Archives for August 2017

All Medicare stakeholders need to know MACRA

Although the Medicare Access and CHIP Reauthorization Act (MACRA) (P.L. 114-10) is best known for changing Medicare provider payments, its true goal is improving the quality of care delivery across the health spectrum. As a result, according to Todd Gower and Lisa Alfieri from the Risk Transformation, Health compliance sector of EY, providers must enhance their relationships and contracts with providers. Gower and Alfieri, speaking at a Health Care Compliance Association (HCCA) webinar titled “MACRA: Not just for Providers,” explained that having the proper infrastructure to obtain and organize all necessary documentation is the key to surviving MACRA.

Gower and Alfieri stressed the need for new discussions within health systems, noting that MACRA has potential to transform the health care system “equally, if not far more” than the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148). As it implements MACRA, HHS is having new conversations with stakeholders including whether the shared risk will actually improve care, and whether the current proposed criteria (see Halfway through QPP ‘transition year,’ CMS proposes substantial changes , June 21, 2017) are too restrictive. They praised HHS’ website on the Quality Payment Program as a new way to communicate with providers and other stakeholders.

MACRA is a complex law with wide-reaching repercussions. Gower and Alfieri suggested infrastructure updates, and predicted that the most-advanced providers will be seeking commercial payer partners by 2019 to maximize incentives for value-based care (VBC) payment models. Therefore, payers should create or enhance existing VBC offerings now to meet that expected need. MACRA steering committees are important to ensure compliance and update risk management programs for providers, but also for non-provider groups.

FDA fights ‘dishonest actors’ to preserve clinical potential of stem cell research

The FDA is increasing its stem cell therapy enforcement activity to diminish the influence of “unscrupulous actors” while protecting the promise of responsible stem cell therapy innovations. According to FDA Commissioner Scott Gottlieb, the agency plans to release a new comprehensive policy framework in the fall of 2017 to properly describe the rules governing the new field of regenerative stem cell research and product development. The framework will provide a more efficient means for stem cell product developers to gain FDA approval.

Enforcement

The announcement of stepped up enforcement activities follows a warning letter issued by the FDA on August 24, 2017 to US Stem Cell Clinic of Sunrise, Florida, due to the manufacturers “significant deviations from current good manufacturing practice requirements” and the seizure, on August 25, 2017, of an unapproved vaccine, which the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, California were using to create an unapproved stem cell product for cancer patients. The warning letter followed an investigation which revealed the clinic failed to develop appropriate procedures to prevent microbiological contamination. The seizure of the vaccine followed an inspection which revealed the vaccine was used to create an intravenous stem cell cancer product with unproven efficacy and risks of serious health problems related to using the virus.

Guidance

In response to the recent enforcement measures, the FDA launched a new working group focused on pursuing similar, “unscrupulous clinics.” The new framework develops a bright line to accommodate what Gottlieb called “good actors working on genuine science.” The FDA plans to set out the policy in a series of guidance documents.

AHA raises concerns about proposed reductions in DSH allotments

The American Hospital Association (AHA) is urging CMS to delay the implementation of the fiscal year (FY) 2018 disproportionate share hospital (DSH) allotment reductions due to significant concerns about the data the agency proposed to use in the DSH Health Reform Methodology (DHRM), according to a letter sent to CMS Administrator Seema Verma. In addition, the AHA is continuing to advocate for the repeal of the Medicaid DSH reductions in the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148). The AHA noted that although Congress cut DSH payments based on its reasoning that hospitals would care for fewer uninsured patients as health care coverage expanded, the projected increase in coverage has not been fully realized. This is because some states chose not to expand Medicaid and there is lower-than-anticipated enrollment in health insurance coverage through the health insurance marketplace.

AHA raised two key issues within the Proposed rule: (1) the data sources used in the DHRM, with a focus on transparency, completeness, and timelines of the data; and (2) the proposed cap that would limit the reductions to only 90 percent of a state’s DSH allotment.

Background

Section 2551 of the ACA established that state Medicaid DSH allotments would be reduced annually in the aggregate in consideration of certain statutory factors. In 2013, CMS published a Final rule that finalized a methodology only for fiscal years (FY) 2014 and 2015 in anticipation of re-evaluation following implementation of the ACA (see CMS lays out methodology for Medicaid DSH reductions in 2014 and 2015, September 16, 2013).

Proposed rule

The Proposed rule reflects a DHRM that accounts for relevant data that was unavailable to CMS during prior rulemaking for DSH allotment reductions originally set to take place for FY 2014 and FY 2015 (see CMS proposes updated method to calculate ACA-mandated Medicaid allotment reductions, Health Law Daily, July. 28, 2017).

Data sources

According to the AHA,CMS plans to use its FY 2017 Medicaid DSH allotment determination, Medicaid Inpatient Utilization Rate (MIUR) data reported by states, and Medicaid DSH audit data reported by the states for state plan rate year 2013. AHA claims that because none of the listed sources are publicly available CMS cannot deliver on its intent to use transparent and readily available data. In addition, CMS has not provided states or stakeholders with the technical guidance on the calculations and data sources to be used as it indicated it would provide in its 2013 Final rule. AHA stressed that having accurate MIUR data is critical to ensuring states are treated equitably under the proposed formula and the delay in the data is a significant limitation to the accuracy of the methodology. The FY 2017 allotments are not expected to be made public until after the start of FY 2018, a further delay of information.

DSH allotment reduction cap

The AHA supports CMS’ proposal to cap DSH allotment reductions at 90 percent of a state’s allotment. The proposal would prevent any state from losing it entire DSH allotment and, therefore could receive an allotment after FY 2025, AHA said. However, AHA suggested that CMS consider a lower cap for the DSH allotment reductions because the number of states affected is likely to be small.

Kusserow on Compliance: Effective hotline programs

All healthcare organizations need confidential compliance communication channels. First and foremost among them is a hotline. By definition, all effective compliance programs should have a hotline. It is an important avenue of communication between employees and management, in that it permits employees to report sensitive matters outside the normal supervisory channels.  The reality is that developing and monitoring a hotline is a critical part of any effective compliance program. It provides an avenue of communication that permits employees to report sensitive matters outside the normal supervisory channels. The compliance officer bears the responsibility of constantly reviewing and improving the effectiveness of the hotline operation.  The US Sentencing Commission, the HHS Office of Inspector General (OIG), and Department of Justice (DOJ) all call for having a hotline, as well as other authorities, including the Sarbanes-Oxley Act for publicly traded companies and the federal courts in connection with unlawful harassment. Failure to establish positive internal compliance reporting channels often results in reporting externally to the OIG and DOJ from “whistleblowers.” The challenge is establishing effective internal compliance communication. Today, it is the exception to find organizations trying to manage a hotline function internally. The fact is that any advantage of internally operated hotlines is more than off-set by the disadvantages.

From a practical standpoint, it simply is not cost effective to operate a hotline 24/7 internally.  Even those that decide to operate and manage the function in house are confronted with a number of challenges—it is extremely inefficient, costly and seldom meets any minimum standards. Hotline numbers will need to be “backstopped” against tracing and all caller identification systems have to be blocked. People answering the calls in house should not be highly visible to the work force. Confidence comes from neither party being known to the other. Hotline vendors have the training and experience to handle complainants. Callers are generally nervous and afraid and knowing they are providing information to an outside party generally is reassuring. They always raise the question of whether anonymity is truly offered and whether employees will ever sufficiently trust calling an employee. It has become the standard practice for organizations to outsource their hotline to a vendor.  However, evaluating those providing the best service at the right price is a challenge. The following are questions that can be used to determine a properly qualified vendor. Those failing key tests should be avoided as they may prove to be a future liability.

 

Questions for hotline vendors

  1. Cost of Service. Does the vendor charge an established fixed rate or sliding rate based upon number of calls? Seek a fixed, not a variable rate, based upon number or time of calls. A good rule of thumb is that the cost of a hotline service should not exceed $1-3 per employee per year.

 

  1. Industry Focus. Can the vendor evidence having understanding and expertise of issues related to the health care industry? Failing to understand healthcare standards and regulatory matters limits the ability to properly debrief callers. Ask for a breakdown of the types of clients they serve by industries.

 

  1. Hours of Service. Does the vendor provide 24/7 service? If not, don’t use them.

 

  1. Call Centers. Does the vendor provide call services? If so, avoid them completely. Call centers provide outbound calls used to promote services and products. Others answer after hour services for businesses (doctors, plumbers, electricians, etc.) and relate messages to their clients. The people doing this are performing a clerical function and answering hotline calls requires more professional expertise. Furthermore, there is the risk of having calls interrupted by a call for some needing emergency service.

 

  1. Hotline Service Types. Does the vendor provide multiple levels of service for (a) receiving live operator calls and (b) a web-based reporting system that prompts individual complainants? One level alone is not enough.

 

  1. Avoiding Vendor Contract Traps. Does the contract permit cancellation at any time with a simple 30 day notice? If not, don’t use them. Staying with a vendor should be because of good service, not because of being locked into them by contract terms. If you have a current contract, check the termination clauses to see if cancelling a contract is cumbersome. If it is, ask to renegotiate the termination clause. If they decline, then take steps to follow termination procedures in the contract.

 

  1. Hotline Number. Does the vendor want to use their phone number? This is a common vendor trap to lock in users to their service. You advertise their number everywhere and to change would necessitate changing all the places you have advertise the number. Always use and own your own hotline number that can be pointed to a vendor.

 

  1. Language Translation. Does the vendor provide a language translation service to address non-English speakers?

 

  1. Check Vendor Background. What is the level of hotline experience among the ownership, management, and operation of the service?

 

  1. Length of Hotline Experience. How many years of experience can the vendor evidence in the management of hotline operations?

 

  1. Policies, Procedures, and Protocols. Does the vendor provide advice on developing operating protocols for following up an allegations and complaints received through the hotline?

 

  1. Business Associate Agreement (BAA). Does the vendor offer to sign a BAA to meet HIPAA protected health information (PHI) requirements for any patient related information received through the hotline? If they don’t know what that means, forget them.

 

  1. Timelines. Will the vendor agree to provide a full written report within one business day of receipt of the call and for urgent matters, immediate notification?

 

  1. Report Delivery Security. Does the vendor deliver call reports by the most secure means? It is critical to establish a secure call report submission process to a specific responsible party and to an alternate should the primary contact be unavailable? Any delivery of reports via fax or email lack necessary security. It is critical that reports are secured to protect those filing the report, as well as those who are subject of the report or mentioned in them. HIPAA PHI, proprietary and confidential data, and personnel information must be protected. Web-based reporting is the most secure with notification of a report being provided via email.

 

  1. Routine vs. Urgent Reporting. Does the vendor assist in establishing a process that alerts the primary contact to any urgent report received? A delay in reporting a serious issue could result in potential liabilities.

 

  1. Insurance. Does the vendor provide at least one to three million dollars liability coverage? If your vendor does not have this insurance, consider changing over to one that provides this assurance.

 

  1. Caller Contact Information. Does the vendor have procedures for providing callers with a means to call back without disclosing their identity?

 

  1. Personalized Service. Does the vendor provide the identity or identities of individuals available to respond to any issues or question that may arise, whether it relates to call reports, invoice issues, or providing general advice? Not having easy access to someone or having to go through a phone system moving you from one office to another before you find a stranger who may or may not be able to answer your questions can be frustrating. If possible, seek an identified accounts manager who will be responsible for any and all issues that arise under the contract.

 

  1. Training and Assistance. Does the vendor provide guidance on the best way to promote understanding of the hotline?

 

  1. Other Useful Benefits. Are there any other services or benefit provided under the contract? This would include such things as supporting policy and procedures for hotline management, poster templates, newsletters, etc. For smaller organizations, these benefits may exceed even the service fees paid to the vendor. Find out what they offer.

 

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.