Category Archives: Regulatory Developments

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OCR Releases Updated HIPAA Audit Protocol and Business Associate Listing Template

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

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

CMS Announces Latest Alternative Payment Model - Comprehensive Primary Care Plus

Continuing in its efforts to promote alternative payment models, on April 11, 2016, CMS announced the Comprehensive Primary Care Plus (CPC+) model. CMS hopes to implement CPC+ in up to 20 regions, accommodating up to 5,000 practices, which would potentially encompass more than 20,000 doctors and clinicians and the 25 million people they serve. The … Continue reading this entry

Four Distinct Federal and State Policies Addressing Prescription Opioid Abuse

The first quarter of 2016 has witnessed a great deal of attention in government to the problem of opioid-related overdose and death in the United States. In just the past few weeks, the Senate passed prescription drug treatment and abuse prevention legislation—the Federal Comprehensive Addiction and Recovery Act (CARA), Senate Bill 524—while two states—Massachusetts and … Continue reading this entry

At The Intersection of New Bundled Payment Programs and New Discharge Rules: Private Equity Opportunities

Recently, CMS has promulgated new bundled payment rules for Comprehensive Joint Replacement (CJR) that require the mandatory participation of approximately 800 hospitals across the US. This bundle includes not only the inpatient DRG care, but also 90 days of post-discharge care. Contemporaneously, CMS has initiated rulemaking which totally revamps the discharge planning process for hospitals by requiring … Continue reading this entry

CMS Proposed Rule Reduces Drug Payments & Requires Implementation of Value-Based Purchasing Tools

Proposed Rule Recently, CMS published a Proposed Rule seeking to test a new model for how Medicare pays for drugs and biologicals paid under the Medicare Part B program. With the goals of determining whether alternative drug payment models will result in “better care” and “smarter spending” by reducing Medicare expenditures while enhancing the quality … Continue reading this entry

Part 2: Shelf Registration Extended Offering Period

This is the second post of a two-part series, you can view the first post here. Our first post in this series examined the regulatory and contractual considerations for municipal securities issuers and conduit borrowers using shelf registration. Now we examine the equally important considerations for implementation.… Continue reading this entry

Shelf Registration Extended Offering Period: Ready for the Municipal Marketplace?

This is the first post of a two-part series. Recently, a significant municipal issuer entered the market with its first sale under a $1 billion borrowing program that will use an offering statement style novel to the municipal market. For years, issuers of traditional corporate securities have used shelf registration for their securities. Shelf registration … Continue reading this entry

Comprehensive Joint Replacement Bundled Payment Program Begins April 1st

Approximately 800 hospitals in 67 Metropolitan Statistical Areas will begin mandatory participation in the Comprehensive Care for Joint Replacement (CJR) Model on April 1, 2016. The CJR bundled payment program applies to MS-DRG 469 (major joint replacement or reattachment of lower extremity with major complications or comorbidities) and MS-DRG 470 (major joint replacement or reattachment … Continue reading this entry

New Game Rules: Out-of-State Sports Team Physicians Now Allowed To Treat Players in Pennsylvania

New Legislation Effective on February 4, 2016, sports team physicians visiting Pennsylvania with their teams from outside the state will now be permitted to treat their players in Pennsylvania without fear of violating Pennsylvania law. Previously, visiting team doctors technically could not treat their own players without a Pennsylvania medical license. Pennsylvania is not the … Continue reading this entry

340B Program Update

The new year has already gotten off to a busy start for health care providers that participate in the 340B Drug Pricing Program (“340B Program”) and government agencies that reimburse these providers. Following on the heels of the publication of a Medicaid Covered Outpatient Drug Final Rule (“Final Rule”), the Centers for Medicare and Medicaid … Continue reading this entry

CMS Proposes Additional Changes to MSSP Regulations

Regulatory-Developments
The Centers for Medicare and Medicaid Services (CMS) recently issued a proposed rule modifying the Medicare Shared Savings Program (MSSP) regulations (the “Rule”). Among other changes, the Rule proposes (a) to modify the method in which cost benchmarks for MSSP-participating Accountable Care Organizations (ACOs) are updated both during a three-year agreement period and upon renewal, and … Continue reading this entry

The Who, What, and When for the CMS Final 60-Day Rule

Four years after the issuance of the Proposed Rule and six years after the authorizing statute, CMS has published the much-awaited Final Rule regarding reporting and returning of Medicare Part A and B overpayments (the “Final Rule”). 81 Fed. Reg. 7654-7684 (Feb. 12, 2016).  Since the inception of section 6402(a) of the Affordable Care Act … Continue reading this entry

SAMHSA Proposes Major Changes to Federal Substance Abuse Privacy Rule

Electronic Health Records
Almost thirty years after the last substantive change to the federal regulations governing the confidentiality of alcohol and drug abuse patient records, the Substance Abuse and Mental Health Services Administration (SAMHSA) today published a proposed rule (Proposed Rule) to modernize the regulations at 42 CFR Part 2 (the Part 2 Rule). Public comment period on … Continue reading this entry

CMS Finalizes Long-Awaited Covered Outpatient Drug Rule

The Centers for Medicare & Medicaid Services (“CMS”) recently issued a final rule implementing provisions of the Patient Protection and Affordable Care Act of 2010 (“ACA”) that pertain to Medicaid reimbursement for covered outpatient drugs (“CODs”) and the Medicaid drug rebate program (the “COD Rule”).  The COD Rule both clarifies and creates a dramatic shift … Continue reading this entry

Potential Part B Drug Payment Cuts for 340B Hospitals

The influential Medicare Payment Advisory Commission (MedPAC) has voted to recommend to Congress in its March report that Medicare Part B drug payment rates for 340B drugs be reduced by 10 percent for hospitals participating in the 340B Drug Pricing Program (340B Program). Currently, hospitals are paid the same rate by Medicare for drugs whether … Continue reading this entry

Laboratory Developed Tests Emerging in FDA Regulation

Health care practitioners are more frequently using laboratory developed tests (LDTs) to diagnose and predict the risk of developing a disease, as well as to inform decisions on disease state management such as for cancer, heart disease and diabetes. As practitioners become increasingly reliant on diagnostic tests to guide important treatment decisions, concerns about the … Continue reading this entry

State Lawmakers Pushing Telemedicine Coverage in 2016

State legislation is heavily contributing to the expected reimbursement/coverage uptick in 2016, as more states consider legislation requiring coverage for telemedicine and in-person visits alike. To date, 29 states and Washington D.C. have enacted legislation ensuring that private insurers offer reimbursement for telemedicine at equivalent levels with in-person services, provided the care is deemed medically … Continue reading this entry

2016 Expected to Be Monumental Year for 340B Drug Discount Program

The 340B Program continues to be an area of focus from federal policymakers, and recent activity and publications indicate that 2016 could be a monumental year for the program. Below is a breakdown of the recent and upcoming key initiatives related to the 340B Program.… Continue reading this entry

New IRS Regulations for Mixed-Use Projects Financed With Tax-Exempt Bonds Have Particular Importance for Nonprofit Health Care Organizations

Tax Exempt Hospitals
The U.S. Treasury Department and Internal Revenue Service published final regulations on October 27, 2015 concerning the treatment of “mixed-use” projects financed with tax-exempt bonds. These new regulations have particular importance for tax planning and tax compliance of 501(c)(3) health care organizations that are borrowers of tax-exempt bonds.… Continue reading this entry

Five Takeaways From North Dakota’s Proposed Telemedicine Rules

Electronic Health Records
The North Dakota Board of Medicine issued proposed regulations designed to move the Peace Garden State to the list of telemedicine-friendly states. The rules properly focus on the quality of care delivered, rather than the technical means through which it is delivered, aligning well with telemedicine practice rules articulated by other state medical boards. The … Continue reading this entry

OIG and CMS Issue Rule: Finalizing Fraud and Abuse Waivers for MSSP ACOs

The Centers for Medicare and Medicaid Services (CMS) and the Office of Inspector General (OIG) of the Department of Health and Human Services just issued a final rule setting forth waivers of specified fraud and abuse laws applicable to the Medicare Shared Savings Program (MSSP). The final rule replaces the Interim Final Rule (IFC) with comment … Continue reading this entry

Budget Bill Aims to Kill Any New Off-Campus Provider-Based Facilities

Medicare’s 60-Day Proposed Refund Rule Imposes Significant Liability on Providers
Legislation being drafted as part of a budget deal between members of Congress and the White House includes language that will significantly alter the future of hospital-based outpatient care. The “discussion draft” of the bipartisan budget agreement would exclude from Medicare’s outpatient hospital prospective payment system (“OPPS”) any new off-campus departments of a hospital, as … Continue reading this entry

Court Strikes Down 340B Orphan Drug Rule Again: Will This Impact the “Mega Guidance”?

Regulatory-Developments
A federal court vacated the Department of Health and Human Services’ (HHS) Orphan Dug Rule that had allowed certain 340B Drug Pricing Program (340B Program) hospital covered entities to receive discounted prices when purchasing orphan drugs for a non-orphan use. In addition to its significant financial impact on hospital covered entities subject to the rule, … Continue reading this entry