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MedPAC Report to Congress on Medicare and the Health Care Delivery System

The Medicare Payment Advisory Commission (MedPAC) has released its June 2015 Report to the Congress on Medicare and the Health Care Delivery System. The report includes a series of recommendations on Medicare hospital short-stay policy, in response in part to hospital concerns about related Medicare Recovery Audit Contractor (RAC) Program audits and appeals and the … Continue Reading

New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog (http://www.healthindustrywashingtonwatch.com) has been updated to report on recent health policy developments, including the following: -- Regulatory Developments. CMS has issued a number of proposed and final rules, including regulations addressing the Medicare Shared Savings Program, Medicaid/CHIP managed care, health insurance summary of benefits and coverage and uniform glossary requirements, and CMS oversight of national accrediting organizations, among others. For details, see http://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/other-cms-developments/. HHS has released its spring 2015 regulatory agenda and is soliciting comments on the use of the health plan identifier in electronic health care transactions (http://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/). -- Other CMS Developments. CMS has released updated Medicare drug payment files, guidance on Medicaid/CHIP provider fingerprint-based criminal background checks, Medicare provider payment data, and guidance on beneficiary drug plan disenrollments by long term care facilities. CMS also has announced a new Cardiovascular Risk Reduction Model and policy changes impacting ventilators. See http://www.healthindustrywashingtonwatch.com/articles/other-cms-developments-1/. -- OIG & GAO Developments. The OIG has issued a fraud alert on physician compensation arrangements, and the OIG released its latest semiannual report and an update to its work plan (http://www.healthindustrywashingtonwatch.com/articles/other-oig-developments/). The GAO has issued reports on the Medicare physician payment ratesetting process and Medicaid fraud controls (http://www.healthindustrywashingtonwatch.com/articles/other-gao-developments/). -- Legislative Developments. Congressional panels have approved a series of health policy bills, including repeal of ACA medical device tax and the Independent Payment Advisory Board, changes to Medicare Advantage requirements and Medicare long-term care hospital policy, Medicare appeals reforms, and 21st Century Cures legislation. Congress also has been considering changes to Medicare sequestration policy as part of pending trade legislation. Congressional committees have held hearings on various health policy issues. See http://www.healthindustrywashingtonwatch.com/articles/legislative-developments/. -- Health Industry Events. Upcoming CMS events will focus on the National Partnership to Improve Dementia Care, hospice quality reporting, Hospital Compare ratings, ICD-10 implementation, Medicare clinical laboratory fee schedule payments, and hospital outpatient payments (http://www.healthindustrywashingtonwatch.com/articles/events/). -- Changes Coming to Health Industry Washington Watch. Our blog will soon have a new look and provide our readers with enhanced access to content and optimal readability across the wide variety of devices. We will also have a revised email notification system to alert subscribers to new content. If you don't already receive email alerts from our blog, we invite you to subscribe at http://www.healthindustrywashingtonwatch.com/. For details on these and other health industry developments, please visit http://www.healthindustrywashingtonwatch.com/.… Continue Reading

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. Recent CMS regulations have addressed Medicare hospice payments and Part D prescribing regulations, and CMS has published a notice clarifying the FY 2016 IPPS/LTCH proposed rule comment deadline. For details, see http://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/other-cms-developments/. HRSA has published a final rule to implement the HIV Organ Policy Equity Act, and OMB is reviewing new HRSA 340B omnibus guidelines (http://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/). -- Other CMS Developments. CMS has announced savings levels for the Pioneer ACO Model, and it is proceeding with the application process for the next round of the Medicare Shared Savings Program. CMS also is soliciting quality measure suggestions for potential use in the PQRS. See http://www.healthindustrywashingtonwatch.com/articles/other-cms-developments-1/. -- OIG & GAO Developments. Recent OIG reports have addressed FDA oversight of generic drug manufacturers, incorrect physician place-of-service coding, home health agency background check policies, and drug rebate policies (http://www.healthindustrywashingtonwatch.com/articles/other-oig-developments/). GAO reports have examined Medicaid payments to hospitals and section 1115 demonstrations (http://www.healthindustrywashingtonwatch.com/articles/other-gao-developments/). -- Legislative Developments. Congress has approved its FY 2016 budget framework, a House panel is marking up the 21st Century Cures Act, and committees have held hearings on various health policy issues. See http://www.healthindustrywashingtonwatch.com/articles/legislative-developments/. -- Health Industry Events. Upcoming CMS events will focus on HCPCS coding applications, potential elimination of CMNs/DIF forms, the National Partnership to Improve Dementia Care, hospice quality reporting, ICD-10 implementation, and Medicare clinical laboratory fee schedule payments (http://www.healthindustrywashingtonwatch.com/articles/events/). For details on these and other health industry developments, please visit http://www.healthindustrywashingtonwatch.com/.… Continue Reading

New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog (http://www.healthindustrywashingtonwatch.com) has been updated to report on recent health policy developments, including the following: -- CMS Regulatory Developments. CMS has issued several proposed rules to update Medicare prospective payment systems (PPS) for FY 2016, including the Medicare inpatient PPS, the long-term care hospital PPS, the skilled nursing facility PPS, the inpatient rehabilitation facility PPS, and the inpatient psychiatric facility PPS. CMS has also proposed updating Medicare and Medicaid Electronic Health Record Incentive program rules, mental health parity rules, and funding for Medicaid eligibility and enrollment systems. For details, see http://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/other-cms-developments/. -- Other HHS Developments. CMS has released information on Medicare DMEPOS competitive bidding, 2016 Medicare Advantage/Part D rates and policies, and Hospital Compare star ratings (http://www.healthindustrywashingtonwatch.com/articles/other-cms-developments-1/). The ONC has issued updated electronic health information privacy/security guidance (http://www.healthindustrywashingtonwatch.com/articles/other-hhs-developments/). The FDA and CMS are establishing an interagency task force on laboratory-developed test oversight, and FDA draft guidance addresses medical device clinical data from studies conducted abroad (http://www.healthindustrywashingtonwatch.com/articles/other-fda-developments/). -- OIG Developments. The OIG has partnered with industry associations to issue guidance for health care governing boards on compliance oversight, and the OIG has issued its Medicaid Fraud Control Units FY 2014 Annual Report (http://www.healthindustrywashingtonwatch.com/articles/other-oig-developments/). -- Legislative Developments. President Obama has signed legislation to permanently reform the Medicare physician reimbursement framework and make other policy changes. Pending trade legislation would extend Medicare sequestration. The House has approved the "Ensuring Patient Access and Effective Drug Enforcement Act." Congressional panels have held hearings on several health policy issues. See http://www.healthindustrywashingtonwatch.com/articles/legislative-developments/. -- Health Industry Events. Upcoming CMS events will focus on home health star ratings and HCPCS coding applications (http://www.healthindustrywashingtonwatch.com/articles/events/). For details on these and other health industry developments, please visit http://www.healthindustrywashingtonwatch.com/.… Continue Reading

New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog (http://www.healthindustrywashingtonwatch.com) has been updated to report on recent health policy developments, including the following: -- Regulatory Developments. HHS has published proposed Stage 3 EHR Incentive Program and health information technology certification rules, along with a final health insurance wraparound coverage rule. CMS has updated its list of DME items subject to face-to-face encounter/written order prior to delivery requirements and published corrections to the 2015 Medicare physician fee schedule (MFPS) final rule. A number of major CMS proposed rules are in the pipeline. For details, see http://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/. -- Other HHS Developments. The Obama Administration has announced its plan to combat antibiotic resistant bacteria, CMS has launched its Health Care Payment Learning and Action Network, and CMS proposes removing two National Coverage Determinations (http://www.healthindustrywashingtonwatch.com/articles/other-hhs-developments/). -- OIG & GAO Developments. The OIG has released the FY 2014 Health Care Fraud and Abuse Control Program Report and its Compendium of Unimplemented Recommendations (http://www.healthindustrywashingtonwatch.com/articles/other-oig-developments/). The GAO reported on Medicare payments to certain cancer hospitals (http://www.healthindustrywashingtonwatch.com/articles/other-gao-developments/). -- Legislative Developments. The House approved legislation to reform Medicare reimbursement policy for physician services, but the Senate has not yet acted to avert pending MPFS cuts. The House and Senate have approved budget resolutions with Medicare, Medicaid, and ACA provisions. The House approved DMEPOS competitive bidding, hospital observation, controlled substances, and trauma care bills. Congressional panels have held hearings on health policy issues. See http://www.healthindustrywashingtonwatch.com/articles/legislative-developments/. -- Health Industry Events. Upcoming CMS events will focus on HCPCS coding applications, home health clinical templates, Open Payments/Sunshine Act Data, the Next Generation ACO Model, and the Medicare Shared Savings Program. MedPAC is meeting to discuss various Medicare policies. See http://www.healthindustrywashingtonwatch.com/articles/events/. For details on these and other health industry developments, please visit http://www.healthindustrywashingtonwatch.com/.… Continue Reading

New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog (http://www.healthindustrywashingtonwatch.com) has been updated to report on recent health policy developments, including the following: -- MedPAC Report to Congress on Medicare Policy. The Medicare Payment Advisory Commission (MedPAC) has released its annual recommendations to Congress on Medicare policies, including Medicare fee-for-service payment updates and a status report on the Medicare Advantage and Medicare Part D programs (see http://www.healthindustrywashingtonwatch.com/2015/03/articles/odds-ends/medpac-report-to-congress-on-medicare-policy/index.html). -- Regulatory Developments. CMS has published a final rule on SMART Act Medicare Secondary Payer appeals provisions, and the FDA has issued draft guidance on the use of electronic informed consent in clinical investigations (see http://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/). -- Other CMS Developments. CMS has announced a new "Next Generation" Accountable Care Organization model, and it is inviting stakeholders to join a "Health Care Payment Learning and Action Network" to promote alternative payment models. CMS also has released the April 2015 Medicare Part B drug average sales price files, a report on the impact of Medicare quality measures, and initial results for the Medicare Physician Value-based Modifier. For details, see http://www.healthindustrywashingtonwatch.com/articles/other-cms-developments-1/. -- OIG & GAO Developments. The OIG has released FY 2014 State Medicaid Fraud Control Unit data, along with reports on Medicare reimbursement for critical access hospital swing-bed services and Medicare Part B drug pricing (http://www.healthindustrywashingtonwatch.com/articles/other-oig-developments/). The GAO has addressed antipsychotic drug use in community settings and state Medicaid program integrity system effectiveness (http://www.healthindustrywashingtonwatch.com/articles/other-gao-developments/). -- Legislative Developments. Today the House of Representatives is scheduled to vote on bills addressing DMEPOS competitive bidding, hospital observation status, Controlled Substances Act amendments, and trauma care. Congressional panels have scheduled hearings on health information technology and the Affordable Care Act. See http://www.healthindustrywashingtonwatch.com/articles/legislative-developments/. -- Health Industry Events. Upcoming CMS events will focus on physician quality reporting programs, HCPCS coding applications, home health clinical templates, and the Medicare Shared Savings Program. The FDA is hosting a clinical outcome assessments public workshop. For details, see http://www.healthindustrywashingtonwatch.com/articles/events/). For details on these and other health industry developments, please visit http://www.healthindustrywashingtonwatch.com/.… Continue Reading

MedPAC Report to Congress on Medicare Policy

The Medicare Payment Advisory Commission (MedPAC) has released its annual recommendations to Congress on Medicare policies, including Medicare fee-for-service (FFS) payment updates and a status report on the Medicare Advantage and Medicare Part D programs. The following are highlights of the recommendations for 2016 (many of which were recommended previously):… Continue Reading

New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog (http://www.healthindustrywashingtonwatch.com) has been updated to report on recent health policy developments, including the following: -- CMS Regulatory Developments. CMS has issued final rules on 2016 ACA Marketplace plan benefit and payment parameters, Medicare Advantage and Part D requirements for contract year 2016, and the 2016 funding methodology for the ACA Basic Health Program. CMS also has published corrections to the 2015 final Medicare OPPS/ASC rule, with an impact on payment rates. In addition, CMS has announced that it needs more time to finalize an ACA rule on return of Medicare overpayments. For details, see http://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/other-cms-developments/. -- Other CMS Developments. CMS has announced changes to the measurements used in the Nursing Home Compare Five Star Quality Rating System, and it is inviting applications for a new Oncology Care Model testing performance-based Medicare payment for episodes of care surrounding chemotherapy administration, along with proposals for Hospital Engagement Network Contracts. See http://www.healthindustrywashingtonwatch.com/articles/other-cms-developments-1/. -- GAO & OIG Developments. The GAO has reported on Medicare program risks and CMS activities to prepare the health industry for ICD-10 (http://www.healthindustrywashingtonwatch.com/articles/other-gao-developments/). The OIG has announced its plans for health reform oversight activities, and it issued a report on Medicare payments to providers with delinquent Medicare debts (http://www.healthindustrywashingtonwatch.com/articles/other-oig-developments/). -- Legislative Developments. Today the Ways and Means Committee is marking up bills addressing Medicare program integrity, DMEPOS competitive bidding, hospital observation status, and EHR meaningful use in ASCs, and several Congressional committees are holding hearings on health policy issues. The Energy & Commerce Committee approved bipartisan public health bills, and the House passed an ACA repeal and replace bill. See http://www.healthindustrywashingtonwatch.com/articles/legislative-developments/. -- CMS Events. CMS is hosting a call on nursing home quality initiatives, and it is holding a meeting on hospital outpatient payment policy (http://www.healthindustrywashingtonwatch.com/articles/events/). For details on these and other health industry developments, please visit http://www.healthindustrywashingtonwatch.com/.… Continue Reading

New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog (http://www.healthindustrywashingtonwatch.com) has been updated to report on recent health policy developments, including the following: -- Obama Budget Proposal. The Obama Administration has released its proposed fiscal year 2016 budget, including numerous provisions impacting Medicare, Medicaid, and other federal health programs. See http://www.healthindustrywashingtonwatch.com/2015/02/articles/legislative-developments/obama-administration-releases-fy-2016-budget-proposal-with-medicaremedicaid-provisions/index.html. -- CMS Regulatory Developments. CMS has extended its moratoria on enrollment of home health agencies and ambulance suppliers in designated areas, and the Agency has announced its intention to issue regulations to modify the Medicare and Medicaid Electronic Health Record Incentive Program meaningful use requirements. See http://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/other-cms-developments/. -- Other HHS Developments. HHS has set goals for adoption of Medicare value-based purchasing and alternative payment models, and the HHS ONC is seeking comments on its draft health information technology interoperability "Roadmap" (http://www.healthindustrywashingtonwatch.com/articles/other-hhs-developments/). CMS has added star ratings to Dialysis Facility Compare, and it is accepting bids for the latest round of Medicare DMEPOS competitive bidding (http://www.healthindustrywashingtonwatch.com/articles/other-cms-developments-1/). -- GAO & OIG Developments. The GAO has examined geographic variation in private payer spending on high-cost procedures (http://www.healthindustrywashingtonwatch.com/articles/other-gao-developments/). OIG reports have addressed Medicare payments to hospitals for clinic visits, hospital quality improvement efforts, compounded pharmaceuticals used in hospitals, and power mobility device claims. The OIG also has responded to concerns raised about its hospital compliance review policies. See http://www.healthindustrywashingtonwatch.com/articles/other-oig-developments/. -- Legislative Developments. House panels are taking steps to speed patient access to medical innovation. The House is scheduled to vote on a bill to repeal and replace the Affordable Care Act. Congressional hearings have been focusing on health policy issues. See http://www.healthindustrywashingtonwatch.com/articles/legislative-developments/. -- Odds & Ends. MedPAC has voiced concerns about the growing volume and burden of Medicare quality measures (see http://www.healthindustrywashingtonwatch.com/articles/odds-ends/). -- Health Industry Events. CMS is hosting calls on Medicare payment, quality, and coding topics; the FTC and DOJ are holding a workshop on health care competition; FDA is holding a workshop on regulation of next generation sequencing diagnostic tests; and CMS is holding a meeting on hospital outpatient payment policy (see http://www.healthindustrywashingtonwatch.com/articles/events/). For details on these and other health industry developments, please visit http://www.healthindustrywashingtonwatch.com/.… Continue Reading

Obama Administration Releases FY 2016 Budget Proposal with Medicare/Medicaid Provisions

On February 2, 2015, the Obama Administration released its proposed federal budget for fiscal year (FY) 2016. The budget would impact all types of health care providers, health plans, and drug manufacturers if adopted as proposed – which is unlikely given Republican control of the House and Senate. Nevertheless, Congress can be expected to consider … Continue Reading

MedPAC Voices Concerns about Growing Volume, Burden of Medicare Quality Measures

In December 2014, CMS released a 329-page list of quality measures under consideration for the Medicare program. In a January 13, 2015 comment letter, MedPAC observes that volume of measures under consideration “reinforces our concerns that Medicare’s provider-level measurement activities are accelerating without regard to the costs or benefits of an ever-increasing number of measures.” MedPAC suggests that … Continue Reading

New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog (http://www.healthindustrywashingtonwatch.com) has been updated to report on recent health policy developments, including the following: -- Regulatory Developments. The Obama Administration has issued proposed rules on Affordable Care Act (ACA) summary of benefits and coverage and uniform glossary requirements and excepted benefits/wraparound coverage. The OIG has published its annual solicitation of recommendations for new anti-kickback statute safe harbor provisions and topics for special fraud alerts. Stage 3 meaningful use criteria and health information technology certification proposed rules are in the pipeline. CMS has published Medicare quality improvement organization criteria. FDA regulations/notices have addressed Drug Supply Chain Security Act compliance, electronic distribution of prescription drug biological prescribing information, and direct-to-consumer television ads for prescription drugs. The IRS has issued additional ACA requirements for tax-exempt hospitals. For details, see http://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/. -- Other HHS Developments. CMS has adjusted the first quarter 2015 Medicare physician fee schedule conversion factor, and it has made announcements regarding provider timeframes for responding to pre-payment review documentation requests and recovery audit contracts (http://www.healthindustrywashingtonwatch.com/articles/other-cms-developments-1/). OIG reports have examined hospice care in assisted living facilities and the appropriateness of Medicare ophthalmology claims (http://www.healthindustrywashingtonwatch.com/articles/other-oig-developments/). -- Legislative Developments. The House has approved bills to modify certain ACA rules for employers related to part-time workers and veterans. President Obama signed into law a previously-reported tax bill with Medicare provisions and an Ebola treatment/vaccine bill. A House hearing next week will focus on SGR reform. See http://www.healthindustrywashingtonwatch.com/articles/legislative-developments/. -- Health Industry Events. MedPAC is meeting to discuss Medicare payment policy, the FDA is holding a workshop on regulatory oversight of next generation sequencing diagnostic tests, and CMS is events will focus on the Open Payments database and hospital outpatient payment policy (http://www.healthindustrywashingtonwatch.com/articles/events/). -- @ReedSmithHealth is on Twitter. For the latest health policy news, follow us at @ReedSmithHealth. For details on these and other health industry developments, please visit http://www.healthindustrywashingtonwatch.com/.… Continue Reading

New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog (http://www.healthindustrywashingtonwatch.com) has been updated to report on recent health policy developments, including the following: -- Legislative Developments. President Obama has signed a government funding bill with health spending/policy provisions. Congress has approved bills to incentivize Ebola treatments and vaccines, extend an enforcement moratorium on rural hospital supervision requirements, and use certain Medicare offsets to pay for a bill to allow individuals with disabilities to establish tax free savings accounts. Congressional panels are seeking input on legislation impacting Medicare fraud and abuse authorities, lab-developed tests, and graduate medical education. Congressional hearings have focused on various health policy issues. For details, see http://www.healthindustrywashingtonwatch.com/articles/legislative-developments/. -- Regulatory Developments. CMS has published rules/notices regarding: the Medicare Shared Savings Program/ACOs; Medicare provider enrollment requirements; revisions to certain Medicare/Medicaid policies to recognize same-sex marriages; 2016 ACA Marketplace plan benefit and payment parameters; disproportionate share hospital payment limits; provider enrollment application fees; a hyperbaric oxygen prior authorization pilot program, and federal financial participation matching amounts, among other issues. HHS has posted its latest regulatory agenda, and it is seeking comments on ethical implications of the public health response to the Ebola outbreak. See http://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/. -- Other HHS Developments. Recent CMS policies have addressed DMEPOS competitive bidding, Medicare coverage with evidence development, Medicare Part D drug prescriber enrollment requirements, the status of Medicaid federal upper limits, Medicare Part B pricing, and Medicare DMEPOS fees (http://www.healthindustrywashingtonwatch.com/articles/other-cms-developments-1/). The Office of the National Coordinator for Health Information Technology is seeking comments on its strategic plan (http://www.healthindustrywashingtonwatch.com/articles/other-hhs-developments/). -- Fraud & Abuse Developments. The OIG has issued a semiannual report to Congress, along with reports on Medicaid managed care, Medicare mail order diabetes test strips, and various Medicare drug policies (http://www.healthindustrywashingtonwatch.com/articles/other-oig-developments/). GAO reports have addressed Medicare DMEPOS competitive bidding, health care cost and quality transparency, group purchasing organizations, and Medicare Part D policies (http://www.healthindustrywashingtonwatch.com/articles/other-gao-developments/). The Department of Justice has released FY 2014 fraud recovery statistics (http://www.healthindustrywashingtonwatch.com/articles/fraud-and-abuse-developments/). -- Health Industry Events. MedPAC is meeting to discuss Medicare payment policy, the FDA is holding a workshop on laboratory-developed tests, and CMS is holding a meeting on hospital outpatient payment policy (http://www.healthindustrywashingtonwatch.com/articles/events/). -- @ReedSmithHealth is on Twitter. For the latest health policy news, follow us at @ReedSmithHealth. For details on these and other health industry developments, please visit http://www.healthindustrywashingtonwatch.com/.… Continue Reading

New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog (http://www.healthindustrywashingtonwatch.com) has been updated to report on recent health policy developments, including the following: -- Regulatory Developments. CMS has issued major final 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 ASC payment system, the home health PPS, and the ESRD PPS (including provisions impacting DMEPOS reimbursement and coverage). CMS also has announced a Medicare prior authorization program for certain ambulance transports. HRSA has withdrawn a pending 340B rule, NIH has released a proposed rule on clinical trial registration and results submission requirements, and HHS is soliciting suggestions for reducing the Medicare appeals backlog. For details, see http://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/. -- Other HHS Developments. CMS has released 2015 HCPCS files, announced 2015 outpatient therapy caps, expanded certain nursing home surveys, and announced a delay in enforcement of HIPAA health plan enumeration/Health Plan Identifier regulations. FDA has revised guidance on drug inspections, and the HHS Office for Civil Rights has issued a bulletin on privacy obligations under HIPAA in emergency situations. For details, see http://www.healthindustrywashingtonwatch.com/articles/other-hhs-developments/. -- OIG Developments. The HHS OIG has released its FY 2015 Work Plan and a compilation of top HHS management and performance challenges (see http://www.healthindustrywashingtonwatch.com/articles/other-oig-developments/). -- Health Industry Events. CMS is hosting calls on Medicare physician quality reporting programs, the improving dementia care in nursing homes, and certifying patients for Medicare home health benefits. CMS is holding meetings on inpatient hospital new technology add-on payment applications and hospital outpatient payments. See http://www.healthindustrywashingtonwatch.com/articles/events/. -- @ReedSmithHealth is on Twitter. For the latest health policy news, follow us at @ReedSmithHealth. For details on these and other health industry developments, please visit http://www.healthindustrywashingtonwatch.com/.… Continue Reading

New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog (http://www.healthindustrywashingtonwatch.com) has been updated to report on recent health policy developments, including the following: -- Regulatory Developments. The OIG and CMS have extended fraud and abuse waivers in connection with the Medicare Shared Savings Program. CMS also published a rule on the ACA Basic Health Program, and CMS is expected to publish several major final 2015 Medicare payment rules in the coming days. Recent CMS notices have addressed clinical diagnostic lab tests and Medicare deductible and coinsurance amounts for 2015. The HHS Office for Human Research Protections issued guidance on disclosing risks in standards of care research, and the Office of the National Coordinator for Health Information Technology is inviting applications for a "Market R&D Pilot Challenge. Reed Smith has released a client alert on the "OIG Proposed Rule to Amend the Anti-Kickback Safe Harbors, CMP Rules on Beneficiary Inducements & Gainsharing Regulations." For details, see http://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/. -- Other HHS Developments. CMS has posted preliminary determinations for new 2015 clinical laboratory fee schedule codes. CMS also has announced new innovation initiatives, including the Transforming Clinical Practice Initiative and the Accountable Care Organization Investment Model. CMS has released Medicare Advantage/Part D drug plan quality data, and it is requesting suggestions for future physician quality measures. CMS also has issued updates regarding the Sunshine Act "Open Payments" system and its Medicare appeals administrative agreement opportunity. For more information, see http://www.healthindustrywashingtonwatch.com/articles/other-cms-developments-1/. CDC has released several guidance documents on management of Ebola patients (http://www.healthindustrywashingtonwatch.com/articles/other-hhs-developments/). The OIG has issued a report on Medicare beneficiary copayment costs for outpatient services provided at critical access hospitals (http://www.healthindustrywashingtonwatch.com/articles/other-oig-developments/). -- Health Industry Events. CMS is hosting calls on inpatient rehabilitation facility quality reporting and transitioning to ICD-10. The HHS Office of Medicare Hearings and Appeals is holding a second Medicare Appellant Forum. Congressional panels are reviewing the government response to the Ebola outbreak. See http://www.healthindustrywashingtonwatch.com/articles/events/. -- @ReedSmithHealth is on Twitter. For the latest health policy news, follow us at @ReedSmithHealth. For details on these and other health industry developments, please visit http://www.healthindustrywashingtonwatch.com/.… Continue Reading

New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog (http://www.healthindustrywashingtonwatch.com) has been updated to report on recent health policy developments, including the following: -- Regulatory Developments. The OIG has published a major proposed rule to amend the safe harbors to the Anti-Kickback Statute and the Civil Monetary Penalty rule. CMS regulations and notices have addressed home health conditions of participation, amount in controversy thresholds for Medicare appeals, and corrections to the final FY 2015 Medicare IPPS/LTCH rule. The ONC has issued a final rule on electronic health record certification criteria, and the DEA published a final rule on secure disposal of controlled substances. For details, see http://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/. -- Other HHS Developments. CMS has announced changes to the Nursing Home Five Star Quality Rating System; launched the "Open Payments" public database; requested input on delivery innovations in Medicare Part D, Medicare Advantage, and other programs; released new Medicare Recovery Auditors statistics; and posted updated Medicare Part B drug pricing files (see http://www.healthindustrywashingtonwatch.com/articles/other-cms-developments-1/). HHS has released guidance on the HIPAA Privacy Rule and same-sex marriage (http://www.healthindustrywashingtonwatch.com/articles/other-hhs-developments/). Draft FDA guidance documents address laboratory developed test regulatory oversight and medical device cybersecurity (http://www.healthindustrywashingtonwatch.com/articles/other-fda-developments/). -- OIG & GAO Developments. The OIG has issued a Special Advisory Bulletin on Pharmaceutical Manufacturer Copayment Coupons, along with a report on this topic. Other recent OIG reports have focused on state standards for access to care in Medicaid managed care, CMS enforcement of rural health clinic location criteria, and Part B drug dispensing and supplying fees. The OIG also has highlighted state Medicaid policies that inflate federal costs. For details, see (http://www.healthindustrywashingtonwatch.com/articles/other-oig-developments/). The GAO has called for improvements to Healthcare.gov information security and privacy controls (http://www.healthindustrywashingtonwatch.com/articles/other-gao-developments/). -- Legislative Developments. President Obama has signed into law the Improving Medicare Post-Acute Care Transformation Act; Reed Smith has prepared a client alert summarizing the new law. President Obama also signed bills addressing muscular dystrophy research, emergency medical care for children, and autism research and intervention. See http://www.healthindustrywashingtonwatch.com/articles/legislative-developments/. -- Health Industry Events. CMS is hosting calls on hospital appeals settlements and transitioning to ICD-10. HHS is holding a workshop on "Integrating Plans for Long-Term Services and Supports and Health Care Delivery through Health Information Technology." MedPAC is meeting to discuss various Medicare policy issues. See http://www.healthindustrywashingtonwatch.com/articles/events/. -- @ReedSmithHealth is on Twitter. For the latest health policy news, follow us at @ReedSmithHealth. For details on these and other health industry developments, please visit http://www.healthindustrywashingtonwatch.com/.… Continue Reading

New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog (http://www.healthindustrywashingtonwatch.com) has been updated to report on recent health policy developments, including the following: -- Regulatory Developments. Recent CMS regulations have addressed the EHR meaningful use timeline and the ACA Marketplace eligibility redetermination/renewal process. HHS has issued regulations on ACA contraception coverage requirements. FDA is seeking comments on informed consent in clinical trials. OMB has cleared an OIG proposed rule that would expand the OIG's fraud and abuse authorities. For details, see http://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/. -- Other CMS Developments. CMS has made additional changes to the Sunshine Act "Open Payments" timeline, and it has implemented fingerprint-based background checks for "high-risk" providers and suppliers. CMS also has offered to settle certain short-stay hospital claims, and it has announced the 2015 Medicare ambulance update factor. See http://www.healthindustrywashingtonwatch.com/articles/other-cms-developments-1/. -- OIG & GAO Reports. Recent OIG reports have focused on nursing facility abuse/neglect reporting practices and Medicaid drug rebate disputes between manufacturers and states (http://www.healthindustrywashingtonwatch.com/articles/other-oig-developments/). GAO reports have addressed Medicare contractor postpayment reviews and the accuracy of Medicare Advantage encounter data (http://www.healthindustrywashingtonwatch.com/articles/other-gao-developments/). -- Legislative Developments. Upcoming House hearings will address ACA implementation and ways to accelerate medical innovation (http://www.healthindustrywashingtonwatch.com/articles/legislative-developments/). -- Health Industry Events. CMS is hosting ICD-10-CM/PCS Coordination and Maintenance Committee meetings and a call on how to avoid 2016 negative payment adjustments under Medicare quality reporting programs. FDA is hosting a workshop on 3-D printing of medical devices. See http://www.healthindustrywashingtonwatch.com/articles/events/. -- @ReedSmithHealth is on Twitter. For the latest news on health policy issues involving Medicare, Medicaid, HIPAA, OIG, FDA, and more, follow us at @ReedSmithHealth. For details on these and other health industry developments, please visit http://www.healthindustrywashingtonwatch.com/.… Continue Reading

New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog (http://www.healthindustrywashingtonwatch.com) has been updated to report on recent health policy developments, including the following: -- Regulatory Developments. CMS has issued several final 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 is extending its current enrollment moratoria for new ground ambulance suppliers and home health agencies in designated areas. HHS has officially set October 1, 2015 as the date for ICD-10 implementation, and the IRS has issued ACA branded prescription drug fee regulations. For details, see http://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/. -- Other CMS Developments. CMS has revised Sunshine Act "Open Payments" system review and dispute deadlines amid concerns about data accuracy. Other CMS announcements involve innovative models for beneficiary engagement and behavioral insights, a Medicare Intravenous Immune Globulin (IVIG) demonstration, and the status of Recovery Audit Contractor reviews. See http://www.healthindustrywashingtonwatch.com/articles/other-cms-developments-1/. -- OIG & GAO Reports. Recent OIG reports have focused on utilization of HIV drugs under Medicare Part D and ACA Marketplace operations, and the OIG has posted guidance on its contractor self-disclosure program (http://www.healthindustrywashingtonwatch.com/articles/other-oig-developments/). GAO reports address federal program drug prices and Healtcare.gov contractor performance (http://www.healthindustrywashingtonwatch.com/articles/other-gao-developments/). -- Legislative Developments. New health policy laws have been enacted and other bills are advancing through Congress, and the Ways and Means Committee is seeking comments on Medicare program integrity legislation (http://www.healthindustrywashingtonwatch.com/articles/legislative-developments/). -- Health Industry Events. CMS is hosting ICD-10-CM/PCS Coordination and Maintenance Committee meetings in September. FDA events will address 3-D printing of medical devices, implementation of Generic Drug User Fee Amendments, and biomarker development. See http://www.healthindustrywashingtonwatch.com/articles/events/. -- @ReedSmithHealth is on Twitter. For the latest news on health policy issues involving Medicare, Medicaid, HIPAA, OIG, FDA, and more, follow us at @ReedSmithHealth. For details on these and other health industry developments, please visit http://www.healthindustrywashingtonwatch.com/.… Continue Reading

New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog (http://www.healthindustrywashingtonwatch.com) 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. See http://www.healthindustrywashingtonwatch.com/articles/odds-ends/. - 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. For details, see http://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/. - 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. See http://www.healthindustrywashingtonwatch.com/articles/other-cms-developments-1/. 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. See http://www.healthindustrywashingtonwatch.com/articles/other-hhs-developments/. FDA has released draft guidance on Medical Device Data Systems (http://www.healthindustrywashingtonwatch.com/articles/other-fda-developments/). - OIG Reports. Recent OIG reports have focused on questionable billing for Medicare clinical lab claims and manufacturer reporting of average sales price (ASP) data. (http://www.healthindustrywashingtonwatch.com/articles/other-oig-developments/). - 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. See http://www.healthindustrywashingtonwatch.com/articles/legislative-developments/. - Odds & Ends. MedPAC has released its 2014 data book (http://www.healthindustrywashingtonwatch.com/articles/odds-ends/). - 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. See http://www.healthindustrywashingtonwatch.com/articles/events/. - @ReedSmithHealth is on Twitter. For the latest news on health policy issues involving Medicare, Medicaid, HIPAA, OIG, FDA, and more, follow us at @ReedSmithHealth (http://twitter.com/ReedSmithHealth/). For details on these and other health industry developments, please visit http://www.healthindustrywashingtonwatch.com/.… Continue Reading

Circuit Split on Availability of ACA Tax Credits in Federal Exchanges

As has been widely reported, on July 22, 2014, two circuit court panels handed down conflicting decisions on whether ACA insurance premium tax credits are available for insurance purchased on federal, rather than state, insurance Marketplaces/Exchanges. On the one hand, a three-judge panel of the U.S. Court of Appeals for the D.C. Circuit ruled 2-1 that … Continue Reading

MedPAC Issues 2014 Medicare/Health Spending Data Book

The Medicare Payment Advisory Commission (MedPAC) has released its 2014 Data Book on Health Care Spending and the Medicare Program. The volume provides detailed information regarding national health care and Medicare spending and utilization, sector profit margins, Medicare and dual-eligible beneficiary demographics, Medicare quality, Medicare beneficiary and other payer liability, and related issues.… Continue Reading

New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog (http://www.healthindustrywashingtonwatch.com) 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. For details, see http://www.healthindustrywashingtonwatch.com/articles/regulatory-developments/hhs-developments/. - 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. See http://www.healthindustrywashingtonwatch.com/articles/other-hhs-developments/. 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. See http://www.healthindustrywashingtonwatch.com/articles/other-cms-developments-1/. 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 (http://www.healthindustrywashingtonwatch.com/articles/other-fda-developments/). - 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 (http://www.healthindustrywashingtonwatch.com/articles/other-oig-developments/). The GAO has issued reports on Medicaid nursing home qualification, Medicaid managed care, and Medicare physical therapy self-referrals (http://www.healthindustrywashingtonwatch.com/articles/other-gao-developments/). - 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. See http://www.healthindustrywashingtonwatch.com/articles/legislative-developments/. - Odds & Ends. MedPAC has issued Medicare delivery reform recommendations, and Medicare contractors are cracking down on DMEPOS supplier violations (http://www.healthindustrywashingtonwatch.com/articles/odds-ends/). - 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. See http://www.healthindustrywashingtonwatch.com/articles/events/. - @ReedSmithHealth is on Twitter. For the latest news on health policy issues involving Medicare, Medicaid, HIPAA, OIG, FDA, and more, follow us at @ReedSmithHealth. For details on these and other health industry developments, please visit http://www.healthindustrywashingtonwatch.com/.… Continue Reading

MedPAC Issues Medicare Delivery Reform Recommendations

On June 13, 2014, the Medicare Payment Advisory Commission (MedPAC) released its June 2014 Report to the Congress on Medicare and the Health Care Delivery System. Among other things, MedPAC addresses ways to align Medicare fee-for-service (FFS), Medicare Advantage, and accountable care organization policies on payment, risk adjustment, and quality measurement. MedPAC also discusses various … Continue Reading

Is anybody home? Medicare contractors on the prowl for DMEPOS supplier violations of posted business hours and other physical facility standards.

This post was written by Paul W. Pitts, Carol C. Loepere, Elizabeth Carder-Thompson, and Nancy Sheliga. Medicare suppliers of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) should be on the alert for enhanced Medicare supplier standard compliance monitoring by CMS, the National Supplier Clearinghouse (NSC), and their agents. Recently, these entities have taken draconian actions to … Continue Reading
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