medicaid Manufacturer Rebate and Pharmacy Reimbursement Provisions
On Friday, January 27, 2012, the Centers for Medicare & Medicaid Services (“CMS”) released its long-awaited proposed rule to implement the provisions of the Affordable Care Act (“ACA”) relating to pharmaceutical manufacturer payment of Medicaid rebates and limits on Medicaid reimbursement to pharmacies. The proposed rule addresses a number of important policy issues relevant to pharmaceutical manufacturers, pharmacies, and other providers, and also would pose significant operational challenges for pharmaceutical manufacturers with respect to the Medicaid Drug Rebate Program (“MDRP”).
Continue Reading CMS Releases Long-Awaited Proposed Rule to Implement ACA Medicaid Manufacturer Rebate and Pharmacy Reimbursement Provisions
CMS Discusses Details of New “National Average Drug Acquisition Cost” Survey
On August 4, 2011, CMS held an “External Stakeholders Meeting” at its Baltimore headquarters to discuss the development of a survey for what it is now calling “National Average Drug Acquisition Cost” or “NADAC”. Earlier this year, CMS announced that it would publish a pricing benchmark based upon pharmacies’ acquisition costs for both brand and generic drugs, which State Medicaid programs could use instead of Average Wholesale Price (AWP) or Wholesale Acquisition Cost (WAC) to establish pharmacy reimbursement rates. CMS has entered into a contract with Myers & Stauffer, LC, to develop NADAC; Myers & Stauffer currently collects pharmacy acquisition costs for Oregon and Alabama, two states that have made such costs an element of their Medicaid pharmacy reimbursement.
Continue Reading CMS Discusses Details of New “National Average Drug Acquisition Cost” Survey
CMS Awards “Survey of Retail Prices” Contract to Myers and Stauffer – Moves One Step Closer to Average Acquisition Cost
On July 8, 2011, CMS announced that it had awarded Myers and Stauffer, LC a contract to prepare a monthly survey of retail community pharmacy (“RCP”) prescription drug prices. The contract is in furtherance of CMS’s commitment to develop and publish “Average Acquisition Cost” data reflecting RCPs’ purchase costs for all covered outpatient drugs, for potential use by State Medicaid agencies in rate-setting.
Continue Reading CMS Awards “Survey of Retail Prices” Contract to Myers and Stauffer – Moves One Step Closer to Average Acquisition Cost
Reed Smith Health Care Reform Review: The Affordable Care Act – Analysis and Implications for Drug, Device and Biotech Manufacturers
In April 2010, Reed Smith provided an extensive analysis of the recently-enacted health reform legislation, H.R. 3590, the Patient Protection and Affordable Care Act (PPACA), as amended by H.R. 4872, the Health Care and Education Reconciliation Act of 2010 (Reconciliation Act). Together, these sweeping measures expand access to health insurance (including subsidies, mandates, and market reforms); reduce health care spending (particularly in the Medicare program); expand federal fraud and abuse authorities and transparency requirements; impose new taxes and fees on health industry sectors; and institute a variety of other health policy reforms.
In this analysis, we concentrate on those provisions in the new law that will affect life sciences entities: pharmaceutical, device, and biologics manufacturers. These include significant revisions to the Medicaid drug rebate program and the Medicare Part D prescription drug program; an expansion of the Public Health Service Section 340B drug discount program; the imposition of substantial new industry fees and excise taxes; creation of an abbreviated approval pathway for follow-on biologics; and sweeping new reporting and disclosure requirements affecting all manufacturers regarding their relationships with physicians and teaching hospitals, among other changes.
Many of the new provisions require the Secretary of the Department of Health and Human Services (HHS) to issue implementing regulations. We have referenced notices that have been published already, and we will be reporting on additional developments in the coming months.
Continue Reading Reed Smith Health Care Reform Review: The Affordable Care Act – Analysis and Implications for Drug, Device and Biotech Manufacturers