The Centers for Medicare & Medicaid Services (CMS) has finalized its Affordable Care Act (ACA) Marketplace health plan payment parameters and essential benefit standards for 2016. The rule addresses numerous policies, including: allocation of risk corridors collections for 2016; recalibration of risk adjustment factors; revisions to reinsurance and cost sharing parameters; user fees for federally-facilitated exchanges; standards for qualified health plans, including quality improvement strategy and provider directory requirements; Small Business Health Options Program requirements; conditions that trigger rate review; clarification that coverage satisfying the minimum value requirement must include substantial coverage of inpatient hospital and physician services; medical loss ratio program revisions; new policies and procedures for enrollee requests for prescription drugs not included on a plan’s formulary; and establishment of the 2016 annual open enrollment period as November 1, 2015 through January 31, 2016. The final rule will be published on February 27, 2015. A related CMS fact sheet is available here.
CMS has published a final rule revising Medicare Advantage (MA) and Part D prescription drug benefit regulations for CY 2016. Among other things, the final rule:
- Implements a statutory provision requiring MA and Part D contracts to provide the right to “timely”’ inspection and audit and allowing CMS to require MA organizations or Part D prescription drug plan (PDP) sponsors to hire an independent auditor to validate correction of CMS audit findings.
- Establishes U.S. citizenship and lawful presence as an eligibility requirement for enrollment in MA and Part D plans (effective June 1, 2015).
- Makes several policy changes intended to promote efficient dispensing of drugs in long-term care (LTC) facilities, including prohibiting payment arrangements that penalize the adoption of more efficient LTC dispensing techniques by prorating dispensing fees based on days’ supply or quantity dispensed, and requiring that any difference in payment methodology among LTC pharmacies incentivizes more efficient dispensing techniques.
- Requires MA Prescription Drug (MA-PD) plans to establish and maintain a process with network pharmacies to ensure timely and accurate point-of-sale transactions and coordinate Part A, Part B, and Part D drug benefits administered by the MA PD plan.
- Requires a sponsor’s Pharmacy & Therapeutics committee to document its process for an objective party to determine whether disclosed financial interests are conflicts of interest and management of any recusals due to conflicts.
Other provisions of the rule address, among other things, business continuity for MA organizations and PDP sponsors; codification of recent quality improvement program policies; and notification requirements related to changes to Part D plans. CMS is not finalizing a number of proposals included in the January 2014 proposed rule, including provisions that would have: lifted the protected class designation on three drug classes; required Medicare Part D sponsors to include in preferred networks any pharmacy willing to accept the sponsor’s terms and conditions; reduced the number of Part D plans a sponsor may offer; and codified CMS interpretation of the Part D non-interference clause.
On February 24, 2015, CMS published its final methodology and data sources 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 is using the same methodology in 2016 as was established in the final 2015 payment notice, with updated values for several factors.
Today CMS published a notice correcting its November 10, 2014 final rule updating the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Ambulatory Surgical Center (ASC) Payment System rates and policies for calendar year 2015. In addition to fixing various technical errors (e.g., status indicator and addenda corrections for specific codes), the notice increases the OPPS conversion factor from $74.144 to $74.173, which will slightly increase payment rates for most ambulatory payment classifications. On the other hand, CMS is reducing the 2015 ASC conversion factor slightly, from $44.071 to $44.058.
CMS warns requirement to report/return overpayments is in effect even without regulations
The Centers for Medicare & Medicaid Services (CMS) needs more time to finalize its February 16, 2012 proposed rule on reporting and returning of Medicare overpayments, according to a CMS notice to be published on February 17, 2015. The 2012 rule would provide details on implementation of an Affordable Care Act (ACA) provision requiring enrolled providers and suppliers (and certain other enrollees) receiving Medicare funds to report and return Medicare overpayments by the later of 60 days after the date on which the overpayment was identified or, if applicable, the date any corresponding cost report is due. Although the requirement to refund an overpayment already exists in federal law, the proposed rule would clarify what constitutes “identification” of an overpayment, the mechanics of when and how an overpayment must be returned, and the period of time subject to repayment. CMS had received a large number of comments from providers and suppliers and their industry associations that the proposed rule’s refund reporting policies and procedures would impose significant administrative burdens.
The Social Security Act requires public notice if an agency will take more than three years to finalize a proposed rule. CMS states that “the complexity of the rule and scope of comments warrants the extension of the timeline for publication” for an additional year (until February 16, 2016). Specifically, CMS has “determined that there are significant policy and operational issues that need to be resolved in order to address all of the issues raised by comments to the proposed rule and to ensure appropriate coordination with other government agencies.” The agency warns stakeholders, however, that “even without a final regulation they are subject to the statutory requirements found in section 1128J(d) of the Act and could face potential False Claims Act liability, Civil Monetary Penalties Law liability, and exclusion from Federal health care programs for failure to report and return an overpayment.”
CMS has announced that it plans to issue regulations this spring to address provider concerns about the burden associated with compliance with Medicare and Medicaid Electronic Health Record (EHR) Incentive Program meaningful use requirements. Specifically, in a January 29, 2015 blog post by Patrick Conway, MD, Deputy Administrator for Innovation and Quality and CMS Chief Medical Officer, CMS announced that upcoming regulations would:
- Realign hospital EHR reporting periods to the calendar year facilitate hospitals incorporation of 2014 Edition software into their workflows and better align with other CMS quality programs;
- Modify other aspects of the program to reduce complexity and lessen providers’ reporting burdens; and
- Reduce the EHR reporting period in 2015 to 90 days to accommodate these changes.
These changes are separate from another rulemaking expected to be released next month that would address the Stage 3 meaningful use criteria for 2017 and subsequent years.
CMS Announces New 6-Month Extension of Moratoria on Enrollment of HHAs, Ambulance Suppliers in Designated Areas
CMS is extending -- for another 6 months -- its current enrollment moratoria for new ground ambulance suppliers and home health agencies (HHAs) in designated metropolitan areas. The moratoria, which affect enrollment in Medicare, Medicaid, and the Children’s Health Insurance Program, apply to new ground ambulances in the Houston and Philadelphia metropolitan areas and new HHAs in the metropolitan areas of Fort Lauderdale, Miami, Chicago, Detroit, Dallas, and Houston. CMS discusses its rationale for extending the enrollment moratoria, including the factors suggesting a high risk of fraud, waste, or abuse, in a notice to be published on February 2, 2015. The extension is effective January 29, 2015. CMS may lift the moratoria before the end of the 6-month period or announce additional extensions.
On December 8, 2014, CMS published a proposed rule that would revise the regulations governing 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) to provide cost-effective, coordinated care to Medicare beneficiaries. The Shared Savings Program now includes more than 330 ACOs in 47 states and serves more than 4.9 million Medicare fee for service (FFS) beneficiaries.Continue Reading...
On December 12, 2014, CMS published a proposed rule to revise selected conditions of participation (CoPs) for providers, conditions for coverage (CfCs) for suppliers, and requirements for long-term care (LTC) facilities to conform with the Supreme Court decision in United States v. Windsor, and ensure that same-sex spouses in legally-valid marriages are recognized and afforded equal rights in Medicare and Medicaid participating facilities. The proposed rule addresses nine specific provisions located in the CoPs and CfCs for ambulatory surgical centers, hospices, hospitals, LTC facilities, and community and mental health centers that CMS believes could be interpreted to support the denial of federal rights and privileges to a same-sex spouse if the state of residence does not recognize same-sex marriages. CMS states that its “goal is to provide equal treatment to spouses, regardless of their sex, whenever the marriage was valid in the jurisdiction in which it was entered into, without regard to whether the marriage is also recognized in the state of residence or the jurisdiction in which the health care provider or supplier is located, and where the Medicare program explicitly or impliedly provides for specific treatment of spouses.” Comments on the proposed rule will be accepted until February 10, 2015.
CMS has issued a proposed rule that would establish ACA Marketplace health plan payment parameters and essential benefit standards for 2016. Specifically, the wide-ranging proposed rule addresses, among other things: the risk adjustment, reinsurance, and risk corridors programs; cost sharing parameters; user fees for federally-facilitated exchanges; standards for qualified health plans, including network adequacy and quality improvement; the Small Business Health Options Program; guaranteed availability and renewability, rate review; the medical loss ratio program; and minimum essential health benefits (including new policies and procedures for enrollee requests for prescription drugs not included on a plan’s formulary). CMS will accept comments on the proposed rule until December 22, 2014.
CMS Finalizes Rule to Strengthen Medicare Provider Enrollment Regulations and Permit Revocations for Patterns/Practices of Improper Claims Submissions; Defers Expanded Awards for Medicare Fraud Tipsters
On December 5, 2014, the Centers for Medicare & Medicaid Services (CMS) published a final rule that expands the circumstances under which it may deny or revoke the Medicare enrollment of entities and individuals on program integrity grounds, effective February 3, 2015.Continue Reading...
CMS has announced that it is delaying a provision of its 2015 Medicare Advantage/Medicare Part D final rule, published on May 23, 2014, that requires physicians and other eligible professionals who prescribe Part D drugs to be enrolled in Medicare (or have a valid opt-out affidavit on file) for their prescriptions to be covered under Medicare Part D. While the final rule stated that the effective date for this requirement would be June 1, 2015, CMS has announced that it is delaying enforcement of this provision until December 1, 2015. CMS notes that Part D drug prescribers must submit their Medicare enrollment applications or opt-out affidavits to their Medicare Administrative Contractors by June 1, 2015 to provide sufficient processing time and prevent prescription drug claims from being denied beginning December 1, 2015.
Today CMS published a notice announcing that the CY 2015 provider enrollment application fee is $553, up from $542 in 2014. This application fee is required for institutional providers that are initially enrolling or revalidating enrollment in the Medicare or Medicaid program or the Children's Health Insurance Program (CHIP) or adding a new Medicare practice location on or after January 1, 2015 and on or before December 31, 2015. Note that CMS uses a broad definition of institutional entities subject to the application fee; it applies to “[a]ny provider or supplier that submits a paper Medicare enrollment application using the CMS-855A, CMS-855B (not including physician and non-physician practitioner organizations), CMS-855S, or associated Internet-based PECOS enrollment application,” along with additional categories of Medicaid-only and CHIP-only institutional providers.
On December 3, 2014, CMS published a final rule that defines “uninsured” for purposes of calculating the Medicaid hospital-specific disproportionate share hospital (DSH) payment limit. Under the Social Security Act, DSH payments to a hospital cannot exceed the uncompensated costs of furnishing hospital services by the hospital to individuals who are Medicaid-eligible or “have no health insurance (or other source of third party coverage) for the services furnished during the year.” The final rule provides this test will be applied on a service-specific basis; that is, the calculation of uncompensated care for purposes of the hospital-specific DSH limit will include the cost of each service furnished to an individual by that hospital for which the individual had no health insurance or other source of third party coverage. Although the final rule’s definition of uninsured may affect the calculation of the hospital-specific DSH limit, the rule does not modify the DSH allotment amounts and will have no effect on a state’s ability to claim federal financial participation (FFP) for DSH payments made up to the published DSH allotment amounts. The final rule also provides additional clarification to states and hospitals regarding costs eligible for inclusion in the calculation of the hospital-specific DSH limit. The rule is effective on December 31, 2014.
On December 2, 2014, CMS published a correction to its November 6, 2014 final 2015 Medicare home health prospective payment system (PPS) rule to correct a technical error related to the applicability date for a therapy reassessment provision. Separately, on November 24, 2014, CMS published a notice making technical amendments to durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) supplier surety bond requirements under 42 CFR 424.57. According to the preamble, the notice corrects non-substantive regulatory paragraph designations, an omission, and a technical correction to previously published regulatory text, and makes terminology and cross-references changes.
CMS intends to conduct a three-year Medicare prior authorization model for non-emergent hyperbaric oxygen therapy services in Illinois, Michigan, and New Jersey, where CMS contends there have been high rates of improper payments for these services. Under this model, CMS will require that all relevant clinical or medical documentation requirements are met before services are rendered to beneficiaries and before claims are submitted for payment; no new clinical documentation requirements will be created. The model is scheduled to begin on March 1, 2015. CMS also recently announced a similar prior authorization model for repetitive scheduled nonemergent ambulance transports.
Today CMS published a notice extending the comment period on its October 9, 2014 proposed rule that would revise the conditions of participation (CoPs) that home health agencies must meet to participate in the Medicare and Medicaid programs. Specifically, the comment period is extended for 30 days, from December 8, 2014 until January 7, 2015.
On November 12, 2014, CMS published its final rule to update the Medicare physician fee schedule (MPFS) for CY 2015. Highlights of the sweeping rule include the following:
- The Protecting Access to Medicare Act (PAMA) of 2014 provides for a 0% update to the conversion factor (CF) for MPFS services furnished between January 1, 2015 and March 31, 2015, with the CF adjusted afterwards according to the statutory Sustainable Growth Rate (SGR) formula. In the final rule, CMS determined that based on the zero percent update under PAMA and adjustments necessary to maintain budget neutrality, the CF for the first quarter of 2015 will be $35.8013 (compared to $35.8228 in 2014). CMS also announced that the CF for April 1, 2015 through December 31, 2015 will be $28.2239 – a 21.2% reduction -- unless Congress establishes an alternative CF or otherwise modifies the SGR formula. While there is an expectation that Congress eventually will override this payment cut, the form any such action might take is speculative at this point.
On November 10, 2014, CMS published its final rule to update the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Ambulatory Surgical Center (ASC) Payment System rates and policies for calendar year (CY) 2015. The following are highlights of this major rulemaking:
- The final OPPS fee schedule increase factor is 2.2%. This update reflects a hospital market basket increase of 2.9%, which is offset by two Affordable Care Act (ACA) provisions: a 0.2% reduction and a -0.5% “multi-factor productivity” (MFP) adjustment. The update for individual procedures can vary, and hospitals that do not meet Hospital Outpatient Quality Reporting (OQR) Program requirements are subject to a 2.0% reduction. CMS projects a 2.3% increase in total OPPS payments (about $900 million) for 2015, considering all policies in the rule.