Below is Alston & Bird’s Healthcare Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.

Week in Review Highlight of the Week:

This past week saw a flurry of legislative action in Washington as both chambers of Congress took up bills dealing with drug pricing and surprise billing. Read more about these proposals and other news below.

I. Regulations, Notices, & Guidance

• On December 12, 2019, the Food and Drug Administration (FDA) issued guidance entitled, Food and Drug Administration Reauthorization Act Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs. This draft guidance addresses early planning for pediatric evaluation of certain molecularly targeted oncology drugs, including biological products, for which original new drug applications and biologics license applications are expected to be submitted to FDA on or after August 18, 2020, in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the FDA Reauthorization Act of 2017 (FDARA). This guidance addresses the implementation of amendments made by FDARA to the FD&C Act regarding molecularly targeted oncology drugs.
• On December 13, 2019, FDA issued a final rule entitled, Medical Device Submissions: Amending Premarket Regulations that Require Multiple Copies and Specify Paper Copies to Be Required in Electronic Format. This final rule amends requirements for medical device premarket submissions to remove paper and multiple copies and replace them with requirements for a single submission in electronic format. This action would reduce the number of copies in electronic format required, thus improving and making more efficient the FDA’s premarket submission program for medical devices.
• On December 13, 2019, FDA issued a final rule entitled, Regulation Requiring an Approved New Drug Application for Drugs Sterilized by Irradiation. This final rule repeals a regulation that requires an FDA-approved new drug application or abbreviated new drug application for any drug product that is sterilized by irradiation. Repealing the irradiation regulation will mean that over-the-counter drug products that are generally recognized as safe and effective, are not misbranded, and comply with all applicable regulatory requirements can be marketed legally without a new drug application or abbreviated new drug application, even if they are sterilized by irradiation. FDA is taking this action because the irradiation regulation is out of date and unnecessary.
• On December 13, 2019, FDA issued guidance entitled, Cocaine Hydrochloride; Nasal Solution. This new draft guidance, when finalized, will provide product-specific recommendations on, among other things, the information and data needed to demonstrate bioequivalence to support abbreviated new drug applications for a cocaine hydrochloride nasal solution.
• On December 13, 2019, FDA issued guidance entitled, Qualification Process for Drug Development Tools. Under the 21st Century Cures Act (Cures Act), enacted on December 13, 2016, a new section was added to the FD&C Act, which defined a three-stage qualification process for drug development tools (DDTs). This guidance meets the Cures Act’s mandate to issue guidance on this qualification process and related Prescription Drug User Fee Act (PDUFA) VI commitments. It elaborates on the new qualification process and transparency requirements and discusses the taxonomy for biomarkers and other DDTs, and the draft guidance of the same name issued January 7, 2014, is withdrawn.

Event Notices 

• December 16-17, 2019: The Centers for Medicare & Medicaid Services (CMS) announced a town hall meeting entitled, Medicare Program; Town Hall Meeting on the FY 2021 Applications for New Medical Services and Technologies Add-On Payments. CMS is holding this meeting in accordance with section 1886(d)(5)(K)(viii) of the Social Security Act (the Act) to discuss Fiscal Year (FY) 2021 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system. Interested parties are invited to this meeting to present their comments, recommendations, and data regarding whether the FY 2021 new medical services and technologies applications meet the substantial clinical improvement criterion.
• December 17, 2019: FDA announced a public meeting entitled, Oncologic Drugs Advisory Committee. The general function of the Oncologic Drugs Advisory Committee is to provide advice and recommendations to FDA on regulatory issues. During the morning session, the committee will discuss supplemental new drug application (sNDA) 208558/010 for LYNPARZA (olaparib) tablets, submitted by AstraZeneca Pharmaceuticals LP. During the afternoon session, the committee will discuss supplemental biologics license application (sBLA) 125514/066 for KEYTRUDA (pembrolizumab) for injection, submitted by Merck Sharpe & Dohme Corp.
• January 14, 2020: FDA announced a public meeting entitled, Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The committees will discuss new drug application 211802 for oxycodegol, a new molecular entity full mu-opioid receptor agonist, submitted by Nektar Therapeutics, for the management of chronic low back pain in adult patients with pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The committees will be asked to discuss the safety and efficacy data as well as the overall risk-benefit profile of the product.
• January 15, 2019: FDA announced a public meeting entitled, Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The committees will discuss new drug application (NDA) 213426, for tramadol 44 milligrams (mg) and celecoxib 56 mg tablet, which contains a fixed-dose combination of an opioid and a non-steroid anti-inflammatory drug, submitted by Esteve Pharmaceuticals, S.A., for the management of acute pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate. They will also discuss NDA 209653, for an extendedrelease oral tablet formulation of oxycodone, submitted by Intellipharmaceutics Corp., with the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

II. Congressional Hearings

House of Representatives

• On December 10, 2019, the House Committee on Energy and Commerce Subcommittee on Health held a legislative hearing entitled, Proposals to Achieve Universal Health Care Coverage. Witnesses present included: Representative Rosa L. DeLauro (D-CT); Representative Pramila Jayapal (D-WA); Representative Brian Higgins (D-NY); Representative Antonio Delgado (D-NY); Representative Tom Malinowski (D-NJ); Sara Rosenbaum, J.D., Harold and Jane Hirsh Professor of Health Law and Policy, George Washington University Milken Institute School of Public Health; Peter Morley, Patient Advocate; Jean Ross, RN, National Nurses United; Douglas Holtz-Eakin, Ph.D., President, American Action Forum; and Scott W. Atlas, M.D., David and Joan Traitel Senior Fellow, Hoover Institution, Stanford University.
• On December 10, 2019, the House Committee on Energy and Commerce Subcommittee on Oversight and Investigations held a hearing entitled, Securing the U.S. Drug Supply Chain: Oversight of FDA’s Foreign Inspection Program. Witnesses present included: Mary Denigan-Macauley, Ph.D., Director, Health Care Government Accountability Office (GAO); and Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research, FDA.
• On December 10, 2019, the House Committee on Oversight and Reform held a hearing entitled, Examining the Need for Comprehensive National Paid Family and Medical Leave. Witnesses present included: Representative Rosa L. DeLauro (D-CT); Jacqui Silvani; Robert Asaro-Angelo, Commissioner, New Jersey Department of Labor and Workforce Development; Aaron Seyedian, Founder, Well-Paid Maids; Jennifer Tucker, Senior Policy Advisor, The National Coalition of Black Civic Participation; and Vicki Shabo, Senior Fellow, Paid Leave Policy and Strategy, Better Life Lab, New America.

Senate

• On December 12, 2019, the Senate Committee on Health, Education, Labor, and Pensions (HELP) held a markup of health legislation. Legislation included: S. 2971, CAPTA Reauthorization Act of 2019; S. 2997, Title VII Reauthorization; S. 2683, Child Care Protection Improvement Act of 2019; and S. 2927, NIMHD Research Endowment Revitalization Act of 2019. All four pieces of legislation were favorably forwarded to the Senate floor.

III. Reports, Studies, & Analyses

• On December 9, 2019, Kaiser Family Foundation (KFF), in partnership with the Peterson Center on Healthcare, published an issue brief entitled, Surprise Bills Vary by Diagnosis and Type of Admission. This brief looks at the prevalence of potential surprise medical bills based on patient diagnosis, emergency visits, and type of inpatient admission. Using claims data from large employer health plans, the analysis finds that patients who may be at higher risk of surprise medical bills include those admitted for surgery, heart attack patients, and people admitted for mental health and/or substance abuse treatment. The brief follows an earlier analysis that examined how often patients get hit with surprise medical bills, what circumstances tend to give rise to them, and what policy proposals are currently being considered to protect consumers from this problem.
• On December 10, 2019, KFF published an issue brief entitled, Medicaid Program Integrity and Current Issues. Medicaid provides health coverage for more than 76 million Americans and accounts for about 1 in 6 dollars spent on health care. Medicaid is a large source of spending in both state and federal budgets, making program integrity efforts important to prevent waste, fraud, and abuse and ensure appropriate use of taxpayer dollars. Recent audits and improper payment reports have brought program integrity issues back to the forefront. This brief explains what program integrity is, recent efforts at CMS to address program integrity, and current and emerging issues.
• On December 10, 2019, GAO published a report entitled, Drug Safety: Preliminary Findings Indicate Persistent Challenges with FDA Foreign Inspections. GAO has had long-standing concerns about FDA’s ability to oversee the increasingly global supply chain, an issue highlighted in GAO’s High-Risk Series for the last 10 years. This report provides preliminary GAO observations on the number of foreign inspections FDA has conducted; inspection staffing levels; and challenges unique to foreign inspections. For this work, GAO examined FDA data, visited FDA foreign offices in China and India, and interviewed drug investigators based in these offices and in the United States

IV. Other Health Policy News

• On December 8, 2019, the Senate HELP Committee and House Committee on Energy & Commerce announced a deal on S. 1895, the Lower Health Care Costs Act. The bipartisan, bicameral surprise billing legislation will reduce what Americans pay out of their own pockets for health care. It would end surprise billing of patients and include a system for independent dispute resolution (i.e., arbitration) if a surprise medical bill is over $750. The legislation also increases prescription drug competition and creates price transparency, funds critical public health programs, including Community Health Centers for five years, and increases the purchasing age of tobacco to 21.
• On December 9, 2019, House Republicans introduced H.R. 19, the Lower Costs, More Cures Act. The bill combines several bipartisan measures to control drug prices—including several from the Senate Finance bill—but it excludes a key measure from the Senate bill that would make drug companies pay back the government when they raise prices faster than inflation. A section-by-section summary of the bill is available here.
• On December 11, 2019, the House Committee on Ways and Means announced a bipartisan agreement to move forward on legislation to address surprise billing. An outline released by the Committee explains that the proposal would set the patient cost-sharing for out-of-network bills at the in-network rate and also calls for a robust reconciliation process, which looks different from the independent arbitration process outlined in the House Energy and Commerce and Senate HELP agreement.
• On December 12, 2019, the U.S. House of Representatives voted in favor of H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act. The bill passed largely along party lines by a vote of 230-132. The updated bill passed after House Speaker Nancy Pelosi made several concessions to progressive Democrats. The revised bill would increase the number of seniors who qualify for financial support for prescription drugs and other health expenses by raising the income eligibility threshold for Medicare’s Low-Income Subsidy Program and Medicare Savings Program. It also adds guaranteed issue protections for supplemental Medigap plans; directs $10 billion to community health centers; doubles investments in the Maternal, Infant and Early Childhood Home Visiting program; reauthorizes and expands the Health Profession Opportunity Grant demonstration; and includes $10 billion to fight opioid abuse over the next five years. However, it is unlikely that H.R. 3 will be taken up in the Senate. Senate Majority Leader Mitch McConnell (R-KY) opposes the bill, and the White House has threatened a veto should it reach the President’s desk. The White House has instead indicated support for the Senate drug-pricing bill.
• On December 12, 2019, the Senate confirmed Stephen Hahn for the position of Food and Drug Administration (FDA) Commissioner by a vote of 72 to 18. Senate HELP Committee Ranking Member Patty Murray (D-WA) voted against the nomination and objected to his lack of firm stance on the youth vaping crisis. Other notable opposition included Senators Chuck Schumer (D-NY), Jeff Merkley (D-OR) and Richard Blumenthal (D-CT).

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