The Daily Scan

November 1, 2018

Last Updated: 1:00 PM EST

Medicare

  • Yesterday, the Centers for Medicare & Medicaid Services (CMS) finalized significant changes to the Home Health Prospective Payment System to strengthen and modernize Medicare. Specifically, CMS made changes to improve access to solutions via remote patient monitoring technology, updated payments for home health care with a new case-mix system, begin the new home infusion therapy benefit, and reduce burden. Beginning with calendar year (CY) 2020, CMS is implementing changes required by law, including a new case-mix system called the Patient-Driven Groupings Model (PDGM) that puts the focus on patient needs rather than volume of care. The PDGM relies more heavily on patient characteristics to more accurately pay for home health services. Changes in data collection under the new case-mix system, coupled with the changes below regarding meaningful measures and the Home Health Quality Reporting Program, will reduce burden for HHAs by approximately $60 million annually, beginning in CY 2020. (CMS.gov)

Medicaid

  • CMS has approved Wisconsin Gov. Scott Walker’s controversial plan to require childless adults on Medicaid to work or lose coverage, but the federal government rejected Walker’s proposal to require drug screening and testing. The state on Wednesday received permission to enact several changes to BadgerCare coverage for poor adults who don’t have dependent children, such as limiting eligibility to four years unless people work, train for a job or participate in certain other activities. Wisconsin can now also charge monthly premiums of up to $8, along with $8 co-payments for emergency room visits for problems that aren’t considered emergencies. Members can reduce their premiums through “healthy behaviors,” such as not smoking or maintaining a healthy weight. But Walker’s plan to require enrollees to be screened for drug abuse — and tested if screening called for it — was not approved. Instead, people will have to complete a health risk assessment, which will include questions about drug use. If the HRA indicates a concern about substance abuse, people will be referred for treatment but won’t have to comply to be eligible for Medicaid. (Madison.com, DHS.Wisconsin.com)

Legislation

  • The Department of Health and Human Services (HHS) has announced plans to move up the effective date of the 340B Drug Pricing Plan by 6 months. A proposed rule published yesterday in the Federal Register explains: "The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), which is referred to as the “340B Drug Pricing Program” or the “340B Program.” HRSA published a final rule on January 5, 2017, that set forth the calculation of the 340B ceiling price and application of civil monetary penalties. On June 5, 2018, HRSA published a final rule that delayed the effective date of the 340B ceiling price and civil monetary rule until July 1, 2019, to allow a more deliberate process of considering alternative and supplemental regulatory provisions and to allow for sufficient time for additional rulemaking. After further consideration of the issue, the Department of Health and Human Services (HHS or Department) proposes to cease any further delay of the rule and change the effective date from July 1, 2019, to January 1, 2019. (FederalRegister.gov)

Litigation

  • On Wednesday, Kentucky physician Dr. Anis Chalhoub was sentenced, by U.S. District Court Judge Gregory F. Van Tatenhove, to serve 42 months in federal prison for health care fraud.  In April 2018, a federal jury returned a guilty verdict, after hearing evidence that Dr. Chalhoub defrauded Medicare, Medicaid, and other insurers by implanting medically unnecessary pacemakers in his patients, and causing the unnecessary procedures and follow-up care to be billed to health insurance programs. Between 2007 and 2011, Dr. Chalhoub implanted approximately 234 pacemakers in patients at St. Joseph London hospital.  The evidence at trial showed that dozens of those patients’ pacemakers were medically unnecessary, under well-established national guidelines and Medicare coverage rules.  A number of patients testified at trial that Dr. Chalhoub pressured them into getting the procedures and told them misleading information about their health conditions.  For instance, several patients recalled Dr. Chalhoub telling them that they might die without a pacemaker.  Sinus node dysfunction, the diagnosis Dr. Chalhoub gave the patients, is a non-fatal condition.  The jury also heard evidence that Medicare, Medicaid, and other insurers suffered hundreds of thousands of dollars in losses from Dr. Chalhoub’s unnecessary procedures. (Justice.gov)

Regulation

  • A coalition of insurers and drug manufacturers wants the Trump administration to stop its research into importing certain prescription drugs from foreign countries. The Council for Affordable Health Coverage, which represents insurers, employers, pharmacy benefit managers and drug companies, said it wants the Food and Drug Administration (FDA) to disband an agency group examining drug importation. In a letter sent to FDA and shared exclusively with The Hill, the group said drug importation is a “risky scheme” that gambles with patient safety. “Consumers would be well served by FDA disbanding the drug importation work group and instead convening stakeholders and administration personnel to continue a conversation on value-based solutions that do not threaten patient safety,” the group wrote. (TheHill.com)

 

  • The HHS Office of Inspector General (OIG) conducted an audit of the Food and Drug Administration and found that the FDA had not sufficiently assessed medical device cybersecurity, an emerging risk to public health and to FDA's mission, as part of an enterprise risk management process. OIG recommends that FDA do the following: (1) continually assess the cybersecurity risks to medical devices and update, as appropriate, its plans and strategies; (2) establish written procedures and practices for securely sharing sensitive information about cybersecurity events with key stakeholders who have a “need to know”; (3) enter into a formal agreement with Federal agency partners, namely the Department of Homeland Security's Industrial Control Systems Cyber Emergency Response Team, establishing roles and responsibilities as well as the support those agencies will provide to further FDA's mission related to medical device cybersecurity; and (4) ensure the establishment and maintenance of procedures for handling recalls of medical devices vulnerable to cybersecurity threats. At the time of the reports publishing, many of these recommendations have already been implemented. (OIG.HHS.gov)

 

 

 

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