The Weekly Scan

March 8, 2019

Last Updated: 1:00 PM EST

Medicare & Medicaid

  • On Tuesday, the CMS announced updates coming next month to Nursing Home Compare and the Five-Star Quality Rating System to strengthen this tool for consumers to compare quality between nursing homes. The April 2019 updates to Nursing Home Compare are part of a broad range of updates that have been under development for the last several years. The Nursing Home Compare website and Five-Star Quality Rating System were created to help consumers, their families, and caregivers compare nursing homes and identify areas they may want to ask about when looking at nursing home care. Nursing Home Compare has a quality rating system that gives each nursing home a rating between 1 and 5 stars. Nursing homes with 5 stars are considered to have above average quality and nursing homes with 1 star are considered to have quality below average. There is one Overall 5-star rating for each nursing home, and a separate rating for each of the following three factors:

    • Health Inspections: Inspections include the findings on compliance to Medicare and Medicaid health and safety requirements from onsite surveys conducted by state survey agencies at nursing homes.

    • Staffing Levels: The staffing levels are the numbers of nurses available to care for patients in a nursing home at any given time.

    • Quality Measures: The quality of resident care measures are based on resident assessment and Medicare claims data. (CMS.gov)

 

  • CMS issued a request for information (RFI) on Wednesday that solicits recommendations on how to eliminate regulatory, operational and financial barriers to enhance issuers’ ability to sell health insurance coverage across state lines.  This announcement builds on President Trump’s October 12, 2017 Executive Order, “Promoting Healthcare Choice and Competition Across the United States,” which intends to provide Americans relief from rising premiums by increasing consumer choice and competition. In particular, CMS is interested in feedback on how states can take advantage of Section 1333 of the Patient Protection and Affordable Care Act, which provides for the establishment of a regulatory framework that allows two or more states to enter into a Health Care Choice Compact to facilitate the sale of health insurance coverage across state lines. (CMS.gov: Press Release, Request for Information)

 

  • On Thursday, Chairman Doggett held a Ways and Means Health Subcommittee hearing on medicines in Medicare. Hearing from experts testifying to policy options and patient experience, it explored ways that Medicare can encourage affordability, competition, and access to medicines, as patients face a prescription drug affordability crisis. It featured expert witnesses Frederick Isasi, Executive Director, Families USA; Robin Feldman, Director of the Institute for Innovation Law, UC Hastings College of Law; Ameet Sarpatwari, Assistant Director of the Program on Regulation, Therapeutics, and Law (PORTAL) Harvard Medical School; Amy Kapczysnki, Co-Director of the Global Health Justice Partnership, Yale Law School; and Douglas Holtz-Eakin, President, American Action Forum. “We have a responsibility to ensure that patients come first and that it is their health and livelihoods that are the only things that are nonnegotiable,” said Chairman Doggett. “Unaffordability and inaccessibility are not the unavoidable side effects of innovation. They are the result of unrestrained monopoly power.” (Doggett.House.gov)

Litigation

  • In the case of Singh v. Cigna Corp., the Second Circuit affirmed the district court's dismissal of a class action alleging violations of federal securities laws by Cigna and its officers. Plaintiffs alleged that certain of defendants' statements were materially misleading, constituting fraud under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and SEC Rule 10b-5. The court held that the statements were not materially misleading, because they were tentative and generic, emphasizing the complex and evolving regulatory environment Cigna faced. Therefore, plaintiffs failed to plausibly allege that a reasonable investor would view these statements as having significantly altered the total mix of information made available. In this case, the statements at issue in Cigna's Code of Ethics were a textbook example of puffery, and a reasonable investor would not rely on the 2013 and 2014 Form 10-K statements as representations of satisfactory compliance. (Law.Justia.com)

 

  • Daniela Gozes-Wagner of Houston, TX has been ordered to pay more than $15 million in restitution following her conviction of conspiring to commit $50 million health care fraud as well laundering money, U.S. Attorney Ryan K. Patrick announced on Wednesday. Beginning in 2009, Gozes-Wagner conspired with others to falsely bill Medicare and Medicaid for millions of dollars of medical tests which were either not performed or were medically unnecessary. Most of these tests supposedly occurred at 28 testing facilities over many years. However, when law enforcement conducted law enforcement operations there, they discovered that many of the facilities were actually empty offices. To prevent Medicare from learning about the scheme, Gozes-Wagner hired “seat warmers” – young women paid to sit and answer phones in the nearly empty offices that comprised many of the “testing facilities.” They believed they could spend most of their time watching streaming movies. However, when Medicare investigators tried to inspect the empty offices, these “seat warmers” were instructed to notify Gozes-Wagner and prevent the investigators from inspecting the offices. (Justice.gov)

 

  • Three health insurers filed status reports with the federal government March 5 asking for billions in unpaid cost-sharing reductions payments. While the insurers don't agree on the estimate, a group of insurers' class-action lawsuit estimates damages of more than $2 billion, according to Health Affairs. The three insurers — Common Ground Healthcare Cooperative, Maine Community Health Options, and Community Health Choice — made the filings to inform the court what they claim is due in unpaid cost-sharing reduction payments for 2017-18. The payments were established under the ACA to help insurers subsidize the cost of coverage for low-income Americans. The three insurers have their own lawsuits, which are before Judge Margaret M. Sweeney. She will consider the requests and decide the best path forward. (BeckersHospitalReview.com, HealthAffairs.org)

Regulation

  • FDA Commissioner Scott Gottlieb, MD submitted his letter of resignation this week, to be effective in one month. Gottlieb wrote: "In the last two years, the FDA set out to advance major new policies to reduce the morbidity associated with tobacco use; to confront teen use of e-cigarettes; to decrease the rate of new opioid addiction; to improve access to affordable generic drugs; to modernize the development process for novel medical technologies like gene therapy and targeted medicines; to implement measures to improve food safety and our ability to identify and track outbreaks of foodborne illness; and to reduce the burden of chronic disease through better information and diets. Working together, my colleagues and I achieved all of these goals, and much more." His successor has not yet been named. 

 

  • On Thursday, the FDA announced an important policy update with respect to the naming convention of biosimilars. The updated draft guidance explains that: a. The FDA no longer intends to modify the proper names of biological products that have already been licensed or approved under the Public Health Service Act without an FDA-designated suffix in their proper names; b. The FDA does not intend to apply the naming convention to the proper names of transition biological products; and c. This framework will help secure pharmacovigilance so that the FDA can effectively monitor all biological products in the post market – originators and biosimilars – and promote patient safety. Going forward, for interchangeable biosimilars, the FDA intends to designate a proper name that is a combination of the core name and a distinguishing suffix that is devoid of meaning and composed of four lowercase letters. (FDA.gov)

 

Private Sector

  • On Wednesday, the health care organization founded by Amazon, Berkshire Hathaway, and JPMorgan Chase, announced its name – Haven. “We want to change the way people experience health care so that it is simpler, better, and lower cost,” explained Haven CEO Atul Gawande, MD, MPH. “We’ll start small, learn from the experience of patients, and continue to expand to meet their needs.” In recent months, Dr. Gawande has been meeting with Amazon, Berkshire Hathaway, and JPMorgan Chase employees to understand their health care experiences. He notes in a letter posted on the new website that Haven will be an “advocate for the patient and an ally to anyone – clinicians, industry leaders, innovators, policymakers and others – who makes patient care and cost better.” The website also outlines a number of areas to improve upon the current health system, including the difficulty people have accessing care, navigating the complex system, and affording their medical treatments and prescription drugs. (HavenHealthcare.com)

 

 

 

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