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<img class="alignright size-medium wp-image-4777" src="https://healthlawupdate.bakerhostetlerblogs.com/wp-content/uploads/sites/19/2017/03/hlu-photo-300x200.jpg" alt="" width="300" height="200" />White House Eyes Panel on Drug Prices While Senators Call for Transparency

President Donald Trump is considering appointing lawmakers to a bipartisan commission that would develop strategies to lower prescription drug prices, while senators last week called for greater transparency into how medicines are priced. Trump has been sharply critical of the pharmaceutical industry, including as recently as last week when he repeated his remarks that drug companies are “getting away with murder.” The president is said to be frustrated that drug prices in the United States are higher than in other industrialized countries where governments set prices.

It is not clear whether a commission will be created or whether it would replace a potential Trump executive order on drug prices, which administration officials had focused on earlier this year. Work on that executive order has cooled in recent months. Industry officials oppose the idea of a commission, which would give their opponents on the Hill – mostly Democrats – a platform to advocate for anti-industry provisions. Democrats have long wanted to lift the ban on the U.S. Department of Health &amp; Human Services (HHS) negotiating prices for Medicare Part D drugs and removing the ban on importation of drugs from other countries where governments set prices.

There were media reports this weekend that Rep. Buddy Carter (R-Ga.) could be appointed to the commission, and the National Community Pharmacists Association circulated a draft letter to Trump urging the president to name Carter to any panel examining drug pricing. Before winning election to Congress, Carter was a pharmacist in Georgia.

Meanwhile, at a Senate <a href="https://www.help.senate.gov/hearings/the-cost-of-prescription-drugs-how-the-drug-delivery-system-affects-what-patients-pay-part-ii">committee hearing</a> last week, Sen. Elizabeth Warren (D-Mass.) criticized Hatch-Waxman patent protections that she said permit drug manufacturers to raise prices without a check from generic drug companies or the government. Sen. Lisa Murkowski (R-Alaska) said she was exasperated by the lack of clarity on drug prices as rebates and discounts negotiated by manufacturers and pharmacy benefit managers mean similar providers can often pay different prices for the same drug. Sen. Al Franken (D-Minn.) asked witnesses why Americans pay more for prescription drugs than do consumers in other industrialized countries.

Lori Reilly of the Pharmaceutical Research and Manufacturers of America (PhRMA) testified that because of current negotiations and competition in the marketplace, spending on retail and physician-administered medicines represents just 14 percent of overall U.S. healthcare spending – a percentage that hasn’t increased in several years despite the approval of several high-cost medicines.

It was the Senate HELP Committee’s second hearing this year on drug prices with witnesses including executives from PhRMA, the Association for Accessible Medicines (formerly GPhA) and the Pharmaceutical Care Management Association. Chairman Lamar Alexander (R-Tenn.) said the panel will hold a hearing next month on a National Academy of Sciences report on access to affordable drug therapies.

ACA Stabilization Bill Stalls Amid GOP Infighting

Senate Majority Leader Mitch McConnell (R-Ky.) said this weekend that he would schedule a vote on bipartisan legislation that would authorize cost-sharing payments to insurers, but he’s waiting for clarity from President Trump after the White House demanded changes to the bill.

Sens. Lamar Alexander and Patty Murray (D-Wash.) last week reached an agreement to renew cost-sharing payments for two years to ensure insurance plans in the individual market were affordable for low-income consumers. The <a href="https://www.help.senate.gov/imo/media/doc/THE%20BIPARTISAN%20HEALTH%20CARE%20STABILIZATION%20ACT%20OF%202017-%20TEXT.pdf">bill</a> also would give states new flexibility from Affordable Care Act (ACA) mandates to design coverage. That plan quickly picked up the support of at least 12 Republicans and all 48 Democrats, meaning the bill had enough votes to overcome a filibuster and win Senate approval.

But House Speaker Paul Ryan (R-Wis.) came out against the bill. White House officials said they wanted to expand the bill to allow the sale of insurance policies across state lines; allow all Americans – not just those younger than 30 years old – to purchase catastrophic-only plans; and expand the use of health savings accounts and flexible spending accounts.

While Senate Democratic Leader Chuck Schumer (D-N.Y.) is calling for a vote on the Alexander-Murray bill as soon as this week, the ongoing disagreements between the White House and Congress may signal that the bill could be delayed and included in larger healthcare legislation Congress is expected to consider in December.

Top Health Officials to Testify at House Panel on Opioids

Food and Drug Administration (FDA) Commissioner Scott Gottlieb will lead a panel of top federal officials <a href="https://energycommerce.house.gov/hearings/federal-efforts-combat-opioid-crisis-status-update-cara-initiatives/">testifying</a> Wednesday before a House committee on the opioid crisis. The Energy and Commerce Committee is examining the federal effort to combat opioids, including the status of the Comprehensive Addiction and Recovery Act. That 2016 law authorized $181 million to boost federal prevention, treatment and law enforcement efforts. Other witnesses include Neil Doherty, deputy assistant administrator at the Drug Enforcement Administration; Dr. Elinore McCance-Katz, assistant secretary for Mental Health and Substance Use, Substance Abuse and Mental Health Services Administration; Dr. Anne Schuchat, principal deputy director at the Centers for Disease Control and Prevention; and Dr. Nora Volkow, director of the National Institutes of Health’s (NIH’s) institute on drug abuse.

Lawmaker Seeks Opioid Data From PBMs, Insurers

The top Democrat on the House Oversight and Government Reform Committee last week called on insurance companies and pharmacy benefit managers (PBMs) to provide information on why they are limiting access to less addictive pain therapies. Responding to media reports, Rep. Elijah Cummings (D-Md.) questioned why cheaper but more addictive opioids were covered while access to more expensive but less addictive pain drugs was restricted. Cummings said Medicare Part D plans frequently require prior approval for non-addictive pain treatments, which are also often on higher cost-sharing tiers. Cummings sent letters to the CEOs of Aetna, Anthem, CVS Health, Humana, Optum and UnitedHealth Group. He asked that companies respond with information by Nov. 2 on each of their covered pain medications and all cost-sharing, co-insurance, co-payment, prior authorization or step therapy practices associated with those drugs.

House Panel to Examine NIH-Funded Research

A House subcommittee Tuesday will hold a <a href="https://appropriations.house.gov/calendar/eventsingle.aspx?EventID=395057">hearing</a> examining the administrative costs associated with NIH-funded research. The House appropriations subcommittee that funds HHS’s budget also will examine the role of external facilities in research backed by NIH grants. While NIH enjoys broad bipartisan support on Capitol Hill, some lawmakers have questioned the administrative costs linked to the agency’s grants. Scheduled witnesses include Dr. Kelvin Droegemeier, vice president for research at the University of Oklahoma; Dr. Gary Gilliland, president of the Fred Hutchinson Cancer Research Center; Dr. Bruce Liang, dean of the University of Connecticut School of Medicine; and Dr. Keith Yamamoto, vice chancellor for science policy and strategy at the University of California at San Francisco.

Democratic Senators Introduce Medicare Public Option Plan

Two Democratic senators last week introduced <a href="https://www.congress.gov/115/bills/s1970/BILLS-115s1970is.pdf">legislation</a> that would allow consumers in rural areas to buy into Medicare via the ACA’s individual health insurance marketplace. The plan by Sens. Michael Bennet (D-Colo.) and Tim Kaine (D-Va.) is designed to strengthen the ACA’s individual markets, especially in rural areas where there is limited competition among insurers. But most Democratic senators are backing <a href="https://www.sanders.senate.gov/download/medicare-for-all-act?id=6CA2351C-6EAE-4A11-BBE4-CE07984813C8&amp;download=1&amp;inline=file">legislation</a> by Sen. Bernie Sanders (I-Vt.) that would establish a single-payer health plan for all consumers. While the Bennet-Kaine legislation may not fully reflect where the Democratic Party’s political center of gravity is currently, the senators say their plan represents a practical and reasonable approach to fortify the ACA.

House Panel to Probe Hurricane Impact on Health Preparedness

The House Energy and Commerce Oversight and Investigations Subcommittee on Tuesday <a href="https://energycommerce.house.gov/hearings/examining-hhss-public-health-preparedness-response-2017-hurricane-season/">will hear</a> from top federal health officials on HHS’s public health preparedness and response to this year’s hurricane season. Witnesses include FDA Commissioner Scott Gottlieb and Kimberly Brandt, principal deputy administrator for operations at the Centers for Medicare &amp; Medicaid Services. Gottlieb on Friday said his agency is working closely with pharmaceutical and medical device companies with manufacturing facilities in Puerto Rico to help them get back online. More than 50 device manufacturing plants on the island have continued to run on generator power but haven’t been able to return to pre-hurricane production levels, Gottlieb said.

Walden Seeks Details on Healthcare Malware Attack

The Chairman of the House Energy and Commerce Committee wants answers from a Massachusetts healthcare communications company that was hit with a malware attack last summer to understand potential cyber policy solutions his panel may pursue. In a <a href="https://energycommerce.house.gov/wp-content/uploads/2017/10/20171019Nuance.pdf">letter</a> to Nuance Communications, Rep. Greg Walden (R-Ore.) said the so-called “NotPetya” cyberattack in June “severely disrupted the ability of healthcare professionals to treat patients.” Nuance provides transcription and voice-to-text dictation services to healthcare providers. Walden asked the company to brief the committee by Nov. 2 about the initial infection, and the company’s efforts to restore its services and prevent future attacks.

Down Syndrome Focus of House Committee Hearing

The House appropriations subcommittee that funds HHS’s budget will hold a <a href="https://appropriations.house.gov/calendar/eventsingle.aspx?EventID=395058">hearing</a> Tuesday on the status of the science and potential for discoveries related to Down Syndrome. Two lawmakers with family members who have Down Syndrome – Reps. Cathy McMorris Rodgers (R-Wash.) and Pete Sessions (R-Texas) – are scheduled to testify. Other witnesses include Rep. Cheri Bustos (D-Ill.), co-chairwoman of the Congressional Down Syndrome Caucus; Michelle Sie Whitten, CEO of the Global Down Syndrome Foundation; Dr. William Mobley, executive director of the Down Syndrome Center for Research and Treatment; Dr. Joaquin Espinosa, executive director for Linda Crnic Institute for Down Syndrome at the University of Colorado School of Medicine; and Frank Stephens, recipient of the Quincy Jones Advocate award from the Global Down Syndrome Foundation.

Capitol Hill Healthcare Update