In the recently published proposed rule related to the CY 2018 Hospital Outpatient Prospective Payment System (OPPS), the Centers for Medicare & Medicaid Services (CMS) announced that it is considering changes to the regulation governing the date of service (DOS) for clinical laboratory and pathology specimens.  The DOS rules are important to laboratories and hospitals because they dictate which party must bill Medicare for certain laboratory testing performed on stored specimens collected during a hospital procedure but ordered after the patient has left the hospital.  If revisions are ultimately finalized, the proposal could have significant business implications for independent laboratories and hospitals.

Continue Reading CMS May Decide to Permit Labs to Bill for Certain Tests Provided to Outpatients

As reported in our 2015 Laboratory Industry Year in Review post, the laboratory industry began 2016 amid confusion regarding how to comply with the Protecting Access to Medicare Act of 2014 (PAMA), which made the most significant changes to the Medicare Part B payment structure for laboratories since implementation of the Medicare Clinical Laboratory Fee Schedule (MCLFS) in 1984.  Despite PAMA’s requirement that the Centers for Medicare & Medicaid Services (CMS) publish final regulations no later than June 30, 2015, CMS did not issue a proposed rule until October 1st and has yet to follow up with the final rule.  Given stakeholders’ substantial concerns regarding the proposed rule – and the track record of CMS – the delay is not surprising. Continue Reading Delay in Final Rule Implementing PAMA: Sunshine Act Revisited?

Those wishing to comment on revisions to the Federal Policy for Protection of Human Subjects (known as the “Common Rule”) could add a 30-day comment period extension to the things they were grateful for at this year’s Thanksgiving dinner. On Wednesday, November 25th, the 16 federal agencies involved in updating the Common Rule announced an extension of the comment period for the September 8, 2015, notice of proposed rulemaking (“NPRM”). The agencies granted the 30-day extension based on requests for additional time to fully review the NRPM and provide comments.

As we’ve previously reported, the NPRM makes some significant changes to the Common Rule. The changes include:

• expanding the scope of the applicability of the Rule to cover all clinical trials conducted at U.S. institutions that receive federal funding for non-exempt human subjects research (even if the research itself is not federally funded);
• updating the IRB review process to a more risk-based framework;
• creating new exemptions from the Common Rule for certain types of research; and
• improving and streamlining the informed consent process.

The Department of Health & Human Services has provided a succinct summary the changes and the Office of Human Subject Research Projections has created a six-part webinar series available on YouTube with more detail about the changes (links to all webinars are available here).

Persons interested in commenting on the NPRM must now submit comments by January 6, 2016.

The U.S. Department of Health and Human Services (“HHS”) and fifteen other Federal Departments and Agencies have announced a proposal to update the Federal Policy for the Protection of Human Subjects known as the “Common Rule,” originally promulgated in 1991.   A Notice of Proposed Rulemaking (“NPRM”), published on September 2, 2015, seeks comments on the proposal, which includes some dramatic changes for researchers. Continue Reading Drastic Changes Proposed for Clinical Research Rules

On December 8th, the Centers for Medicare & Medicaid Services published its proposal for long-awaited changes to the Medicare Shared Savings Program (MSSP).  Our colleagues Daria Niewenhous, Andrew Shin, Lauren Moldawer *, and Stephanie Willis have authored an Advisory that provides an in-depth analysis of key provisions of the proposed changes and how they may impact current and future MSSP accountable care organizations created under the authority of the Affordable Care Act.

The Advisory is a prelude to upcoming blog posts and publications on the proposed rule and evolving stakeholder reactions to its potential effects.

* Lauren Moldawer is a law clerk, acting under the guidance and supervision of Members of the D.C. office.

Last Friday, the HHS Office of the Inspector General issued a highly anticipated proposed rule that provides new and modified regulatory safe harbors to the Anti-Kickback Statute, amends regulatory provisions related to enforcement of the Beneficiary Inducement Civil Monetary Penalty Law (CMP) provisions, and attempts to narrow the prohibitions covered by the Gainsharing CMP.   The proposed rule affects a wide range of increasingly common health care business arrangements, including referral services, cost-sharing waivers (including under Medicare Part D), free transportation services, coupons, rebates, and retailer reward programs.

A Health Care Alert authored by my colleagues Theresa Carnegie, Thomas Crane, Carrie Roll, and Stephanie Willis provides an in-depth summary and analysis of the OIG’s proposals and notes areas ripe for stakeholder input.  Comments to the Proposed Rule are due December 2, 2014.

Written by: Kate Stewart

Drug and device manufacturers breathing a sigh of relief after completing their 2013 data submissions under the Physician Payment Sunshine Act (the “Sunshine Act’) must now contend with four proposed changes to the Sunshine Act regulations.  On July 3, 2014 the Centers for Medicare & Medicaid Services (“CMS”) released its proposed rule on the 2015 Medicare Physician Fee Schedule (the “Proposed Rule”).  The Proposed Rule includes four proposed changes to the Sunshine Act’s reporting requirements based on feedback and experience from the first annual reporting period (covering August 1, 2013 to December 31, 2013).  If finalized, these four proposed changes would become effective on January 1, 2015 and would not apply to 2014 reports.

Continue Reading CMS Proposes Changes to Sunshine Act Reporting

Written by Kate Stewart

Last week, the IRS issued a Notice of Proposed Rulemaking (“2013 Proposed Rule”) regarding the community health needs assessment (“CHNA”) requirement of 26 U.S.C. § 501(r)(3) (added to the Internal Revenue Code by the Affordable Care Act).  Section 501(r) imposes new requirements on hospitals that are exempt from taxation under Section 501(c)(3).  In addition to the requirements applicable to all 501(c)(3) organizations, nonprofit hospitals must: (1) establish a financial assistance policy, (2) limit charges for patients eligible under the financial assistance policy, (3) follow new billing and collections guidelines, and (4) conduct a CHNA.   

As with many other aspects of the Affordable Care Act, the implementation of Section 501(r) has been a lengthy process.  The IRS previously issued twoTreasury Notices addressing the CHNA requirement and also issued a Notice of Proposed Rulemaking on other portions of 501(r) in June 2012 (the “2012 Proposed Rule”).  The IRS intends to finalize all of the regulations under 501(r) simultaneously.  The 2013 Proposed Rule provides much-needed guidance on the CHNA, addresses penalties for non-compliance, and updates some definitions relevant to all of the requirements under Section 501(r).  Continue Reading IRS Provides Additional Guidance for Non-Profit Hospitals

Written by Joshua Booth

Last week, federal regulators released a Proposed Rule outlining accommodations for religious employers that object to the Affordable Care Act’s contraception coverage mandate.  The Proposed Rule expands the range of employers that qualify for the existing religious exemption and outlines promised accommodations for other religious employers.

Continue Reading Obama Administration Outlines Religious Accommodations for Contraception Coverage Mandate

Written by Julie Lappas and Karen Lovitch

Yesterday the Centers for Medicare & Medicaid Services (CMS) filed a proposed rule (the Proposed Rule) that would make significant changes to existing regulations governing the proficiency testing (PT) process mandated by the Clinical Laboratory Improvement Amendments of 1988 (CLIA).  Under current regulations, any laboratory that intentionally refers a PT sample to another laboratory for analysis will automatically lose its CLIA certificate for at least one year.  CMS has always interpreted the term “intentional” very broadly to mean an intention to act and thus has not considered the circumstances surrounding the referral of a PT sample when imposing revocation.  Even so, CMS recognizes in the Proposed Rule that revocation of the laboratory’s CLIA certificate in cases of certain PT referrals involving “reflex” or “confirmatory” testing may have adverse effects on patients and has therefore proposed an exception.  Described by CMS as “an infrequent and narrowly crafted carve-out from the long-standing interpretation of ‘intentional,’” the exception would apply only to a laboratory that refers a PT sample to another laboratory for “reflex” or “confirmatory” testing in accordance with the laboratory’s standard operating procedures for patient testing.  As long as the PT referral is not a repeat referral (i.e., no other PT referral occurred during the two survey cycles prior to the time of the PT referral at issue), CMS would consider the referral to be “improper” rather than “intentional” and would impose alternative sanctions, rather than revoke a laboratory’s CLIA certificate.

Continue Reading CMS Publishes Proposed Changes to CLIA’s Proficiency Testing Regulations