Medicare Part B Drugs

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On December 28, 2022, the Department of Health and Human Services’ Office of Inspector General (OIG) issued a favorable advisory opinion on a proposal by a drug manufacturer to enter into an arrangement with certain hospitals to provide up to a specified number of free samples of a long-acting antipsychotic drug for inpatient use.

The OIG indicated it would not impose administrative sanctions, despite the fact that there is no safe harbor available under the federal Anti-Kickback Statute (AKS) to protect the proposed arrangement.Continue Reading OIG approves arrangement involving free drug samples for inpatient hospital use

The Inflation Reduction Act included some very significant changes to the ways in which the Medicare program handles drug pricing.

Among the changes are a redesign of the Medicare Part D (prescription drug benefit) program, as well as requirements that certain drug prices be negotiated with the Centers for Medicare & Medicaid Services and a provision that drug manufacturers pay inflation rebates to on utilization of drugs covered by Medicare Part B and Part D in certain circumstances.

To address these changes to the law, Reed Smith has put together a series of alerts and webinars on the topics.Continue Reading Analysis of Medicare Prescription Drug Pricing Changes in Inflation Reduction Act

On August 1, 2021, the Senate released the legislative text of the bipartisan infrastructure bill, the “Infrastructure Investment and Jobs Act,” H.R. 3684.  The Senate is expected to vote this week, before a month-long recess beginning on August 9, 2021.  The 2,702 page legislation contains several relevant health care-related provisions, including a delay of the implementation of the rule eliminating the Anti-Kickback Statute (“AKS”) safe harbor protection for Medicare Part D rebates.

Rebate for Discarded Amounts of Medicare Part B Single-Dose Container or Single-Use Package Drugs

First, the legislation requires manufacturers of single-dose container or single-use package drugs payable under Medicare Part B to provide a rebate to the government for any discarded portion of that drug.  The rebates will be charged each quarter, beginning with the first quarter of 2023, and must be paid in regular intervals, as determined appropriate by the Secretary of the U.S. Department of Health and Human Services (“HHS”).  The legislation provides that, in order to enforce this provision, HHS will conduct periodic audits of both drug manufacturers and providers who submit claims.  For violations of this provision, HHS will impose Civil Monetary Penalties in amounts equal to the sum of the amount that the manufacturer would have paid and twenty-five percent of such amount.Continue Reading Health Care Provisions in the Infrastructure Investment and Jobs Act

Recent Congressional hearings and markups have concentrated on prescription drug pricing, insurance access, and other health topics.  For instance, last week the House Ways and Means Committee unanimously approved H.R. 2113, the Prescription Drug Sunshine, Transparency, Accountability and Reporting Act of 2019 (STAR Act).   The legislation would, among other things:

  • Require drug manufacturers to report their “justification” for drug price increases that exceed certain thresholds.
  • Mandate that manufacturers of drug, biologicals, devices, and medical supplies publicly report on the Open Payments database the value and quantity of free samples given to providers.
  • Extend to manufacturers without a Medicaid rebate agreement the requirement to report average sales price for drugs covered under Medicare Part B, and authorize civil money penalties for failure to report such information or for reporting false information.
  • Direct the Secretary of Health and Human Services to publicly disclose certain rebates, discounts, and other price concessions achieved by pharmaceutical benefits managers (PBMs) and to report on drugs furnished in the inpatient hospital setting.

Earlier this month the House Energy and Commerce Committee approved 12 bills aimed at reducing prescription drug and other health care costs, including legislation intended to:  bolster generic drug competition; support Affordable Care Act insurance enrollment programs and state-based insurance marketplaces; reverse Trump Administration policies on short-term, limited duration health insurance and State Relief and Empowerment Waivers; and establish an “Improve Health Insurance Affordability Fund” to help states lower premiums in the individual health insurance market.

In addition to these markups, Congressional panels have held hearings various health policy issues, including the following:
Continue Reading Congressional Committees Continue Focus on Prescription Drugs, Insurance Coverage Policy

Reducing prescription drug prices is a major theme in the Trump Administration’s fiscal year (FY) 2020 budget proposal, with policies intended to increase competition, encourage better negotiation, incentivize lower list prices, and cut out-of-pocket costs for beneficiaries.  The Administration’s projected savings from its designated prescription drug budget proposals top $69 billion over 10 years, although that does not include savings for provisions for which the budget impact was not available or that were included in other sections of the budget (e.g., a Medicaid State Drug Utilization Review provision within the Medicaid budget section).

We summarize below the major prescription drug pricing and related proposals in the President’s proposed budget, covering Medicare Parts B and D, Medicaid, and the 340B discount drug program.  All budget savings reflect the 10-year period of FYs 2020-2029.  Note that while most of these provisions would require legislative approval, Congressional committees have already held several hearings this year on prescription drug pricing.  Stay tuned for more action in this area.

Major Medicare Part B Proposals

The proposed Trump budget would:
Continue Reading Trump Administrations’ Proposed FY 2020 Budget Targets Prescription Drug Prices

The Centers for Medicare & Medicaid Services (CMS) has issued its final Medicare physician fee schedule (PFS) rule for calendar year (CY) 2019.  In addition to updating rates for physician services, the rule adopts changes to numerous other Medicare Part B policies.  Highlights of the final rule include the following:

  • The final 2019 conversion factor (CF) is $36.0391, up slightly from the 2018 CF of $35.9996.  This rate is based on a statutory update of 0.25%, offset by a -0.14% relative value unit (RVU) budget neutrality adjustment.
  • The rule reduces from 6% to 3% the “add-on” payment for new, separately-payable Part B drugs and biologicals that are paid based on wholesale acquisition cost when average sales price during first quarter of sales is unavailable.
  • The rule makes a number of changes to the Appropriate Use Criteria (AUC) program, which requires that physicians who order outpatient advanced diagnostic imaging (ADI) services (diagnostic magnetic resonance imaging, computed tomography, and positron emission tomography/nuclear medicine) for a Medicare beneficiary consult with AUC developed by provider-led organizations approved by CMS via a qualified clinical decision support mechanism (CDSM).  Specifically, the final rule:
    • Extends the requirements to independent diagnostic testing facilities (joining physician offices, hospital outpatient departments, and ambulatory surgical centers).
    • Clarifies that AUC consultation information must be reported on all applicable technical component and professional component claims (i.e., not just reported on claims by furnishing facilities).
    • Provides that when delegated by the ordering professional, clinical staff under the direction of the ordering professional may perform the AUC consultation with a qualified CDSM (a modification to the proposed rule, which would have specified that AUC consultations may be performed by auxiliary personnel under the direction of the ordering professional and incident to the ordering professional’s services).
    • Uses established coding methods (e.g., G-codes and modifiers) to report required information.
    • Revises the significant hardship exception criteria to include (1) insufficient internet access; (2) electronic health record or CDSM vendor issues; (3) extreme and uncontrollable circumstances; and (4) self-attestation of hardship status for ordering professionals.

For information regarding the AUC implementation schedule, see our previous post.
Continue Reading CMS Publishes Final CY 2019 Medicare Physician Fee Schedule Rates and Policies

The Trump Administration is considering a controversial plan, the International Pricing Index (IPI) model, which would tie Medicare Part B prescription drug payment rates to amounts paid for such drugs in other developed countries.  The Centers for Medicare and Medicaid Services’ proposed IPI model also would replace the current “buy and bill” system for…

CMS has issued its proposed rule to update Medicare Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System rates and policies for calendar year (CY) 2019.  In addition to providing routine annual updates, the proposed rule includes several provisions intended to encourage “site-neutral payments” for different types of providers.  CMS also proposes a change to the basis for updating ASC rates that has long been sought by stakeholders.  CMS will accept comments on the proposed rule until September 24, 2018.

Hospital Outpatient Provisions

CMS proposes a 1.25% update to Medicare OPPS rates for 2019, reflecting an expected 2.8% market basket increase that is partly offset by both a statutory 0.75 percentage point reduction and a 0.8% multi-factor productivity (MFP) reduction.  The update for hospitals that fail to meet quality reporting requirements is reduced by 2.0% points.  Payment changes for individual procedures vary.

In the proposed rule, CMS emphasizes its interest in addressing payment differentials that the agency believes drives site-of-service decisions, especially between the physician’s office and hospital outpatient department settings, and increases costs to the Medicare program and beneficiaries.  In particular, CMS targets certain off-campus hospital provider-based departments (PBD) that are “excepted” under section 603 of the Bipartisan Budget Act of 2015.  Section 603 provides that effective for services provided on or after January 1, 2017, certain off-campus PBDs are generally paid under the physician fee schedule (PFS), rather than the typically higher-paying OPPS, unless an exception applies.  For 2019, CMS proposes:

  • Paying a PFS equivalent rate for clinic visit services (G0463, Hospital outpatient clinic visit for assessment and management of a patient) when provided at an “excepted” PBD. CMS observes that clinic visits are the most common service billed under the OPPS, and this policy is expected to save approximately $760 million in FY 2019, including $150 million in reduced beneficiary copayments.
  • CMS proposes to apply to exempted PBDs a current policy that reduces OPPS payment for separately payable, nonpass-through drugs and biologicals (other than vaccines) purchased through the 340B drug discount program from average sales price (ASP) plus 6% to ASP minus 22.5% (with certain exceptions).
  • Revising payment when an excepted PBD expands into new lines of service. Under the proposed rule, if an excepted off-campus PBD furnishes a service from one of 19 proposed clinical families of services that it did not furnish during a baseline period (November 1, 2014 through November 1, 2015), the service from the “new” family would be paid under the PFS rather than the OPPS.
  • CMS notes that it is “developing a method to systematically control for unnecessary increases in the volume of other hospital outpatient department services.” In the meantime, CMS requests comments on alternative approaches to controlling unnecessary volume increases, while “not impeding development or beneficiary access to new innovations.”

Other proposed provisions include the following:  
Continue Reading CMS Proposes CY 2019 Medicare OPPS, ASC Update, with Emphasis on Promoting Site-Neutrality

The Centers for Medicare & Medicaid Services (CMS) has issued its proposed Medicare physician fee schedule (PFS) rule for calendar year (CY) 2019.  In addition to updating rates for physician services, the sweeping rule proposes changes to numerous other Medicare Part B policies.  Highlights of the proposed rule include the following:

  • CMS proposes a

…

The Trump Administration has launched a high-profile initiative aimed at reducing prescription drug prices, including release of a blueprint containing a series of short- and long-term policy proposals and a request for public comments on additional reforms.

First, on May 11, 2018 the Department of Health and Human Services released its “Blueprint to Lower…

The Trump Administration has released its fiscal year (FY) 2019 budget proposal, which includes extensive health policy provisions. While most of the President’s policy proposals for Department of Health and Human Services (HHS) programs would require Congressional approval, others are characterized as administrative proposals that presumably would not involve Congress.
Continue Reading Trump Administration’s Proposed FY 2019 Budget Targets Medicare, Medicaid for Savings, Seeks (Again) to Repeal/Replace ACA

Rule Would Delay Appropriate Use Criteria Requirement until 2019, Cut Rates for Off-Campus Hospital Departments

The Centers for Medicare & Medicaid Services (CMS) has published its proposed rule to update the Medicare physician fee schedule (PFS) for calendar year (CY) 2018. The proposed rule addresses numerous Medicare policies, including:  implementation of appropriate use criteria (AUC) for advanced diagnostic imaging services; a deep reduction in reimbursement for off-campus hospital outpatient departments; and consideration of potentially misvalued codes, among many others.  Highlights of the proposed rule include the following: 

  • Under the proposed rule, the 2018 MPFS conversion factor (CF) would be $35.9903, up slightly from the 2017 CF of $35.8887. This update reflects a 0.5% update factor specified under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), which is partially offset by a -0.03% relative value unit (RVU) budget neutrality adjustment and a -0.19% “target recapture amount” (since savings from proposed revisions to the RVUs of misvalued codes would not meet a statutory-0.5% target).
  • CMS proposes to revise a policy adopted in the final 2017 Medicare Hospital Outpatient Prospective Payment System (OPPS) rule to implement Section 603 of the Bipartisan Budget Act of 2015, which establishes a site-neutral payment policy for certain newly-acquired, provider-based, off-campus hospital outpatient departments (which CMS calls “off-campus provider-based departments” or “off-campus PBDs”). Effective for services provided on or after January 1, 2017, off-campus PBDs are paid under the PFS in most cases, rather than the generally higher-paying OPPS (with certain exceptions). In the 2017 rule, CMS established new PFS site-of-service payment rates to pay non-excepted off-campus PBDs for the technical component of non-excepted services; these rates generally are based on OPPS payments scaled downward by 50% (called the PFS Relativity Adjuster). For CY 2018, CMS is proposing to reduce the Relativity Adjuster by 50%; that is, the technical component rates for these services would be reduced from 50% of the OPPS rate to 25% of the OPPS rate. CMS invites comments on whether a different PFS Relatively Adjuster would be appropriate.

Continue Reading CMS Proposes Medicare Physician Fee Schedule Update for 2018

The Government Accountability Office (GAO) is out with the latest installment of its “High-Risk Series,” which identifies federal programs “that are especially vulnerable to waste, fraud, abuse, and mismanagement, or that need transformative change.” Once again, GAO flags Medicare and Medicaid as high-risk programs.

With regard to Medicare, GAO notes that while Congress,…

Included in the 21st Century Cures Act are numerous changes to Medicare and Medicaid policies, including provisions with significant reimbursement impacts for certain types of Medicare providers and suppliers, along with changes intended to reduce the regulatory and administrative burdens associated with the use of electronic health records.  Furthermore, the law once again expands the…

The HHS Office of Inspector General (OIG) and the Government Accountability Office (GAO) recently issued several reports on various Medicare Part B drug reimbursement issues. In a report entitled “Medicare Part B: Data on Coupon Discounts Needed to Evaluate Methodology for Setting Drug Payment Rates,” the GAO assessed the impact of manufacturer coupon programs on Medicare payment rates for high-expenditure Medicare Part B drugs. The GAO observed that while coupon programs are prohibited in the Medicare program, they are generally available to privately insured patients, and the Part B drug payment methodology, which is based on reported average sales price (ASP), does not take into account coupon discounts that reduce the effective market price. The GAO estimated that for 18 high-expenditure drugs for which it obtained coupon discount data, the ASP exceeded the effective market price by an estimated 0.7% in 2013. According to the GAO, Part B spending for these drugs could have been reduced by an estimated $69 million “if ASP equaled the effective market price.” The GAO suggested that “[u]pward trends in coupon program use and drug prices suggest that these programs could cause the methodology for setting Part B drug payment rates to become less suitable over time for drugs with coupon programs.” The GAO therefore recommended that Congress consider (1) giving CMS authority to collect data from drug manufacturers on coupon discounts for Part B drugs paid based on ASP; and (2) requiring CMS to periodically collect these data and report on the implications of coupon programs for this methodology.
Continue Reading GAO, OIG Issue Reports on Medicare Part B Drug Payment Issues

The OIG has issued a report entitled “MACs Continue to Use Different Methods to Determine Drug Coverage,” which reviews how Medicare Administrative Contractors (MACs) make Medicare Part B drug coverage determinations and ensure that claims are paid according to these determinations. Based on the results of a survey of MACs regarding 2012 Part…

A recent Government Accountability Office (GAO) report, “Medicare Part B: CMS Should Take Additional Steps to Verify Accuracy of Data Used to Set Payment Rates for Drugs,” questions the reliability of pricing for Medicare Part B drugs reimbursed based on average sales price (ASP). The GAO observes that while CMS performs various electronic…

MedPAC has released its June 2016 Report to the Congress on Medicare and the Health Care Delivery System. The report includes recommendations for a number of Medicare policy reforms and analyses of various health care market developments. Several chapters address Medicare drug policy, including a review of external factors that influence the prices Medicare pays for prescription drugs. With regard to Medicare Part B drug policy, MedPAC discusses potential modifications to Medicare Part B drug reimbursement, such as reducing dispensing and supplying fees, along with approaches to improving the quality and reducing the costs of oncology care (since more than half of Medicare Part B drug spending is associated with anticancer and related drugs). Likewise, MedPAC examines the Medicare Part D prescription drug program and offers recommendations for giving plan sponsors greater financial incentives and mechanisms to manage the benefits of high-cost enrollees; exclude manufacturer discounts on brand-name drugs from counting as enrollees’ true out-of-pocket spending; eliminate beneficiary cost sharing above the catastrophic cap; and increase financial incentives for low-income beneficiaries to use lower-cost drugs and biologicals.

MedPAC also discusses development of a unified Medicare payment system for post-acute care, including its unified prospective payment system (PPS) prototype that it believes accurately predicts resource needs for nearly all patient groups. MedPAC raises various implementation considerations, including the need to develop separate payment models for nontherapy ancillary services and the combination of routine and therapy services; adjustments to recognize lower costs in home health agencies compared to institutional settings; the need for outlier policies and labor cost adjustments; future adjustments to reward high-quality, efficient care; conforming regulatory reforms; and an appropriate transition period, among other policy provisions.

In addition, the report addresses:
Continue Reading MedPAC Issues Recommendations on Medicare Drug, Post-Acute Care, and Other Payment Policies

Recent Congressional hearings focusing on health policy topics include the following:

  • House Energy and Commerce Committee hearings on HHS cybersecurity responsibilities, Medicare and Medicaid program integrity, the Administration’s proposed Medicare Part B drug payment model, and patient-focused health insurance reforms.
  • House Ways and Means Committee hearings on implementation of the Medicare Access & CHIP Reauthorization

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