Nathaniel Arden

Nathaniel Arden

Nathaniel Arden is a member of Robinson+Cole’s Health Law Group. He advises hospitals, physician groups, community providers, and other health care entities on a wide variety of health law and business matters. He regularly assists clients with transactional and regulatory issues, including Medicare and Medicaid fraud and abuse, health information privacy and security, compliance, licensure, clinical trials and health care-related information technology issues. Read his full rc.com bio here.

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CMS Issues Guidance on Texting Patient Information

On December 28, 2017, the Centers for Medicare and Medicaid Services (CMS) published a memo to state survey agency directors clarifying its position on the use of text messaging among health care providers. In its memo, CMS stated that it does not permit texting of patient orders by health care providers, as texting of patient orders does not comply with the applicable Medicare conditions of participation (COPs), specifically 42 C.F.R. § 489.24. Instead of texting patient orders, CMS states that its preference is for health care providers to either hand-write …

The Joint Commission Relaxes Process for Credentialing Independent Pathologists

Effective January 3, 2018, The Joint Commission (TJC) has revised its standards to no longer require TJC-accredited hospitals, critical access hospitals, and ambulatory care organizations to credential and privilege pathologists that provide diagnostic services through reference laboratories. TJC Introduction to Leadership Standard LD.04.03.09 generally requires that each hospital, critical access hospital or ambulatory care organization credential and privilege all licensed independent practitioners from whom it receives laboratory services under a contractual relationship. A new exception has been added to the general rule to state that the hospital, critical access hospital …

CMS Updates Hospital Compare Website

CMS recently announced updates to its Hospital Compare website. CMS provides the Hospital Compare website to give patients, their families and other health care stakeholders information on the performance of hospitals participating in Medicare. CMS also provides a star rating for each hospital to assist patients in choosing a hospital for their care. CMS updated the star rating methodology in response to feedback from hospitals and other industry stakeholders. In addition to changes to the statistical modeling used, CMS has decreased the emphasis on patient experience and increased the importance …

OIG Rescinds Advisory Opinion Due to Requestor’s Failure to Disclose Information

On November 28, 2017, the Office of Inspector General (OIG) rescinded advisory opinion 06-04, in which it had previously determined that a charity’s (Requestor) proposal to provide assistance to financially needy Medicare beneficiaries did not warrant the imposition of sanctions. The OIG explained that “public interest requires rescission” after finding that Requestor failed to comply with earlier factual certifications that were material to the original advisory opinion.

Under the program, the Requestor provides assistance with premiums and cost-sharing obligations for patients with two specific chronic diseases. Most of the …

CMS Unexpectedly Withdraws Three Proposed Rules

The Centers for Medicare and Medicaid Services (CMS) recently announced the withdrawal of three proposed rules that, in one case, had been pending since 2014. The first proposed rule that CMS decided to scrap was proposed in December of 2014 that would have ensured same-sex spouses were recognized and afforded equal rights as opposite-sex couples in Medicare and Medicaid participating facilities. The proposed rule was initiated to ensure that the Medicare conditions of participation and conditions of coverage were consistent with the U.S. Supreme Court decision in United States v.

CMS Proposes to Cancel EPM and CR Bundled Payment Programs and to Reduce Mandatory Participation in CJR Model

The Centers for Medicare and Medicaid Services (CMS) recently published a proposed rule (Proposed Rule) to scale back its mandatory bundled payment programs. Under the Proposed Rule, CMS would cancel the episode payment models (EPMs) and cardiac rehabilitation incentive payment model (CR), and it would also reduce the mandatory participation in the comprehensive care for joint replacement model (CJR). CMS stated that it believed the proposed changes are necessary because the continued mandatory participation in bundled payment models may impede CMS’s ability to engage providers in future, voluntary initiatives. CMS …

EHR Vendor Settles False Claims Act Suit for $155 Million

Electronic health record (EHR) vendor eClinicalWorks (eCW) recently entered into a settlement with the US Department of Justice (DOJ) and the Department of Health and Human Services’ Office of Inspector General (OIG) to resolve allegations under the federal False Claims Act (FCA) that eCW misrepresented its software and paid customers kickbacks to promote its products. The settlement imposes joint and several liability for payment on the EHR Vendor and three of its founders for $154.92 million, and liability for settlement payments individually by a developer ($50,000) and two project managers …

Federal Court Holds Online Medical Products Auction Contract Violates the AKS

The U.S. District Court for the District of Connecticut granted a motion for summary judgment in favor of Becton, Dickinson & Co. (BDC), a medical products provider, on the grounds that its contracts with MedPricer.com, Inc. (MedPricer), a company operating an online auction platform, violated the federal Anti-Kickback Statute (AKS), and were therefore unenforceable under Connecticut state law. MedPricer.com, Inc. v. Becton, Dickinson & Co., 2017 U.S. Dist. LEXIS 30854 (Memorandum opinion).

As described in the opinion, MedPricer enters into service agreements with hospitals and other health care providers to …

Massachusetts’ Health Policy Commission Further Limits Health Care Cost Growth

On March 29, 2017, the Massachusetts Health Policy Commission voted to decrease its annual health care cost growth benchmark from 3.6 percent to a 3.1 percent, effective in 2018. The benchmark applies to hospitals, certain physician groups and individual health insurers. The Commission also voted to finalize regulations to require those entities that fail to comply with the benchmark to file and follow performance improvement plans. Non-compliant entities will be subject to oversight by the Commission, during which they will be required to file monthly progress reports and demonstrate that …

OIG Applies The Access To Care Exception In Favorable Advisory Opinion For Hospital Meal And Lodging Assistance Program

The Office of the Inspector General (OIG) recently issued Advisory Opinion 17-01 to a health system (Requestor) for an arrangement to provide free and reduced-cost lodging and meals to financially disadvantaged patients (Proposed Arrangement). In issuing this positive opinion, the OIG applied the Access to Care exception to the prohibition on beneficiary inducements under the Civil Monetary Penalties (Beneficiary Inducement CMP).

One of the hospitals operated by the Requestor provides services to a rural and medically underserved patient population. Under the Proposed Arrangement, the Requestor would offer financially needy patients …

Massachusetts Issues Mass HIway Regulations

Massachusetts recently released a final regulation concerning its health information exchange, which became effective February 10, 2017. Under this regulation, Provider Organizations are required to connect to Massachusetts’ statewide health information exchange known as the Mass HIway. Provider Organizations include Massachusetts acute care hospitals, community health centers, and medical ambulatory practices. These regulations continue the push toward increased interoperability of patient medical records across health care providers, in an effort to improve the ability of a provider to see the full medical picture of a patient.

Provider Organizations must connect …

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