Reed Smith Client Alert: Analysis of HHS OIG Proposed Rule to Amend the Anti-Kickback Safe Harbors, CMP Rules on Beneficiary Inducements & Gainsharing Regulations

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.

The Client Alert is available here.

OIG and CMS Extend Fraud/Abuse Waivers for Medicare Shared Savings Program/ACOs; Invite Feedback on Waiver Policy

Today the OIG and CMS published a joint notice continuing the effectiveness of fraud and abuse law waivers granted in 2011 in connection with the Medicare Shared Savings Program, which is intended to encourage physicians, hospitals, and certain other types of providers and suppliers to form accountable care organizations (ACOs). 

By way of background, in a November 2, 2011 joint OIG-CMS interim final rule with comment period, the agencies established waivers of the application of the federal physician self-referral law, the federal anti-kickback statute, and certain civil monetary penalties law provisions to specified arrangements involving ACOs participating in the Shared Savings Program (the Waiver IFC).  In 2011 Reed Smith prepared an in-depth analysis of the Medicare Shared Savings Program, including an analysis of the Waiver IFC.  Because of a general 3-year deadline for publishing Medicare final rules after the publication of a proposed or interim final rule, the agencies are extending the timeline for publication of a final rule concerning Shared Savings Program waivers to avoid “creating legal uncertainty for ACOs participating in the Shared Savings Program and potentially disrupting ongoing business plans or operations of some ACOs.”  The notice also states that CMS is developing a proposed rule to make certain modifications to the Shared Savings Program regulations; in order to ensure that the final waiver regulations align with the Shared Savings Program rules, the agencies believe “the prudent course of action at this time is to extend the effectiveness of the Waiver IFC.”  Thus the Waiver IFC will remain in effect through November 2, 2015, unless a final waiver rule becomes effective on an earlier date.

 

In the notice, the agencies also suggest that they would benefit from additional stakeholder input to inform their understanding of:

  1. how and to what  extent ACOs are using the waivers;
  2. whether the existing waivers serve the needs of ACOs and the Medicare program;
  3. whether the  waivers adequately protect the Medicare program and beneficiaries from the types of harms associated with referral payments or payments to reduce or limit services; and
  4. whether there are new or changed  considerations that should inform the development of additional notice  and comment rulemaking.

No deadline is specified for providing feedback on these considerations. 

Proposed Revisions to Home Health Conditions of Participation

On October 9, 2014, CMS is publishing a proposed rule that would extensively revise the conditions of participation (CoPs) that home health agencies (HHAs) must meet to participate in the Medicare and Medicaid programs. The rule is intended to provide HHAs with enhanced flexibility while focusing provider efforts on the services delivered to the patient, the quality of care furnished by the HHA, and quality assessment and performance improvement efforts. According to CMS, the proposed CoPs “reflect a fundamental change in our regulatory approach -- a change that to a large extent establishes a shared commitment between CMS and HHA providers to achieve improvements in the quality of care furnished to HHA patients.” CMS expects its patient-centered, outcome-oriented approach to enhance the working relationship between state survey agencies and HHAs, and provide a basis for improved performance that will help ensure that quality care is provided to all patients.

More specifically, CMS proposes to establish the following four CoPs (in addition to retaining current requirements related to comprehensive assessment of patients):

  • “Patient rights” would emphasize the HHA's responsibility to respect and promote the rights of each home health patient.
  • “Care planning, coordination of services, and quality of care” would incorporate the interdisciplinary team approach to provide home health services focusing on the care planning, coordination of services, and quality of care processes.
  • “Quality assessment and performance improvement” (QAPI) would require each HHA to conduct ongoing quality assessment, incorporate data-driven goals, and maintain an evidence-based performance improvement program of its own design to affect continuing improvement in the quality of patient care.
  • “Infection prevention and control” would require HHAs to follow accepted standards of practice to prevent and control the transmission of infectious diseases and to educate staff, patients, and family members or other caregivers on these accepted standards.

CMS proposes to remove many process details from the current CoPs where they do not achieve the goal of ensuring desired outcomes. CMS is not proposing to incorporate by reference any specific clinical practice guidelines or professional standards of practice; HHAs would be responsible for identifying their own performance problems through their QAPI programs, addressing them, and continuously striving to improve the quality of care, patient outcomes and satisfaction, and efficiency/economy. The proposed CoPs also are designed to enable surveyors to look at outcomes of care and “how effectively the provider was pursuing a continuous quality improvement agenda.”  CMS will accept comments for 60 days after publication (December 8, 2014).

CMS Corrects Final FY 2015 Medicare IPPS/LTCH Rule

CMS has published corrections to its August 22, 2014 final update to the Medicare Hospital Inpatient Prospective Payment System (IPPS) and the Long-Term Care Hospital Prospective Payment System for FY 2015. Among other things, CMS made technical errors in its calculation of the operating and capital IPPS budget neutrality factors, outlier threshold, operating standardized amounts, capital federal rates, and impacts. CMS also made errors in determining the FY 2015 readmissions payment adjustment factors; CMS has revised the estimated savings under the Hospital Readmissions Reduction Program to $428 million, from $424 million in the final rule.

CMS Releases CY 2015 Amount in Controversy Thresholds for Medicare Appeals

CMS has published a notice announcing the annual adjustment in the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review under the Medicare appeals process. Specifically, the calendar year 2015 AIC threshold amounts are $150 for ALJ hearings and $1,460 for judicial review. These amounts are effective for requests for ALJ hearings and judicial review filed on or after January 1, 2015.

ONC Final Rule on EHR Certification Criteria

The Office of the National Coordinator for Health Information Technology (ONC) published a final rule on September 11, 2014 that is intended to introduce regulatory flexibilities with regard to certification to the 2014 Edition Electronic Health Records (EHR) Certification Criteria. The rule also codifies certain revisions to the ONC Health Information Technology (HIT) Certification Program for certification to the 2014 Edition and future editions, and it makes administrative updates to associated regulations. ONC specifies that EHR technology developers do not have to update and recertify their products to the revised 2014 Edition Release (also referred to as the “2014 Edition Release 2”), nor do eligible providers have to upgrade to EHR technology certified to the 2014 Edition Release 2, although ONC encourages such stakeholders “to consider whether the 2014 Edition Release 2 offers any opportunities that they might want to pursue.”

DEA Issues Final Rule on Safe, Secure Disposal of Controlled Substances

The Drug Enforcement Administration (DEA) has published a final rule to implement the Secure and Responsible Drug Disposal Act of 2010, which was intended to mitigate prescription drug abuse by providing safe and secure mechanisms for “ultimate users” to dispose of unused or unwanted pharmaceutical controlled substances. The regulations allow authorized manufacturers, distributors, reverse distributors, narcotic treatment programs, hospitals/clinics with an on-site pharmacy, and retail pharmacies to voluntarily administer mail-back programs and maintain collection receptacles. In addition, this rule expands the authority of authorized hospitals/clinics and retail pharmacies to voluntarily maintain collection receptacles at long-term care facilities. According to the DEA, it has expanded the entities that may be authorized collectors in response to public concerns regarding ultimate users’ ability to have convenient disposal options. The rule also establishes standards related to each element of the disposal process, including the transfer, delivery, collection, destruction, return, and recall of pharmaceutical controlled substances. Also in response to comments, the DEA has relaxed some of the proposed security requirements related to storage and destruction of controlled substances. The rule is effective October 9, 2014. 

OIG Releases Proposed Revisions to Anti-Kickback Safe Harbors, CMP Rules on Beneficiary Inducements & Gainsharing

The OIG has just released a major proposed rule to amend the safe harbors to the Anti-Kickback Statute (AKS) and the Civil Monetary Penalty (CMP) rule to protect certain payment practices and business arrangements from criminal prosecution or civil sanctions under the anti-kickback statute.  In particular, with regard to the AKS, the OIG proposes:

  • a technical correction to the existing safe harbor for referral services;
  • protection for certain cost-sharing waivers, including: pharmacy waivers of cost-sharing for financially needy Medicare Part D beneficiaries, and waivers of cost-sharing for emergency ambulance services furnished by state- or municipality-owned ambulance services;
  • protection for certain remuneration between Medicare Advantage organizations and federally qualified health centers;
  • protection for discounts by manufacturers on drugs furnished to beneficiaries under the Medicare Coverage Gap Discount Program; and
  • protection for free or discounted local transportation services that meet specified criteria.

The OIG also proposes to amend the definition of “remuneration” in the CMP regulations at 42 CFR 1003 by adding certain statutory exceptions for:

  • copayment reductions for certain hospital outpatient department services;
  • certain remuneration that poses a low risk of harm and promotes access to care;
  • coupons, rebates, or other retailer reward programs that meet specified requirements;
  • certain remuneration to financially needy individuals; and
  • copayment waivers for the first fill of generic drugs.

The OIG also proposes to codify the gainsharing CMP rule set forth in section 1128A(b) of the Social Security Act.  The official version will be published tomorrow; Reed Smith is preparing an analysis of this proposed rule.

HHS OIG Paints with Broad Brush in Criticizing Drug Manufacturer Coupon Programs

This post was written by Robert Hill, Carol Loepere, and Joseph Metro

In its September 19, 2014 Special Advisory Bulletin (SAB), the Office of Inspector General (OIG) of the Department of Health & Human Services (HHS) noted the potential risks to federal health care programs presented by pharmaceutical manufacturers’ coupon programs designed to reduce or eliminate patient copayment requirements for brand-name drugs, and emphasized that coupon program sponsors and pharmacies are at risk of sanctions if they fail to take appropriate steps to carve out federal health care program beneficiaries from using the coupons. The OIG points out these coupon programs – which may take different forms, such as print coupons, electronic coupons, debit cards, and direct reimbursements – are remuneration offered to consumers to induce the purchase of specific items, and therefore implicate the criminal federal anti-kickback statute, 42 U.S.C § 1320a-7b(b). Where remuneration is knowingly and willfully paid with the intent to induce or reward referrals of items or services payable by a federal health care program, the anti-kickback statute is violated. The OIG goes on to observe that a claim that includes items or services resulting from a kickback violation would also constitute a false or fraudulent claim under the False Claims Act, 31 U.S.C. § 3729, and grounds for civil money penalties for beneficiary inducement if offer or acceptance of copayment coupons may induce a beneficiary to use a particular practitioner or pharmacy, 42 U.S.C § 1320a-7a(a)(5). While the SAB’s focus is on manufacturer coupon practices, in a footnote, the OIG states that pharmacies accepting coupons for Part D copayments may also be subject to these sanctions.

Notwithstanding the potential benefits of coupon programs to provide access to brand-name drugs and adherence to drug regimens, the OIG claims that such coupon programs may interfere with federal health care program cost-sharing requirements to promote prudent prescribing and purchasing choices by physicians and patients based on the “true costs” of drug and price competition in the market. As a result, the OIG writes, “[w]hile copayment coupons provide an immediate financial benefit to beneficiaries, they ultimately can harm both Federal health care programs and their beneficiaries.”

In the SAB, the OIG acknowledges that the pharmaceutical industry is aware of the potential anti-kickback concerns and generally has implemented a variety of controls to exclude federal health care program beneficiaries from these programs. The OIG’s concern seems to be that these controls don’t go far enough or don’t always work. In other words, the OIG sees the glass as “half empty.” The OIG does not seem to acknowledge that the glass may actually be half-full – i.e., the industry's attempt to have some controls (even if imperfect) evidences manufacturers’ intent to comply with the statute, making it difficult to show criminal liability.

In fact, the OIG’s report, “Manufacturer Safeguards May Not Prevent Copayment Coupon Use for Part D Drugs” (OEI-05-12-00540) http://go.usa.gov/pdYQ, issued concurrently with the SAB, describes in detail mechanisms used by various manufacturers, most notably through claims processing and “switches,” to prevent use of the coupons for drugs paid for by Medicare Part D. The report identifies the principal shortcomings identified with these mechanisms as stemming from the fact that CMS does not permit manufacturers to submit Part D enrollment verification requests (“E1 transactions”) to the Part D Transaction Facilitator because of privacy concerns, so that manufacturers must use various “proxies” to attempt to determine whether the individual using the coupon is enrolled in a Part D plan. The report finds that these proxies, which may include elements as inexact as beneficiary age, may not be accurate enough to guarantee exclusion of Part D claims. Consequently, the OIG appears to be asserting that manufacturers may have liability for having imperfect controls, even though the current claims-processing system does not make a perfect solution available to them. The report did not identify any specific Part D claims for which coupons had in fact been used contrary to coupon terms and conditions.

The OIG recommends that CMS cooperate with industry stakeholders to improve the reliability of pharmacy claims edits, and make coupons transparent. CMS concurred with the recommendation.

OMB Clears OIG Proposed Rule on Anti-Kickback Safe Harbors, CMPs for Beneficiary Inducements & Gainsharing

The Office of Management and Budget (OMB) has cleared an HHS Office of Inspector General (OIG) proposed rule that would expand the OIG’s Medicare and state health care program fraud and abuse authorities. Specifically, on September 4, 2014, the OMB gave final regulatory clearance to an OIG proposed rule that would add new anti-kickback safe harbors to reflect statutory changes, codify the ACA’s definition of "remuneration," and add a gainsharing civil monetary penalty (CMP) regulation. The proposed rule should be published in the Federal Register in the near future.

CMS Final Rule Revises EHR Meaningful Use Timeline

The Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) have issued a final rule that gives providers additional options in how they use certified electronic health record (EHR) technology (CEHRT) to meet meaningful use requirements for the 2014 EHR Incentive Program reporting period. Under the final rule, eligible providers can use the 2011 Edition CEHRT or a combination of 2011 and 2014 Edition CEHRT for an EHR reporting period in 2014. All eligible professionals, eligible hospitals, and critical access hospitals will be required to use the 2014 Edition CEHRT in 2015. Among other things, the final rule also extends meaningful use Stage 2 through 2016 for certain providers (Stage 2 meaningful use criteria focus on exchange of clinically relevant information between providers and promote patients’ secure online access to their health information). The rule also provides that Stage 3 will begin in 2017 for providers who first became meaningful EHR users in 2011 or 2012 (under Stage 3, meaningful use will include demonstrating improvement in quality of health care). 

CMS Finalizes ACA Marketplace Eligibility Redetermination/Renewal Process for 2015

On September 5, 2014, CMS is publishing a final rule that specifies additional options for annual eligibility redeterminations and renewal and re-enrollment notice requirements for qualified health plans (QHP) offered through the ACA insurance Exchange/Marketplace, beginning with annual redeterminations for coverage for plan year 2015. The rule provides an auto-enrollment process intended to provide current Marketplace consumers with a simple way to keep their 2014 QHP, although CMS encourages consumers to reevaluate their plan options and financial assistance eligibility for 2015. The rule also gives state-based Marketplaces flexible options to implement annual redetermination procedures.

HHS Revises ACA Contraception Coverage Requirements

The Obama Administration has issued two regulations addressing coverage of contraceptive services under QHPs in response to recent court rulings (in particular the Supreme Court ruling in Burwell v. Hobby Lobby Stores, Inc.) addressing certain religious objections to such coverage. First, an interim final rule provides an additional pathway for nonprofit organizations eligible for a religious accommodation to provide notice of their religious objection to covering contraceptive services. These eligible organizations are permitted to notify the Department of Health and Human Services (HHS) in writing of their religious objection to providing contraception coverage. HHS and the Department of Labor will in turn notify insurers and third party administrators so the organization’s enrollees will receive separate coverage for contraceptive services, with no additional cost to the enrollee or the employer. The interim final rule is effective August 27, 2014; comments will be accepted until October 27, 2014.

The Administration also published a related proposed rule that would extend to certain “closely-held” for-profit entities (such as Hobby Lobby) the same accommodation that is available to non-profit religious organizations with religious objections to coverage of contraceptive services. Under the proposed rule, these companies would not be required to contract, arrange, pay or refer for contraceptive coverage to which they object on religious grounds. Payments for contraceptive services provided to participants and beneficiaries in the eligible organization's plan would be provided separately by an issuer or arranged separately by a third party administrator, consistent with existing regulations for certain religious employers. Comments on the proposed rule are due by October 21, 2014.

FDA Seeks Comments to Updated Guidance on Informed Consent in Clinical Trials

This post was written by Jennifer Pike and Vicki Morris.

Earlier this summer, the Food and Drug Administration (FDA) issued a draft 42-page "Informed Consent Information Sheet" that provides guidance for institutional review boards (IRBs), clinical investigators, and clinical trial sponsors on complying with the Agency’s informed consent regulations. Once finalized, the draft guidance will supersede FDA’s previous Information Sheet on this topic, "A Guide to Informed Consent," which was last updated over 15 years ago, in 1998.  The guidance, which is a compilation of FDA’s regulations and past guidances on informed consent, also reflects the Agency’s coordinated efforts with the Department of Health and Human Services (HHS) to facilitate consistency across informed consent requirements and policies among federal government agencies.

Broadly, the new guidance indicates FDA policy shifting towards enhanced informed consent processes. More narrowly, the draft guidance explains the various and often caveated elements of informed consent (including providing patients with a description of the trial, its risks, benefits, alternative treatments, confidentiality and compensation in the event of injury), depicts the detailed responsibilities of IRBs, clinical investigators and sponsors of clinical trials (including compliance with the process, elements and documentation of informed consent), and provides examples of recommended language to assist industry parties in complying with FDA’s informed consent regulations. FDA accomplishes this task by clarifying some aspects of existing guidance and creating additional guidance in new areas.

The following provides an overview of some of the draft guidance’s notable new and revised provisions.

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CMS Finalizes Medicare Hospice Payment Policies for FY 2015

On August 22, 2014, CMS will publish a final rule to update the Medicare hospice wage index for FY 2015 and make other payment and policy changes. CMS estimates that hospice payments will increase by 1.4% ($230 million) in FY 2015 compared to FY 2014 under the final rule. Specifically, CMS will update the hospice per diem rates by 2.1% (reflecting a 2.9% market basket increase that is reduced by 0.8 percentage points under ACA-mandated adjustments), but this update is partially offset by a 0.7 percentage point cut resulting from the use of updated wage data and CMS’s continued phase-out of its wage index budget neutrality adjustment factor. Hospices that fail to report quality data will have their market basket update reduced by 2 percentage points.

CMS is finalizing a number of policy proposals. For instance, the final rule requires hospices to file a beneficiary Notice of Election (NOE) within five calendar days after the effective date of hospice election (compared to three days in the proposed rule). If an NOE is not filed timely, the days from the effective date of election to the date of filing the NOE would be the financial responsibility of the hospice (unless there are exceptional circumstances). Likewise, CMS is requiring hospices to file a notice of termination/revocation within five (rather than the proposed three) calendar days of a beneficiary’s discharge or revocation, unless the hospice has already filed a final claim. The rule also, among other things: requires the hospice to identify the attending physician on the election form; revises the applicability of quality reporting penalties to new hospices; requires hospices to complete their hospice cap determinations within five months after the cap year but no sooner than 3 months after the cap period and remit any overpayments; and describes the development of the CAHPS® Hospice Survey.

CMS Issues FY 2015 Medicare SNF PPS Final Rule

This post was written by Susan Edwards.

The Centers for Medicare & Medicaid Services (CMS) published the final FY 2015 Medicare skilled nursing facility (SNF) prospective payment system (PPS) rule on August 5, 2014 (Final Rule). The Final Rule largely adopts the proposals set forth in the FY 2015 proposed SNF PPS rule (Proposed Rule). CMS estimates that the Final Rule will result in a $750 million increase in aggregate payments to SNFs during FY 2015 as compared to FY 2014. The Final Rule will implement a market basket update of 2%, resulting from a market basket increase of 2.5 percentage points, reduced by the Multifactor Productivity Adjustment of 0.5 percentage points, as required by the Affordable Care Act (ACA). Below we discuss highlights of the Final Rule, including: (1) the adopted wage index update; (2) revised change of therapy (COT) Other Medicare Required Assessment (OMRA) policy; (3) revisions to the Civil Money Penalties (CMP) regulations; and (4) CMS’s responses to comments regarding the agency’s observations on therapy trends.

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CMS Finalizes Medicare IPPS/LTCH PPS Update for FY 2015

On August 22, 2014, CMS is publishing a final rule to update the Medicare acute hospital inpatient prospective payment system (IPPS) and long-term care hospital (LTCH) prospective payment system (PPS) for fiscal year (FY) 2015, which begins October 1, 2014.  The following are highlights of the sweeping regulations.

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CMS Publishes Final FY 2015 Update to Medicare IRF PPS

On August 6, 2014, CMS published its final rule to update Medicare payment policies under the inpatient rehabilitation facility (IRF) PPS for FY 2015. Under the final rule, CMS expects aggregate Medicare payments to IRFs will increase by $180 million, or 2.4%, compared to 2014 levels. The standard payment conversion factor for discharges for FY 2015 is $15,198, up from $14,846 in FY 2014. The update to the conversion factor reflects a 2.9% market basket update, reduced by a -0.5% MFP adjustment and an additional -0.2 percentage point adjustment mandated by the ACA. CMS also is decreasing the outlier threshold amount for FY 2015 to $8,848 from $9,272 in FY 2014, which increases IRF PPS payments by about 0.2%. In addition, CMS adopted a freeze in the facility-level adjustment factors (e.g., adjustments for Low-Income Percentage, teaching status, and location in a rural area, if applicable) for FY 2015 and all subsequent years at FY 2014 levels while the effects of FY 2014 changes are evaluated.

In other policy areas, the final rule revises the list of impairment group codes that presumptively meet the “60 percent rule” compliance criteria; however, in response to public comments, CMS is delaying the effective date for these changes and revisions finalized in the FY 2014 IRF PPS final rule until compliance review periods beginning on or after October 1, 2015. In addition, the rule adds a therapy data item to the IRF patient assessment instrument. Beginning October 1, 2015, IRFs must record the total number of therapy minutes received and the type of therapy provided (i.e. individual, group, concurrent or co-treatment) during the first two weeks of an IRF stay. CMS also is revising the IRF Quality Reporting Program to update measures, add a reconsideration policy, and adopt a data accuracy validation policy. The final rule also discusses the transition from ICD-9-CM to ICD-10-CM for use on Medicare claims (although this transition has been put on hold temporarily as a result of the Protecting Access to Medicare Act of 2014).

IRS issues ACA Branded Prescription Drug Fee Regulations

The Internal Revenue Service has published final regulations that provide guidance on the annual fee imposed by the Affordable Care Act on covered entities engaged in the business of manufacturing or importing branded prescription drugs. The regulations describe the rules related to the fee, including how it is computed and how it is paid. The document also withdraws the Branded Prescription Drug Fee temporary regulations published August 18, 2011, and contains new temporary regulations regarding the definition of “controlled group” that apply beginning on January 1, 2015. The text of the temporary regulations also serves as the text of proposed regulations. Comments on the proposed regulations and requests for a public hearing must be received by October 27, 2014. Finally, the IRS also has issued Notice 2014-42, which provides additional guidance on the fee for 2015 and subsequent years.

CMS Issues Final Medicare Inpatient Psychiatric Facility PPS Rule for FY 2015

CMS has published a final rule that updates prospective payment rates for Medicare inpatient hospital services provided by inpatient psychiatric facilities (IPFs) for FY 2015. Under the final rule, the federal per diem base rate will be increased by 2.1%, reflecting a market basket increase of 2.9%, offset by a 0.3 percentage point reduction and a productivity adjustment reduction of 0.5 percentage points (both reductions were mandated by the ACA). CMS also anticipates that the final update to the outlier fixed-dollar loss threshold amount will provide an additional 0.4% boost in overall payments to IPFs. In light of all payment policies, CMS estimates that total payments to IPFs under the final rule will increase by $120 million (2.5%) compared to FY 2014 payments. The final rule also, among other things, establishes a new methodology for updating the cost of living adjustment (consistent with the inpatient hospital methodology), expands quality measures under the IPF Quality Reporting Program, adopts coding changes related to comorbidity categories and unspecified codes, and discusses CMS’s future plans to propose an IPF-specific market basket. The final rule was published August 6, 2014.

Older Entries

August 12, 2014 — HHS Officially Sets October 1, 2015 Date for ICD-10 Implementation

August 12, 2014 — CMS Again Extends Moratoria on Enrollment of HHAs, Ambulance Suppliers in Designated Areas

July 25, 2014 — CMS Issues Proposed CY 2015 Medicare OPPS/ASC Rule

July 25, 2014 — CMS Publishes Proposed MPFS Rule for 2015

July 25, 2014 — CMS Proposes ESRD PPS Update for CY 2015

July 25, 2014 — Proposed ACA Eligibility Redetermination/Renewal Process for 2015

July 23, 2014 — OIG Seeks Input on Potential Revisions to its Permissive Exclusion Criteria

July 23, 2014 — Proposed ACA Eligibility Redetermination/Renewal Process for 2015

July 7, 2014 — CMS Proposes Major Changes to Medicare DMEPOS Payment/Coverage Policy Inside/Outside of Competitive Bidding Areas

July 3, 2014 — CMS Proposes Changes to Sunshine Act "Open Payments" Regulations in 2015 Medicare Physician Fee Schedule Rule

July 1, 2014 — CMS Proposes 0.3% Cut in Medicare Home Health PPS Rates for CY 2015

June 27, 2014 — CMS Planning Changes to Medicare Shared Savings Program/Accountable Care Organization (ACO) Rules

June 24, 2014 — Medicare Payment Adjustments for Low-Volume Hospitals and Medicare-Dependent Hospitals

June 24, 2014 — HHS Issues Spring 2014 Semiannual Regulatory Agenda

June 24, 2014 — Obama Administration Finalizes Employment Orientation Limit Applicable to ACA Health Coverage Waiting Period

June 2, 2014 — CMS Finalizes Updates to Medicare Advantage/Part D Policies for 2015

June 2, 2014 — CMS Finalizes ACA Exchange, Insurance Market Standards for 2015 and Beyond

May 30, 2014 — CMS Formally Proposes Modified Electronic Health Record (EHR) Meaningful Use Timeline

May 22, 2014 — CMS Proposes Medicare Prior Authorization Process for DMEPOS Subject to "Unnecessary Utilization"

May 20, 2014 — OIG Proposed Rule Would Expand Civil Monetary Penalty Authority

May 16, 2014 — HHS OIG Proposes Expansion of Exclusion Authorities

May 16, 2014 — Another OIG Fraud Rule in the Pipeline: Anti-kickback Safe Harbors, CMPs for Beneficiary Inducements, Gainsharing

May 15, 2014 — CMS Adopts Final Rule to Reduce Provider Regulatory Burdens

May 15, 2014 — CMS Proposes Medicare Hospice Payment Policies for FY 2015

May 15, 2014 — CMS Proposes FY 2015 Update to Inpatient Psychiatric Facility PPS

May 15, 2014 — CMS Adopts PPS for Federally Qualified Health Centers (FQHCs), Amends CLIA Rules

May 15, 2014 — IRS Issues Final Rules on Affordable Insurance Exchange Reporting Requirements

May 14, 2014 — CMS Proposes FY 2015 Update to Medicare IRF PPS

May 14, 2014 — OIG Proposes Rules to Expand Exclusion, CMP Authorities

May 13, 2014 — CMS Invites Comments on Sunshine Act "Open Payments" Dispute Resolution/Corrections Process

May 13, 2014 — CMS Issues FY 2015 Medicare SNF PPS Proposed Rule

May 8, 2014 — Hundreds of Drugs and Biologics Face Labeling Changes under New FDA Plan

May 8, 2014 — CMS Streamlines Medicare Requirements for Imaging Services Performed in ASCs and Hospital Radiopharmaceutical Preparation

May 1, 2014 — CMS Releases Proposed Medicare Inpatient PPS/LTCH Update for FY 2015

April 28, 2014 — Proposed FY 2015 Medicare Payment Rules in the Pipeline

April 28, 2014 — CMS Proposes Updated Life Safety Code for Health Care Facilities

April 25, 2014 — Busy Week for FDA's Center for Devices and Radiological Health

April 8, 2014 — RACs Correct $2.4 Billion in Medicare Claims in FY 2012

April 8, 2014 — CMS Announces System to Collect Hospice Care Data Beginning July 1, 2014

April 2, 2014 — FDA Proposal Amends Medical Device Classification Rules

March 24, 2014 — Obama Administration Continues to Update ACA Insurance Exchange and Health Plan Regulations

March 20, 2014 — CMS Rule Increases FY 2014 Medicare Payments for Low-Volume Hospitals

March 19, 2014 — CMS Rule Requires Qualified Health Plans to Accept Certain Third-Party Premium Payments

March 4, 2014 — ONC Proposes Updated Electronic Health Record (EHR) Certification Criteria for 2015

March 4, 2014 — Preliminary FY 2014 DSH Allotments Announced

March 3, 2014 — CMS Takes First Steps to Cut Medicare DMEPOS Fees Based on Competitive Bidding Prices

March 3, 2014 — Obama Administration Issues ACA Health Coverage Waiting Period Regulations

February 27, 2014 — There are HOW many calories in that? FDA Seeks Comments on Proposal to Update Nutrition Facts Food Label

February 24, 2014 — FDA to Overhaul an OTC System That "Isn't Working"

February 24, 2014 — Coming to a TV Near You? FDA Seeks Public Input on Limiting Risks Presented in Direct-to-Consumer Television Ads

February 18, 2014 — CMS Extends and Expands Moratoria on Enrollment of Home Health Agency, Ambulance Suppliers in Designated Areas

February 17, 2014 — CMS Seeks New Participants for Bundled Payments for Care Improvement Initiative

February 17, 2014 — IRS Issues ACA Employer "Shared Responsibility" Guidance; Delays Compliance Deadlines for Certain Employers

February 17, 2014 — Final HIPAA Rule Gives Patients Right to Access Test Results Directly from Labs

February 11, 2014 — CMS Invites Proposals for Frontier Community Health Integration Demonstration

January 30, 2014 — CMS Finalizes Rule to Strengthen Home- and Community-Based Services (HCBS) Options

January 30, 2014 — HHS Publishes FY 2015 FMAP Amounts

January 29, 2014 — Reed Smith Client Alert: CMS/OIG Extend Protections for Electronic Health Record Donations

January 20, 2014 — FDA Seeks Comments on Drug Company Social Media Guidance

January 8, 2014 — CMS Proposes Updates to Medicare Advantage/Part D Policies for 2015

January 7, 2014 — CMS Proposes Emergency Preparedness Requirements for Medicare/Medicaid Providers

January 7, 2014 — CMS, FDA Extend Pilot Program for Parallel Review of Medical Products

January 7, 2014 — OIG Seeks Anti-Kickback Safe Harbor, Fraud-Alert Topic Proposals

January 7, 2014 — HHS Proposes HIPAA Amendments Addressing Gun Background Checks

January 7, 2014 — CMS Proposes 2015 Funding Methodology for ACA Basic Health Program

January 7, 2014 — CMS Issues Formally Updates 2014 Health Exchange Enrollment Deadlines

January 7, 2014 — FDA Releases Final Guidance on Qualification Process for Drug Development Tools

January 6, 2014 — HHS Proposed Rule on Health Plan Certification of Compliance Requirements

January 6, 2014 — CMS Seeks Comments on MSP CMP Policies, Appeals Process

December 27, 2013 — Final Rules Issued Extending Protections of Electronic Health Record Donations

December 10, 2013 — CMS Issues Final Medicare OPPS, ASC Policies for 2014

December 10, 2013 — CMS Updates Medicare Physician Fee Schedule, Other Part B Policies for CY 2014

December 10, 2013 — CMS Finalizes 2014 ESRD PPS Rates; Phases in ESRD Drug Utilization Cut

December 10, 2013 — CMS Proposed Rule on ACA Benefit and Payment Parameters for 2015

December 10, 2013 — CMS Boosts Provider Enrollment Fee for 2014

December 3, 2013 — CMS Adopts Changes to Medicare Payment, Coverage Rules for DMEPOS

November 25, 2013 — Medicare Home Health PPS Rates Cut 1.05% Under Final 2014 Rule

November 25, 2013 — CMS Seeks Input on Quality Ratings for ACA Exchange Plans

November 14, 2013 — CMS Invites Nominees for Members of Advisory Panel on Hospital Outpatient Payment

November 14, 2013 — HHS Corrects March 2013 ACA Benefit, Payment Parameter Rules

November 13, 2013 — Obama Administration Publishes Final Mental Health/Substance Abuse Parity Rule

October 30, 2013 — CMS Finalizes ACA Exchange Program Integrity & Financial Oversight Standards

October 30, 2013 — CMS Releases Medicare Deductible, Coinsurance Amounts for 2014

October 30, 2013 — Nominees Invited for PCORI Physician Representative

October 30, 2013 — CMS Warns of Delay in Final CY 2014 Medicare Rules

October 29, 2013 — CMS Finalizes Medicare Conditions of Participation for Community Mental Health Centers

October 10, 2013 — HHS Proposes ACA Basic Health Program Regulations

October 10, 2013 — CMS Final Rule Refines FY 2014 DSH Payment Calculations

October 10, 2013 — CMS Proposes Rules for Medicare FQHC PPS, CLIA Amendments

October 9, 2013 — CMS Announces 2014 Amounts in Controversy Threshold Amounts for Medicare Appeals

October 9, 2013 — CMS Corrects FY 2014 Medicare Payment Rules

September 17, 2013 — HHS Seeks Comments on Draft National Action Plan for Adverse Drug Event Prevention

September 17, 2013 — OIG Call for Medicare Part B Drug Rebates Rejected by CMS

September 17, 2013 — CMS Finalizes ACA Exchange/Qualified Health Plan Financial Integrity and Oversight Standards

September 17, 2013 — IRS Finalizes ACA Individual "Shared Responsibility" Payment Requirements

September 16, 2013 — CMS Releases ACA Medicaid DSH Funding Final Rule

September 16, 2013 — HHS Invites Suggestions for Streamlining Regulations

September 16, 2013 — OIG Report Examines Critical Access Hospital Qualifications

September 16, 2013 — HHS Draft Strategic Plan Outlines Department Goals

September 16, 2013 — OIG Focuses on Improper Medicare Diabetes Test Strip Payments