Finance Committee Releases Comments on Sovaldi Report

Senate Finance Committee Ranking Member Ron Wyden (D-Ore.) and former committee chairman Chuck Grassley (R-Iowa) have released the comments received from stakeholders in response to the questions raised in their investigation into the pricing and marketing of the Hepatitis C drug Sovaldi. The report was released on December 1, 2015. Since then, the committee received 63 comments from individuals, organizations and businesses from the health care and patient community. The submissions can be found here.

CDC Issues Opioid Prescribing Guidelines

The Centers for Disease Control and Prevention (CDC) have released final guidelines for the prescribing of opioid medications. In order to improve patient care and safety, the agency recommends that non-opioid therapies be preferred for chronic pain outside of cancer or end-of-life care. CDC also suggests that the lowest effective dosage be prescribed and that doctors be vigilant in prescribing opioids and monitoring their use. Physicians should start patients on immediate release drugs before prescribing extended-release opioids. Prescribers should also begin with a dosage of three days or less before evaluating how well a treatment is working, continuing to check in at least every three months for patients requiring opioid medication for longer periods of time. For those patients with a history of abuse, providers should consider prescribing naloxone alongside the painkiller medication, check the patient through their prescription drug monitoring program, and test the patient for other medication and illicit drug use. For those individuals with a substance use disorder, physicians should arrange for medication-assisted treatment and behavioral therapy. The guidelines do not make recommendations about specific numbers of pills or dosages, and the agency acknowledges that the guidelines should not replace clinical judgment. The guidelines were met with praise from congressional leadership involved in recent efforts to address the opioid epidemic.

President Nominates Merrick Garland to Supreme Court

President Obama has announced Judge Merrick Garland as his nominee to fill Justice Antonin Scalia’s seat on the Supreme Court. Garland led the effort on the Oklahoma City bombing and the Unabomber cases. He has been defended by the administration as a moderate with a centrist track record. He has been on the U.S. Court of Appeals for the D.C. Circuit for 19 years. The announcement was immediately met with opposition from congressional Republicans, who reiterated their intent to block the nomination to allow the next president to nominate someone.

Greg Simon Named Executive Director of Cancer Moonshot

The White House has named Greg Simon, a former pharmaceutical executive and congressional staffer, the executive director of the cancer moonshot initiative. In recent years he has worked as a venture capitalist in the biotechnology and life sciences sector. Cancer is also a subject of personal interest, given Simon’s diagnosis and treatment for lymphocytic leukemia in 2014. Last week, Vice President Biden met with House Energy and Commerce Committee Chairman Fred Upton (R-Mich.), ranking member Frank Pallone Jr. (D-N.J.), Rep. Diana DeGette (D-Colo.), Senate Health, Education, Labor and Pensions Committee Chairman Lamar Alexander (R-Tenn.) and ranking member Patty Murray (D-Wash.) to discuss the lawmakers’ medical innovation initiatives. The 21st Century Cures Act and the Senate Innovations package could be a potential path to funding for the cancer moonshot.

Groups Push Back Against Medicare Part B Drug Payment Model

Stakeholders in the health care community continue to express opposition to the Centers for Medicare and Medicaid Services’ (CMS) proposal to experiment with decreasing the cost of drugs purchased under Medicare Part B by reducing reimbursement for these drugs from average sales price (ASP) plus six percent to ASP plus 2.5 percent plus a flat fee. 100 groups cosigned a letter to U.S. Department of Health and Human Services (HHS) Secretary Burwell and CMS Acting Director Slavitt expressing concerns about the model and its potential impact on cancer patients. The ASP Coalition with more than 300 state and national organizations sent a letter to congressional leadership urging members to ask CMS to withdraw the proposed rule.

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