Category Archives: Compliance

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New Attorney General Issues Guidance on Corporate Compliance Programs

Capitol
The US Department of Justice (DOJ) Fraud Section has published new guidance for corporate entities on corporate compliance programs.  The guidance, titled, “Evaluation of Corporate Compliance Programs” (Compliance Program Evaluation)  provides companies – and their compliance teams – with key insights into how government regulators will assess efforts taken to develop, implement and evaluate the … Continue reading this entry

HRSA Announces Final Rule on Civil Monetary Penalties for Drug Manufacturers that Overcharge 340B Covered Entities

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A new regulation issued by the Health Resources and Services Administration (“HRSA”) sets forth a process by which civil monetary penalties may be imposed on drug manufacturers that knowingly and intentionally charge 340B covered entities for covered outpatient drugs more than the statutory ceiling price. The regulation addresses the ceiling price calculation for drugs purchased … Continue reading this entry

Hawai’i Receives Approval for the First State Innovation (Section 1332) Waiver

Regulations
The federal Department of Health and Human Services and Department of Treasury (the Departments) agreed that certain small employer health insurance coverage provisions of the Affordable Care Act (ACA) would be waived for the state of Hawai’i, beginning with January 1, 2017. The waiver was authorized pursuant to Section 1332 of the ACA, which allows … Continue reading this entry

21st Century Cures Act Provides Some Welcome Relief

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The 21st Century Cures Act (the “Cures Act”) (Pub. L. No. 114-255), which was signed into law by President Obama on December 13, 2016, includes a number of important health care provisions, and several address the long-anticipated relief for Medicare “site-neutrality” policies relating to off-campus outpatient hospital departments (“OCODPs”), certain cancer hospitals, and long-term care … Continue reading this entry

OPPS Final Rule Finalizes Limits for Off Campus Departments

Regulations
Center for Medicare and Medicaid Services (CMS) issued the long-awaited implementation of the “site-neutrality” provisions of the H.R. 1314 Bipartisan Budget Act of 2015 (BiBA Section 603) on November 1, 2016. The Final Rule will cause new (non-grandfathered) hospital off-campus outpatient departments to no longer be reimbursed under the Medicare Outpatient Prospective Payment System (OPPS). … Continue reading this entry

The Top 10 Things you Need to Know About Voluntary Disclosures and Government Refunds

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In February 2016, CMS issued the highly anticipated Final Rule on reporting and returning Medicare Part A and B overpayments. The Final Rule was meant to clear up some of the confusion among providers regarding such overpayments. Summarized below is our Top 10 list of the things you need to know:… Continue reading this entry

ONC Releases Enhanced Regulatory Requirements to Improve Transparency for Health Information Technology Products

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The Office of the National Coordinator for Health Information Technology (“ONC”) has operationalized regulatory requirements to improve transparency in health information technology (“health IT”). The regulations, which were finalized in October 2015, clarified in December 2016, and effective as of January 14, 2016, apply to all health IT products and services certified to the 2014 Edition … Continue reading this entry

CMS Expands Mandatory Bundled Payments to Cardiac Care

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On Monday July 25, 2016, CMS proposed new models that expand mandatory participation in bundled payments and continue CMS’s initiative to shift Medicare payments from fee for service to alternative payment models.  Coming just as the Comprehensive Care for Joint Replacement (CJR) initiative gets underway, the new models are, according to CMS, intended to reward … Continue reading this entry

Ransomware Reporting Requirements & New HHS Guidance

New York Office of the Medicaid Inspector General Releases 2014-2015 Work Plan
Ransomware is malicious software that denies access to data, usually by encrypting the data with a private encryption key that is only provided once a ransom is paid. Sometimes the ransomware will actually destroy, steal, or export data from information systems. Ransomware has become a significant threat to all U.S. businesses and individuals, and a … Continue reading this entry

Additional Opioid Policy Changes Announced: What You Need to Know

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Despite the July 4 holiday, the past week featured significant regulatory and legislative action addressing the use of opioids and pain management. The changes are in keeping with the Government-wide push to better understand and reduce opioid drug abuse. We discuss here the week’s two most notable developments. Updating the HCAHPS Hospital Survey and Value-Based Purchasing … Continue reading this entry

“Site Neutrality” for Off-Campus Outpatient Departments: Proposed Rule is Worse than You Expected!

Capitol
Please note, Cheryl Storey, CPA with Moss Adams LLP is also a co-author of this post. CMS issued its Outpatient Prospective Payment System (“OPPS”) Proposed Rule for 2017 (the “Proposed Rule”) on July 6, 2016. The Proposed Rule will  be published in the Federal Register on July 14, 2016. One highly-anticipated section of the Proposed Rule … Continue reading this entry

CMS Issues Final Rule on ACOs Participating in the Medicare Shared Savings Program

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The Centers for Medicare & Medicaid Services (“CMS”) issued a final rule (the “Final Rule”) for accountable care organizations (“ACOs”) participating in the Medicare Shared Savings Program (“MSSP”) on June 6, 2016. In the Final Rule, CMS reflects its continuing efforts to modify alternative payment programs to make them more workable while also moving toward … Continue reading this entry

HIPAA Compliance: Navigating a Health Care Minefield

Compliance
In the two decades since its original passage, complying with the federal Health Insurance Portability and Accountability Act (HIPAA) hasn’t gotten any easier. Enacted with the primary goal of protecting the confidentiality, integrity and availability of healthcare information, HIPAA presents daunting administrative, technological and financial burdens for health care organizations. The burdens are only becoming … Continue reading this entry

Health Care IT Program Discusses Alternative Payment Model Opportunities

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A distinguished panel of providers, consultants and IT firms convened on Tuesday, June 21st  in New York at the Foley and Lardner LLP offices to share a discussion focused on the convergence of IT spend and new value based purchasing models (“VBP”) coming out of CMS in increasing frequency—ACOs, BPCI, CJR and CCM.  Key Takeaways … Continue reading this entry

DOJ and North Carolina Challenge Anti-Steering and Tiering Provisions in Managed Care Contracts

CMS Releases Medicare Part B Supplier Billing and Payment Data
The Department of Justice’s antitrust division (the “DOJ”)and the State of North Carolina (“NC”) jointly sued, on June 9, 2016, Carolinas HealthCare System (“CHS”), the largest healthcare system in North Carolina, over anti-steering restrictions in its managed care contracts that the DOJ believes limits competition. In its complaint, the DOJ and NC claim that CHS used its … Continue reading this entry

Summary: Final Rule on Nondiscrimination in Health Programs and Activities

Regulations
Section 1557 of the Affordable Care Act (“ACA”) establishes a broad prohibition on discrimination on the basis of race, color, national origin, sex, age or disability in health programs and activities. After almost 3 years of rulemaking activity, the Department of Health and Human Services(“HHS”) Office for Civil Rights (“OCR”) issued its final rule implementing … Continue reading this entry

Shining a Brighter Light on Massachusetts Public Records - HB 4333

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If, as Justice Louis Brandeis famously said, “sunlight is said to be the best of disinfectants,” Massachusetts public records have just received a substantial splash of bleach. On June 3, 2016, Governor Charlie Baker signed into law the first update to Massachusetts’s public records law since 1973.  The law, as amended, will change how Massachusetts … Continue reading this entry

Legislation to Expand Definition of Grandfathered Off-Campus Hospital Departments to Address “Mid-Build” and Cancer Hospital Projects Moves Forward

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A bill amending the “site neutrality” limitations brought by Section 603 of the Bipartisan Budget Act of 2015 was introduced in the House of Representatives last week and passed out of committee yesterday. H.R. 5273, the “Helping Hospitals Improve Patient Care Act of 2016,” was introduced by two powerful Members of the House Ways and … Continue reading this entry

Recent New York Medicaid Settlement with Pharmacy Shows Importance of Checking Excluded Provider List Prior to Filling Prescriptions

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A New York pharmacy has agreed to pay approximately $500,000 to the State of New York for improperly billing New York Medicaid for prescriptions written by a physician who had been excluded from the Medicaid program. This settlement serves as an important reminder to all pharmacies operating in New York: Before filling a prescription, pharmacies … Continue reading this entry

DOL’s Increased Salary Test: What Health Care Employers Need to Know

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As detailed here in our Labor & Employment blog, the Department of Labor recently announced significant increases to its minimum salary threshold to be considered exempt from the overtime requirements under the Fair Labor Standards Act (FLSA).  Health care employers — both in the non-profit and for-profit sector — will be impacted profoundly because many managers … Continue reading this entry

Employee Assistance Programs and State Insurance Regulation Structuring EAPs to Ensure Compliance

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Employee Assistance Programs (or EAPs) have served employers and their employees for decades, providing a variety of benefits to address issues that might otherwise adversely affect the overall health and work of employees. A National Study of Employers conducted in 2008 found that 65 percent of employers in the United States provided EAP benefits, an … Continue reading this entry

Finance Committee Report Place Medical Device Arrangements under Increasing Scrutiny

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Hospitals and providers participating in physician-owned distributorships, or “PODs” may be at increased risk for government investigation or enforcement. A Senate Finance Committee (SFC) Report issued this month highlights the SFC’s concerns that certain POD structures may violate fraud and abuse statutes, including the Anti-Kickback Statute, Stark Law, as well as the Sunshine Act. According … Continue reading this entry

OCR Releases Updated HIPAA Audit Protocol and Business Associate Listing Template

Regulations
The Office of Civil Rights (OCR) recently updated the audit protocol that it will be using to assess Covered Entities’ and Business Associate’s compliance with the Health Insurance Portability and Accountability Act (HIPAA) privacy, security, and breach notification rules. OCR also released a template that Covered Entities and Business Associates may use to keep track of … Continue reading this entry

CMS Abandons Payment Cut Imposed By Two-Midnight Rule

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In the Fiscal Year (FY) 2014 Inpatient Prospective Payment System (IPPS) final rule, the Centers for Medicare & Medicaid Services (CMS) revised its Medicare policy for determining whether hospital encounters will be considered appropriately inpatient or outpatient. The status distinction has important consequences for both the provider and the beneficiary, including differences in co-insurance and … Continue reading this entry