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Wednesday, September 2, 2020

CMS finalizes nearly 3% boost to acute hospital payment rates in new rule

The Trump administration finalized a rule that increases payment rates for general acute care hospitals by approximately 2.9% and boosted add-on payments for new technologies in the next federal fiscal year.

The Centers for Medicare & Medicaid Services issued a final rule on Wednesday that updates the Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System for the 2021 fiscal year. The agency also made several changes on how it will calculate payment weights for Medicare fee-for-service payments.

CMS said that it expects total Medicare spending for acute care inpatient hospital services to increase by about $3.5 billion in the next fiscal year that begins in October.

“This rule is another critical step in our effort to modernize the program and strip away bureaucratic barriers between our seniors and the latest innovative treatments,” said CMS Administrator Seema Verma in a statement.

As part of the final rule, CMS approved 13 new technologies that applied for new technology add-on payments under Medicare.

The agency is also continuing new technology add-on payments, which are used to entice hospitals to buy pricey new drugs and medical devices, for 10 technologies. An additional eight technologies which previously earned those add-on payments will no longer be eligible.

In addition, CMS created a new Medicare Severity Diagnostic Related Group that gives a predictable payment for compensating hospitals that administer the pricey cancer treatment called CAR-T cell therapy. The treatment uses a patient’s genetically modified immune cell to treat specific types of cancers, CMS said.

The agency also expanded the add-on payment for antibiotics.

Price transparency


CMS has made several changes to the pricing strategies for hospitals.

Generally, Medicare pays a weighted rate for the relative cost of providing services. “These weights are currently based in large part on the charges that hospitals report to the federal government, which often have little relevancy to the actual rates paid by insurance companies,” the agency said.

Hospitals already must post negotiated rates as part of an effort to boost price transparency. Hospital groups have sued to halt the rule, but a

federal judge sided with the Trump administration.

But the final rule requires hospitals to report to CMS the median rate negotiated with Medicare Advantage plans for inpatient services instead of their charge-based data.

“CMS will begin to collect this data in 2021 and will use it in the methodology for calculating inpatient hospital payments beginning in 2024,” the agency said. “These provisions will introduce the influences of market competition into hospital payment.”

CMS also announced it will distribute $8.3 billion in payments to hospitals for uncompensated care, which is a decline of about $60 million compared with the 2020 fiscal year.

“This estimate of total uncompensated care payments reflects CMS Office of the Actuary’s projections that incorporate the estimated impact of the COVID-19 pandemic,” according to a fact sheet on the rule.”

https://www.fiercehealthcare.com/hospitals/cms-finalizes-nearly-3-boost-to-acute-hospital-payment-rates-new-rule


NIH awards nine companies $129 mln to scale up COVID-19 testing

The National Institutes of Health is awarding $129.3 million to nine companies to support scaling-up coronavirus testing and manufacturing new testing technologies, the U.S. health agency said on Wednesday.

The funding is part of NIH’s Rapid Acceleration of Diagnostics (RADx) initiative that was launched in April to speed up innovation in the development, commercialization, and implementation of technologies for COVID-19 testing. (https://bit.ly/2YZo5w8)

NIH said three of the selected companies, MatMaCorp, Maxim Biomedical Inc and MicroGEM International, offer point-of-care tests that produce immediate results.

The remaining six – Aegis Sciences, Broad Institute, Ceres Nanoscience Inc, Illumina Inc, PathGroup and Sonic Healthcare – offer lab-based tests.

The funding will help significantly expand national testing in September, with the laboratories managing collection, analysis and reporting of tens of thousands of tests a day, the agency said in a statement.

In July, NIH made a similar contribution of $248.7 million to seven companies. “Diagnostic testing is a critical component of the nation’s strategy to meet the challenge of the COVID-19 pandemic,” said NIH Director Francis Collins.


Administration Asks States to Be Ready for Vaccine by November

The Trump administration is asking states to speed up approval for vaccine distribution sites by Nov. 1, the latest sign the federal government is eager to get a vaccine out before the end of the year.

Centers for Disease Control and Prevention Director Robert Redfield urged state governors to remove barriers to building permits for distribution sites for use by McKesson Corp. and the drug wholesaler’s subsidiaries, according to an Aug. 27 letter. The Dallas-based company has a deal with the federal government to distribute a coronavirus vaccine when it becomes available.

“CDC urgently requests your assistance in expediting applications for these distribution facilities, and, if necessary, asks that you consider waiving requirements that would prevent these facilities from becoming fully operational by Nov. 1, 2020,” read the letter from Dr. Redfield to the states.

The administration has been pushing for a coronavirus vaccine. Food and Drug Administrator Stephen Hahn said in a recent interview with the Financial Times that an emergency authorization for a vaccine could be appropriate even before the vaccine has completed Phase 3 clinical trials.

An FDA vaccine advisory committee will meet Oct. 22 to discuss the development, authorization and licensing of vaccines to prevent Covid-19.

The CDC also provided documents to states outlining some of the most detailed descriptions to date of a vaccine rollout plan

The agency said vaccines would either be approved as licensed vaccines or under emergency-use authorization and would likely require two administrations.

“Vaccine and ancillary supplies will be procured and distributed by the federal government at no cost to enrolled Covid-19 vaccination providers, ” the documents state.

They also state that jurisdictions must be prepared to immediately vaccinate identified critical populations when the earliest Covid-19 vaccine doses are available.

A screening tool on the CDC website will help individuals determine their eligibility for a vaccine and direct them to a vaccine finder.

One scenario described the availability of about two million doses by the end of October and another 10 million to 20 million doses available by the end of November, according to the documents sent to states.

The Trump administration has prioritized a vaccine through an initiative it has dubbed Operation Warp Speed, and the Department of Health and Human Services has said it is preparing to launch a November public-awareness campaign across TV, radio and social media, focusing on vaccine safety, efficacy and patient hesitancy.

Dr. Hahn’s comments and the push to set up distribution sites by Nov. 1 has concerned some public-health experts who worry a vaccine could be rushed because of political pressure before it is determined to be fully safe. Election Day is Nov. 3, though many voters will have cast their ballots by mail well before that date.

Trump administration officials have pushed back on the criticism, saying Americans can trust the vaccine process.

“We all recognize that the public will have confidence in our decisions only if they are supported by the science. My personal commitment is to assure that all decisions meet FDA’s standard. The patient and the public always come first,” Dr. Hahn tweeted on Tuesday.

The administration on Tuesday ramped up its messaging on the safety of a vaccine. HHS Secretary Alex Azar and Dr. Moncef Slaoui, chief adviser to Operation Warp Speed, issued a release saying the optimistic target for a safe and effective vaccine is no later than January 2021.

“While one can never guarantee success in any scientific endeavor, it is now becoming increasingly likely we will deliver this historic victory for the American people and the world,” they said in the release.

The administration this week said it won’t join an international vaccine effort because it is co-led by the World Health Organization. President Trump has criticized WHO, saying it is too beholden to China.

Some public-health leaders have said the decision could mean the U.S. would have trouble getting vaccine doses if another country develops a successful vaccine more quickly. It also puts more pressure on the U.S. to develop a vaccine.

McKesson, one of the world’s largest drug wholesalers, said last month that it would be a centralized distributor of future Covid-19 vaccines and the supplies needed to administer vaccinations.

“Vaccines and related supplies will be delivered to point-of-care sites across the country at the U.S. government’s direction,” the company said in an Aug. 14 press release.

National distribution plans call for prioritizing front-line health workers and people especially vulnerable to more severe symptoms of Covid-19.

Three vaccines are in Phase 3 clinical trials in the U.S. They are an AstraZeneca PLC vaccine developed with Oxford University, a vaccine from Moderna Inc., and a candidate from Pfizer Inc. and German-based BioNTech SE.

Thirty-five percent of Americans said they wouldn’t get a free FDA-approved vaccine if it were ready, according to a poll released Aug. 7 by Gallup. Four in 10 nonwhite Americans and nearly half of Republicans said they wouldn’t get vaccinated, while Democrats were more likely to say they would.


Option Care Health to distribute Duchenne med viltolarsen

Option Care Health (NASDAQ:OPCH) announces that is has been selected to participate in the limited distribution network for NS Pharma’s (OTC:NPNKF) Viltepso (viltolarsen), approved by the FDA on August 12 for Duchenne muscular dystrophy (DMD) patients amenable to exon 53 skipping.

NS Pharma Chief Commercial Officer Gardner Gendron says, “We chose to include Option Care Health in our distribution network because of its commitment to providing excellent clinical care and national footprint. Its expertise in providing infusions for complex neuromuscular conditions, broad access to insurance networks and service in all 50 states give us the confidence that our patients will be able to receive Viltepso.”


Magenta nabs NIH grant to fund HIV cure research

Magenta Therapeutics (MGTA -3.1%) is a co-recipient of a five-year $14.6M NIH grant aimed at exploring the use of gene therapies and cell-based therapies to cure HIV.

The company, along with researchers from six academic/clinical institutions, will investigate novel hematopoietic stem and progenitor cell (HSPC) engineering and transplantation approaches aimed at achieving complete remission of HIV-1 infection.

Magenta will use its conditioning technology to optimize cell dose in animal models and determine whether targeted conditioning and gene-modified HSPC transplant enables disease control.


Ionis up after cardio-renal pipeline update

Ionis Pharmaceuticals (IONS +1.3%) is slightly ahead of the broad market advance following its update on its cardio-renal franchise. Highlights:

Company expects to file at least 10 marketing applications through 2025.

Candidates are based on ligand conjugated antisense (LICA) technology which enhances drug delivery with 20x – 30x greater potency while allowing less-frequent dosing (monthly or less) with an excellent safety profile.

Two Phase 3 programs: AKCEA-TTR-Lrx in transthyretin amyloidosis and pelacarsen in cardiovascular disease (CVD).

Seven additional programs in preclinical – Phase 2.

Phase 3 study of AKCEA-APOCIII-Lrx in patients with high triglycerides and established CVD to launch this year. More than 90% of treated patients in a Phase 2 trial achieved serum triglyceride levels less than 150 mg/dL (normal healthy range). Additional indications include high and very high triglycerides and multifactorial chylomicronemia syndrome.

Pfizer to conduct expanded Phase 2b study of vupanorsen (AKCEA-ANGPTL3-Lrx) in statin-treated patients with elevated non-HDL-C (high levels of “bad” cholesterol) and triglycerides this year. Results to inform on optimal dose for Phase 3 CV outcomes study.

Phase 3 HORIZON trial evaluating pelacarsen (AKCEA-APO(a)-Lrx) is recruiting CVD patients with elevated Lp(a) levels. Lp(a) is an inherited risk factor for CVD.

Licensee Bayer to launch Phase 2b study evaluating anti-thrombotic IONIS-FXI-Lrx in patients with end-stage renal disease on dialysis this year.

Phase 3 study, CARDIO-TTR, evaluating AKCEA-TTR-Lrx in patients with transthyretin-mediated amyloid cardiomyopathy is underway. Data expected in 2023.

Results from two Phase 2 studies assessing IONIS-AGT-Lrx in patients with treatment-resistant hypertension expected this year.


Prepare for coronavirus vaccine as soon as late October – CDC

The Centers for Disease Control and Prevention (CDC) has notified public health officials in all 50 states and five large cities to prepare for the distribution of a COVID-19 vaccine as soon as late October/early November reports the New York Times.

The CDC sent out guidance the same day that President Trump told the nation in his speech to the Republican National Convention that a vaccine may arrive before year-end. The plans detail technical specifications for two candidates, dubbed “Vaccine A” and Vaccine “B,” including requirements for shipping, mixing, storage and administration. The details appear to match vaccines being developed by Pfizer (PFE +0.8%) and partner BioNTech (BNTX +6.9%) and Moderna (MRNA +2.0%), both requiring two shots 28 days apart. Pfizer has stated publicly that it is on track to seek an emergency use nod as early as next month.

NIAID’s Dr. Anthony Fauci and the FDA’s Dr. Stephen Hahn have both stated that a vaccine could be available to certain groups, such as front-line healthcare workers, before clinical trials are completed, if the data are strongly positive.

Public health experts agree that agencies at all levels of government should urgently prepare for the daunting and complex effort to vaccinate hundreds of millions of Americans.

Critics, such as Arizona-based epidemiologist Saskia Popescu, calls the timeline “deeply worrisome” adding “It’s hard not to see this as a push for a pre-election vaccine.”