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Court Supports HHS on 340B Cut

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The federal government may institute a nearly 30 percent cut in payments to some hospitals for prescription drugs, a federal court has ruled.

The cut, to the 340B program, was first proposed in 2017 the Department of Health and Human Services but has been blocked by the courts ever since.  Last week, though, a federal appeals court paved the way for the reduction.

Hospitals that serve especially large numbers of low-income patients participate in the federal 340B prescription drug discount program, which gives them discounts on prescriptions they distribute to low-income outpatients.  Under the program, participating hospitals are then supposed to use the savings they derive from the discount to provide additional services to low-income residents of their communities.

Several hospital groups sued when HHS first proposed the cut, arguing that the agency was exceeding its authority.  In last week’s ruling the court concluded that

At a minimum, the statute does not clearly preclude HHS from adjusting the [340B] rate in a focused manner to address problems with reimbursement rates applicable only to certain types of hospitals.

The cut will cost participating hospitals approximately $1.6 billion, with HHS maintaining that this money will be distributed among other deserving providers.

NASH has long opposed the proposal to cut 340B payments to providers.  In a letter to the Centers for Medicare & Medicaid Services in March on behalf of private safety-net hospitals, NASH wrote that

The 340B program was created by Congress to enable hospitals (and other providers) that serve low-income communities to maximize their resources when working to serve those communities. The program helps improve access to high-cost prescription drugs for low-income patients and helps put additional resources into the hands of qualified providers so those providers can do more for their low-income patients: provide more care that their patients might otherwise not be able to afford, offer more services that might otherwise be unavailable to such patients, and do more outreach into communities consisting primarily of low-income residents. This was the purpose of the 340B program when Congress created it in 1992 and Congress has not modified that purpose since that time. NASH believes that through this proposed data collection CMS is seeking to exert authority it does not have to demand of providers information to which the agency is not entitled.

Learn more about the court decision and its implications in this Fierce Healthcare article.

 

NASH Asks Senate for COVID-19 Help

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Private safety-net hospitals need help with the challenges posed by the COVID-19 public health emergency, NASH wrote yesterday in a letter to Senate majority leader Mitch McConnell and minority leader Charles Schumer.

In its letter, NASH asked for:

  • An additional $100 billion for hospitals.
  • Forgiveness for money provided to hospitals through the federal CARES Act’s Accelerated and Advance Payment Program.
  • Action to prevent implementation of the Medicaid fiscal accountability regulation.
  • An increase in the federal Medicaid matching rate (FMAP).
  • An increase in states’ Medicaid disproportionate share (Medicaid DSH) allotments.
  • A moratorium on changes in hospital eligibility for the 340B prescription drug discount program, Medicare indirect medical education program, Medicare disproportionate share (Medicare DSH) program, and other programs.

See NASH’s letter here.

 

NASH Opposes Proposed 340B Data Collection

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The federal government should not require hospitals to submit new data on their acquisition costs for prescription drugs they dispense to low-income patients through the section 340B prescription drug discount program, NASH has told the Centers for Medicare & Medicaid Services.

In a formal comment letter in response to new data collection requirements proposed by CMS last month, the National Alliance of Safety-Net Hospitals wrote on behalf of private safety-net hospitals that

The 340B program was created by Congress to enable hospitals (and other providers) that serve low-income communities to maximize their resources when working to serve those communities. The program helps improve access to high-cost prescription drugs for low-income patients and helps put additional resources into the hands of qualified providers so those providers can do more for their low-income patients: provide more care that their patients might otherwise not be able to afford, offer more services that might otherwise be unavailable to such patients, and do more outreach into communities consisting primarily of low-income residents. This was the purpose of the 340B program when Congress created it in 1992 and Congress has not modified that purpose since that time. NASH believes that through this proposed data collection CMS is seeking to exert authority it does not have to demand of providers information to which the agency is not entitled.

In the letter, NASH also objected that the proposed data collection would be costly and burdensome for hospitals and is premature because the courts are still considering challenges to CMS’s authority to reduce 340B payments to providers; the latter is why CMS seeks this data.

Go here to see NASH’s formal comment letter to CMS.

340B Déjà Vu: CMS Seeks to Collect Data From Hospitals

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For the second time in four months, the federal government has announced its intention to collect data from hospitals and other providers on what they pay for the prescription drugs they purchase through the section 340B prescription drug discount program.

Last week the Centers for Medicare & Medicaid Services published a notice announcing its intention to collect this data.  Previously, health care interests sued CMS when it attempted in 2018 to reduce payments to providers for drugs purchased through the 340B program and the court ruled against CMS, maintaining that the agency did not have enough data on hospitals’ acquisition costs for the drugs to justify the proposed payment reduction.  The newly announced data collection effort seeks to rectify that shortcoming as the court considers CMS’s appeal of a similar decision in a lawsuit filed after CMS again proposed reducing 340B payments and was again rebuffed by the courts in 2019.

Under federal law, CMS must publish a notice declaring its intention to collect such data and seek input from stakeholders.  For this particular notice, stakeholders have until March 9 to respond.

CMS published a similar notice in September of 2019 announcing its intention to collect similar data.  That data collection never took place.  NASH opposed that data collection proposal in a formal comment letter to CMS, writing on behalf of private safety-net hospitals that

NASH and the nation’s private safety-net hospitals oppose the proposed collection of data involving the section 340B prescription drug discount program for three reasons:

  • we oppose CMS’s continued efforts to reduce 340B reimbursement to eligible hospitals;
  • the proposed data collection would be exceptionally burdensome; and
  • we disagree with attempting to address a matter still being litigated.

Most private safety-net hospitals participate in the 340B program and consider it a vital tool in serving the many low-income residents of the communities in which they are located.

See NASH’s complete comment letter here.

To learn more about CMS’s 340B data collection effort, see the notice it published in the Federal Register and read the Becker’s Hospital Review article “CMS ready to survey 340B hospitals about drug acquisition costs.”

NASH Unveils 2020 Advocacy Agenda

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The National Alliance of Safety-Net Hospitals has published its 2020 advocacy agenda.

To advance the interests of private safety-net hospitals, in the coming year NASH will:

  • Continue to address the major policy challenges of 2019 that had not been resolved as that year ended:  an extended delay of Medicaid disproportionate share (Medicaid DSH) cuts, surprise medical bills, and prescription drug prices.
  • Respond to administration-driven policies such as the calculation of Medicare disproportionate share (Medicare DSH) payments, reduced payments for prescription drugs under the 340B prescription drug discount program, and efforts to reduce Medicaid eligibility and benefits and to limit the means through which states may finance their share of Medicaid payments.
  • Respond to expected judicial decisions addressing the extension of site-neutral Medicare outpatient payments to additional outpatient settings and the implementation of a new public charge regulation.

For a more detailed look at NASH’s advocacy plans for the coming year, see its complete 2020 advocacy agenda.

340B Doesn’t Drive Up Hospital Drug Spending, MedPAC Says

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Hospitals do not prescribe more expensive drugs because they know the 340B program will help pay for them.

That is the conclusion drawn in a recent analysis by the Medicare Payment Advisory Commission.

Prescription drug spending has risen markedly in recent years and the pharmaceutical industry maintains that part of that increase can be attributed to hospitals that participate in the section 340B prescription drug discount program, which requires pharmaceutical companies to give discounts to hospitals and other selected providers that care for especially large numbers of low-income patients.

A new analysis by the Medicare Payment Advisory Commission, however, concludes that any such effect is minimal.

340B discounts are available for qualified patients receiving drugs on an outpatient basis, and the program’s greatest costs are associated with drugs to treat cancer.  MedPAC found that prescribing decisions “appears to be specific to the type of cancer” and concluded that “…we are unable to attribute these findings to incentives created by 340B discounts” and that “Overall effects on cost sharing for cancer patients is likely to be small, if any, depending on cancer and the patient’s supplemental coverage.”

MedPAC warns that the empirical evidence underlying its analysis was limited.

Most private safety-net hospitals participate in the 340B program and consider it a vital resource in helping them serve their many low-income patients.

Learn more about the impact of the 340B program on the drugs prescribed by participating hospitals in the Becker’s Hospital Review article “340B has minimal effect on health spending, study finds” and the MedPAC presentation “Congressional request on health care provider consolidation: Does the 340B program create incentives for participating hospitals to use more expensive drugs?”

GAO: Feds Need Better Oversight of 340B Eligibility

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The federal government needs to do a better job of ensuring that non-government hospital participants in the 340B prescription drug discount program are eligible for that program, the U.S. Government Accountability Office concluded in a recent report.

With growing numbers of non-government hospitals now participating in the 340B program, the GAO found that the federal Health Resources and Services Administration, which oversees the program, is not doing enough to ensure that these hospitals meet the criteria for inclusion in the program.  In particular, the GAO found, HRSA needs to do more to ensure that such hospitals have valid contracts with state or local governments to care for low-income patients who qualify for 340B assistance with the cost of prescription drugs.  In particular, the GAO believes HRSA relies too much on hospitals’ own attestations that they have such contracts.

The GAO recommended a number of steps to ensure that hospitals truly are eligible to participate in the 340B program, including better and more frequent review of hospitals’ contracts with state or local governments.

Most private safety-net hospitals participate in the 340B program and consider it an essential tool in serving the low-income residents of the communities in which they are located.

Learn more about the problems the GAO found with HRSA’s management of non-government hospitals’ eligibility for the 340B program and how it recommends that HRSA address those problems in the GAO report “340B Drug Discount Program:  Increased Oversight Needed to Ensure Nongovernmental Hospitals Meet Eligibility Requirements

NASH Conveys End-of-Year Priorities to Congress

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Preventing Medicaid DSH cuts, a fair approach to protecting patients from surprise medical bills, and reducing prescription drug costs are among the policy positions that the National Alliance of Safety-Net Hospitals recently shared with Congress.

In its message to Congress, NASH also asked lawmakers to protect 340B prescription drug discounts for private safety-net hospitals and to preserve dedicated funding for community health centers, the National Health Service Corps, and the Teaching Health Center Graduate Medical Education.

Learn more about NASH’s end-of-year policy priorities from the message “Protect Safety-Net Hospitals and the Communities They Serve in Upcoming Budget and Legislative Deliberations” that NASH delivered yesterday to all 535 members of Congress.

Hospital Groups Critical of CMS 340B Proposal

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The federal government should not survey providers to determine their costs for drugs covered by the section 340B prescription drug discount program, hospitals and hospital groups have told the Centers for Medicare & Medicaid Services.

Their comments came in response to a regulation CMS proposed in September that would require hospitals to report their acquisition costs for 340B-covered drugs.  CMS proposed such data collection after federal courts ruled against its attempt to reduce 340B reimbursement to hospitals that participate in the program.  Among the court’s objections were CMS’s lack of data about those drug acquisition costs.

Among the reasons hospitals conveyed in expressing their opposition were the cost of reporting the data in question; the design of the survey; the flawed premise underlying the survey; and the proposed rule’s requirement that all hospitals complete the survey and not just those that participate in the 340B program.

Among the groups criticizing the proposed regulation were the Association of American Medical Colleges, which wrote in its comment letter that

Congress did not design the 340B program to pay hospitals at acquisition costs…Congress designed the program so that eligible hospitals could purchase covered drugs at a discounted rate below the Medicare reimbursement rate and use the difference to reach more eligible patients and provide more comprehensive services.

The National Alliance of Safety-Net Hospitals was among the groups commenting on the proposed regulation.  Writing on behalf of private safety-net hospitals, NASH observed in its November 27, 2019 formal comment letter that

The 340B program was created by Congress to enable hospitals (and other providers) that serve low-income communities to maximize their resources when working to serve those communities.  The program helps improve access to high-cost prescription drugs for low-income patients and helps put additional resources into the hands of qualified providers so those providers can do more for their low-income patients:  provide more care that their patients might otherwise not be able to afford, offer more services that might otherwise be unavailable to such patients, and do more outreach into communities consisting primarily of low-income residents.  This was the purpose of the 340B program when Congress created it in 1992 and Congress has done nothing to modify that purpose since that time:  it has not directed that special assistance to qualified providers be reduced; it has not insisted that participating providers document the expenditure of their savings in service to their communities; and it most certainly has not dictated that 340B payments to eligible providers be reduced so that payments to non-340B providers could be increased.  NASH believes that through this proposed data collection CMS is seeking to exert authority it does not have to demand of providers information to which the agency is not entitled.

Learn more about hospital industry opposition to the proposed 340B regulation in the Fierce Healthcare article “Hospitals blast CMS’ proposed 340B survey.”

Back Off 340B Data Collection, NASH Tells CMS

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The federal government should not impose a new, major data reporting requirement on 340B-eligible hospitals to support the implementation of a new policy that federal courts twice have rejected, NASH told the Centers for Medicare & Medicaid Services last week.

In formal comments in response to a CMS proposal to require hospitals that participate in the section 340B prescription drug discount program to provide CMS with extensive data on their acquisition costs for 340B drugs, NASH wrote that such data collection would be burdensome; that CMS should not be reducing 340B payments to providers because such a policy decision falls solely within the purview of Congress, which created the program; and that instead of focusing on just this one aspect of the court’s rejection of its attempts to reduce 340B payments, CMS should instead focus on the court’s order that the agency develop a means of reimbursing hospitals for the lost 340B payments Medicare has withheld from providers for the past two years.

Most private safety-net hospitals participate in the 340B program and count on the resources the program generates to help them provide additional services to the low-income residents of the communities in which they are located.

Learn more about why NASH objects to CMS’s planned data reporting requirement in NASH’s formal comment letter to CMS.