Happy Holidays from Innovation Partners! We hope everyone has a lovely holiday and a Happy New Year. We’re heading into an election year, and that means that several bills on Capitol Hill may be stalled until after November. Lobbyists continue to meet with lawmakers about Nancy Pelosi’s drug pricing bill, predicting it will squelch innovation among small biotech firms and destroy funding sources if it passes. New advances in the field of breast cancer offer hope, and CVS continues to lead with innovative partnerships that may offer advanced genomic testing for cancer patients in selected stores. These are the top stories in this week’s Innovation Partners BioBlog. Read on for more.

Innovation Partners Weekly BioBlog for December 20, 2019

Congress likely to punt on drug prices, surprise billing as year-end deadline nears

Although there’s been plenty of talk from Washington about lowering drug prices and ending surprise billing, both decisions and debates are likely to be pushed off until 2020. The House passed a bill requiring lower drug prices but it is unlikely to pass in the Senate. The proposal to end surprise billing has received bipartisan support but a competing bill in the House requires consideration before Congress moves forward. Since 2020 is a presidential election year, it is unlikely that much will get done until after the November election.
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Breast biopsies after neoadjuvant chemotherapy accurately predict presence of residual breast cancer

Researchers from The University of Texas MD Anderson Cancer Center have identified a standardized protocol that uses image-guided breast biopsies to reliably predict residual disease in breast cancer patients and that potentially identifies exceptional responders who may not require surgery. Data analyzed from 166 women in the study showed that the cancer could be completely eradicated with NAC given first, also called overall pathologic complete response (pCR) in 51.2%. This high rate of pCR suggests that many patients may not benefit from surgery if the cancer already is eradicated. When the image-guided biopsy was representative, the false negative rate (FNR) across the whole cohort was 18.7%. The results are being studied with an eye towards the elimination of surgery in exceptional responders after neoadjuvant chemotherapy (NAC).
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Judge strikes down AHA’s bid to halt CMS’ site-neutral payment cuts for 2020

A federal judge refused to strike down the Trump administration’s Medicare payment cuts to off-campus clinics due to go into effect in 2020. Despite heavy lobbying from the hospital industry, U.S. District Court Judge for the District of Columbia Rosemary Collyer found that the cuts starting January 1, 2020 can continue. The ruling means that hospitals could face a 60% reduction in Medicare payments for off-campus hospital outpatient departments.
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Trade deal takes away pharma’s biologic exclusivity and promotes drug competition

The new United States-Mexico-Canada trade deal takes away pharmaceutical companies’ 10-year exclusive right to make biologics as well as removes three additional years of patent protection when drug companies submit paperwork about a new use of a drug. The deal puts politics over patients, according to the Pharmaceutical Research and Manufacturers of America. The House and Senate must still vote on the deal in the next few weeks.
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CVS unveils new precision medicine initiative for oncology patients

People with advanced cancer may find new access to genetic testing in their local CVS. CVS announced it will partner with Tempus through a program called Transform Oncology Care to offer advanced genomic tests to patients. These broad panel tests identify more individual variations in cancer that allow docs to pinpoint the best treatment option. Tempus’ platform also enables people to enroll faster in clinical trials. The program will be available nationwide to health plans who contract with CVS Caremark. Aetna will launch it for participating provider networks in fully insured commercial plans across 12 states.
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Investors fear Pelosi’s drug price plan will kill small biotech firms

Many are lobbying against Nancy Pelosi’s drug price plan, but this week, private equity investors began speaking out against the plan. Venture capitalists met with lawmakers and others on Capitol Hill to express deep concern that the plan will halt innovation and destroy small biotech firms. If the bill passes, they predict funding will disappear for small biotech companies. Small biotech firms are important for clinical trials and head up 7 out of 10 trials.
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