October 2014

The OIG published a notice today announcing that it is extending the public comment period on its July 11, 2014 notice soliciting recommendations for revising OIG’s non-binding criteria for implementing its permissive exclusion authority under Section 1128(b)(7) of the Social Security Act.  The OIG notes that due to a technical problem, the public may have been unable to

The Reed Smith Health Industry Washington Watch blog (https://www.healthindustrywashingtonwatch.com) has been updated to report on recent health policy developments, including the following:

— Regulatory Developments. The OIG and CMS have extended fraud and abuse waivers in connection with the Medicare Shared Savings Program. CMS also published a rule on the ACA Basic Health Program, and CMS is expected to publish several major final 2015 Medicare payment rules in the coming days. Recent CMS notices have addressed clinical diagnostic lab tests and Medicare deductible and coinsurance amounts for 2015. The HHS Office for Human Research Protections issued guidance on disclosing risks in standards of care research, and the Office of the National Coordinator for Health Information Technology is inviting applications for a “Market R&D Pilot Challenge. Reed Smith has released a client alert on the “OIG Proposed Rule to Amend the Anti-Kickback Safe Harbors, CMP Rules on Beneficiary Inducements & Gainsharing Regulations.” For details, see https://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/.

— Other HHS Developments. CMS has posted preliminary determinations for new 2015 clinical laboratory fee schedule codes. CMS also has announced new innovation initiatives, including the Transforming Clinical Practice Initiative and the Accountable Care Organization Investment Model. CMS has released Medicare Advantage/Part D drug plan quality data, and it is requesting suggestions for future physician quality measures. CMS also has issued updates regarding the Sunshine Act “Open Payments” system and its Medicare appeals administrative agreement opportunity. For more information, see https://www.healthindustrywashingtonwatch.com/articles/other-cms-developments-1/. CDC has released several guidance documents on management of Ebola patients (https://www.healthindustrywashingtonwatch.com/articles/other-hhs-developments/). The OIG has issued a report on Medicare beneficiary copayment costs for outpatient services provided at critical access hospitals (https://www.healthindustrywashingtonwatch.com/articles/other-oig-developments/).

— Health Industry Events. CMS is hosting calls on inpatient rehabilitation facility quality reporting and transitioning to ICD-10. The HHS Office of Medicare Hearings and Appeals is holding a second Medicare Appellant Forum. Congressional panels are reviewing the government response to the Ebola outbreak. See https://www.healthindustrywashingtonwatch.com/articles/events/.

— @ReedSmithHealth is on Twitter. For the latest health policy news, follow us at @ReedSmithHealth.
For details on these and other health industry developments, please visit https://www.healthindustrywashingtonwatch.com/.
Continue Reading New Postings on the Reed Smith Health Industry Washington Watch Blog

CMS is expected to publish several major final Medicare payment rules for 2015 in the coming days. The agency has already submitted to the White House Office of Management and Budget (OMB) for regulatory clearance the final 2015 rules updating Medicare payments for outpatient hospitals, ambulatory surgical centers, home health agencies, and end-stage renal disease

On October 27, 2014, CMS published a notice announcing that it is establishing an Advisory Panel on Clinical Diagnostic Laboratory Tests, as authorized by the Protecting Access to Medicare Act of 2014 (PAMA). The Panel will provide recommendations to CMS on the following issues:

  • Calculation of weighted median for laboratory services using private payor

On October 23, 2014, CMS published the proposed methodology for determining federal payment amounts for states that elect to use the Basic Health Program to offer health benefits to low-income individuals otherwise eligible to purchase coverage through an Affordable Insurance Exchange/Marketplace for 2016. CMS proposes to use the same methodology in 2016 as was established

CMS has released the Medicare Part A inpatient hospital deductible and hospital and extended care services coinsurance amounts for 2015. Specifically, the 2015 Part A deductible for hospital inpatient admissions for the first 60 days of care will be $1,260, followed by $315 per day for days 61-90 and $630 per day for stays beyond

On October 24, 2014, the HHS Office for Human Research Protections published a notice announcing that it is seeking comments on draft guidance for the research community entitled “Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care.” The guidance addresses risks to subjects that are presented by research evaluating risks

The Office of the National Coordinator for Health Information Technology (ONC) is launching the “Market R&D Pilot Challenge,” which will bring together health care organizations and innovative companies to test new health information technology products through pilot funding awards and facilitated matchmaking. Pilot proposals could be awarded in three domains: clinical environments (e.g.

CMS has announced its newest innovative delivery reform program, called the “Transforming Clinical Practice Initiative,” which will provide up to $840 million over four years to help clinicians share, adapt, and develop quality improvement strategies. CMS intends to make awards for the following two types of systems:

  • Practice Transformation Networks are peer-based learning networks

CMS has announced a new Accountable Care Organization “Investment Model” that was developed in response to concerns that some providers lack adequate access to the capital needed to invest in infrastructure necessary to successfully implement population care management. CMS will provide as much as $114 million in upfront investments to up to 75 ACOs across

CMS is inviting quality measure suggestions for potential use in the Physician Quality Reporting System (PQRS) and other physician quality programs. Measure suggestions will be accepted on an ongoing basis, with measures submitted prior to June 15, 2015 eligible to be considered for inclusion in the PQRS as early as 2017.

As previously reported, CMS is offering an “administrative agreement” providing partial payment to hospitals that drop their appeals related to certain short-stay hospital claims in an effort to reduce the backlog in Medicare appeals. CMS has posted updated “frequently asked questions” on its proposed settlement process. The deadline for applying for the settlement is

The OIG has issued a report on Medicare beneficiary copayment costs for outpatient services provided at critical access hospitals (CAH). Beneficiaries who receive services at CAHs pay Medicare coinsurance amounts based on CAH charges, in contrast to patients at acute care hospitals who are responsible for coinsurance amounts based on outpatient prospective payment system (OPPS)

On November 6, 2014, the Senate Appropriations Committee is holding a hearing on the U.S. government response to the Ebola outbreak. This follows an October 24 House Oversight Committee hearing on coordination of a multi-agency response to the Ebola crisis, along with an October 16 House Energy and Commerce Committee hearing on the U.S. public

CMS is hosting a conference call for inpatient rehabilitation facility (IRF) providers regarding the IRF Quality Reporting Program on October 29, 2014. Specifically, CMS will discuss data collection and submission information for outcome measures related to hospital-onset methicillin-resistant Staphylococcus aureus (MRSA) bacteremia and Clostridium difficile infection (CDI), which IRF providers are required to report to

CMS has released a beta version of its Open Payments search tool, which is intended to facilitate public review of payments and transfers of value made by drug and device manufacturers and group purchasing organization (GPOs) to physicians and teaching hospitals, as well as physician ownership information.  The tool allows the public to search

On October 29, 2014, the OMHA is hosting its second OMHA Medicare Appellant Forum. The meeting will update OMHA appellants on the status of OMHA operations and discuss OMHA and CMS initiatives designed to mitigate the Medicare appeals backlog at the OMHA-level of the administrative appeals process. The deadline for in-person registration is October 28,

The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) has published a major proposed rule that would amend the safe harbors to the Anti-Kickback Statute (AKS) and the Civil Monetary Penalty rules to protect certain payment practices and business arrangements from criminal prosecution or civil sanctions under the AKS. Reed Smith has prepared a Client Alert analyzing the proposed rule, highlighting areas where the OIG is seeking public comment. Overall, the OIG appears to recognize that new health care delivery mechanisms demand a more flexible approach to fraud and abuse enforcement than has been the case in the past, as discussed in our analysis.
Continue Reading Reed Smith Client Alert: Analysis of HHS OIG Proposed Rule to Amend the Anti-Kickback Safe Harbors, CMP Rules on Beneficiary Inducements & Gainsharing Regulations