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April 2019

HELP Sends Surprise Billing Policies to CBO for Analysis

The Senate Health, Education, Labor, and Pensions (HELP) Committee has sent the Congressional Budget Office (CBO) a series of options for analysis that would protect patients from surprise billing. One option sent to CBO for consideration would entail an arbitration process to determine how much the insurer pays the doctor or hospital. Another option would set a payment rate based on a percentage of Medicare’s payment rates or another similar metric. Under a third option, a single hospital bill would be sent to the insurer that includes all doctor’s fees. Additional policies were also sent to the CBO for consideration. Chairman Lamar Alexander (R-Tenn.) and Ranking Member Patty Mur (D-Wash.) are currently working with a bipartisan group of senators, including Bill Cassidy (R-La.), Michael Bennet (D Colo.), and Maggie Hassan (D-N.H.), on a legislative solution to the issue of surprise billing.


Finance Committee Questions POD Reporting

Bipartisan leadership of the Senate Finance Committee have sent a letter to the U.S. Department of Health and Human Services (HHS) Office of the Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) outlining concerns about physicians who fail to disclose when they have a financial stake in the medical devices that are supplied to their practices.


A physician-owned distributorship (POD) is an arrangement in which a physician purchases ownership shares in an entity that sells medical devices used in the physician’s surgeries. Chairman Chuck Grassley (R-Iowa) and Ranking Member Ron Wyden (D-Ore.) ask the agencies how they are coordinating to ensure that POD reporting is taking place and that the data reported is accurate. They also ask about what changes can be made to the Sunshine Act or the Stark Law to improve the accuracy of reporting, and whether OIG’s hospital guidance has been updated to account for such distributorships.


Azar Calls for Stark Law Update

HHS Secretary Alex Azar has suggested that laws which prohibit providers from having a financial stake in the entities to which they refer patients are hindering the advancement of value-based care. Azar recognized the importance of preventing health care fraud, while expressing support for updating the 30-year-old anti-kickback statute known as the Stark Law during a speech before a conference of health lawyers last week. The administration sought input on a proposal to update the anti-kickback statute in June 2018, and CMS Administrator Seema Verma has stated that a regulation to reform the Stark Law will be issued later this year.


Surgeons Can Access Facility-based Score for 2019 MIPS Reporting

Beginning with the 2019 performance year of the Merit-based Incentive Payment System (MIPS), clinicians, groups, or virtual groups who meet the Centers for Medicare & Medicaid Services (CMS) facility-based clinician criteria will be able to use their Hospital Value-Based Purchasing (VBP) program performance score for MIPS reporting. Surgeons can determine whether they meet the facility-based criteria through the QPP Participation Status lookup tool.


This new policy uses the surgeon’s facility-based VBP score for the Quality and Cost performance categories in MIPS to reduce administrative burdens. Although the policy eliminates the need for facility-based clinicians to report Quality and Cost for MIPS, health care professionals have the option to report MIPS measures themselves, and CMS will use the higher of the two scores to calculate the MIPS final score. Clinicians who are identified as facility-based and who provide services attributed to a facility with a fiscal year (FY) 2020 Hospital VBP score will receive a Facility-based Preview to help estimate their Quality and Cost scores based on their Hospital VBP data. Previews can be accessed by logging into the QPP portal on the QPP website and clicking on the Preview Facility Score on the home page. It is important to remember that preview reports are not 2019 MIPS performance scores; rather, they are generated from past data to help surgeons estimate their possible scores for 2019.


“Medicare for All” Proposal Released

House Progressive Caucus co-chair Pramila Jayapal (D-Wash.) formally introduced her “Medicare for All” legislation last week. The 120-page Medicare for All Act of 2019 (H.R. 1384) would replace almost all private and employer-sponsored health insurance with a government-run health insurance system within two years. Every American would get an expanded ar of health care for life, including long term care. The bill does not detail how the overhaul would be financed. Jayapal has said that she plans to release a separate list of potential pay-fors. The legislation is an expansion on previously-introduced versions of Medicare for All. It currently has 107 Democratic cosponsors, and Jayapal hopes to garner the support of at least 40 more House Democrats.


Senators Comment on Insulin and FDA Biosimilars Guidance

A bipartisan group of senators have written to the Food and Drug Administration (FDA) regarding the pace of approvals for generic insulin products. The lawmakers requested that the agency amend a 2018 agency guidance that was meant to ease the approval pathway for biosimilar products. The letter expressed concern that while the guidance will bring new insulin options onto the market in 2020, it could delay the introduction of insulin generics in the short-term.


Ensuring Lasting Smiles Reintroduced

Senators Tammy Baldwin (D-Wis.), Joni Ernst (R-Iowa), Sherrod Brown (D-Ohio), and Lisa Murkowski (R Alaska) have reintroduced bipartisan legislation to ensure health insurance for the treatment of individuals born with congenital anomalies or birth defects, such as cleft lip and palate, skeletal and maxillofacial abnormalities, facial paralysis, microtia, hypodontia, and craniosynostosis. The Ensuring Lasting Smiles Act (ELSA) would close a coverage gap that occurs when health plans deny claims for oral or dental-related procedures deeming them cosmetic in nature or covered under a separate dental plan. Bipartisan companion legislation has been introduced in the House by Representatives Collin Peterson (D-Minn.) and Denver Riggleman (R-Va.).


FDA Administrator Retires

Administrator of Food and Drugs Scott Gottlieb announced his decision to resign effective next month. According to his formal statement, Gottlieb is leaving the agency to spend more time with his family. His replacement has not yet been announced. During his two years at the Food and Drug Administration (FDA) he led the agency’s response to the opioid epidemic, prioritized the approval of generic drugs, and spearheaded a plan to curb youth vaping. His contributions were praised by lawmakers on both sides of the aisle and by U.S. Department of Health and Human Services (HHS) Secretary Alex Azar following the announcement of his resignation.


Lawmakers Consider Measles Outbreaks and Rise of Under-Vaccination

Lawmakers have turned their focus to recent measles outbreaks across the country resulting from a small but growing portion of the population questioning the safety of vaccines and the rise of under vaccination. The measles outbreaks have been the subject of two congressional hearings in recent weeks. Reps. Adam Schiff (D-Calif.) and Michael Burgess (R-Texas) introduced a bipartisan resolution (H.Res. 179) last week recognizing the importance of vaccines and urging parents to immunize their children. In response to a request for information from Rep. Schiff, Chairman of the House Intelligence Committee, Facebook and Google released details of their plans to address misinformation about vaccines. Schiff had expressed concerns about the platforms promoting information that discouraged parents from vaccinating their children. The Annals of Internal Medicine also published new research last week reaffirming the medical consensus denying any connection between the measles, mumps, rubella (MMR) vaccine and autism. Researchers also concluded that vaccination is not likely disorders.


Energy and Commerce Expands Investigation into Short-Term Health Plans

The House Energy and Commerce Committee has sent two additional letters to Pivot Health and LifeShield National Insurance Co. as a part of its probe into the sale of short-term, limited-duration health insurance plans. Democratic lawmakers characterize such plans as “junk” insurance because they do not have to comply with all of the ACA’s consumer protections and they have expressed concerns that consumers are being misled about the benefits covered by such plans. The panel requests information from Pivot Health and LifeShield about their policies and marketing practices for short- term, limited-duration health insurance products.


President Trump Releases 2020 Budget Proposal

President Trump’s 2020 budget proposal was released, calling for domestic spending cuts of five percent across the federal government. The President’s budget will be largely ignored by the Democratic-controlled House but serves as a guide to the administration’s priorities and offers insight into the White House’s health care strategy for fiscal year (FY) 2020. The budget request would raise overall defense spending, while cutting non- defense programs by nine percent from $597 billion to $567 billion, in line with the cap set in the 2011 Budget Control Act (BCA). The request also calls for $1.9 trillion in cuts from automatic spending over the next decade. The administration argues that its proposal would balance the budget over a 15-year window.


FDA Acting Commissioner Named

HHS Secretary Alex Azar announced last week that NCI Director Ned Sharpless will serve as acting commissioner of the FDA upon Scott Gottlieb’s departure. Sharpless is a researcher and oncologist who has led the NCI for the last 18 months. During his time at the institute, he advocated for increased data sharing and analysis to benefit the development of new cancer treatments. Prior to his time at NIH, he was the director of the University of North Carolina’s Lineberger Comprehensive Cancer Center. Douglas Lowy, NCI’s deputy director, will serve as acting director of NCI while Sharpless is at the FDA. It is still unclear whether Sharpless will be considered as a permanent replacement for Gottlieb at the FDA.