The Weekly Scan

February 1, 2019

Last Updated: 1:00 PM EST

Medicare & Medicaid

  • On Monday, the Centers for Medicare & Medicaid Services (CMS) launched a new app that gives consumers a modernized Medicare experience with direct access on a mobile device to some of the most-used content on Medicare.gov. The new “What’s Covered” app lets people with Original Medicare, caregivers and others quickly see whether Medicare covers a specific medical item or service. Consumers can now use their mobile device to more easily get accurate, consistent Original Medicare coverage information in the doctor’s office, the hospital, or anywhere else they use their mobile device. In addition to the “What’s Covered” app, through Blue Button 2.0 the agency is enabling beneficiaries to connect their claims data to applications and tools developed by innovative private-sector companies to help them understand, use, and share their health data. (CMS.gov)

 

  • On Wednesday, the CMS released proposed changes that will take significant steps in continuing the agency’s efforts to maximize competition among Medicare Advantage and Part D plans. These proposals will increase plan choices and benefits and include important actions to address the opioid crisis. The proposed changes will expand opportunities for seniors to choose Medicare Advantage plans that for the first time are providing new supplemental benefits in 2019. Beginning with the 2019 plan year, Medicare Advantage plans can provide certain enrollees with access to different benefits and services. For the 2020 plan year and beyond, under statutory changes and the proposed guidance on which CMS is soliciting comment, Medicare Advantage plans will have greater flexibility to offer chronically ill patients a broader range of supplemental benefits that are tailored to their specific needs, such as providing home-delivered meals or transportation for non-medical needs. The agency is also proposing new action to combat the nation’s opioid crisis. CMS is encouraging Medicare Advantage plans to take advantage of new flexibilities to offer targeted benefits and cost sharing reductions for patients with chronic pain or undergoing addiction treatment, and encouraging Part D plans to provide lower cost sharing for opioid-reversal agents. (CMS.gov)

 

  • On Thursday, Health and Human Services Secretary Alex Azar and Inspector General Daniel Levinson proposed a rule to lower prescription drug prices and out-of-pocket costs by encouraging manufacturers to pass discounts directly on to patients and bringing new transparency to prescription drug markets. “This proposal has the potential to be the most significant change in how Americans’ drugs are priced at the pharmacy counter, ever, and finally ease the burden of the sticker shock that millions of Americans experience every month for the drugs they need,” said Azar. The HHS proposal would expressly exclude from safe harbor protection under the Anti-Kickback Statute rebates on prescription drugs paid by manufacturers to pharmacy benefit managers (PBMs), Part D plans and Medicaid managed care organizations. It would create a new safe harbor for prescription drug discounts offered directly to patients, as well as fixed fee service arrangements between drug manufacturers and PBMs. (HHS.gov)

Regulation

  • On Wednesday, the Department of Veterans Affairs (VA) announced its proposed access standards for community care and urgent care provisions that will take effect in June and guide when Veterans can seek care to meet their needs under the MISSION Act – be it with VA or with community providers. Access standards, effective when the final regulations publish (expected in June 2019), will be based on average drive time and appointment wait times. For primary care, mental health, and non-institutional extended care services, VA is proposing a 30-minute average drive time standard.For specialty care, VA is proposing a 60-minute average drive time standard. VA is proposing appointment wait-time standards of 20 days for primary care, mental health care, and non-institutional extended care services, and 28 days for specialty care from the date of request with certain exceptions.Eligible Veterans who cannot access care within those standards would be able to choose between eligible community providers and care at a VA medical facility. (VA.gov)

 

  • Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-NJ) and Oversight and Investigations Subcommittee Chair Diana DeGette (D-CO) sent letters to the three manufacturers of insulin in the U.S. on Wednesday – Eli Lilly, Novo Nordisk, and Sanofi – requesting information on the root causes of the rising cost of insulin and the obstacles to providing more affordable medication. “When patients go without insulin—or ration their doses—there can be tragic consequences,” Pallone and DeGette wrote in their letters. As part of their inquiry, the Democrats are requesting documents and answers from each of the companies by February 13, 2019 to a series of questions, including:

    • The average price of each of the companies’ insulin products for the last 10 years as well as an explanation of factors that prompted any price increases;

    • The net profit of the companies’ insulin products each year for the last 10 years;

    • A list of changes or modifications, if any, to the companies’ insulin products over the last 10 years;

    • An explanation of the root causes of rising prices of insulin;

    • An explanation of the barriers to lowering insulin prices and making insulin more affordable;

    • Whether any of the companies have entered into any agreements in the last 10 years that delay, limit, or prevent the availability of generic insulin; and, 

    • How the companies expect the overall market price of insulin to change in the next five years. (EnergyCommerce.House.gov

Litigation

  • Pathology laboratory company Inform Diagnostics has agreed to pay $63.5 million to settle allegations that it violated the False Claims Act by engaging in improper financial relationships with referring physicians, the Justice Department announced Wednesday. The settlement resolves allegations that the company violated the Anti-Kickback Statute and the Stark Law by providing to referring physicians subsidies for electronic health records (EHR) systems and free or discounted technology consulting services. The Anti-Kickback Statute and the Stark Law restrict the financial relationships that health care providers, including laboratories, may have with doctors who refer patients to them.  Although regulations adopted by the Department of Health and Human Services (HHS) in 2006 included provisions that allowed laboratories to provide EHR donations to physicians under certain conditions, the United States alleged that the defendant violated those conditions. HHS withdrew those exemptions for laboratories in 2013. (Justice.gov)

 

  • California Attorney General Xavier Becerra announced a $935,000 settlement on Wednesday resolving allegations that Aetna Inc. violated California health privacy laws in connection with its 2017 breach of patient confidentiality. Due to a mailing error, a vendor for Aetna sent letters to 1,991 Californians that revealed through an oversized clear window on mailed envelopes that the recipient was taking HIV-related medication. On July 28, 2017, Aetna mailed letters to approximately 12,000 people nationwide, including 1,991 Californians. The letters revealed through an enlarged window on the envelope that the recipient was taking HIV-related medication. Attorney General Becerra alleges that by breaching its customers’ confidential medical information, Aetna violated state law, including the Confidentiality of Medical Information Act, Health and Safety Code section 120980, the State Constitution, and the Unfair Competition Law. The injunctive terms of the settlement require Aetna to implement and maintain specific mailing procedures that preserve the confidentiality of medical information. Additionally, Aetna must designate an employee responsible for Aetna’s implementations and maintenance of the revised mailing program, compliance with state and federal privacy laws, and management of external vendors handling medical information in compliance with Aetna’s privacy policies and procedures. Aetna is also required to complete an annual privacy risk assessment evaluating compliance with the terms of the settlement for three years. (OAG.CA.gov)

Affordable Care Act

  • The Government Accountability Office released a new report on "Health Insurance Exchanges: Claims Costs and Federal and State Policies Drove Issuer Participation, Premiums, and Plan Design." The Patient Protection and Affordable Care Act included a provision for GAO to examine exchange activities, including issuers’ experiences participating in the individual market exchanges. This report examines (1) claims costs of issuers participating in exchanges, and (2) factors driving selected issuers’ changes in exchange participation, premiums, and plan design. GAO reviewed data from nine issuers participating in five states, which were selected to represent a range in size, tax status, and exchange participation. The five states— California, Florida, Massachusetts, Minnesota, and Mississippi—were selected to provide variation in geography and whether they had a federally facilitated or state-based exchange. GAO also conducted a literature review, reviewed federal data, and interviewed the selected issuers, officials in the selected states, and stakeholder groups. (GAO.gov)

Private Sector

  • Dignity Health and Catholic Health Initiatives (CHI) announced today that they have completed their merger and come together as CommonSpirit Health, creating a new Chicago-based nonprofit Catholic health system focused on advancing health for all people and serving communities in 21 states. The $29 billion system will operate more than 700 care sites and 142 hospitals, as well as research programs, virtual care services, home health programs, and living communities. CommonSpirit Health also supports a range of community health programs to create healthier communities and address the root causes of poor health such as access to quality care and health equity, affordable housing, safe neighborhoods, and a healthy environment. The new organization is built on the legacy of 17 congregations of women religious who founded health ministries to serve people most in need. Today, it is supported by approximately 150,000 employees and 25,000 physicians and advanced practice clinicians. Catholic Health Initiatives CEO Kevin E. Lofton and Dignity Health President and CEO Lloyd H. Dean will both serve as CEOs in the Office of the CEO for the new health system. (CommonSpirit.org)

 

 

 

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