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pharmaceutical drug pricing and 340B

Hospitals will have until Nov. 21 to complete the recertification process through the new Office of Pharmacy Affairs Information System.

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pharmaceutical drug pricing and 340B

America's Essential Hospitals opposed the proposed payment model, which would have reduced Medicare payments to providers for Part B drugs.

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pharmaceutical drug pricing and 340B

The delay allows for implementation of a new online tool that will allow providers to register and recertify 340B sites and contract pharmacies.

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pharmaceutical drug pricing and 340B

Senate Republican leaders aim to submit a draft bill to the Congressional Budget Office early this week and vote on the bill before the July Fourth recess.

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pharmaceutical drug pricing and 340B

The committee’s intentions remain unclear; we recommend essential hospitals prepare to publicly describe what auditors found and corrective actions taken.

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pharmaceutical drug pricing and 340B

The final rule on drug ceiling prices and manufacturer civil monetary penalties under the 340B Drug Pricing Program now will go into effect on Oct. 1.

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pharmaceutical drug pricing and 340B

CMS projects that Medicare Advantage organization payment rates will increase by 0.25 percent in 2018.

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pharmaceutical drug pricing and 340B

The regulation makes "penny pricing" final and sets fines of up to $5,000 per instance of a manufacturer overcharging providers for covered medications in the 340B Drug Pricing Program.

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pharmaceutical drug pricing and 340B

OIG found that the federal portion of spending on catastrophic coverage reached $33.2 billion in 2015, compared with $10.8 billion in 2010.

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pharmaceutical drug pricing and 340B

In a FAQ document, CMS states that the required JW modifier and patient documentation policy applies to separately payable Part B drugs.

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pharmaceutical drug pricing and 340B

Medicare Part D spending increased 17 percent, outpacing overall prescription drug spending increases, according to CMS data.

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pharmaceutical drug pricing and 340B

The decision follows the pharmaceutical company's recent recalculation of 340B ceiling prices for 25 products for the third quarter of 2012 through the second quarter of 2013.

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pharmaceutical drug pricing and 340B

March 8 proposed rule details two approaches agency will test to encourage prescribing of lower-cost medications: reimbursement rate adjustments and value-based purchasing.

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pharmaceutical drug pricing and 340B

Proposed regulations would dramatically narrow access to 340B, harming vulnerable patients and putting entire communities at risk of losing vital services.

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pharmaceutical drug pricing and 340B

Final rule and implementation as described in the guidance could significantly reduce Medicaid payments for 340B-covered outpatient drugs in some states.

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pharmaceutical drug pricing and 340B

House, Senate panels to examine rising cost of drugs, lack of transparency in the drug price negotiation process, and barriers to generic drug applications.

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pharmaceutical drug pricing and 340B

U.S. District Court says 2014 HRSA interpretive rule is contrary to plain language of ACA provision that excludes certain hospitals from 340B discounts on orphan drugs.

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pharmaceutical drug pricing and 340B

Heritage Pharmaceuticals Inc., charged 340B covered entities incorrect rates between April 18, 2008 and Dec. 31, 2014. Refunds are available for products purchased directly from Heritage or through a wholesale distributor.

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pharmaceutical drug pricing and 340B

Proposed changes could significantly narrow the scope of patients for whom 340B pricing may be utilized and reduce potential savings from program

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pharmaceutical drug pricing and 340B

Omnibus guidance proposes an expanded list of six requirements for an individual to be considered a patient of a 340B covered entity.

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pharmaceutical drug pricing and 340B

Participants learned about HRSA's guidance on the 340B Drug Pricing Program and how it will affect their hospital.

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pharmaceutical drug pricing and 340B
pharmaceutical drug pricing and 340B

Failure to recertify will result in removal from the 340B program. Authorizing officials from all hospitals should have already received an email with information needed to recertify from the Office of Pharmacy Affairs.

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pharmaceutical drug pricing and 340B

Sen. Grassley requested a hearing on recent 340B GAO report. House calls and clinical trials for Medicare patients each pass one chamber. Committees review Medicare hospital payments, HIT, and marketplaces.

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pharmaceutical drug pricing and 340B

Report suggests financial incentive for hospitals to prescribe 340B drugs, a claim America's Essential Hospitals calls unfounded and troubling.

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pharmaceutical drug pricing and 340B

Association challenges unfounded conclusions in report, including suggestion that hospitals overuse 340B for financial gain.

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pharmaceutical drug pricing and 340B
pharmaceutical drug pricing and 340B
pharmaceutical drug pricing and 340B

The 2015 recertification period will be from Aug. 5 to Sept. 9. Failure to recertify will result in removal from the program.

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pharmaceutical drug pricing and 340B

Proposed rule also calls for increased transparency in ceiling price calculation. Separate guidance to replace mega reg.

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pharmaceutical drug pricing and 340B

Parts of the Cures package will now likely go to other House committees for review. The Senate will discuss NSA surveillance after recess.

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pharmaceutical drug pricing and 340B

We are pleased to see that this amendment was not included in the Cures package and look forward to working with lawmakers to strengthen the 340B program in the future.

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pharmaceutical drug pricing and 340B

We look forward to working with the committee and others in Congress as they seek to strengthen this valuable program and provide other support for those in need.

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pharmaceutical drug pricing and 340B

Association urges committee to reject inclusion of 340B program changes in 21st Century Cures bill

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pharmaceutical drug pricing and 340B

It remains unclear what 340B Drug Pricing Program provisions could be included in the legislation.

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pharmaceutical drug pricing and 340B

The Energy and Commerce Committee is scheduled to vote on 21st Century Cures Wednesday, possibly including an amendment that would make changes to the 340B Drug Pricing Program.

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pharmaceutical drug pricing and 340B

America's Essential Hospitals is pleased that the House Committee on Energy and Commerce is working collaboratively with stakeholders on the proposal.

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pharmaceutical drug pricing and 340B

Letter emphasizes value of program to vulnerable patients and hospitals, and risk of harming care by limiting program access

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pharmaceutical drug pricing and 340B

For now, lawmakers focused on information gathering, better oversight, clarity, and accountability

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pharmaceutical drug pricing and 340B

Congress will attempt to pass SGR and budget legislation by Friday. The SGR package includes a one-year delay of Medicaid DSH cuts. House Committees will hold hearings on 340B, heroin and prescription drug abuse, and Medicare Fraud. The Senate HELP Committee will hold a hearing on patient research.

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pharmaceutical drug pricing and 340B

Contact your lawmakers on the House Energy and Commerce and Senate Health, Education, Labor, and Pensions committees to underscore the critical need for the 340B program. An update on the SGR package will be provided as more information is available.

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pharmaceutical drug pricing and 340B

Learn more about association and member efforts to defend the 340B Drug Pricing Program

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pharmaceutical drug pricing and 340B

New association materials include messaging on Medicaid DSH, Medicare, risk adjustment for sociodemographic status, 340B, and more.

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pharmaceutical drug pricing and 340B

Congress must pass a homeland security spending bill this week, and health insurance marketplaces are under scrutiny as oral arguments in the King v. Burwell Supreme Court case begin.

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pharmaceutical drug pricing and 340B

Commentary argues to keep program savings with essential hospitals to benefit low-income patients and entire communities

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pharmaceutical drug pricing and 340B

Top issues include protecting Medicaid and Medicare from cuts, protecting the 340B program, and risk adjusting quality incentive program measures

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pharmaceutical drug pricing and 340B

Legislation includes provisions on Ebola response funding, 340B Drug Pricing Program, children's hospital GME, and Health Centers Program

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pharmaceutical drug pricing and 340B

Previously, HRSA submitted a comprehensive proposed rule to OMB on 340B issues, but a subsequent court ruling called into question the agency's authority to issue a rule.

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pharmaceutical drug pricing and 340B

Review the results and impact of the 2014 midterm elections, and share strategies on preparing for the 114th Congress.

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pharmaceutical drug pricing and 340B

America's Essential Hospitals condemns drug makers' attempts to gut a federal rule that allows hospitals to purchase expensive orphan drugs at a discount to serve low-income and other vulnerable patients

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pharmaceutical drug pricing and 340B

Latest critique of 340B disappoints with fiction and unsupported assertions, rather than the plain facts of this important program for the vulnerable

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pharmaceutical drug pricing and 340B

OPA webinar will cover recent changes to 340B audit process. The office is also working to standardize the process for self-disclosing a 340B requirement breach and notes successful recertification process.

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pharmaceutical drug pricing and 340B

Court ruled that PhRMA must file second lawsuit to challenge OPA's interpretative rule implementing the orphan drug provision for new 340B covered entities under the ACA.

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pharmaceutical drug pricing and 340B

OPA notify hospitals via email of the need to recertify for eligibility for the 340B program. Hospitals must recertify annually to show compliance with all parts of the 340 program.

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pharmaceutical drug pricing and 340B

These members of Congress went on record supporting the 340B Drug Pricing Program and the patients it benefits.

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pharmaceutical drug pricing and 340B

New interpretive rule will address the 340B orphan drug exclusion.

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pharmaceutical drug pricing and 340B

In particular, OPA has changed the process for correcting or otherwise addressing any findings on which covered entities and auditors disagree.

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pharmaceutical drug pricing and 340B

HRSA announced that it plans to stand by its interpretation of the 340B orphan drug rule and will continue to publish updated orphan drug designation lists to assist organizations with compliance with the policy.

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pharmaceutical drug pricing and 340B

The regulations - to be released later this year and early next year - provide guidance for the AIDS Drug Assistance Program and National Hemophilia Program.

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pharmaceutical drug pricing and 340B

The district court held that the rule was outside the scope of the agency’s rulemaking authority. Because the court vacated the final rule, newly designated 340B entities will not be able to purchase orphan drugs at discounted prices, regardless of whether the drugs are used for their designated purpose or other purposes.

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pharmaceutical drug pricing and 340B

During the June 9, 2 pm ET call, officials from OPA will update hospitals on changes to the 340B Drug Pricing Program registration process and outline upcoming registration database changes.

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pharmaceutical drug pricing and 340B

During the conference, providers, industry representatives, government regulators, federal contractors, and advocacy organizations will discuss several 340B policy matters including the forthcoming mega-reg and key legislative issues.

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pharmaceutical drug pricing and 340B

Discussions included hospital eligibility in 340B, the definition of a patient at 340B-eligible hospitals, and contract pharmacies. The 340B rule is widely expected to be released in June.

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pharmaceutical drug pricing and 340B

Congress continues its two-week recess. Five Senate Democrats sent a letter to OMB and HRSA supporting the 340B program. The 340B mega reg set to be released in June is currently at OMB. House and Senate appropriations committees begin their markup processes, although nothing has been announced regarding HHS and related agencies.

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pharmaceutical drug pricing and 340B

The Office of the Inspector General (OIG) released Feb. 4 a report on the use of contract pharmacies in the 340B Drug Pricing Program. The OIG gathered information from a sample of covered entities—15 disproportionate share hospitals and 15 community health centers—to learn about their contract pharmacy arrangements.

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pharmaceutical drug pricing and 340B
pharmaceutical drug pricing and 340B

Association, two other national organizations file amicus brief in support of HRSA interpretation of law

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pharmaceutical drug pricing and 340B

Argues in brief that HRSA interpretation consistent with the language of the ACA

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pharmaceutical drug pricing and 340B
pharmaceutical drug pricing and 340B

Analysis finds program is likely to grow in states expanding their Medicaid program

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pharmaceutical drug pricing and 340B

Failure to complete recertification could result in dismissal from program

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pharmaceutical drug pricing and 340B

All 340B authorizing officials expected to receive access to complete process by email

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pharmaceutical drug pricing and 340B
pharmaceutical drug pricing and 340B

Separate physical inventories not required for compliance with group purchasing organization prohibition guidance

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pharmaceutical drug pricing and 340B

Senator's letter requests specific information about 340B covered entities

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pharmaceutical drug pricing and 340B
pharmaceutical drug pricing and 340B

Certain providers may receive drug discounts for uses outside indication associated with orphan designation

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pharmaceutical drug pricing and 340B

On law's 20th anniversary, members of Congress say law helps reduce drug costs for hundreds of hospital

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pharmaceutical drug pricing and 340B

President and CEO Bruce Siegel focused on program's benefits to patients and the hospitals on which they depend

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pharmaceutical drug pricing and 340B

Hospitals urged to review language on certification of compliance with group purchasing organization guidance

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pharmaceutical drug pricing and 340B

Deadline extended after significant pressure from America's Essential Hospitals and association members

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pharmaceutical drug pricing and 340B

About America’s Essential Hospitals

America’s Essential Hospitals is the leading association and champion for hospitals and health systems dedicated to high-quality care for all, including the most vulnerable. Since 1981, America’s Essential Hospitals has initiated, advanced, and preserved programs and policies that help these hospitals ensure access to care. We support members with advocacy, policy development, research, and education.