New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog has been updated to report on recent health policy developments, including the following:

  • Circuit Split on Availability of ACA Tax Credits in Federal Exchanges. Two circuit court panels have handed down conflicting decisions on whether Affordable Care Act (ACA) insurance premium tax credits are available for insurance purchased on federal, rather than state, insurance Marketplaces/Exchanges.
  • HHS Regulatory Developments. CMS has issued major proposed rules to update Medicare payment and other policies under the physician fee schedule (including proposed changes to Physician Payment Sunshine Act regulations), hospital outpatient prospective payment system, the ambulatory surgical center prospective payment system (PPS), the home health PPS, and the end-stage renal disease PPS (including provisions impacting DMEPOS reimbursement and coverage). The HHS OIG is seeking comments on potential revisions to its permissive exclusion criteria. HHS has proposed ACA eligibility redetermination and renewal process rules for 2015.
  • Other HHS Developments. CMS has released information on the next phase of Medicare DMEPOS competitive bidding, revised its policy on Medicare Part D drugs for hospice enrollees, and modified ACA requirements for health plans in the territories, and the CMS Sunshine Act Open Payments System review/dispute process is underway. HHS has announced a “Settlement Conference Facilitation” pilot as an ALJ hearing alternative and a Medicaid Innovation Accelerator Program. HRSA has published an interpretative ruling on the 340B orphan drug exclusion. FDA has released draft guidance on Medical Device Data Systems.
  • OIG Reports. Recent OIG reports have focused on questionable billing for Medicare clinical lab claims and manufacturer reporting of average sales price (ASP) data.
  • Legislative Developments. A Senate committee report calls for Medicare audit and local coverage policy reforms. Congress is considering a number of bipartisan public health bills, and committee hearings have addressed various health policy issues.
  • Odds & Ends. MedPAC has released its 2014 data book.
  • Health Industry Events. Upcoming CMS events will focus on Medicare hospital outpatient payments and policies. FDA events will address 3-D printing of medical devices and biomarker development.
  • @ReedSmithHealth is on Twitter. For the latest news on health policy issues involving Medicare, Medicaid, HIPAA, OIG, FDA, and more, follow us at @ReedSmithHealth.

New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog has been updated to report on recent health policy developments, including the following:

  • HHS Regulatory Developments. HHS has released its spring semiannual regulatory agenda, along with a final rule on the employment orientation limit applicable to Affordable Care Act (ACA) health coverage waiting periods. CMS has announced Medicare payment adjustments for low-volume hospitals and Medicare-dependent hospitals.
  • Other HHS Developments. Secretary Sylvia Mathews Burwell has been sworn in as HHS Secretary. HHS has provided updates on ACA insurance costs and choices and announced management changes. HRSA is standing by its interpretation of the 340B orphan drug exclusion despite a court ruling. CMS is adding a “Provider Relations Coordinator” for MAC/RAC auditor process issues, and it plans to expand Medicare quality “star” ratings. CMS also has released Medicare Part B drug payment files and a variety of Medicare charge and other data. FDA has announced its “openFDA” data initiative, and it has released draft social media guidance documents and guidance on communicating new risk information about drugs.
  • OIG & GAO Developments. The OIG has issued a Special Fraud Alert on lab payments to referring physicians, along with reports on drug manufacturers’ Medicaid AMP determinations, state Medicaid drug rebate reporting, Medicare long-term care hospital interrupted stay policy, mail-order competitive bidding for diabetes test strips, and Medicare Part D drug formularies. The GAO has issued reports on Medicaid nursing home qualification, Medicaid managed care, and Medicare physical therapy self-referrals.
  • Legislative Developments. The Finance Committee is inviting comments on health care data transparency. Congress is considering a number of bipartisan public health bills, and committee hearings have addressed various health policy issues.
  • Odds & Ends. MedPAC has issued Medicare delivery reform recommendations, and Medicare contractors are cracking down on DMEPOS supplier violations.
  • Health Industry Events. Upcoming CMS events will focus on clinical laboratory payments, home health orders, and Medicare hospital outpatient payments and policies. An FDA workshop will address 3-D printing of medical devices.
  • @ReedSmithHealth is on Twitter. For the latest news on health policy issues involving Medicare, Medicaid, HIPAA, OIG, FDA, and more, follow us at @ReedSmithHealth.

New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog has been updated to report on recent health policy developments, including the following:

  • HHS Regulatory Developments. CMS has published regulations on Medicare prior authorization process for certain durable medical equipment, prosthetics, orthotics, and supplies; the electronic health record (EHR) meaningful use timeline; Medicare Advantage/Part D drug policies; and ACA Exchange and insurance market standards. Reed Smith has released client alerts on recent OIG exclusion and civil monetary penalty rules.
  • Other HHS Developments. CMS has extended the partial ICD-9-CM and ICD-10 code freeze. CMS just announced it is abandoning plans to finalize ACA Medicaid federal upper payment limits (FUL) for multiple source drugs in July 2014, as previously intended.  CMS also has announced a new public comment process on certain requests to discontinue HCPCS codes, and a second round of funding under the State Innovation Models Initiative. FDA has released guidance on expedited drug development and review.
  • OIG Developments. The OIG has issued an advisory bulletin on Independent Charity Patient Assistance Programs, along with its spring semiannual report to Congress and a report summarizing state requirements for home health agency employee background checks.
  • Legislative Developments. The Senate Finance Committee has voted to approve the nomination of Sylvia Burwell to be HHS Secretary. The House Energy and Commerce Subcommittee on Health has approved three bipartisan public health bills. Congressional hearings have addressed various health policy issues.
  • Health Industry Events. Upcoming CMS events will focus on the Physician Payment Sunshine Act “Open Payments Program,” clinical laboratory payments, a new Suggested Electronic Clinical Template for Home Health, and Medicare hospital outpatient payments and policies. An FDA workshop will address 3-D printing of medical devices.
  • @ReedSmithHealth is on Twitter. For the latest news on health policy issues involving Medicare, Medicaid, HIPAA, OIG, FDA, and more, follow us at @ReedSmithHealth.

New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog has been updated to report on recent health policy developments, including the following:

  • HHS Regulatory Developments. The HHS OIG has proposed major rules to expand its exclusion and CMP authorities. CMS has issued several proposed rules to update Medicare prospective payment systems (PPS) for FY 2015, including the Medicare inpatient PPS, the long-term care hospital PPS, the skilled nursing facility PPS, the inpatient rehabilitation facility PPS, the inpatient psychiatric facility PPS, and the hospice payment system. CMS also has published a final rule that reforms Medicare regulations that CMS has identified as unnecessary, obsolete, or excessively burdensome on health care providers and suppliers. Moreover, CMS has published a final rule to adopt a PPS for federally qualified health centers and amend CLIA proficiency testing rules. CMS is seeking comments on the Sunshine Act “Open Payments” dispute resolution/corrections process. The FDA has announced plans to promote updated drug and biological labeling.
  • Other HHS Developments. CMS has announced reforms to the Quality Improvement Organization program, extended its “hardship exemptions” policy for certain health insurance purchasers, and set its schedule for implementing ordering/referring denial edits for HHA certifying physicians. HRSA has released the results of audits of covered entity compliance with 340B drug discount program rules.
  • OIG Reports. The OIG has issued reports on Medicare Part B payments for compounded drugs and payments to Medicare Advantage plans for unlawfully-present beneficiaries.
  • Legislative Developments. Recent Congressional hearings have addressed the nomination of Sylvia Burwell to be HHS Secretary, along with various health policy issues. Next week the House Ways and Means Health Subcommittee is holding a hearing on Medicare hospital issues.
  • Health Industry Events. Upcoming CMS events will focus on HCPCS coding applications, clinical laboratory payments, a new Suggested Electronic Clinical Template for Home Health, the Clinical Laboratory Improvement Amendments Individualized Quality Control Plan, the National Partnership to Improve Dementia Care in Nursing Homes, and Medicare hospital outpatient payments and policies.
  • @ReedSmithHealth is on Twitter. For the latest news on health policy issues involving Medicare, Medicaid, HIPAA, OIG, FDA, and more, follow us at @ReedSmithHealth.

New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog has been updated to report on recent health policy developments, including the following:

  • CMS Regulatory Developments. CMS has published a proposed rule that would amend fire safety standards applicable to certain Medicare- and Medicaid-participating health care facilities, and CMS has sent several major fiscal year 2015 Medicare payment rules to the White House for final regulatory clearance.
  • Other HHS Developments. CMS has announced that it will implement fingerprint-based background checks for certain Medicare and Medicaid providers and suppliers in 2014. Other CMS policy announcements involve Medicare inpatient psychiatric facility quality data, the Comprehensive End-Stage Renal Disease Care Initiative, Physician Quality Reporting System quality measures, and Medicaid disproportionate share hospital audits. President Obama has formally nominated Sylvia Mathews Burwell to replace Kathleen Sebelius as HHS Secretary. The FDA has released draft guidance on pathways to speed medical devices to market.
  • Fraud & Abuse Developments. Recent HHS OIG reports have focused on Medicare hospital outpatient prospective payment system payments, Medicare home health face-to-face documentation requirements, and Medicaid program integrity activities. GAO reports have addressed advanced diagnostic imaging accreditation and CMS physician feedback efforts.
  • Health Industry Events. Upcoming CMS events will focus on HCPCS coding applications, clinical laboratory payments, a new “Suggested Electronic Clinical Template for Home Health," the Clinical Laboratory Improvement Amendments Individualized Quality Control Plan, and the National Partnership to Improve Dementia Care in Nursing Homes. Congressional hearings will examine health policy issues.

New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog has been updated to report on recent health policy developments, including the following:

  • HHS Developments. CMS has released highly-anticipated Medicare payment data for individual Medicare physicians and certain other Part B suppliers. In addition, CMS has announced final 2015 Medicare Advantage and Part D drug plan rates and policies, published a notice announcing a new system to collect hospice care data, and extended deadlines for certain individuals to enroll for health coverage through Affordable Insurance Exchanges. CMS also is seeking comments on supervision levels for select hospital outpatient services. HHS has developed a HIPAA Security Risk Assessment tool.
  • Fraud & Abuse Developments. The OIG and GAO have issued separate reports examining the Medicare DMEPOS competitive bidding program. The OIG has identified its top 25 priorities to protect the integrity of HHS programs, and it has issued reports on Medicare billing for electrodiagnostic tests, Medicare payments for hospital clinic visits, and Medicare ESRD drug payment policies. According to new CMS data, RACs corrected $2.4 billion in Medicare claims in FY 2012.
  • Legislative Developments. President Obama has signed into law a Medicare physician fee schedule fix bill with numerous health policy provisions, along with a bill that provides funding for pediatric medical residency programs. Congressional hearings have examined health policy issues.
  • Health Industry Events. Upcoming CMS events will focus on HCPCS coding applications and clinical laboratory payments.

New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog has been updated to report on recent health policy developments, including the following:

  • Regulatory Developments. The Administration has issued several regulations making changes to operational policies, payment provisions, and other standards applicable to health plans and Health Insurance Exchanges under the Affordable Care Act. CMS also has issued a final rule that increases Medicare payments for low-volume hospitals.
     
  • Other CMS Developments. Recent CMS announcements have addressed: ACA insurance coverage and exchange policies; the Medicare electronic health record “Meaningful Use” hardship exception; a new “Medicare Care Choices Model” to allow certain hospice patients to seek curative care; Medicare payment for hospice enrollees' drug expenses; an upcoming deadline for using the revised 1500 form for Medicare paper claims; Medicare Part B drug payment files; and Medicare inpatient admissions criteria.
     
  • Legislative Developments. The clock is winding down for Congress to pass Medicare physician fee schedule reform legislation before steep payment cuts are triggered, and Congressional hearings have examined health policy issues.
     
  • Fraud & Abuse Developments. The OIG has released its Annual Report on Medicaid Fraud Control Unit Activities, along with reports on Medicare Part B drug pricing and diabetic test strip cost and compliance concerns. Medicare contractors have issued a joint open letter to physicians warning about DMEPOS Supplier “Marketing Schemes."
     
  • Odds & Ends. MedPAC and MACPAC have issued reports to Congress making Medicare and Medicaid payment policy recommendations, respectively.
     
  • Health Industry Events. Upcoming CMS events will focus on HCPCS coding applications, clinical laboratory payments, and the Medicare Shared Savings Program.

Medicare/Medicaid Provisions in Obama Administration's Proposed FY 2015 Budget; Other New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog has been updated to report on recent health policy developments, including the following:

  • FY 2015 Obama Administration Proposed Budget. Yesterday the Obama Administration released its proposed FY 2015 budget, which includes a number of legislative proposals to reduce Medicare and Medicaid spending.
     
  • Regulatory Developments. CMS is inviting comments on potential changes to Medicare reimbursement for DMEPOS that could impact payment to suppliers nationwide regardless of whether they participate in competitive bidding. CMS also published preliminary federal share disproportionate share hospital allotments for FY 2014. HHS has proposed updated electronic health record certification criteria and ACA health coverage waiting period regulations. FDA is seeking input on direct-to consumer television ads and the Nutrition Facts label.
     
  • Other CMS Developments. CMS has announced that it is “pausing” Recovery Audit Contractor (RAC) audits and making a number of changes to the RAC program. CMS also has proposed updates to Medicare Advantage and Part D drug plan policies and rates, and it is allowing retroactive ACA insurance subsidies in certain cases, including for certain non-Marketplace plans. CMS is requesting suggestions for advanced diagnostic imaging quality and safety regulations. In addition, CMS continues to modify implementation of the two-midnight inpatient admissions policy, and it has posted HIPAA administrative simplification transaction testing checklists.
     
  • Legislative Developments. A number of Congressional panels have held hearings on health policy issues.
     
  • Fraud & Abuse Developments. The OIG has issued reports on the Medicare hospital "DRG window” and adverse events among Medicare beneficiaries in SNFs, and the Obama Administration cites record-breaking recoveries under the Health Care Fraud and Abuse Control Program.
     
  • Health Industry Events. Upcoming CMS events will focus on hospital outpatient services and HCPCS coding applications. The FTC is holding a workshop on health care competition, MedPAC is meeting this week to address a variety of Medicare payment policies, and FDA Is meeting to discuss modernizing over-the-counter drug reviews.

 

New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog has been updated to report on recent health policy developments, including the following:

  • Regulatory Developments. CMS has expanded its moratoria on the enrollment of home health agencies and ambulance suppliers in designated areas, and it is inviting applications under the Bundled Payments for Care Improvement Initiative and the Frontier Community Health Integration Demonstration. HHS has published a final rule to amend HIPAA and CLIA regulations expand direct access to lab test reports. The IRS has released ACA "shared responsibility" guidance that delays compliance deadlines for certain employers.
  • Other CMS Developments. CMS is requesting comments on episode-based payment models for outpatient specialty practitioner services. CMS has made announcements regarding implementation of the “2 midnight” inpatient admissions criteria, “Sunshine Act” Open Payments Program registration and data submission, and Qualified Health Plan issuer requirements.
  • Legislative Developments. Congress has approved legislation that extends Medicare sequestration.  In addition, a major bipartisan, bicameral Medicare physician fee schedule reform bill has been released, and a House hearing examined drug shortages. 
  • Fraud & Abuse Developments. The OIG has released its FY 2014 Work Plan and a report on the 340B discount drug program, and there have been recent developments involving physician-owned distributors. A GAO report urges CMS to finalize pending Medicaid drug pricing reforms. The DOJ has announced updated health care fraud recovery statistics.
  • Health Industry Events. Upcoming CMS events will focus on the future of the Physician Compare website, hospital outpatient services, and the National Partnership to Improve Dementia Care in Nursing Homes. The FTC is holding a workshop on health care competition.

New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog has been updated to report on recent health policy developments, including the following:

  • Legislative Developments. The Congressional Budget Office has raised the specter that pending Medicare physician fee schedule reform legislation could result in the Affordable Care Act’s Independent Payment Advisory Board (IPAB) mechanism being triggered. The President has signed into law an omnibus spending bill that specifies funding for HHS agencies and initiatives, and a number of Congressional hearings have focused on health policy issues. 
  • Regulatory Developments. CMS has published a final rule to expand Medicaid home- and community-based service options, and the agency has loosened restrictions on disclosure of physician-specific Medicare payment data.  In other developments, HHS has published FY 2015 FMAP amounts. The FDA is seeking comments on drug company social media guidance. Reed Smith has issued a client alert on recent CMS and OIG rules extending protections for electronic health record (EHR) donations.
  • Other HHS Developments. A Medicare appeals backlog has prompted a hold on new provider appeals. The FDA has issued guidance for industry on “Dear Doctor” letters. 
  • Fraud & Abuse Developments. OIG reports have addressed inconsistencies in local Medicare coverage policies, Medicare vulnerabilities associated with EHR use, enforcement of the HIPAA Security Rule, and organ procurement organization billing. The GAO has issued a report on the effect of prior health insurance coverage on Medicare beneficiaries.
  • Odds & Ends. An advisory panel has recommended access standards for medical diagnostic equipment.
  • Health Industry Events. Upcoming CMS events will focus on Medicare inpatient hospital admission and medical review criteria, new medical technologies under the inpatient prospective payment system, hospital outpatient services, and the National Partnership to Improve Dementia Care in Nursing Homes, and the HHS Office of Medicare Hearings and Appeals is hosting a Medicare Appellant Forum.  

New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog has been updated to report on recent health policy developments, including the following:

  • Regulatory Developments. CMS has issued regulations regarding emergency preparedness requirements for Medicare and Medicaid providers, Medicare Advantage/Part D policies, Medicare Secondary Payer rules, the ACA Basic Health Program, and 2014 Exchange enrollment deadlines. Other recent HHS rules have addressed electronic health records (EHR), solicitation of anti-kickback safe harbor and fraud-alert proposals, health plan certification of compliance requirements, HIPAA amendments pertaining to gun background checks, and CMS/FDA parallel reviews of medical products.
  • Other HHS Developments. New CMS policy announcements address “recalcitrant” Medicare providers and suppliers, hospice enrollees’ drug expenses, hospital equipment maintenance requirements, Medicare DMEPOS payments, and accountable care organizations. Other HHS policies have addressed health insurance policy cancellations and drug development tools. 
  • Fraud & Abuse Developments. The Department of Justice has released updated False Claims Act recovery statistics. The OIG has issued reports on HHS management challenges, clinicians with high cumulative Medicare payments, and hospital EHR technology, and it released its Fall 2013 Semiannual Report. A GAO report examined ZPIC program integrity efforts.
  • Legislative Developments. The President has signed into law a budget bill with Medicare provisions, and an upcoming House hearing will review Medicare “extenders” policies. 
  • Health Industry Events. Upcoming CMS events will focus on Medicare inpatient hospital admission and medical review criteria, the Medicare ESRD Quality Incentive Program, new medical services and technologies under the Medicare hospital inpatient prospective payment system, and hospital outpatient services, and the HHS Office of Medicare Hearings and Appeals is hosting a Medicare Appellant Forum.

New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog has been updated to report on recent health policy developments, including the following:

  • Regulatory Developments. CMS has issued several major Medicare payment rules for 2014, including rules updating reimbursement for hospital outpatient departments, ambulatory surgical centers, physicians and other Part B providers, end-stage renal disease facilities, durable medical equipment suppliers, and home health agencies. Other recent CMS rules and notices have addressed enrollment fees, quality ratings, and payment parameters for Affordable Care Act (ACA) exchange plans.
  • Other CMS Developments. CMS has made subregulatory announcements regarding Medicaid drug pricing policy, implementation of the Stage 3 meaningful use criteria, 2014 HCPCS codes and clinical lab rates, Medicare national coverage policies, Medicare Part B drug rates, the ACA insurance grandfathering policy, and Medicaid and CHIP integrated care models.
  • OIG Developments. Recent OIG reports examine Medicare acute hospital outlier payments and hospitalization of nursing home patients.
  • Legislative Developments. The House has approved the “Keep Your Health Plan Act.” Congressional hearings continue to focus on ACA implementation and other health policy issues. President Obama has signed several bills into law, including major drug distribution security legislation. The Senate Finance Committee is scheduled to considerMedicare physician payment reform. 
  • Health Industry Events. Upcoming CMS events will focus on Medicare physician quality reporting, new medical services and technologies under the Medicare hospital inpatient prospective payment system, and hospital outpatient services.

New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog has been updated to report on recent health policy developments, including the following:

  • Regulatory Developments. The Obama Administration has published final mental health/substance abuse parity regulations, along with corrections to an ACA benefit and payment parameter rule and a notice soliciting nominations for the Advisory Panel on Hospital Outpatient Payment.
  • Other HHS Developments.  The Obama Administration will grandfather certain health insurance policies cancelled under ACA rules, and it has released initial health insurance marketplace enrollment numbers.  CMS has announced the implementation date for “Phase 2” ordering/referral denial edits, the names of Medicare DMEPOS bidding Round 1 Recompete contract suppliers, updated “Sunshine Act” reporting thresholds, guidance on the hospital admissions “two-midnight” policy, and the launch of its Virtual Research Data Center. The OIG has examined inappropriate Medicare payments on behalf of deceased or unlawfully-present beneficiaries.
  • Legislative Developments. The House has scheduled a vote on the “Keep Your Health Plan Act.” Congressional hearings continue to focus on HealthCare.gov enrollment and other health policy issues. Congress has taken action on the HIV Organ Policy Equity Act, the Prematurity Research Expansion and Education for Mothers who deliver Infants Early (PREEMIE) Reauthorization Act, and the Children's Hospital GME Support Reauthorization Act. Key House and Senate panels have unveiled a bipartisan, bicameral SGR reform plan. The CBO has presented to Congress a number of health-related budget options.
  • Health Industry Events. CMS is hosting calls on LTCH quality reporting, the Medicare IVIG Demonstration, the National Partnership to Improve Dementia Care in Nursing Homes, and provider/supplier access to PECOS, the EHR Incentive Program, and NPPES.

New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog has been updated to report on recent health policy developments, including the following:

  • Regulatory Developments. CMS is warning of delays in the release of major final Medicare payment rules for CY 2014. CMS also has issued a final rule on ACA Health Insurance Exchange program integrity standards, final Medicare conditions of participation for community mental health centers, and notices on Medicare deductible and coinsurance amounts for 2014.
  • Other CMS Developments. CMS has issued guidance to align the Exchange enrollment deadline and the “Shared Responsibility” penalty trigger. CMS expects a delay in the release of the 2014 HCPCS update. IPPS new technology add on applications for FY 2015 are due next month.
  • OIG & GAO Reports. An OIG report highlights the volume of spinal surgeries tied to physician-owned distributors. The GAO has issued reports tying Medicare supplemental coverage to higher health spending and providing updated data on Medicare electronic health record incentive payments.
  • Legislative Developments. Congress has taken action to temporarily fund government operations while a budget panel considers a broader spending plan. Several House hearings have focused on the rocky HealthCare.gov site rollout.
  • Health Industry Events. CMS is hosting calls on dementia care in nursing homes and providers/supplier access to PECOS, EHR, and NPPES files.

New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog has been updated to report on recent health policy developments, including the following:

  • Top Stories. The Affordable Care Act’s Health Insurance Marketplace has opened for business to mixed reviews, and the ongoing partial federal government shutdown is having a varied impact on health care provider operations.
  • Regulatory Developments. HHS has published a proposed rule that would establish the ACA Basic Health Program. CMS has issued rules on disproportionate share hospital payment calculations, a new Medicare Federally Qualified Health Center PPS, and enforcement actions for proficiency testing referrals. CMS also has released updated “amount in controversy” threshold amounts and technical corrections to the FY 2014 IPPS/LTCH and SNF PPS final rules.
  • Other HHS Developments. CMS has announced that Medicare rates will drop sharply under the DMEPOS competitive bidding “Round 1 Recompete” contracts. Other HHS policy developments involve Medicare ambulance rates for 2014, compliance reviews under the new “2 midnight” inpatient admissions policy, clinical laboratory tests, and the HIPAA Privacy Rule.
  • Fraud & Abuse Developments. The Obama Administration has warned consumers about potential “Obamacare” fraud, and the OIG has issued reports on Medicare ambulance transport utilization, Medicare polysomnography claims, and Medicare appeals volumes and timeliness.

New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog has been updated to report on recent health policy developments, including the following:

  • Regulatory Developments. CMS has finalized financial integrity and oversight standards for Affordable Insurance Exchanges and state Medicaid disproportionate share hospital allotments under the Affordable Care Act (ACA). CMS also has released technical corrections to the CY 2014 proposed rule updating the Medicare Hospital Outpatient Prospective Payment System (OPPS) and ambulatory surgical center payments. HHS has published notices seeking comments on its latest draft Departmental Strategic Plan, a draft National Action Plan for Adverse Drug Event Prevention, and options for streamlining HHS regulations. The Internal Revenue Service (IRS) has finalized ACA individual “shared responsibility” payment requirements.
     
  • Other CMS Developments. CMS has delayed enforcement of an ACA provision requiring a face-to-face encounter as a condition of Medicare payment for durable medical equipment (DME) items. The agency also issued guidance on admission order and certification requirements for inpatient admissions, released updated Medicare drug payment files, and requested input on the Advanced Diagnostic Imaging (ADI) program. 
     
  • OIG & GAO Reports. The OIG has issued reports on potential Medicare Part B drug rebates, Medicaid drug pricing changes, critical access hospital qualifications; Medicare diabetes test strip payments, Medicaid DME reimbursement, and Medicare program integrity efforts. GAO reports have addressed self-referral of anatomic pathology and IMRT services.
     
  • Legislative Developments. The House has approved a bill to require verification of ACA individual subsidy eligibility, and Congressional panels have addressed a variety of health policy issues. Several hearings this week will focus on ACA implementation.
     
  • Health Industry Events. CMS is hosting a call on the 2015 Value-Based Payment Modifier.

New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog has been updated to report on recent health policy developments, including the following:

  • Regulatory Developments. CMS has released a number of final FY 2014 Medicare payment rules, including rules updating the acute inpatient prospective payment system, the long-term care hospital prospective payment system (PPS), the inpatient rehabilitation facility PPS, the skilled nursing facility PPS, hospice rates and policies, and inpatient psychiatric facility PPS rates. CMS also has issued notices on the Medicare national coverage determination process and Medicaid disproportionate share hospital allotments. HHS is seeking comments on implementation of an ACA provision preventing discrimination in certain health programs, and FDA has proposed regulations on its detention authority with respect to drugs intended for human or animal use.
     
  • Other HHS Developments. CMS is seeking comments on the release of physician-specific payment data. It also has updated its list of HCPCS codes that it considers to be off-the-shelf orthotics – and therefore subject to inclusion in a future round of the Medicare DMEPOS competitive bidding program. Further, CMS also suspended certain Medicaid drug data collection. FDA has issued a number of draft guidance documents. 
     
  • OIG Reports. The HHS Office of Inspector General has issued reports on Medicare billing for cancelled elective surgeries, hospital use of observational stays, and clinical trial data and safety monitoring boards.
     
  • Legislative Developments. A House panel is inviting comments on draft legislation to reform Medicare post-acute care policy, and legislation has been introduced to narrow the in-office ancillary services exception to the Stark law.
     
  • Odds & Ends. MedPAC has released its 2013 Data Book on Health Care Spending and the Medicare Program. Recent Reed Smith blog posts address a case in which hard drives on used photocopiers resulted in HIPAA violations, and a China life sciences regulatory crackdown impacting the medical device sector. 
     
  • Health Industry Events. CMS is hosting a call on a draft electronic clinical template for lower limb prostheses.

New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog has been updated to report on recent health policy developments, including the following:

  • Regulatory Developments. CMS has announced the first temporary moratoria on provider enrollment in high fraud risk areas under its Affordable Care Act (ACA) authority. CMS has issued proposed rules to update Medicare payment and other policies under the physician fee schedule, hospital outpatient prospective payment system, the ambulatory surgical center prospective payment system (PPS), the end-stage renal disease PPS, and the home health PPS. CMS also has proposed updates to durable medical equipment (DME), prosthetics, orthotics, and supplies payment policies. CMS has issued final ACA regulations regarding Affordable Insurance Exchange "Navigators" and Medicaid enrollment and eligibility rules.  The Obama Administration also has announced a delay in employer ACA “shared responsibility” payments and reporting requirements, and it has issued ACA contraceptive coverage requirement rules. HHS also has released its spring 2013 semiannual regulatory agenda, and HRSA has finalized policies on exclusion of orphan drugs under the 340B program.
     
  • Other HHS Developments. CMS has delayed enforcement of its DME face-to-face requirement and has released information on the Physician Payment Sunshine Act. The OIG has announced an online submission process for the Self-Disclosure Protocol.
     
  • Legislative Developments. The House has approved legislation to amend the ACA to delay insurance mandates, Congressional panels have approved bipartisan physician fee schedule reform legislation and the HIV Organ Policy Equity Act, Congressional leaders are seeking feedback on Medicare cost sharing proposals, and Congressional hearings have addressed a number of health policy issues.
     
  • Health Industry Events. Upcoming events include meetings/calls on Medicare hospital outpatient payments, ICD-10 basics, PQRS reporting, and the Value-based Payment Modifier.

New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog has been updated to report on recent health policy developments, including the following:

  • Regulatory Developments. CMS has issued rules addressing Affordable Care Act (ACA) shared responsibility payments, financial integrity and oversight standards for participants in ACA Affordable Insurance Exchanges, requirements for long term care facilities providing hospice services, and corrections to the proposed Medicare inpatient prospective payment system and long-term acute care hospital prospective payment system rule for FY 2014.  Other recent regulations address orphan drug rules and institutional review board assessment of risks in standard of care interventions research.
  • Other HHS Developments. CMS has released information on Medicare outpatient hospital payments, new beneficiary Medicare Summary Notices, insurance premium savings under the ACA, and preparation for ACA Exchanges. Draft FDA guidance recommends cybersecurity risk assessments and management plans for premarket medical device submissions.
  • OIG & GAO Developments. The OIG has issued reports on inappropriate prescribing of Medicare Part D drugs and Medicare reimbursement for clinical lab tests. The GAO has highlighted gaps in the Medicare imaging accreditation framework, and it has reviewed the status of ACA insurance exchange development.
  • Legislative Developments. Congressional leaders are seeking feedback on Medicare post-acute care payment reform, and Congressional hearings have addressed a number of health policy issues.
  • Odds & Ends. The Medicare Payment Advisory Commission (MedPAC) and the Medicaid and CHIP Payment and Access Commission (MACPAC) have released reports to Congress on Medicare and Medicaid policy issues.
  • Health Industry Events. Upcoming events include meetings/calls on Medicare clinical laboratory test payment determinations, Medicare hospital outpatient payments, PQRS reporting and the Value-based Payment Modifier, and dementia care in nursing homes.

For details on these and other health industry developments, please visit http://www.healthindustrywashingtonwatch.com/.

New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog has been updated to report on recent health policy developments, including the following:

  • Regulatory Developments. CMS has issued rules addressing the Affordable Care Act (ACA) Pre-Existing Condition Insurance Plan Program and Small Business Health Option Program, Medicare Advantage and Part D plan medical loss ratio rules, the Bundled Payments for Care Improvement initiative, and state Medicaid disproportionate share hospital allotments. The OIG has issued a final rule on data mining by State Medicaid Fraud Control Units.  The Administration has issued final ACA wellness program rules and guidance to employers on ACA insurance exchange notices, and a bioethics commission seeks comments on “incidental findings” in research and testing.
     
  • Other HHS Developments. The Medicare Board of Trustees has released a financial assessment of the Medicare trust fund. CMS has released updated Medicare Part B drug payment files, guidance to states on facilitating Medicaid and CHIP enrollment, and draft cancer hospital quality measures. FDA has issued draft guidance on access to investigational drugs.
     
  • OIG & GAO Developments. The OIG has issued its latest semiannual report to Congress, along with reports on high-risk compounded sterile preparations, hospice care, drugs commonly used by dual eligibles, Medicare Part B claims with “G” modifiers, Medicare dialysis payments, and inaccuracies in Medicare enrollment databases. GAO reports have examined state efforts to establish ACA insurance exchanges and government drug purchase prices.
     
  • Legislative Developments. The House of Representatives has approved a drug distribution security plan and ACA repeal legislation, the Senate has confirmed Marilyn Tavenner as CMS Administrator, and Congressional hearings have addressed a number of health policy issues.
     
  • Health Industry Events. Upcoming events include meetings/calls on Medicare clinical laboratory test payment determinations, Medicare hospital outpatient payments, PQRS and eRx Incentive Program payment adjustments, the Medicare Shared Savings Program application process, Medicare and Medicaid EHR Incentive Programs, the HHS insurance market risk adjustment data validation process, and Medicare orders for lower limb prostheses.