CMS grants New Hampshire Medicaid funding compliance extension

CMS has clarified that New Hampshire’s Medicaid expansion may end next year, but the current program can continue until the end of 2018. CMS stated that New Hampshire’s use of voluntary donations from health care providers and hospitals in the New Hampshire Health Protection Fund fails to comply with the federal requirements. CMS raised the possibility that federal funds may be withheld which would have resulted in a termination of the program.

The Medicaid statute in Section 1903(w) of the Soc. Sec. Act and implementing regulations at 42 CFR Sec. 433.54 and 433.66 establish a prohibition on provider-related donations, except in very limited circumstances. In a letter to New Hampshire officials, CMS indicated that there is a relationship between the donations and Medicaid payments, because Medicaid expansion is conditioned on the receipt of donations as articulated in New Hampshire legislation. The state’s use of voluntary donations from hospitals to supplement federal Medicaid funding violates federal law. The non-federal share financing of the New Hampshire Health Protection Program or Medicaid expansion through the use of provider-related donations to pay for Medicaid service-related costs violates the requirement that a bona fide provider-relation is a donation that has no direct or indirect relationship to Medicaid payments.

The 50,000 New Hampshire residents participating in the Medicaid expansion will not see any change in their coverage through the current re-authorization which continues until the end of 2018.New Hampshire’s next legislative session will need to address compliance with the federal law for the 2019 budget to bring the state’s non-federal share financing into compliance with the existing federal statute and regulations. Otherwise, Medicaid expansion in the state will lose federal funding. Governor Chris Sununu (R) stated that stripping coverage from Medicaid enrollees would have been “grossly unfair,” and will use the transition period to consider future changes.

AMA provides resources to help physicians with MIPS reporting

As part of its effort to improve Medicare Payment Reform, the American Medical Association (AMA) is providing tools for physicians to better understand and meet the reporting requirements under the new Quality Payment Program from CMS. The AMA has created a “One Patient, One Measure, No Penalty” campaign to help physicians understand the reporting requirements and avoid the 4 percent penalty for not reporting under the Merit-Based Incentive Payment System (MIPS) track. Along with this campaign, the AMA has created an interactive MIPS Action Plan that provides deadlines and a step-by-step plan of how to meet the reporting requirement deadlines.

As part of the “One Patient, One Measure, No Penalty” campaign, the AMA has provided a short video that demonstrates how to fill out CMS forms to accurately report a quality measure on a patient encounter. A step-by-step guide is also provided as a supplement to the video, along with a sample form to review. There are also links to other tools, such as the CMS Quality Measure Search tool, so that all of the resources are available in one easy-to-find location.

The MIPS Action Plan is a ten-step plan that begins with a determination of whether MIPS applies to the physician. The AMA provides a detailed breakdown of some of the determining factors, such as whether a physician is considered a hospital-based physician, in a frequently asked questions supplemental resource. The MIPS Action Plan then proceeds to walk through the process of reporting, including deadlines to start reporting, and submitting 2017 MIPS data.

Compounding pharmacy enjoined from manufacturing until remedial measures are implemented

Isomeric Pharmacy Solutions LLC (Isomeric) and three executives are permanently enjoined from manufacturing and distributing drugs considered adulterated in violation of the federal Food, Drug and Cosmetic Act (FDC Act) (21 U.S.C. §301 et seq.). The injunction was entered in the Utah district court following a complaint entered by the Department of Justice (DOJ) after finding that Isomeric, a compounding pharmacy, was producing drugs under insanitary conditions.

Isomeric

Isomeric manufactures, labels, and distributes drugs, particularly injectable hormones and corticosteroids, as well as ophthalmic drops. Most of the drugs are directly distributed to physicians. The company initiated three recalls in 2016 involving three types of injectable drugs. In April 2017, Isomeric recalled all lots of non-expired drug products that should have been sterile and were compounded between October 4, 2016 and February 7, 2017.

Complaint

According to the complaint, the FDA found that Isomeric repeatedly found several types of microorganisms in the air and on surfaces that should have been sterile. Products that were manufactured in these areas were prepared in insanitary conditions. The FDA found that Isomeric deviated from current good manufacturing practice requirements, and failed to thoroughly review discrepancies or failures found in batches of drugs.

The injunction was entered through a consent decree as part of a settlement. Isomeric and its chief executive officer, chief sales officer, and chief operating officer will not resume manufacturing, holding, or distributing drugs until proper remedial measures have been taken.

Kusserow on Compliance: Reminder to compliance officers—EMTALA is a high risk area

EMTALA enforcement is on the rise, and a good example of this was AnMed Health, a hospital located in South Carolina. The hospital recently agreed to pay $1.3 million for violating EMTALA; the largest such settlement to date and it included a CIA. This was as result of failing to provide appropriate screening examinations and stabilizing treatment to patients presented to the emergency department (ED) with psychiatric conditions. As large as the penalty was, the OIG indicated it would have likely been much larger, but AnMed was credited with being cooperative with the OIG during the investigation and having engaged in significant corrective action. It is worth recalling that the OIG issued new regulations that (1) increased the civil monetary penalty amounts for EMTALA violations and (2) encourage providers to self-report EMTALA violations to CMS in order to potentially receive more lenient penalties where there is a violation of the law. Compliance officers should ensure the EMTALA high-risk area is being addressed by ongoing monitoring and auditing. The following offers a suggestions and tips for Compliance officers provided by the Policy Resource Center that have detailed audit guides for high-risk areas, including EMTALA, as well as many related policies and procedures. For more information, contact them directly.

EMTALA Policies

Comprehensive EMTALA policies should address:

  • Who conducts screening with detailed screening protocols
  • Processes for reassessing patients after initial screenings
  • Screenings to be conducted by a physician or qualified medical personnel
  • Documentation and uniformity of screenings regardless of ability to pay
  • Conduct and timeframes for stabilization of patients as obligated under EMTALA
  • Process and patients’ rights for transfers
  • Requirements for physician certifications and medical record documentation for transfers
  • Processes for transfers into the hospital
  • Transfers to medical records and patient consent
  • Refusal for emergencies transfers and state-specific transfer requirements
  • Prohibition of retaliation against whistleblowers that make reports
  • Creating a method to internally report and address potential violations and timely conduct investigations
  • Any changes in the law or accreditation standards.

Training on Policies

The key to a successful EMTALA program is education so that the policies can be followed appropriately by frontline staff. All new staff assigned to the ED should first undergo intensive training on EMTALA policies and annual refresher training is advisable. The training should address scenarios of real life situations that prepare for making quick decisions on the job.

Determine EMTALA Investigating and Reporting Responsibility

EMTALA complaints can come from many sources, including other hospitals, patients, family members and ambulance companies. They frequently also are reported to CMS and the OIG.  It is critical that reported EMTALA issues are addressed promptly and appropriately and how this is handled is viewed seriously by regulatory and enforcement agencies. Clinical leadership should play a key role in this process, but they should understand when and how they would work with the compliance officer and legal counsel who will need to be involved in guiding investigations and interactions with government agencies. Investigations at the direction of legal counsel, especially outside counsel, will preserve privilege, especially since EMTALA provides for the potential for a private cause of action in malpractice cases.

22 Ongoing Auditing EMTALA Tips

  1. Verify that policies/procedures specifically address EMTALA compliance.
  2. Check to see that transfer policies and arrangements are being followed
  3. Determine if there are long delays in the ED
  4. Review triage and screening protocols and training
  5. Review on-call polices and contracts to ensure the ED has adequate coverage
  6. Review bylaws related to who can conduct screenings
  7. Ensure that staff members are not requesting payment prior to screening patients
  8. Review transfer forms and logs
  9. Conduct a medical record audit for screening and transfers
  10. Confirm whistleblower protections
  11. Review internal reporting chain
  12. Review training materials and documentation
  13. Verify specialists are on staff to meet the screening and stabilization requirements, as well as inpatient capabilities for stabilizing emergency patients
  14. Ensure there are no payments requested prior to screening patients
  15. Verify policies prohibit retaliation against whistleblowers that make reports
  16. Verify a method for internally reporting (e.g. hotline) and addressing potential violations
  17. Check to see there is a central log that is properly maintained for disposition and compliance with legal requirement
  18. Confirm that the physician on-call list reflects coverage of services available to inpatients
  19. Verify triaging of patients is being performed properly
  20. Verify all physicians come to the facility when called and are in compliance with the timeframes set forth in policies
  21. Confirm all transfers of individuals with un-stabilized EMCs are initiated either by (a) a written request for transfer or (b) a physician certification regarding the medical necessity for the transfer
  22. Verify there is an established a transfer request log to capture necessary information.

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

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Copyright © 2017 Strategic Management Services, LLC. Published with permission.