1. Congress


House and Senate Democrats Introduce Legislation to Stop Rising Drug Prices

On March 29, Democrats in the House and Senate introduced companion bills to address drug prices. The bill was introduced in the Senate by 15 Democrats including Sens. Al Franken (D-MN), Dick Durbin (D-IL) and Elizabeth Warren (D-MA). Bernie Sanders (I-VT) also signed on. A companion bill was introduced in the House by Reps. Elijah Cummings (D-MD), Janice Schakowsky (D-IL), Peter Welch (D-VT) and Rosa DeLauro (D-CT).

The legislation includes a variety of policies from government price controls, drug rebates, disclosure requirements for drug makers’ research and marketing spending, cost-sharing caps, exclusivity cuts and drug advertising restrictions.

Transparency is one of the four titles in the bill. Drug companies would be forced to report, by product, their costs for research and development, manufacturing and acquisitions, and HHS would publicly post that information. Companies would also have to report other information, such as federal investments and revenues. Another transparency section would require independent charity assistance programs to disclose the amount of patient assistance provided for drugs that are donated to those charities.

CMS would be directed to negotiate drug prices, and expensive drugs would be prioritized. The HHS inspector general would monitor drug prices for spikes and take steps to prevent price gouging. The bill would also speed the closing of the Part D coverage gap by two years, and it would let wholesalers and pharmacies import drugs made at FDA-inspected facilities, starting in Canada. Drug companies would have to provide rebates on drugs taken by dual-eligible beneficiaries for which plans receive low-income subsidies.

The bill would limit how much plans can make individuals shoulder the cost of drugs. Cost sharing would be capped at $250 a month for each individual and $500 a month for families in either qualified health plans or employer plans.

To spur the development of antibiotics for difficult-to-treat infections, the bill would create a $2 billion fund at the National Institutes of Health for companies that develop antibiotics that treat serious and life-threatening bacterial infections. To get the reward, companies would have to sell products at a “reasonable price” and share clinical data.

The bill would publicly fund clinical trials by creating a clinical research center at NIH, as well.

Lastly, the legislation reduces the exclusivity periods that drug companies currently receive.


Pence Casts Tie-Breaking Vote to Roll Back Planned Parenthood Protections

On March 30, Vice President Mike Pence broke a 50-50 tie in the Senate to roll back an Obama administration regulation and allow states to withhold federal family planning funding from Planned Parenthood and other abortion providers.

Republican Sen. Johnny Isakson (GA), who is recovering from back surgery, and the vice president were summoned to help pass the measure. All the Senate Democrats opposed the rollback, along with Republican Sens. Susan Collins (ME) and Lisa Murkowski (AL), who have long fought against blocking funding for the family planning organization.

The bill reverses an HHS regulation, finalized by the Obama administration in December, which prohibited states from restricting Title X family planning grants to Planned Parenthood and other abortion providers. Title X grants cover contraception, STD screenings and treatments but cannot be used to pay for abortion services.

Thirteen Republican-controlled states restricted the family planning grants to Planned Parenthood before the Obama administration issued the regulation. Federal funding for abortion is already prohibited under the Hyde Amendment. Republicans say the bill is not an attack on Planned Parenthood and is intended to uphold states’ rights.

Republican Sens. Introduce Legislation for Temporary Obamacare Relief

On March 29, Tennessee Sens. Lamar Alexander, chairman of the Senate Health, Education, Labor and Pension Committee, and Bob Corker introduced legislation designed to help Obamacare customers who have no insurance plans to choose from on the health insurance exchanges.

Roughly 40,000 residents of the Knoxville area are in this predicament after the sole insurer selling exchange plans in that market, Humana, announced that it is pulling out of the market for 2018. Roughly one-third of counties nationwide currently have just one insurer selling plans on the exchange.

The Alexander-Corker legislation would allow individuals with no exchange options to use their subsidies to help purchase coverage off of the exchangecurrently, subsidies can only be applied to health plans purchased through state and federal health insurance marketplaces set up under the law. It would also waive the individual mandate penalty for individuals in that situation.

Senate Democrats Ask Trump to Rescind Executive Order for ACA Repeal

On March 29, 44 Senate Democrats asked the Trump administration to abandon all efforts to repeal the Affordable Care Act and withdraw its January 20 executive order to unravel the law.

The letter stated that rescinding the order—in which President Donald Trump called on his administration to undo as much of the law as possible but provided few specifics—could serve as a first step toward bipartisanship on Obamacare.

“While we would welcome your sincere interest in bipartisan work to improve quality, lower costs, and expand coverage, we are concerned by your recent statement indicating it would be a good thing to make the ACA ‘explode,’ which would hurt millions of Americans,” the Democrats wrote to Trump. “Instead, we urge you to use your executive authority to support a stable, competitive insurance marketplace.”

Moderate Democratic Sens. Joe Manchin (WV), Jon Tester (MT) and Heidi Heitkamp (ND), as well as Independent Angus King (ME), did not sign the letter.

Sen. McCaskill Launches Investigation into Opioid Manufacturers’ Sales Practices

Sen. Claire McCaskill (D-MO) has launched an investigation into whether the business practices of the country’s top-five opioid manufacturers contributed to the overutilization of the drugs and the resulting addiction epidemic.

McCaskill sent letters to Purdue, Johnson & Johnson, Insys, Mylan and Depomed on March 28, asking for information related to the sales, marketing and education strategies these companies used to promote opioid use.

“This epidemic is the direct result of a calculated sales and marketing strategy major opioid manufacturers have allegedly pursued over the past 20 years to expand their market share and increase dependency on powerful—and often deadly—painkillers,” McCaskill wrote. Many opioid makers have faced legal penalties for these actions, but McCaskill is concerned drug companies are still inappropriately marketing opioids today.

McCaskill is seeking marketing and business plans, including those for consumer and physician marketing developed since January 2012. She also wants to know what quotas the companies put in place for sales representatives who recruited physicians to speak favorably about the drugs. And she want details on funding the companies contributed to third-party pain advocacy groups.

The investigation comes as the White House issued an executive order that aims to conduct a review of the opioid crisis and take new action to combat abuse.

2. Administration

FDA Nominee to Recuse Himself From Decisions on Certain Companies

President Donald Trump’s nominee to lead the FDA, Scott Gottlieb, will recuse himself for one year from agency decisions on more than 20 companies, including GlaxoSmithKline and Bristol-Myers Squibb. This announcement came as the Senate HELP Committee announced it will hold a hearing on Gottlieb’s nomination on April 5.

Gottlieb is a board member or adviser to various drug companies, and he funds the industry through roles at a venture capital firm, New Enterprise Associates, and an investment bank, T.R Winston & Company. His close ties to the drug industry will likely draw intense scrutiny during his confirmation process, particularly from Senate Democrats.

For instance, according to financial disclosures, Gottlieb indicated GlaxoSmithKline has paid him more than $87,000 for consulting work since 2016. In 2015, he received nearly $200,000 in payments from eight pharmaceutical companies, according to a federal database tracking drug industry payments.

Gottlieb earned more than $3 million between 2016 and March 1, according to disclosure forms filed with the Office of Government Ethics. That includes a $1.85 million retainer bonus from T.R. Winston. He was also paid $210,916 by the conservative American Enterprise Institute.

White House Executive Order Calls for Agencies to Act on Opioid Crisis

The White House recently released an executive order establishing “the President’s Commission on Combating Drug Addiction and the Opioid Crisis.” The order instructs four federal agencies to conduct a review of the opioid crisis and recommend new action within 90 days.

Under the order, President Donald Trump would create a high-level commission for “combating opioid abuse, addiction and overdose.” The commission would include Attorney General Jeff Sessions, HHS Secretary Tom Price, VA Secretary David Shulkin, Defense Secretary James Mattis and as many as five other stakeholders who are not federal employees.

New Jersey Gov. Chris Christie, a Trump ally who has made the opioid crisis a policy priority, will chair the commission.

The draft order calls for the participating agencies to:

  • Review the funding and availability of treatment;
  • Determine best practices for prevention and recovery;
  • Evaluate federal programs and the U.S. health system to identify regulatory barriers or ineffective initiatives; and
  • Recommend changes to federal criminal law or other processes.

The commission would review the agencies’ findings and issue recommendations to agency heads, who would then issue their own directives.

Trump Administration Lays Out Major Cuts to Health Agencies

Overall, the Trump administration has proposed $18 billion in cuts across more than 20 federal departments for the current fiscal year, according to a proposal sent to appropriators on Friday.

The proposed NIH cut is one of the three largest reductions to individual agencies spelled out in the document—but the cuts are unlikely to be implemented. House appropriators have said that it is too late for the Trump administration to request drastic cuts to agencies this year.

The proposed reductions would come from long-settled discretionary spending bills and could prompt a major showdown with only a month left before the deadline to keep the government funded.

The NIH cuts would include a $1.18 billion reduction in research grants and the elimination of $50 million in spending on new Institutional Development Award (IDeA) grants. The White House also would cut more than $300 million from the CDC, with about $100 million coming from its HIV/AIDS programs and the remainder coming from various public health research programs, initiatives and preparedness.

The White House also is calling for a $50 million cut to the Agency for Healthcare Research and Quality (AHRQ)—roughly 15 percent of the agency’s budget—by reducing new grants and a $40 million cut to FDA through staffing savings.

The Republican chair of the House Appropriations Labor-HHS subcommittee said he will not accept the proposed cuts to the NIH and CDC. Chairman Tom Cole said during a hearing that reducing funding to the NIH and CDC would leave the nation less secure, and that he will push for major revisions to the budget plan.

HHS Reportedly Working on Drug Pricing Plan

HHS Secretary Tom Price told House appropriators the agency is partnering with the White House on a strategy for tackling drug pricing reform, emphasizing Trump’s commitment to bringing down the cost of pharmaceuticals. However, he offered no specifics on how the administration might accomplish that. Price has yet to endorse permitting Medicare to negotiate drug prices or the importation of medicines from other countries, two ideas that Trump has floated as potential solutions for bringing prices down.

CMS Delays Reporting Deadline for New Lab Fee Schedule

CMS delayed by 60 days the deadline for certain laboratories to report private payer data for the new lab fee schedule, the agency announced March 30. CMS delayed the deadline because many labs won’t be able to give the agency a complete set of information by March 31. The American Clinical Laboratory Association is pleased with CMS’s decision.

For more information, click here.

CMS Issues Final Rule on Medicaid Disproportionate Share Hospital (DSH) Payments

On March 30, CMS issued a final rule clarifying federal requirements regarding the treatment of third-party payers in determining the hospital-specific Medicaid DSH payment limit, which is set by statute as a hospital’s “uncompensated costs” incurred in providing hospital services to Medicaid and uninsured patients. The final rule makes clearer the agency’s existing policy that uncompensated costs include only those costs for Medicaid-eligible individuals that remain after accounting for all payments received by or on behalf of Medicaid-eligible individuals, including Medicare and other third-party payments. This is consistent with the statutory requirements governing Medicaid DSH and applicable limits.

To see the final rule, click here.

For more information, click here.

3. State Activities

Arkansas: Lawmakers Vote to Continue Funding Medicaid Expansion Model

Arkansas state lawmakers have voted to keep funding the state’s Medicaid expansion model after the legislation initially fell short of the necessary votes in the state House and Senate. The Arkansas Legislature has to annually appropriate funding for Medicaid expansion with a three-fourths majority of each chamber. Gov. Asa Hutchinson plans to file a new request to the federal government to make a handful of conservative changes to its program, including a work requirement and limiting eligibility to those with incomes up to the federal poverty line, instead of 138 percent of the FPL. He will call a special session for lawmakers to consider the proposed revisions.

Iowa: New Managed Care Initiative Could Cost Much More Than Expected

Iowa’s decision to help insurance companies stem financial losses from the state’s new Medicaid managed care program could end up costing the federal government $225 million, on top of $10 million for the state. The new managed care initiative, which has been highly contested, began last April. The managed care companies involved say they have been spending more money because Medicaid enrollees have utilized more medical services than expected. Gov. Terry Branstad’s office continues to argue that the shift to managed care is beneficial to the state both in terms of budget savings and care for low-income enrollees.

Kansas: Kansas Governor Vetoes Medicaid Expansion

On March 30, Kansas Gov. Sam Brownback vetoed a bill to accept Obamacare’s Medicaid expansion, saying the legislation “burdens the state budget with unrestrainable entitlement costs.”

The legislation, guided by GOP legislators, passed the Kansas state House and Senate by overwhelming margins. But it is not clear whether they can override Brownback’s veto. The bill was just a few votes short of a veto-proof majority in each chamber.

Brownback said in a veto message that it was unwise to expand Medicaid when Republicans are still trying to overhaul Obamacare. He also said he blocked the legislation because it increased Medicaid funding for Planned Parenthood.

Minnesota: Minnesota Approves Obamacare Stabilization Program

On March 30, the Minnesota legislature passed legislation to set up a reinsurance program that would spend $271 million each year in 2018 and 2019, similar to what Alaska created last year to prevent its Obamacare exchange from collapsing. Minnesota’s individual market saw skyrocketing premiums this year, prompting the state’s Democratic governor to issue a rare criticism of Obamacare at the height of the presidential campaign.

The new Minnesota program, which would reimburse insurers for their most expensive patients, would be funded through state dollars and an existing health care fund. To establish the program, Minnesota would also need the Trump administration to approve an Obamacare waiver that lets states enact their own health reforms. If approved, the federal government would potentially pick up most of the program’s cost.

Gov. Mark Dayton will announce today whether he plans to sign or veto the legislation. HHS Secretary Tom Price has encouraged states to apply for 1332 waivers to set up reinsurance programs or high-risk pools to stabilize their markets.

Nevada: Nevadans Working to Decrease Insulin Prices

Increasing insulin prices have prompted Nevadans to try to take on the drug industry. Democratic lawmakers, union leaders and other supporters of Senate Bill 265 want to rein in prices by mandating that pharmaceutical companies reimburse Nevada patients for insulin costs that go above the highest price paid in other developed counties and if the price increases are higher than inflation would warrant. In addition to requiring manufacturers to disclose the research costs of making drugs for diabetics, it would force them to give government health agencies and insurers a 90-day notice before increasing prices above the previous year’s inflation rate.

4. Regulations Open for Comment

CMS Proposes Average 0.25 Percent Hike for Medicare Advantage Plans

On Feb. 1, the Trump administration issued guidance that proposes updates to the methodologies used to pay Medicare Advantage plans and Part D sponsors. The guidance calls for raising Medicare Advantage payments an average of 0.25 percent.

Health plans take in roughly $200 billion a year from the government to provide care for seniors enrolled in private Medicare plans. There are currently more than 18 million people enrolled in Medicare Advantage, accounting for roughly a third of all of the program's beneficiaries. More than 1 million seniors have been added to private Medicare plans in the past year, continuing a trend of robust growth that goes back a decade.

"These proposals will continue to keep Medicare Advantage strong and stable and provide high quality, affordable care to seniors and people living with disabilities," said Patrick Conway, acting administrator of the Centers for Medicare and Medicaid Services.

Obamacare included major cuts to Medicare Advantage—America's Health Insurance Plans puts the total figure at $200 billion—that were designed to bring payments more in line with traditional government-run Medicare. Last year, the federal government paid private plans an average of 102 percent of traditional fee-for-service costs per member.

UnitedHealth Group and Humana are the biggest national players, accounting for roughly 40 percent of the Medicare Advantage market in 2015.

CMS will accept comments until March 3 and the final notice will be posted on April 3.

To read a fact sheet on the rate proposal, click here.

CMS Announces RFI for Input on Improving Pediatric Care

CMS announced Feb. 27 a Request for Information (RFI) seeking input on approaches to improve pediatric care, specifically to improve the quality and reduce the cost of care for children and youth enrolled in Medicaid and the Children’s Health Insurance Program (CHIP). CMS is also exploring concepts that encourage pediatric providers to collaborate with health-related social service providers at the state, tribal and local levels and share accountability for health outcomes for children and youth enrolled in Medicaid and CHIP.

CMS is asking stakeholders to submit comments via email to [email protected] by 11:59 p.m. on March 28, 2017.

For more information about the RFI, visit the CMS Innovation Center website.

FDA Considers Establishing New Office of Patient Affairs

The FDA is considering establishing a new Office of Patient Affairs that would centralize its work on patient involvement in the review and approval of drugs and medical devices, according to a March 14 notice in the Federal Register.

Comments on the new office are due by June 12, 2017.

FDA Proposes 1,000 Medical Devices to Exempt From Premarket Notification

On March 14, FDA took one of its first actions to begin implementing the 21st Century Cures Act, by proposing more than 1,000 medical devices it will exempt or partially exempt from the premarket review process. The devices on the list are sufficiently well understood and do not present risks that require premarket notification to provide a reasonable assurance of safety and effectiveness, FDA said. The agency will finalize the list after a 60-day public comment period. Comments are due by May 15, 2017.

FDA Extends Comment Period on Biosimilar Interchangeability Guidance

FDA is extending the public comment period for its draft guidance outlining how biosimilar sponsors can demonstrate that their products are interchangeable with other biologics, following extension requests from top trade associations.

The agency laid out in a January 2017 draft guidance its first attempt at codifying the requirements that sponsors must satisfy to demonstrate interchangeability. The agency said it would make case-by-case determinations of interchangeability, but indicated it would require studies measuring the impact of switching on clinical pharmacokinetics and pharmacodynamics.

The Biotechnology Innovation Organization (BIO), Pharmaceutical Research and Manufacturers of America and Covington & Burling all requested comment period extensions, according to documents posted on Regulations.gov.

The comment period, which was set to close on March 20, will be extended 60 days until May 19.

CMS Announces Pediatric Care Improvement Request for Information Extension

On March 28, CMS announced that it is extending the deadline for comments on the request for information (RFI) on approaches to improve pediatric care announced on Feb. 28, 2017. The deadline for receipt of comments has been extended to April 7, 2017 at 11:59 p.m.

Through this RFI, CMS is specifically seeking input on approaches to improve the quality and reduce the cost of care for children and youth enrolled in Medicaid and the Children’s Health Insurance Program (CHIP). Furthermore, CMS is exploring concepts that encourage pediatric providers to collaborate with health-related social service providers at the state, tribal and local levels and share accountability for health outcomes for children and youth enrolled in Medicaid and CHIP.

Comments and questions can be submitted via email to [email protected] by 11:59 p.m. on April 7, 2017.

For additional information about the RFI, please visit the CMS Innovation Center website.

5. Reports

GAO Releases Review of PPACA’s Financial Statement Audit

On March 31, GAO released its review of the Patient-Centered Outcomes Research Institute’s (PCORI) fiscal year 2016 financial statement audit. PCORI was created in 2010 by the Patient Protection and Affordable Care Act (PPACA) as a federally funded, nonprofit corporation. According to PPACA, PCORI’s purpose is to assist patients, clinicians, purchasers, and policymakers in making informed health decisions by advancing the quality and relevance of evidence concerning the manner in which diseases, disorders, and other health conditions can effectively and appropriately be prevented, diagnosed, treated, monitored, and managed through research and evidence synthesis.

In its review of the financial audit for PCORI’s fiscal year 2016 financial statements, GAO did not identify any significant issues related to the audit that it believes require attention. The independent public accounting firm (IPA) provided an unmodified audit opinion on PCORI’s fiscal years 2016 and 2015 financial statements. Specifically, the IPA found that PCORI’s financial statements were presented fairly, in all material respects, in accordance with U.S. generally accepted accounting principles.

Furthermore, for fiscal year 2016, the IPA did not identify any deficiencies in internal control that it considered to be material weaknesses or any reportable noncompliance with the selected provisions of laws, regulations, contracts, and grant agreements it tested. PCORI did not disagree with the IPA report’s conclusions.

To see the report, click here.

GAO Administers Survey of State Pharmacy Regulatory Bodies on Drug Compounding

As part of its report on drug compounding—Drug Compounding: FDA Has Taken Steps to Implement Compounding Law, but Some States and Stakeholders Reported Challenges, GAO—GAO conducted a survey of state pharmacy regulatory bodies (e.g., boards of pharmacy) in the 50 states, the District of Columbia, Guam, Puerto Rico, and the U.S. Virgin Islands, and all but 4 states completed the survey.

The Drug Quality and Security Act, enacted in 2013, helped clarify the FDA’s authority to oversee drug compounding nationally and created a new category of compounders called outsourcing facilities. Outsourcing facilities compound sterile drugs and must register with and be inspected by FDA, among other requirements. In contrast to other drug compounders, outsourcing facilities are allowed to compound drugs without patient-specific prescriptions. In general, states oversee drug compounding as part of their regulation of the practice of pharmacy.

The survey collected information on the following: each state pharmacy regulatory body and its oversight responsibilities for drug compounding; pharmacists, pharmacies, and drug compounding in each state; types of state laws, regulations, and policies related to drug compounding; inspections and enforcement actions states can take related to drug compounding; states’ perspectives on communication and interactions with FDA and other states, and any associated challenges; and states’ perspectives on FDA’s implementation of section 503A—the section of the Federal Food, Drug, and Cosmetic Act with requirements for drug compounders that are not outsourcing facilities—and section 503B—the section of the act that added outsourcing facilities—including any challenges that states reported on these efforts; among other things.

GAO administered the survey from February 8, 2016, through April 15, 2016.

For more information, click here.