America's Essential Hospitals urged CMS to finalize withdrawal of the Trump administration's Most Favored Nation Model, citing procedural deficiencies, ongoing legal challenges, and significant reduction in provider payment rates.

In response to the calendar year 2022 Outpatient Prospective Payment System proposed rule, America's Essential Hospitals urged CMS to halt elimination of the inpatient-only list and to restore adequate payment to hospitals in the 340B program and to off-campus provider-based departments.

The comprehensive plan includes potential legislative and administrative actions that could be used to lower drug prices. The plan also notes the importance of the 340B Drug Pricing Program and its role in supporting the health care safety net.

House committees begin marking up portions of the forthcoming "human infrastructure" reconciliation package, which is expected to include provisions to expand health coverage and lower prescription drug prices. The association's calls for government relations professionals will resume Sept. 9.

CMS proposes to rescind the Trump administration’s Most Favored Nation model interim final rule, which aimed to reduce payment for 50 Medicare Part B drugs. America’s Essential Hospitals previously urged the agency to withdraw the model due to substantive and procedural issues.

The Aug. 11 webinar will complement other federal resources on the annual 340B Drug Pricing Program recertification period for hospitals, which is scheduled to start Aug. 16. Hospitals will have until Sept. 13 to complete the process.

Notable to essential hospitals, the Biden administration's July 9 executive order includes health care items related to prescription drugs, price transparency, hospital consolidation, and health insurance.

The Biden administration proposes to rescind a Trump-era final rule requiring federally qualified health centers to charge certain low-income patients no more than the 340B Drug Pricing Program price for insulin and injectable epinephrine. Comments on the proposed rule are due July 16.

The Health Resources and Services Administration enforcement action marks a crucial victory for essential hospitals, which have seen their access to drugs with 340B discounts cut off by manufacturers since last summer.

Senate Republicans release a $568 billion infrastructure framework to kickstart negotiations. House Democrats and Republicans reintroduce opposing prescription drug pricing bills. A CMS decision delays advancement of Chiquita Brooks-LaSure's nomination for CMS administrator.

In accordance with the presidential regulatory freeze, HHS proposes to further delay until July 20 a final rule requiring federally qualified health centers to charge certain low-income patients no more than the 340B Drug Pricing Program price for insulin and injectable epinephrine. 

Two federal courts halted implementation of the Centers for Medicare & Medicaid Services' most favored nation model interim final rule. The seven-year model was set to begin Jan. 1, 2021, phasing in a reduced payment rate for 50 Medicare Part B drugs.

The rule builds on an International Pricing Index model CMS first outlined in an advance notice of proposed rulemaking in late 2018. The mandatory model will include most providers and suppliers who purchase and receive reimbursement for Medicare Part B drugs.

America's Essential Hospitals urges HHS to prevent drug manufacturers from restricting access to life-saving drugs in the 340B Drug Pricing Program. Manufacturers recently notified covered entities that the companies will cease shipping 340B-priced drugs to some pharmacies; other manufacturers are requiring biweekly data on all contract pharmacy claims.

The executive orders aim to end retrospective rebates to Medicare Part D pharmacy benefit managers; allow patients of federally qualified health centers to purchase certain drugs at 340B discounted prices; and tie Medicare Part B payment to international drug prices, among other provisions.

GAO found that state Medicaid programs did not always have written procedures to identify 340B drugs and prevent duplicate discounts. Even when states have written policies and procedures, GAO found they were not always adequate to prevent duplicate discounts.

As the impeachment trial ends, House and Senate leaders will transition back to their legislative priorities, including reducing out-of-pocket health care costs.

The package, expected to become law, would delay a $4 billion cut to Medicaid disproportionate share hospital payments through May 22, 2020. It does not include proposals to reduce surprise medical bills or prescription drug prices.

Bipartisan Senate committee leaders released drug pricing legislation that includes a provision to eliminate $12 billion of Medicaid disproportionate share hospital cuts over two years. House and Senate committees announced bipartisan legislation to end surprise billing.

Lawmakers have three weeks to agree on funding for the federal government and various health care programs, including Medicaid disproportionate share hospital payments. The House resumes its impeachment investigation with a Judiciary Committee hearing.

While lawmakers continue negotiations on fiscal year 2020 spending bills and prescription drug pricing legislation, committees will hold hearings on electronic cigarette use, state efforts to undermine reproductive health care, and the presidential impeachment inquiry.

The final rules for Medicare’s Outpatient Prospective Payment System and Physician Fee Schedule for calendar year 2020 also expand access to opioid use disorder treatment and establish a prior authorization process for certain services.

A House vote on the Lower Drug Costs Now Act of 2019, scheduled for this week, has been postponed to allot more time for the Congressional Budget Office (CBO) to score the bill.

Essential hospital leaders will meet with lawmakers this week at our fall Policy Assembly amid government funding talks and drug pricing negotiations.

Negotiations continue on funding the federal government — and averting Medicaid DSH cuts — while House committees hold hearings and markups on the Lower Drug Costs Now Act.

President Trump signed a short-term continuing resolution delaying disproportionate share hospital funding cuts to Nov. 22; House Speaker Pelosi launched an impeachment inquiry.

DSH cuts will start Oct. 1 without congressional action; House Speaker Nancy Pelosi (D-CA) is expected to introduce a drug pricing proposal; the House considers a stopgap government funding measure.

The House advanced a federal budget and debt limit deal before leaving for August recess; the Senate will consider the measure this week. House and Senate committees consider legislation to reduce prescription drug pricing.

As Congress returns from the July Fourth recess, lawmakers focus on legislation to reduce surprise medical bills and prescription drug costs, as well as extend short-term funding for community behavioral health clinics.

Also last week, the Senate Committee on Health, Education, Labor, and Pensions advanced the bipartisan Lower Health Care Costs Act and the House Committee on Ways and Means marked up five Medicare-focused bills.

House and Senate committees this month remain focused on legislation to reduce surprise billing and health care costs. The House last week began deliberations on a $987 million spending package to fund many federal agencies for FY 2020.

The state plan amendment is specifically designed to allow the state to negotiate under a “subscription” model with manufacturers of prescription drugs that treat patients with hepatitis C. Washington is the fourth state cleared to pursue value-based purchasing agreements for supplemental rebates.

The Pandemic and All-Hazards Preparedness and Advancing Innovations Act would provide $385 million annually for the Hospital Preparedness Program. Congress stacks its agenda ahead of the July Fourth recess, focusing on health care funding, surprise billing, single-payer proposals, and drug pricing.

A draft plan from the Senate Health, Education, Labor, and Pensions Committee aims to end surprise medical bills for out-of-network emergency services, reduce prescription drug prices, and improve transparency in health care costs, among other priorities.

The Senate last week passed a new version of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019. House and Senate panels continue work to address balance billing and drug pricing ahead of next week's recess.

The House this week will take up legislation to protect people with pre-existing conditions and help generic drug and biosimilar manufacturers bring their products to market. A House letter calling for a delay of Medicaid DSH payment cuts has 286 bipartisan signatures; the deadline to sign is May 8.

A House letter calling for a delay of Medicaid disproportionate share hospital payment cuts has 178 bipartisan signatures; the deadline to sign is May 3. A House committee holds the first congressional hearing on the Medicare for All Act.

Hearings focused on rising drug costs and pricing transparency. Sen. Elizabeth Warren (D-MA) reintroduced a measure to bolster consumer protections under the Affordable Care Act. Both chambers will return to legislative business on April 29.

Reps. Eliot Engel (D-NY) and Pete Olson (R-TX) are circulating a bipartisan letter to their colleagues calling for a two-year delay of an impending $4 billion cut to Medicaid disproportionate share hospital (DSH) funding.

The legislation allows states to establish Medicaid health homes to coordinate complex care for children and provides $20 million in additional funding for the "Money Follows the Person" demonstration program, among other provisions.

The House also will mark up a dozen bills aimed at lowering health care and prescription drug costs. House and Senate committees move forward on work to address surprise billing.

Lawmakers have introduced bipartisan legislation to give states additional support for combating the opioid crisis by extending Medicaid's certified community behavioral health clinic demonstration program. Committees remain focused on prescription drug prices.

The president's fiscal year 2020 budget plan calls on Congress to significantly reform the two programs, including ending Medicaid expansion and changing Medicare uncompensated care payments.

Long-expected "Medicare-for-all" bill formally introduced; Congressional hearings continue to focus on rising health care costs and prescription drug prices.

Seven pharmaceutical company executives will testify in a Senate Committee on Finance hearing about prescription drug pricing practices.

Congressional committees requested information from providers and health plans on balance billing practices and invited several pharmaceutical companies to testify in a hearing on drug pricing; congressional negotiators strike a tentative deal to avoid another federal shutdown.

Congressional leaders and the White House reached a deal to fully reopen the federal government until Feb. 15; congressional hearings this week focus on prescription drug prices and protections for individuals with pre-existing conditions.

The association urged the agency to consider the interplay of new policies with existing government programs, such as the 340B Drug Pricing Program.

Ahead of the holiday recess, the Senate needs to approve the Pandemic and All-Hazards Preparedness and Advancing Innovations Act, while both chambers work to finalize a year-end spending bill to avoid a partial government shutdown.

The five-year demonstration, beginning in 2020, would be open to hospitals and physicians in selected geographic areas representing 50 percent of Medicare Part B spending on separately payable drugs.

The discussion draft addresses several patient care scenarios that could lead to surprise billing; Congress is expected to vote this week on reauthorization of the Pandemic and All-Hazards Preparedness Act, government funding for fiscal year 2019, and a bipartisan opioid package.

Bills to repeal the medical device tax and expand health savings accounts go to a House floor vote; a House committee advanced legislation that would fund the Hospital Preparedness Program at about $265 billion annually.

Hospitals will have until Sept. 12 to complete the recertification process through the Office of Pharmacy Affairs Information System.

CMS approved Oklahoma's proposal to advance Medicaid value-based arrangements with drugmakers in negotiating supplemental rebate agreements; The agency rejected Massachusetts' request to institute a closed formulary for Medicaid outpatient prescription drugs.

The legislation, containing more than 50 bills to combat the opioid crisis, now heads to the Senate; it is unclear whether senators will pass the package or consider their own legislation.

The House aims to complete voting by the July Fourth recess, but Senate work on opioid legislation likely will continue into August amid a shortened recess.

Lawmakers previously aimed to pass an opioid package by Memorial Day; Committee hearings focus on the Pandemic and All-Hazards Preparedness Act, the Department of Health and Human Services, and the president's blueprint to lower drug prices.

The Pandemic and All-Hazards Preparedness Reauthorization Act, which includes $385 million annually for the Hospital Preparedness Program, has been cleared for consideration on the Senate floor; Congress aims to vote on opioid package before the July Fourth recess.

The dashboards, which show spending for drugs purchased in Medicaid and Medicare Parts B and D, for the first time include data on year-over-year price increases for individual drugs.

The plan cites and builds on proposed changes to the 340B Drug Pricing Program in the president’s fiscal year 2019 budget, as well as damaging cuts implemented through the calendar year 2018 Outpatient Prospective Payment System final rule.

House Republicans this week hope to bring to the floor a bill to fund the government through the remainder of the fiscal year; America's Essential Hospitals CEO asked to testify during Senate committee hearing on 340B Drug Pricing Program.

Even with its long record of success, the 340B program still faces undue scrutiny, distorted and misleading claims, and demands for onerous new reporting.

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

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

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

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.

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

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.

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

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.

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

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

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

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.

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

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

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

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

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.

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.

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

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

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.

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.

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

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

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

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

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.

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

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.

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

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

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.

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.

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

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.

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

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

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.

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.

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.

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.

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

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

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

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.

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

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.

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.

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.

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.

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.

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.

Bill would fund the government through fiscal year 2014

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

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

Failure to complete recertification could result in dismissal from program

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

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

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

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

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

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

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

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