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Articles Posted in Health Law

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The New York State Office of the Medicaid Inspector General (OMIG) issued guidance on its requirements for Medicaid compliance, effective October 26, 2016.  This Compliance Program Review Guidance (“Guidance”) will assist the Medicaid Required Provider (“Required Provider”) community in developing and implementing compliance programs that meet the requirements of Social Services Law Section 363-d (“SSL 363-d”) and title 18 New York Codes of Rules and Regulations Part 521 (“Part 521”).

For the purposes of this Guidance, “Required Provider” means a provider meeting any of criteria listed: (a) persons subject to the provisions of articles twenty-eight or thirty-six of the public health law; (b) persons subject to the provisions of articles sixteen or thirty-one of the mental hygiene law; or (c) other persons, providers or affiliates who provide care, services or supplies under the medical assistance program or persons who submit claims for care, services, or supplies for or on behalf of another person for which the medical assistance program is or should be reasonably expected by a provider to be a substantial portion of their business operations.

The comprehensive Guidance addresses all requirements under each of the eight program elements. Invariably in compliance program guidance there are seven key elements of an effective compliance program which are as follows: written policies and procedures, compliance oversight, effective training/ education, effective communication, internal monitoring and auditing, enforcement of standards and corrective action with the OMIG Guidance adding an eight element in the form of a policy on non-intimidation and non-retaliation.

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Following a lengthy dispute process and significant delays, on October 31, 2016, CMS awarded new Medicare Fee-for-Service RAC contracts to the following contractors:

  • Region 1 – Performant Recovery, Inc.
  • Region 2 – Cotiviti, LLC
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Private practitioners who wish to remain independent, but who are struggling to survive because of decreased third-party reimbursements and increasing overhead expenses, are being aggressively courted by various business entities that will analyze-often for free-whether the concierge model of medicine, or some variation thereof, might add significant profitability to the practice’s bottom line.

The earliest concierge models generally required patients to pay an annual membership fee in order to receive enhanced accessibility to their physician. In return, the physician would agree to limit his patient base to, say, 600 patients. In this way, the physician would conceptually be able to spend more time with each individual patient, yet still maintain (if not increase) his historic revenue stream. This meant that those patients who chose not to participate in the physician’s new concierge program would be required to leave the practice in order to find another physician to care for their healthcare needs.

In the past, many patients who have been approached to transition to a physician’s concierge practice chose not to do so because they did not perceive that the enhanced accessibility to their physician was worth the cost of the annual membership fee. Oftentimes, they were already able to get same day or next day appointments, and prompt return phone calls from their doctor so, the thought went, why pay all that money? What does one get in return?

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Medicare has developed a new incentive payment framework (“MACRA”) which is intended to fundamentally change the way in which the Federal Government evaluates and pays for the healthcare services that are provided to Medicare beneficiaries. It is designed to move us away from a volume-based “fee-for-service” reimbursement system to one which emphasizes the quality of the care provided. The new reimbursement program is scheduled to begin on January 1, 2017.

To avoid penalties and qualify for bonuses under MACRA, physicians must participate in the new Merit Based Incentive Payment System (MIPS, for short) unless they have a substantial amount of their revenue at risk under a qualifying alternative payment model (“APM”) — and the vast majority of physicians do not.

Physicians were supposed to start reporting performance data next year, and many complained that smaller practices in particular wouldn’t be ready. The framework calls for them to choose from an array of measures in four categories: 1. quality; 2. resource use; 3. clinical practice improvement; and 4. meaningful use of electronic health records.

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On July 28th, 2016, researchers from Harvard, in conjunction with researchers from several hospitals, published a study in the BMJ which found that the implementation of new electronic health records (EHRs) systems does not have material repercussions on patient care in hospitals.

The study observed 17 hospitals implementing new EHRs, along with a control group of 399 hospitals in the same hospital referral region. Researchers looked at 6-month periods both before and after this implementation, and found that 30-day mortality and adverse safety event rates did not vary significantly. There was an unadjusted decrease in 30-day readmission rates, from 19.9% to 19.0%, however, the researchers confirmed that “there was no significant change in any outcome between pre-implementation and post-implementation periods.”

Despite increasing alarm over patients’ safety  after hospital-wide transitions to EHR systems, it appears that hospitals are able to overcome any disruptions associated with the transition, with no overall negative effect on short-term inpatient mortality, adverse safety events, or higher rates of hospital readmissions.

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On July 29, 2016, the Centers for Medicare & Medicaid Services (“CMS”) announced that it is expanding statewide (and extending for an additional six (6) months), the temporary enrollment moratoria on new Medicare Part B home health agencies (“HHAs”) in Florida, Texas, Illinois, and Michigan.  The statewide expansion also applies to Medicaid and Children’s Health Insurance Program (“CHIP”).

The expansion and extension also apply to non-emergency ground ambulance suppliers in New Jersey, Pennsylvania, and Texas.  CMS is also lifting the temporary moratoria on all Medicare Part B, Medicaid, and CHIP emergency ground ambulance suppliers.  These changes are effective as of July 29, 2016.

CMS also announced the Provider Enrollment Moratoria Access Waiver Demonstration (“PEWD”).  Under PEWD, CMS can allow exceptions to enroll providers and suppliers in the moratoria areas if access to care issues are identified and for the development and improvement of methods of investigating and prosecuting fraud in Medicare, Medicaid, and CHIP.

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The United States Department of Health and Human Services has new actions planned to address the opioid crisis. The buprenorphine rule has been finalized, which allows physicians who have waivers to prescribe buprenorphine products (e.g., Suboxone) for up to 100 patients for 1 year or more to obtain a waiver to treat up to 275 patients. Also, per Centers for Medicare & Medicaid Services (CMS) many doctors have reported feeling financial pressure to overprescribe opioids since Medicare payments to hospitals are tied to scores on the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey, therefore CMS is recommending that the pain management questions on the HCAHPS be eliminated. Lastly, Indian Health Service is mandating that its opioid pharmacists and prescribers check their state prescription drug monitoring program database before dispensing or prescribing any opioids. In an effort to improve and expand prescriber education and training programs, HHS will also be conducting over a dozen studies on pain treatment and opioid misuse.

To learn more about the latest actions by HHS see the HHS July 6, 2016 news release.

Robert S. Iwrey, Esq., a founding partner of The Health Law Partners, P.C., practices in all areas of healthcare law and devotes a substantial portion of his practice assisting clients in pharmacy legal matters including compliance, third party payor audits, government investigations, state licensing and DEA registrations. For more information regarding this article or pharmacy legal matters, please contact Robert S. Iwrey, Esq. at (248) 996-8510 or (212) 734-0128 or riwrey@thehlp.com.

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New rules published on June 30th, 2016 in the Federal Register could dramatically change the regulatory enforcement landscape for healthcare providers, with fraud penalties nearly doubling under the False Claims Act and the Anti-Kickback Act.

The False Claims Act (which in pertinent part imposes penalties on healthcare providers for submitting false claims to a government program) has had a penalty range of $5,500 to $11,000 per claim since 1996, but such penalties will increase to a range of $10,781 to $21,563 per claim. Penalties for violations of the Anti-Kickback Act (which prohibits physicians from referring Medicare beneficiaries to an entity in which they have a financial relationship for designated health services) will correlatively be substantially enhanced, from $11,000 per violation to $21,563 per violation.

The basis for these adjustments is the Federal Civil Monetary Penalties Inflation Adjustment Act of 1990, which requires that civil monetary penalties be adjusted regularly in order to account for inflation. These changes are set to take effect on August 1st, 2016. Public comments on the changes can be submitted to the Justice Department until August 29th, 2016.

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On Thursday, the U.S. Supreme Court issued a decision that recognizes implied certification as a viable theory under which to pursue False Claims Act cases against healthcare providers. Implied certification can impose liability if a contractor has engaged in a lie by omission, for instance, failing to disclose its noncompliance.

In the case, Universal Health Services v. Escobar, the court ruled that companies are subject to False Claims Act liability and the implied certification theory, but only if: (1) claims from healthcare providers request payment and make “specific representations about the goods or services provided” and (2) an organization’s failure to disclose noncompliance with “material” requirements would equate to “misleading half-truths.”

This case could result in a significant increase in False Claims Act cases being pursued against healthcare providers.

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The HHS Office for Civil Rights (“OCR”) has begun issuing notices for Phase 2 HIPAA Audits applicable to covered entities and their business associates. In Phase 2, OCR will review the policies and procedures adopted and employed by covered entities and their business associates to satisfy standards and implementation specifications of the Privacy, Security, and Breach Notification Rules. Phase 2 audits will primarily be desk audits, however, some on site audits will occur.

Please be sure to check your spam filters and junk email folders because notices for Phase 2 HIPAA Audits are sent via email. The initial email notice for a Phase 2 HIPAA Audit seeks to confirm an entity’s address and contact information. Following confirmation of this contact information OCR will send a pre-audit questionnaire.

We have a number of clients who are undergoing Phase 2 HIPAA Audits and our experience in responding to these audits will minimize any potential disruption to your healthcare operations. Contact Clinton Mikel, Esq., at cmikel@thehlp.com, or at 248-996-8510, for guidance and counsel on how best to respond to any Phase 2 HIPAA Audit notice that you have received.

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