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Nancy Halstead

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The U.S. Department of Health and Human Services (HHS) started the new decade by keeping up its momentum to encourage patient engagement and support the secure expansion of digital health by releasing proposed rules and policy initiatives. On January 15, 2020, the HHS Office for the National Coordinator for Health Informational Technology (ONC) released a draft of its 2020-2025 Federal Health IT Strategic Plan (Plan). The outcomes-driven Plan, which ONC collaboratively developed with 25 federal organizations, aims to promote a health IT economy that balances increased transparency, competition, and consumer choice with privacy and security of patient health information. The Plan reflects HHS’ ongoing efforts to create pathways for patients to actively engage in their health outcomes and navigate personalized care alternatives.

The Plan is intended to serve as a five-year roadmap for federal health IT initiatives and activities, and to function as a catalyst for streamlined activities in the private sector. In particular, the Plan highlights four key goals with supporting objectives, all focused on meeting the needs of patients, caregivers, health care providers, payers, researchers, developers, and innovators by increasing access to health information, emphasizing product and pricing transparency, and encouraging interoperability.
Continue Reading HHS Sustains Digital Health Momentum and Continues Publishing Policy Initiatives to Kick-off 2020

Today, the Department of Health and Human Services (HHS) announced proposed changes to modernize the regulations that interpret the Physician Self-Referral Law (the Stark Law) and the Federal Anti-Kickback Statute. In a press release, HHS states these proposed rules are intended to “provide greater certainty for healthcare providers participating in value-based arrangements and providing coordinated care for patients . . . while maintaining strong safeguards to protect patients and programs from fraud and abuse.”

Over the last 30 years, HHS has issued a series of final regulations establishing exceptions and safe harbors that limit the reach of the Stark Law’s strict liability civil penalties and the Anti-Kickback Statute’s criminal penalties to protect from enforcement certain non-abusive and beneficial arrangements. These final regulations have not, however, reflected the significant shift in recent years in health care delivery and payment systems from a fee-for-service model to models based on improving value and quality of care provided to patients. As a result, many in the health care industry identify these laws, as well as the Civil Monetary Penalty (CMP) Law, as barriers to more effective care coordination and management that can deliver value-based care to improve quality of care, health outcomes, and efficiency. In response, on June 25, 2018, the Centers for Medicare & Medicaid Services (CMS) published a Request for Information seeking input on how it could address existing Stark Law barriers to these emerging value-based payment and delivery systems. Similarly, on August 27, 2018, the Office of Inspector General (OIG) published a Request for Information seeking feedback on how OIG could modify or add new safe harbors addressing these barriers. CMS and OIG received more than 350 comments each, which HHS has considered in publishing these proposed rules.

CMS and OIG Coordinated Proposals

The proposed rules, which span hundreds of pages, reflect close coordination between CMS and OIG, which tried to align the regulations, where appropriate, and the proposals are significant. More specifically, the coordinated proposals include:

  1. Three new exceptions and safe harbors for value-based payment arrangements
  2. Modifications to the existing electronic health record (EHR) exception and safe harbor
  3. The addition of a new exception and safe harbor related to the provision of cybersecurity technology and services

Continue Reading Proposed Rules to Modernize Stark Law and Anti-Kickback Statute Released Today

A recent False Claims Act (“FCA”) settlement involving an allegedly overpaid Florida medical practice reaffirms the interplay between the 60-Day Overpayment Statute and the FCA, but also highlights the importance for all providers and suppliers to report and return overpayments, regardless of the source of federal funds.

According to the Department of Justice (“DOJ”), First Coast Cardiovascular Institute (“FCCI”) allowed credit balances from various federal health care programs to accrue despite multiple internal warnings that the balances should be paid back. DOJ alleged that FCCI’s failure to return those credit balances within 60 days violated the FCA. DOJ’s comments are notable, however, because the credit balances not only involved Medicare and Medicaid, but also TRICARE and the Department of Veterans Affairs, both of which are outside the scope of the 60-Day Overpayment Statute. DOJ and FCCI resolved the alleged $175,000 in unreturned overpayments for a $448,821.58 price.
Continue Reading DOJ Settles Second 60-Day Overpayment Case, Highlights Broader Reach of the FCA’s Reverse False Claims Provision

In a clear turnabout from its previous position, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule on June 5, 2017 that would lift the agency’s ban on pre-dispute arbitration agreements in the long term care (LTC) setting. By contrast, less than nine months earlier, CMS prohibited LTC facilities from entering into pre-dispute arbitration agreements with residents, conditioning admission to a facility on the execution of such agreements, or making a resident’s continuing right to remain at a facility contingent upon a post-dispute arbitration agreement.

The industry’s response to the ban was swift and resolute—on October 17, 2016, the American Health Care Association and a group of nursing homes filed a lawsuit in federal court seeking a preliminary and permanent injunction to prevent CMS from enforcing the ban on pre-dispute arbitration agreements. The U.S. District Court for the District of Mississippi granted the request for preliminary injunction on November 7, 2016, stalling enforcement of the final rule’s arbitration provisions.
Continue Reading CMS Reverses Course in Pre-Dispute Arbitration Agreement Ban

CMS has issued its proposed rule to update Medicare skilled nursing facility (SNF) prospective payment system (PPS) rates and policies for FY 2018, while at the same time soliciting comments regarding a forthcoming and potentially ground-breaking proposed rule to replace the SNF PPS RUG-IV case-mix classification methodology, which forms the basis for SNF payment, with the Resident Classification System, Version I (RCS-I), as early as FY 2019.

For nearly ten years, CMS, the Office of Inspector General, and the Medicare Payment Advisory Commission have raised concerns that the current SNF payment system encourages providers to deliver therapy to residents based on financial goals and not patient need.  The RCS-I case-mix model, which was developed during the SNF Payment Models Research initiative, attempts to address those concerns by removing service-based metrics from the SNF PPS and deriving payment, almost exclusively, from objective resident characteristics.  Most notably, the proposed RCS-I case-mix model would:
Continue Reading CMS Simultaneously Releases Proposed Rule to Update SNF PPS for FY 2018 & Advance Notice of Proposed Rulemaking (ANPRM) to Replace RUG-IV Case-Mix Methodology as Early as FY 2019

The Centers for Medicare & Medicaid Services (“CMS”) published the long-awaited final rule February 12, 2016, clarifying the specific procedures applicable to the statutory requirement under the Affordable Care Act (“ACA”) for providers and suppliers to report and return overpayments within 60 days. While the final rule eased some of the law’s more unforgiving aspects, its limited scope brought up new questions about the breadth of the law itself.

Despite concerns raised by a number of commenters in response to the proposed rule, CMS limited the scope of the final rule to Medicare Parts A and B only. In other words, the final rule clarifies the obligations of Medicare providers and suppliers to report and return overpayments originating under Medicare Parts A and B. Commenters expressed concern about this limitation and the lack of rationale for distinguishing Medicare Parts A and B from Medicare Parts C and D; they also voiced the need shared by all providers and suppliers for guidance on the overpayment requirements. In response, CMS reasoned that differences in how the Medicare programs are administered necessitated separate rulemakings. Interestingly, the agency did not indicate whether a separate rulemaking would be forthcoming, but instead directed providers and suppliers to their existing statutory obligations under the ACA, and a prior rulemaking applicable to reporting and returning overpayments in the Medicare Parts C and D context, for further guidance. In its response, CMS appears to assume, without stating expressly, that the law and the agency’s prior rulemaking apply to providers and suppliers receiving payments under Parts C and D.

Continue Reading So You’re an Overpaid Medicare Part C/D Provider or Supplier: Can You Keep the Change?

Immediately following Sunday’s tragic shooting at a nightclub in Orlando, friends and family frantically gathered at Orlando Regional Medical Center, attempting to get information about their loved ones.  However, hospital officials hesitated to provide specific updates.  Why?  Because the Health Insurance Portability and Accountability Act (HIPAA) and implementing regulations restrict the patient-identifiable health information that “covered entities,” like Orlando Regional Medical Center, are permitted to disclose without proper patient authorization or consent.

Shortly following the massacre, Orlando local news outlets reported that after Orlando Regional’s CEO expressed concern regarding families requesting detailed patient health information at the hospital’s emergency room, Orlando Mayor Buddy Dyer contacted the White House and requested a waiver of the HIPAA regulations.  While the HIPAA Privacy Rule is not automatically suspended during a national or public health emergency, the Secretary of the Department of Health and Human Services (HHS) may waive certain provisions of HIPAA under the Project Bioshield Act of 2004 (PL 108-276) and section 1135(b)(7) of the Social Security Act.  In order to take advantage of the waiver, the President must declare an emergency or disaster and the Secretary of HHS must declare a public health emergency.Continue Reading Reexamining HIPAA’s Applicability During Emergencies After the Tragedy in Orlando

The Centers for Medicare & Medicaid Services (“CMS”) released today the long awaited final rule clarifying the statutory requirement under the Affordable Care Act for providers and suppliers to report and return Medicare overpayments within 60 days (the “Overpayment Final Rule”).  The Rule only applies to Medicare Part A and Part B providers and suppliers and will be effective 30 days after publication, which will occur tomorrow. Noteworthy provisions of the Overpayment Final Rule include:
Continue Reading CMS Eases 60-Day Overpayment Requirement in Final Rule While Raising New Questions

On June 9, 2015, the Office of the Inspector General of the Department of Health and Human Services (OIG) released a fraud alert warning physicians to scrutinize carefully the conditions and terms of any medical director or other compensation arrangement they enter into with potential recipients of Federal health care program business. The risks associated with these arrangements under the anti-kickback statute are not new. However, the fraud alert signals  the OIG’s current focus on physicians, which reportedly has also included hiring additional attorneys to handle investigative and enforcement activity involving physicians. Moreover, the government now has access to unprecedented amounts of data regarding financial arrangements between physicians and drug and device manufacturers.

The fraud alert follows on the heels of a dozen recent settlements between the OIG and individual physicians who allegedly received kickbacks disguised as medical directorships and other office staff arrangements. In those settlements, the OIG determined the physicians played an integral role in the schemes and specifically alleged that the agreements:Continue Reading An Apple a Day Keeps the OIG Away: Practical Guidelines for Structuring Physician Compensation Arrangements to Avoid Kickback Allegations

As part of the final 2015 Medicare physician fee schedule rule, CMS is adopting – with certain refinements – its proposed changes to the regulations implementing the Physician Payment Sunshine Act. By way of background, the Sunshine Act requires pharmaceutical and medical device manufacturers and group purchasing organizations to submit to CMS certain…

Today the Centers for Medicare & Medicaid Services (CMS) issued an advance copy of the CY 2015 Medicare Physician Fee Schedule (PFS) proposed rule, which includes certain changes to the regulations implementing the Physician Payment Sunshine Act, also known as the Open Payments program. These proposed changes come just three days after the inaugural…

The Centers for Medicare & Medicaid Services (CMS) has published the long-awaited Final Rule to implement the “Sunshine” provisions of the Affordable Care Act of 2010 (ACA).  The Sunshine provisions – intended to provide increased transparency regarding the scope and nature of financial and other relationships among manufacturers, physicians, and teaching hospitals – require that…

This post was also written by Elizabeth D. O’Brien.

On January 25, 2013, the HHS Office for Civil Rights published its long-awaited final rule implementing major changes to the HIPAA Privacy, Security, Breach Notification, and Enforcement Rules mandated by the 2009 Health Information Technology for Economic and Clinical Health Act (HITECH Act). Among other…

The Centers for Medicare & Medicaid Services (CMS) released late today its final rule implementing the physician payment transparency provisions of the Patient Protection and Affordable Care Act (Section 6002), commonly referred to as the “Physician Payments Sunshine Act.” Among other things, the Act requires drug, device, biological or medical supply manufacturers to report…

The Office for Civil Rights (“OCR”) of the Department of Health and Human Services released today the long awaited, and much anticipated, omnibus final rule modifying the HIPAA Privacy, Security, Breach and Enforcement Rules. The final rule, which implements the statutory requirements of the Health Information Technology for Economic and Clinical Health Act (“HITECH”) and the Genetic Information Nondiscrimination Act (“GINA”), is comprised of four final rules and addresses the July 2010 HITECH proposed rule, the Breach Notification and Enforcement interim final rules, as well as the October 2009 GINA proposed rule (collectively, the “HITECH Final Rule”). Notably, the HITECH Final Rule does not address the May 2011 proposed accounting and access report rule.
Continue Reading It’s Here: OCR Releases Long Awaited HIPAA/HITECH Final Rule

This post was also written by Tillman J. Breckenridge. As has been widely reported, today the U.S. Supreme Court ruled that the Affordable Care Act’s (ACA) individual health insurance mandate does not violate the Constitution because it may be viewed as a permissible tax on individuals who do not obtain health insurance.  The only provision of the law that the Court invalidated is a Medicaid provision that threatened states with the loss of existing Medicaid funding if they decline to comply with the ACA’s Medicaid coverage extension. By preserving the vast majority of the landmark health reform law, the Court avoided the policy chaos that would have resulted from striking down the ACA in its entirety. There is now legal certainty for state and federal governments, health care providers and suppliers, drug and device manufacturers, employers and individuals.  As discussed below, the focus in Washington will return to continuing implementation of the law. Nevertheless, although the legal battle is over, the political fight will continue and likely reverberate through the coming Presidential and Congressional election campaigns.
Continue Reading Supreme Court Upholds ACA Insurance Mandate, Limits Withholding of Medicaid Funds to States

The Centers for Medicare & Medicaid Services (CMS), tasked with implementing the Physician Payments Sunshine Act, announced yesterday that it will not require pharmaceutical, device, and other applicable manufacturers and group purchasing organizations (GPOs) to begin collecting reportable data before 2013.
Continue Reading CMS Announces Data Collection for the Physician Payments Sunshine Act Will Not Be Required Before 2013

On December 19, 2011, the Centers for Medicare & Medicaid Services (“CMS”) published a proposed rule (the “Proposed Rule”) related to section 6002 of the Affordable Care Act, commonly referred to as the “Physician Payment Sunshine Act” (so referenced herein, or as the “Act”). The Physician Payment Sunshine Act requires applicable manufacturers of drugs, devices, biologicals, or medical supplies covered under Medicare, Medicaid, or CHIP to report annually to the Secretary of the Department of Health and Human Services (“Secretary”) certain payments or other transfers of value to physicians and teaching hospitals. Additionally, applicable manufacturers and applicable group purchasing organizations (“GPOs”) must report certain information regarding the ownership or investment interests in them that are held by physicians or their immediate family members.
Continue Reading Overview and Analysis of the Proposed Federal Sunshine Regulations

The Centers for Medicare & Medicaid Services’ (“CMS”) Medicare Shared Savings Program final rule offers potential opportunities as well as risks to health care providers and suppliers interested in forming accountable care organizations (“ACOs”). While the core principle of the Medicare Shared Savings Program is simple—reward improvements in quality and cost containment through a share…