Senate Democrats aim to include Medicare drug price negotiation authority in $3.5T infrastructure deal (7/14)
Senate Democrats say they aim to include legislation giving Medicare the power to negotiate with drugmakers for lower prices in a massive $3.5 trillion infrastructure package. They announced that the package will expand Medicare benefits to offer dental, vision and hearing.
Medicare price negotiation authority would be the latest major healthcare priority that Democrats would include in the legislation.
The moderate and more progressive lawmakers are in talks to strike a balancing act. Progressive House Democrats have supported legislation to also require drugmakers to offer any price negotiated with Medicare to commercial plans. It remains unclear whether that provision will be included in any final language on Medicare drug pricing negotiation authority.
The $3.5 trillion legislation is expected to be considered in the Senate under a procedural move called reconciliation. The move enables budget legislation to move through the Senate via a simple majority and bypass the 60 votes needed to break a legislative filibuster.
One of those priorities is legislation to create a program like Medicaid that will cover eligible residents in the dozen states that did not expand Medicaid under the Affordable Care Act. The legislation would also boost the federal matching rate for Medicaid payments for states that newly expand.
Budget proposal to allow Medicare to negotiate prices should 'enrage' seniors, PhRMA says (7/16)
PhRMA (Pharmaceutical Research and Manufacturers of America), the industry lobbying association, responded with ire to the sweeping drug pricing reforms Congress is considering and the executive order which encourages biosimilar and generic competition and Medicare to negotiate drug costs.
The group blasted the initiatives as “an attempt to upend Medicare to help pay for Tesla tax credits and other government programs at seniors’ expense. This plan puts in motion a system that will allow government bureaucrats to tell seniors which medicines they can have while repealing a policy that would immediately lower what they pay at the pharmacy counter.”
J&J, AstraZeneca explore Covid-19 vaccine modification in response to rare blood clots (7/13)
Johnson & Johnson, AstraZeneca, and the University of Oxford, along with outside scientists, are conducting early-stage research into whether potential modifications of their Covid-19 vaccines could reduce or eliminate the risk of rare but serious blood clots associated with the shots.
The risks of clotting combined with low blood platelets are roughly 1 to 2 per 100,000 vaccinations, according to UK and European tallies of cases. US government data show a lower rate of around 0.3 instances of the clotting condition per 100,000 doses for the J&J vaccine.
National healthcare organizations call on hospitals to require vaccines for employees (7/14)
A group of professional healthcare organizations including The Society for Post-Acute and Long-Term Care Medicine and six others, said hospitals, nursing homes and other health facilities should require employees to get a COVID-19 vaccine.
The statement comes as the nation is experiencing a rise in COVID-19 cases, a 16% increase compared to the prior week's seven-day moving average of daily cases, according to the Centers for Disease Control and Prevention. The highly transmissible delta variant is fueling the jump in cases and is taking off in areas with low vaccination rates.
Currently, about 48% of the US population is fully vaccinated, below the threshold experts said is needed. The total number of cases in the US is significantly lower than the peak reached in January. However, experts worry the latest rise in cases will hamper the fight to stop the pandemic.
Medicare to review coverage for new Alzheimer’s drug Aduhelm (7/12)
Medicare officials are beginning a review of Biogen’s new Alzheimer’s drug to decide whether to standardize coverage of the medicine nationally, a widely-anticipated step that would allow the government to place limits on who can receive the medicine.
The so-called national coverage determination will decide whether Aduhelm is a “reasonable and necessary” treatment. If so, Medicare, the federal government’s health-insurance program for the elderly, is required by law to pay for it.
Yet it could still place restrictions on the drug, such as by limiting it to patients who match the criteria approved by the US Food and Drug Administration.
AstraZeneca deal for Alexion to close soon as UK regulator clears acquisition (7/14)
AstraZeneca expects to complete its $39 billion acquisition of Alexion on July 21 after receiving the last regulatory clearance it needed, from the UK Competition and Markets Authority.
The US Federal Trade Commission, which has signaled a tougher approach toward pharmaceutical mergers and acquisitions, approved the transaction in April. Shareholders from both companies gave the deal a green light on May 11.
Shares issued to Alexion investors should begin trading on July 22 and Alexion's stock will be de-listed from the Nasdaq.
Lilly wagers up to $1B on a biotech's plan for a new type of insulin (7/14)
Eli Lilly will pay up to $1 billion for privately held biotech Protomer Technologies in a deal that gives the big pharma access to an experimental glucose-responsive insulin.
Founded in 2015, Protomer develops drugs that respond to "molecular activators" like glucose, which is elevated to unhealthy levels in people with diabetes. Lilly joined with the Juvenile Diabetes Research Foundation to provide the startup with venture funding, and owned a 14% stake in Protomer before agreeing on Wednesday to buy the whole company.
Diabetes researchers have sought to develop a glucose-responsive insulin since the 1970s, but they have been limited by a lack of speed and sensitivity. That could soon change, however. Novo Nordisk began a Phase 1 trial of an experimental project last year, and Lilly could keep pace through its acquisition of Protomer.
J&J recalls Aveeno, Neutrogena spray sunscreens (7/14)
Johnson & Johnson is recalling most of its Neutrogena and Aveeno spray sunscreens from US stores after detecting benzene, a potentially cancer-causing chemical, in some samples.
J&J said it doesn’t use benzene in the manufacturing of the spray sunscreens and is investigating the cause of the contamination.
Cleveland Clinic, Mount Sinai and Providence won’t give biogen’s new Alzheimer’s drug (7/15)
Three large hospitals are declining to administer Biogen’s new Alzheimer’s treatment, Aduhelm, the latest rupture to emerge from the FDA’s controversial approval of the drug last month.
They said they wouldn’t administer Aduhelm to patients amid a debate about the drug’s effectiveness and whether the FDA lowered its standards in approving the medicine.
The hospitals’ moves come as some health insurers also restrict access to the therapy—unusual pushback against a drug targeting a devastating disease like Alzheimer’s that has few effective treatments.
Takeda, AbbVie, BMS, Sanofi, Lilly and others join growing tally of pharma's July price hikes (7/15)
As drug pricing chatter gains steam once again in Washington DC, pharma companies have been quietly raising prices on dozens of drugs behind the scenes. In July, pharma companies large and small have driven up prices on 65 drugs, mostly brand name, by an average of 3.5%. This is double the count from early July.
While smaller drugmakers dealing in rare disorders dominated the initial price jumps to start the month, now big pharma players such as Pfizer, Eli Lilly, Sanofi, AstraZeneca, Bristol Myers Squibb, Novartis and AbbVie have also gotten involved. Many of the price hikes are in the low single-digit percentages.
Compared with January, July is typically a slower month when it comes to price increases. Earlier this year, companies increased the cost of drugs by an average of 4.5% on more than 800 drugs. While it wasn’t uncommon for pharma companies to raise prices twice per year, many drugmakers moved to a once-per-year schedule in recent years amid scrutiny.
During a daylong meeting that featured a debate over Biogen’s new Alzheimer’s drug Aduhelm’s cost and more, ICER (Institute for Clinical and Economic Review) experts voted 15 to 0 that Aduhelm doesn't provide benefits above routine care.
The experts' rejection comes amid the controversy following the FDA’s approval, issued just over a month ago. In just a matter of weeks, regulators have narrowed Aduhelm’s label and called for an independent investigation into the reportedly cozy dealings between Biogen execs and FDA personnel.
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HHS provides $398 million to small rural hospitals for COVID-19 testing and mitigation (7/13)
The US Department of Health and Human Services (HHS) through the Health Resources and Services Administration (HRSA) provided $398 million in funding through the Small Rural Hospital Improvement Program (SHIP) to 1,540 small rural hospitals for COVID-19 testing and mitigation.
Small rural hospitals—those with fewer than 50 beds and Critical Access Hospitals—are key health care access points and trusted community resources. Hospitals will use the funds to maintain or increase COVID-19 testing, expand access to testing for rural residents, and tailor mitigation efforts to reflect the needs of local communities.
CMS proposes extension of Medicare telehealth coverage (7/14)
CMS is proposing to extend Medicare coverage of certain telehealth services granted for the COVID-19 public health emergency to the end of 2023 to help gather data that can determine whether the services should be permanently covered.
The annual rulemaking also includes changes to the Quality Payment Program and seeks feedback on how to improve data gathering from providers in an effort to better health equity.
But provider groups were not happy with the payment adjustment included — a 3.75% reduction to the conversion factor, due to budget neutrality requirements. The Medical Group Management Association, which represents physician practices, said in a statement that it would seek congressional intervention to avoid the cut.
Biden Administration launches “Summer Sprint to Coverage” campaign for final 30 days of Special Enrollment Period (7/15)
The Biden Administration is launching the “Summer Sprint to Coverage” campaign as part of robust efforts to get more Americans to sign up for health coverage in the final 30 days of the Special Enrollment Period (SEP) on HealthCare.gov.
The “Summer Sprint to Coverage” campaign will mobilize an all-hands effort including integrated paid media placements, increased community outreach, and more to encourage Americans who need coverage to sign up at HealthCare.gov by August 15 for zero-cost or low-cost, quality health insurance.
The 2021 SEP offers new and existing consumers an opportunity to update or create a new application and newly enroll or change their current plan selection. Since February 15, more than 2 million consumers have signed up for coverage which includes an additional 600,000 enrolling in coverage through the 15 state-based Marketplaces during the SEP.
 https://www.fiercehealthcare.com/payer/senate-democrats-aim-to-include-medicare-drug-price-negotiation-authority-3-5t-infrastructure  https://www.fiercepharma.com/pharma/budget-proposal-to-allow-medicare-to-negotiate-prices-should-enrage-seniors-phrma-says  https://www.wsj.com/articles/j-j-astrazeneca-explore-covid-19-vaccine-modification-in-response-to-rare-blood-clots-11626173015  https://www.healthcaredive.com/news/national-healthcare-organizations-call-on-hospitals-to-require-vaccines-for/603314/  https://www.wsj.com/articles/medicare-to-review-coverage-for-new-alzheimers-drug-aduhelm-11626130325  https://www.biopharmadive.com/news/astrazeneca-alexion-deal-close-uk-regulators/603317/  https://www.biopharmadive.com/news/lilly-acquire-protomer-glucose-sensitive-insulin/603325/  https://www.wsj.com/articles/j-j-recalls-aveeno-neutrogena-spray-sunscreens-11626303616  https://www.wsj.com/articles/cleveland-clinic-mount-sinai-wont-give-biogens-new-alzheimers-drug-11626366968?mod=searchresults_pos2&page=1  https://www.fiercepharma.com/pharma/sanofi-bms-allergan-lilly-and-others-join-growing-list-pharma-s-july-price-hikes-report  https://www.fiercepharma.com/pharma/despite-biogen-s-sharp-rebuke-cost-watchdog-experts-unanimously-refute-aduhelm-s-benefits  https://www.hhs.gov/about/news/2021/07/13/hhs-provides-398-million-to-small-rural-hospitals-for-covid-testing.html  https://www.healthcaredive.com/news/cms-proposes-extension-of-medicare-telehealth-coverage/603298/  https://www.cms.gov/newsroom/press-releases/biden-harris-administration-launches-summer-sprint-coverage-campaign-final-30-days-special